(28 days)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration
- trays* containing medical devices in a single or double pouch configuration
- small items requiring surface sterilization in a single pouch configuration within a tray*
NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
to be sterilized in the:
- Lumen. Non Lumen. Flexible. Fast Non Lumen and Fast Cvcles of the V-PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- Express, Standard, Flex Scope and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
Intended Sterilization Cycles and Intended Pouch Loads when Medical Devices are:
- Directly pouched
- Placed inside of a tray and the tray pouched
The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
- Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO Low Temperature Sterilization Systems
- Default Cycle of the STERRAD®* 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
Prior to placing in the Sterilizer, the trays must either be:
- wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above
Or - placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.
The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO or STERRAD Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self-seal pouch, a heat-seal pouch, or heat-seal tubing.
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems and STERRAD Sterilizers. The trays are available in various sizes to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K183402) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material. Optional instrument organizers and sterilization mats are provided as accessories.
This document, a 510(k) Premarket Notification from the FDA, describes the acceptance criteria and the study proving the device meets these criteria for two products: "Vis-U-All Low Temperature Sterilization Pouches/Tubing" and "PRO-LITE Sterilization Trays."
Since the request is about "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically for a device (implying a medical device with an associated study), and the document describes the performance testing for these sterilization products, I will extract and synthesize the information relevant to these performance tests as evidence of meeting acceptance criteria.
Note: The provided document is a 510(k) summary for medical devices (sterilization pouches and trays), not an AI/ML powered device. Therefore, typical AI/ML study components like "number of experts used to establish ground truth," "adjudication method," "MRMC study," "effect size of human readers improving with AI," "standalone performance," "training set size," and "ground truth for training set" are not applicable to this type of submission. The document focuses on demonstrating substantial equivalence through non-clinical performance testing (e.g., sterilization efficacy).
Here's an analysis of the acceptance criteria and proof, as presented for these sterilization devices:
1. A table of acceptance criteria and the reported device performance
For both devices, the acceptance criteria implicitly align with demonstrating "Sterile efficacy" and the "ability to sterilize medical devices" under various conditions and cycles. The performance is reported as meeting these implicit criteria, indicated by "PASS" results for all tests.
For "Vis-U-All Low Temperature Sterilization Pouches/Tubing" (Table 3, Page 18):
| Acceptance Criteria (Implicit) | Reported Device Performance (Result) | Conclusion |
|---|---|---|
| Sterile Efficacy for Mated Surfaces under Worst-Case Conditions in V-PRO Sterilizer Cycles | Sterile efficacy was demonstrated for mated surfaces under worst case conditions in the V-PRO Sterilizer cycles. | PASS |
| Sterile Efficacy with Standard Injection Weight | The standard injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. | PASS |
| Ability to Sterilize Medical Devices under Worst-Case Processing Conditions (Simulated Use) | Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. | PASS |
| Ability to Sterilize Patient-Soiled, Clinically-Cleaned Medical Instruments (In Use) | The in use investigation demonstrated the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. | PASS |
For "PRO-LITE Sterilization Tray" (Table 8, Page 29-30):
| Acceptance Criteria (Implicit) | Reported Device Performance (Result) | Conclusion |
|---|---|---|
| Sterile Efficacy for Mated Surfaces under Worst-Case Conditions in V-PRO Sterilizer Cycles | Sterile efficacy was demonstrated for mated surfaces under worst case conditions in the V-PRO Sterilizer cycles. | PASS |
| Sterile Efficacy with Standard Injection Weight | The standard injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. | PASS |
| Ability to Sterilize Medical Devices under Worst-Case Processing Conditions (Simulated Use) | Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. | PASS |
| Ability to Sterilize Patient-Soiled, Clinically-Cleaned Medical Instruments (In Use) | The in use investigation demonstrated the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. | PASS |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes (e.g., number of pouches/trays, number of sterilization cycles) used for each test. It refers to "worst-case conditions" and "validation load." Similarly, data provenance (country of origin, retrospective/prospective) is not specified, but the testing would typically be prospective and conducted in a controlled laboratory or simulated clinical environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to the type of device and study presented. Ground truth for sterilization efficacy is typically established through scientific methods like sterility testing (e.g., microbial challenge tests, biological indicators) and physical/chemical monitoring, not human expert interpretation of images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is related to human interpretation of data, which is not the primary method for evaluating sterilization efficacy.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. These are physical devices for sterilization, not AI-powered diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This concept pertains to AI algorithms, not sterilization instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for sterilization efficacy is established through direct measurements of sterility (e.g., absence of viable microorganisms after sterilization) and functional performance under simulated and actual use conditions as described in the summary:
- Sterile efficacy: Demonstrated through microbial challenge and physical/chemical indicators.
- Simulated Use Test: Verifies the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions.
- In Use Test: Demonstrates the ability to sterilize patient-soiled, clinically-cleaned medical instruments.
This involves direct, objective testing for sterility, rather than interpretation by human experts.
8. The sample size for the training set
Not applicable. These devices do not use "training sets" as they are not AI/ML models.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
September 9, 2022
Steris Anthony Piotrkowski Director Regulatory Affairs 5960 Heisey Road Mentor, Ohio 44060
Re: K222440
Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches / Tubing, PRO-LITE Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, KCT Dated: August 11, 2022 Received: August 12, 2022
Dear Anthony Piotrkowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222440
Device Name
Vis-U-All Low Temperature Sterilization Pouches/Tubing
Indications for Use (Describe)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- · medical devices in a single or double pouch configuration
- · trays* containing medical devices in a single or double pouch configuration
- · small items requiring surface sterilization in a single pouch configuration within a tray*
NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
to be sterilized in the:
- · Lumen. Non Lumen. Flexible. Fast Non Lumen and Fast Cvcles of the V-PRO® Low Temperature Sterilization Systems
- · Default Cycle of the STERRAD 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
· Express, Standard, Flex Scope and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
Intended Sterilization Cycles and Intended Pouch Loads when Medical Devices are:
- Directly pouched
- · Placed inside of a tray and the tray pouched
V-PRO 60 & s2 Lumen Cycle
· Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- · Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
- o single or dual lumen devices
- ≥ 0.77 mm internal diameter (ID) and < 410 mm in length
- ≥ 1.8 mm ID x ≤ 542 mm in length
- o triple lumen devices
- ≥1.2 mm ID and ≤ 275 mm in length
- ≥1.8 mm ID and ≤ 310 mm in length
Or
≥2.8 mm ID and ≤ 317 mm in length
V-PRO 60 & s2 Non Lumen Cycle Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with
{3}------------------------------------------------
diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO 60 & s2 Flexible Cycle
Load 1: One flexible surgical endoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
· single or dual lumen device with lumens that are ≥ 1 mm ID and < 990 mm in length
Load 2: Non-lumened devices including non-lumened rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semirigid endoscopes, with the following configurations:
≥ 0.76 mm ID and ≤ 233 mm in length
≥ 1.0 mm ID and ≤ 254 mm in length
≥ 1.8 mm ID and ≤ 542 mm in length
V-PRO s2 Fast Cycle
· Non-lumened devices including non-lumened rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
· Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
o single or dual lumen devices
≥ 0.77 mm ID and ≤ 410 mm in length
≥ 1.8 mm ID x ≤ 542 mm in length
· Triple channeled devices with stainless steel lumens that are either:
≥1.2 mm ID and ≤ 275 mm in length
≥1.8 mm ID and < 310 mm in length
Or
≥2.8 mm ID and ≤ 317 mm in length
V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle
· Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
· Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
· Medical devices, including single, dual or triple channeled stainless steel lumens that are:
≥ 0.77 mm ID and ≤ 527 mm in length
≥ 0.8 mm ID and ≤ 542 mm in length
≥ 0.48 mm ID and < 100 mm in length
• Medical devices with Dead end lumens that are ≥ 1.3 mm ID and ≤ 73 mm in length
· Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
≥ 3 mm ID and ≤ 298 mm in length
4 mm ID and < 424 mm in length
V-PRO 1, 1 Plus, maX & maX2 Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO maX and maX 2 Flexible Cycle
Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either a single or dual channel lumen that is > 1 mm ID and < 1050 mm in length Load 2:
• Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
· Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length.
V-PRO maX 2 Fast Non Lumen Cycle
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Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
STERRAD 100S Default Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Metal and nonmetal lumened instruments with:
- ≥ 6 mm ID and ≤ 310 mm in length
Medical devices with a single stainless steel lumen with:
≥ 1 mm ID and ≤ 125 mm in length
≥ 2 mm ID and ≤ 250 mm in length
≥ 3 mm ID and ≤ 400 mm in length
STERRAD NX and NX with ALLClear Technology Standard Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with a single stainless steel lumen with:
≥ 1 mm ID and ≤ 150 mm in length
≥2 mm ID and < 400 mm in length
STERRAD NX and NX with ALLClear Technology Advanced Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical Devices, including most flexible endoscopes, with:
a single stainless steel lumen with:
≥ 1 mm ID and ≤ 500 mm in length
Single channel polyethylene and Teflon (polytetrafluoroethylene)
≥1 mm ID and ≤ 850 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with a single stainless steel lumen with:
0.7 mm ID and < 500 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Flex Scope Cycle
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical Devices, including most flexible endoscopes, with:
□ Single channel polyethylene and Teflon (polytetrafluoroethylene)
≥ 1 mm ID and ≤ 850 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Express Cycle
Metal and nonmetal medical devices (surfaces sterilization only) and instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle
Medical devices including:
most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with > 1 mm ID and < 875 mm in length
□ accessory devices that are normally connected to a flexible endoscope during use
□ flexible endoscopes without lumens
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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{6}------------------------------------------------
Indications for Use
510(k) Number (if known) K222440
Device Name PRO-LITE Sterilization Tray
- The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
- · Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO Low Temperature Sterilization Systems
- · Default Cycle of the STERRAD®* 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
• Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
Prior to placing in the Sterilizer, the trays must either be:
· wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above
Or
· placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0048, VP0048, VP0050. VP0051. VP0052
V-PRO 60 and s2 Lumen Cycle:
- · Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
· Medical devices, including single, dual and triple channeled rigid endoscopes with the following configurations:
o Single or dual channeled devices with stainless steel lumens that are:
≥ 0.77 mm ID and ≤ 410 mm in length
≥ 1.8 mm ID x ≤ 542 mm in length
o Triple channeled devices with stainless steel lumens that are:
≥ 1.2 mm ID and ≤ 275 mm in length
≥ 1.8 mm ID and ≤ 310 mm in length
Or
≥ 2.8 mm ID and ≤ 317 mm in length
V-PRO 60 and s2 Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO 60 and s2 Flexible Cycle:
Load 1: One flexible surgical endoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
· Single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length
Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened
{7}------------------------------------------------
devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes with the following configurations:
- ≥ 0.76 mm ID and ≤ 233 mm in length
- ≥ 1.0 mm ID and < 254 mm in length
- ≥ 1.8 mm ID and ≤ 542 mm in length
Intended Sterilization Cycle and Intended Tray Load for Tray Models: VP0045, VP0047, VP0049, VP0049, VP0049
V-PRO s2 Fast Cycle:
· Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes, and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps and scissors.
• Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
o Single or dual channeled devices with stainless steel lumens
≥ 0.77 mm ID and ≤ 410 mm in length
≥ 1.8 mm ID and ≤ 542 mm in length
o Triple channeled devices with stainless steel lumens that are either
≥ 1.2 mm ID and ≤ 275 mm in length
≥ 1.8 mm ID and < 310 mm in length
≥ 2.8 mm ID and ≤ 317 mm in length
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053
V-PRO 1, 1 Plus, maX, and maX 2 Lumen Cycle:
· Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
· Medical devices, including single, dual or triple channeled stainless steel lumens that are:
≥ 0.77 mm ID and ≤ 527 mm in length
≥ 0.8 mm ID and < 542 mm in length
≥ 0.48 mm ID and ≤ 100 mm in length
• Medical devices with dead end stainless steel lumens that are ≥ 1.3 mm ID and ≤ 73 mm in length
· Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
3 mm ID and < 298 mm in length
≥ 4 mm ID and ≤ 424 mm in length
V-PRO 1 Plus, maX, and maX 2 Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
V-PRO maX, and maX 2 Flexible Cycle:
Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either a single or dual lumen that is > 1 mm ID and ≤ 1050 mm in length.
Load 2:
• Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Single, dual or triple channel stainless steel lumens that are > 0.48 mm ID and ≤ 100 mm in length
V-PRO maX 2 Fast Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049,
{8}------------------------------------------------
VP0050, VP0051, VP0052
STERRAD 100S Default Cycle:
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Metal and nonmetal lumened instruments with
≥ 6 mm ID and ≤ 310 mm in length
Medical devices with a single stainless steel lumen with:
≥ 1 mm ID and ≤ 125 mm in length
2 mm ID and < 250 mm in length
≥3 mm ID and ≤ 400 mm in length
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0049
STERRAD NX and NX with ALLClear Technology Standard Cycle:
Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with a single stainless steel lumen with:
≥ 1 mm ID and ≤ 150 mm in length
≥2 mm ID and < 400 mm in length
STERRAND NX and NX with ALLClear Technology Advanced Cycle:
Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors
Medical devices, including most flexible endoscopes, with:
-
o a single stainless steel lumen with:
≥ 1 mm ID and ≤ 500 mm in length -
o single channel polyethylene and Teflon (polytetrafluoroethylene)
≥ 1mm ID and ≤ 850 mm in length
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0048, VP0051, VP0052, VP0053
STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle:
Metal and nonmetal medical devices including instruments with have diffusion-restricted spaces, such as the hinged portion of forceps and scissors
Medical devices with a single stainless steel lumen with:
≥ 0.7 mm ID and ≤ 500 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Flex Scope Cycle:
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices, including most flexible endoscopes, with:
· Single channel polyethylene and Teflon (polytetrafluoroethylene)
≥ 1mm ID and < 850 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Express Cycle:
Metal and nonmetal devices surfaces and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle:
Medical devices including:
· most flexible endoscopes with a single channel of polyethylene and Teflon (polytetraffluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length
· accessory devices that are normally connected to a flexible endoscope during use
{9}------------------------------------------------
· flexible endoscopes without lumens
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/10/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water.
510(k) Summary for Vis-U-All Low Temperature Sterilization Pouches/Tubing
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Anthony Piotrkowski Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tony piotrkowski(@steris.com
Submission Date: September 7, 2022
Premarket Notification Number: K222440
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
{11}------------------------------------------------
1. Device Name
| Trade Name: | Vis-U-All Low Temperature SterilizationPouches/Tubing | |
|---|---|---|
| Device Classification: | Class II | |
| Common/Usual Name: | Sterilization pouch | |
| Classification Name: | Sterilization wrap | |
| Classification Number: | 21 CFR 880.6850 | |
| Product Code: | FRG |
2. Predicate Device
Vis-U-All Low Temperature Sterilization Pouches/Tubing, K183401
3. Description of Device
The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO or STERRAD Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self-seal pouch, a heat-seal pouch, or heat-seal tubing. Available sizes and configurations are shown in Table 1.
| Table 1. Sizes and Configurations of Vis-U-All Low Temperature Sterilization Pouches/Tubing | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | --------------------------------------------------------------------------------------------- | -- | -- | -- |
| Type | Size * | Type | Size* | Type | Size* |
|---|---|---|---|---|---|
| HeatSealPouch | 3 x 7 | 3 x 7 | Tubing | 3" x 100' | |
| 4 x 9 | 4 x 9 | 4" x 100' | |||
| 4 x 12 | Self SealPouch | 4 x 12 | 6" x 100' | ||
| 4 x 22 | 4 x 22 | 9" x 100' | |||
| 6 x 10 | 6 x 10 | 14" x 100' | |||
| 8 x 12 | 8 x 12 | ||||
| 10 x 15 | 10 x 15 | ||||
| 12 x 18 | 12 x 18 | ||||
| 8 x 21 | |||||
| 8 x 27 | |||||
| 9 x 27 | |||||
| 11 x 22 | |||||
| 12 x 27 |
*Sizes are in inches unless specified otherwise
The purpose of this submission is to qualify use of the Vis-U-All Low Temperature Sterilization Pouches and Tubing for extended claims in the V-PRO 60, s2, maX and maX 2 Sterilizer Cycles.
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Intended Use/ Indications for Use 4.
The Vis-U-All Low Temperature Sterilization Pouches/Tubing Intended use remains the same. The indications for use are being modified to expand lumen claims. A detailed comparison of the cleared and proposed indications for use are provided in Table 2.
5. Comparison of the Modified Device to the Predicate
The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Table 2 summarizes the difference between the proposed device and predicate device cleared under K183401.
| Table 2. Technical Comparison to the Predicate. |
|---|
| ------------------------------------------------- |
| Feature | Modified Vis-U-All Low TemperatureSterilization Pouch (proposed) K222440 | Vis-U-All Low TemperatureSterilization Pouch (K183401) | Comparison |
|---|---|---|---|
| IntendedUse /Indicationsfor Use | The Vis-U-All Low TemperatureSterilization Pouches/Tubing aresterilization containment pouches for useby health care providers to enclose:• medical devices in a single or doublepouch configuration• trays* containing medical devices in asingle or double pouch configuration• small items requiring surfacesterilization in a single pouchconfiguration within a tray*NOTE: Trays must be legally marketedfor use in the V-PRO Low Temperatureor STERRAD Sterilization Systems andcontain a vent surface area to trayvolume ratio ≥ $0.135 in^{-1}$ with themaximum number of instrumentorganizers installed.to be sterilized in the:• Lumen, Non Lumen, Flexible, FastNon Lumen and Fast Cycles of the V-PRO® Low Temperature SterilizationSystems• Default Cycle of the STERRAD 100SSterilizer• Standard and Advanced Cycles of theSTERRAD NX and NX withALLClear Technology Sterilizers• Express, Standard, Flex Scope andDUO Cycles of the STERRAD 100NXand 100NX with ALLClearTechnology Sterilizers | The Vis-U-All Low TemperatureSterilization Pouches/Tubing aresterilization containment pouches for useby health care providers to enclose:• medical devices in a single or doublepouch configuration• trays containing medical devices in asingle or double pouch configuration• small items requiring surfacesterilization in a single pouchconfiguration within a trayNOTE: Trays must be legally marketedfor use in the V-PRO Low Temperatureor STERRAD Sterilization Systems andcontain a vent surface area to trayvolume ratio ≥ $0.135 in^{-1}$ with themaximum number of instrumentorganizers installed.to be sterilized in the:• Lumen, Non Lumen, Flexible, FastNon Lumen and Fast Cycles of the V-PRO® Low Temperature SterilizationSystems• Default Cycle of the STERRAD 100SSterilizer• Standard and Advanced Cycles of theSTERRAD NX and NX with ALLClearTechnology Sterilizers• Express, Standard, Flex Scope andDUO Cycles of the STERRAD 100NXand 100NX with ALLClearTechnology Sterilizers | Identical exceptfor:• Clarificationof lumenclaims for V-PRO lumencycles• Clarificationof endoscopeclaims for V-PRO flexiblecycles• Removal of"stainless steelor titanium"from V-PRONon Lumencycles. |
| Feature | Modified Vis-U-All Low TemperatureSterilization Pouch (proposed) K222440 | Vis-U-All Low TemperatureSterilization Pouch (K183401) | Comparison |
| *STERRAD and ALLClear aretrademarks of Advanced SterilizationProducts | *STERRAD and ALLClear aretrademarks of Advanced SterilizationProducts | ||
| The pouches maintain the sterility of theenclosed devices until used. | The pouches maintain the sterility of theenclosed devices until used. | ||
| When used to enclose medical devices,the pouches are intended to contain thedevices in such a manner as to leave aminimum of one inch between thedevices and seal on all sides. When usedto enclose a tray, the tray must fit looselywithin the pouch. | When used to enclose medical devices,the pouches are intended to contain thedevices in such a manner as to leave aminimum of one inch between thedevices and seal on all sides. When usedto enclose a tray, the tray must fit looselywithin the pouch. | ||
| Intended Sterilization Cycles andIntended Pouch Loads when MedicalDevices are:• Directly pouched• Placed inside of a tray and the traypouched | Intended Sterilization Cycles andIntended Pouch Loads when MedicalDevices are:• Directly pouched• Placed inside of a tray and the traypouched | ||
| V-PRO 60 & s2 Lumen Cycle• Non-lumened devices with diffusion-restricted spaces such as the hingedportion of forceps and scissors.• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single, dualand triple channeled rigid and semi-rigid endoscopes, with the followingconfigurations:o single or dual lumen devices• $\ge$ 0.77 mm internal diameter(ID) and $\le$ 410 mm in length• $\ge$ 1.8 mm ID x $\le$ 542 mm inlengtho triple lumen devices• $\ge$ 1.2 mm ID and $\le$ 275 mm inlength• $\ge$ 1.8 mm ID and $\le$ 310 mm inlengthOr• $\ge$ 2.8 mm ID and $\le$ 317 mm inlength | V-PRO 60 & s2 Lumen Cycle• Instruments with diffusion-restrictedspaces such as the hinged portion offorceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single, dualand triple channeled rigid and semi-rigid endoscopes, with the followingconfigurations:o single or dual lumen devices• $\ge$ 0.77 mm internal diameter(ID) and $\le$ 410 mm in lengtho triple lumen devices• $\ge$ 1.2 mm ID and $\le$ 275 mm inlength• $\ge$ 1.8 mm ID and $\le$ 310 mm inlengthor• $\ge$ 2.8 mm ID and $\le$ 317 mm inlength | ||
| Feature | Modified Vis-U-All Low TemperatureSterilization Pouch (proposed) K222440 | Vis-U-All Low TemperatureSterilization Pouch (K183401) | Comparison |
| V-PRO 60 & s2 Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces such asthe hinged portion of forceps andscissors. | V-PRO 60 & s2 Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces such asthe hinged portion of forceps andscissors. | ||
| V-PRO 60 & s2 Flexible CycleLoad 1: One flexible surgical endoscopeor bronchoscope with a light cord (if notintegral to endoscope) and mat withoutany additional load. The flexibleendoscope may be a:• single or dual lumen device withlumens that are $\ge$ 1 mm ID and $\le$990 mm in lengthLoad 2: Non-lumened devices includingnon-lumened rigid semi-rigid, andflexible endoscopes and non-lumeneddevices with diffusion-restricted areassuch as the hinged portion of forceps orscissors. Medical devices, including rigidand semi-rigid endoscopes, with thefollowing configurations:• $\ge$ 0.76 mm ID and $\le$ 233 mm in length• $\ge$ 1.0 mm ID and $\le$ 254 mm in length• $\ge$ 1.8 mm ID and $\le$ 542 mm in length | V-PRO 60 & s2 Flexible CycleLoad 1: One flexible surgical endoscopeor bronchoscope with a light cord (if notintegral to endoscope) and mat withoutany additional load. The flexibleendoscope may be a:• single or dual lumen device withlumens that are $\ge$ 1 mm ID and $\le$ 990mm in lengthLoad 2: Non-lumened devices includingnon-lumened rigid, semi-rigid, andflexible endoscopes and non-lumeneddevices with diffusion-restricted areassuch as the hinged portion of forceps orscissors. Medical devices, including rigidand semi-rigid endoscopes, with thefollowing dimensions:• $\ge$ 2 mm ID and $\le$ 400 mm in length• $\ge$ 0.76 mm ID and $\le$ 233 mm in length• $\ge$ 1.0 mm ID and $\le$ 254 mm in length | ||
| V-PRO s2 Fast Cycle• Non-lumened devices including non-lumened rigid and semi-rigid andflexible endoscopes and non-lumeneddevices with diffusion-restricted spacessuch as the hinged portion of forcepsand scissors.• Medical devices (including single, dualand triple channeled rigid and semi-rigid endoscopes) with the followingconfigurations:• single or dual lumen devices$\ge$ 0.77 mm ID and $\le$ 410 mm inlength$\ge$ 1.8 mm ID x $\le$ 542 mm inlength• Triple channeled devices with stainless | V-PRO s2 Fast Cycle• Non-lumened devices including non-lumened rigid and semi-rigid andflexible endoscopes and non-lumeneddevices with diffusion-restricted spacessuch as the hinged portion of forcepsand scissors.• Medical devices (including single, dualand triple channeled rigid and semi-rigid endoscopes) with the followingconfigurations:single or dual channeled deviceswith stainless steel lumens thatare $\ge$ 0.77 mm ID and $\le$ 410 mmin length• Triple channeled devices with stainless | ||
| steel lumens that are either: | steel lumens that are either: | ||
| Feature | Modified Vis-U-All Low TemperatureSterilization Pouch (proposed) K222440 | Vis-U-All Low TemperatureSterilization Pouch (K183401) | Comparison |
| $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length Or$\geq$ 2.8 mm ID and $\leq$ 317 mm in length V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Non-lumened devices including non-lumened rigid and semi-rigid endoscopes Medical devices, including single, dual or triple channeled stainless steel lumens that are: $\geq$ 0.77 mm ID and $\leq$ 527 mm in length $\geq$ 0.8 mm ID and $\leq$ 542 mm in length $\geq$ 0.48 mm ID and $\leq$ 100 mm in length Medical devices with Dead end lumens that are $\geq$ 1.3 mm ID and $\leq$ 73 mm in length Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: $\geq$ 3 mm ID and $\leq$ 298 mm in length $\geq$ 4 mm ID and $\leq$ 424 mm in length | $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length Or$\geq$ 2.8 mm ID and $\leq$ 317 mm in length V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors Non-lumened devices including non-lumened rigid and semi-rigid endoscopes Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: single or dual lumen devices $\geq$ 0.77 mm ID and $\leq$ 410 mm in length triple lumen devices $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length or$\geq$ 2.8 mm ID and $\leq$ 317 mm in length | ||
| V-PRO 1, 1 Plus, maX & maX2 Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. | V-PRO 1, 1 Plus, maX & maX2 Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | ||
| Feature | Modified Vis-U-All Low TemperatureSterilization Pouch (proposed) K222440 | Vis-U-All Low TemperatureSterilization Pouch (K183401) | Comparison |
| Load 1: Single or dual lumen surgicalflexible endoscopes (such as those usedin ENT, Urology and Surgical Care) andbronchoscopes with a light cord (if notintegral to endoscope) and mat with noadditional load.The flexible endoscopes may containeither a single or dual channel lumen thatis $\geq$ 1 mm ID and $\leq$ 1050 mm in lengthLoad 2:• Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces suchas the hinged portion of forceps andscissors• Single, dual or triple channel stainlesssteel lumen that is $\geq$ 0.48 mm ID and$\leq$ 100 mm in length. | Load 1: Single or dual lumen surgicalflexible endoscopes (such as those usedin ENT, Urology and Surgical Care) andbronchoscopes with a light cord (if notintegral to endoscope) and mat with noadditional load.The flexible endoscopes may containeither:• a single lumen that is $\geq$ 1 mm IDand $\leq$ 1050 mm in length• or two lumens with:• one lumen that is $\geq$ 1 mm ID and$\leq$ 990 mm in length• and the other lumen that is $\geq$ 1mm ID and $\leq$ 850 mm in lengthLoad 2: Non-lumened instrumentsincluding instruments with diffusion-restricted areas such as the hingedportion of forceps or scissors. | ||
| V-PRO maX 2 Fast Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces such asthe hinged portion of forceps andscissors. | V-PRO maX 2 Fast Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith stainless steel or titanium diffusion-restricted spaces such as the hingedportion of forceps and scissors. | ||
| STERRAD 100S Default CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Metal and nonmetal lumened instrumentswith:• $\geq$ 6 mm ID and $\leq$ 310 mm in lengthMedical devices with a single stainlesssteel lumen with:• $\geq$ 1 mm ID and $\leq$ 125 mm in length• $\geq$ 2 mm ID and $\leq$ 250 mm in length• $\geq$ 3 mm ID and $\leq$ 400 mm in length | STERRAD 100S Default CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Metal and nonmetal lumened instrumentswith:• $\geq$ 6 mm ID and $\leq$ 310 mm in lengthMedical devices with a single stainlesssteel lumen with:• $\geq$ 1 mm ID and $\leq$ 125 mm in length• $\geq$ 2 mm ID and $\leq$ 250 mm in length• $\geq$ 3 mm ID and $\leq$ 400 mm in length | ||
| STERRAD NX and NX with ALLClearTechnology Standard CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors. | STERRAD NX and NX with ALLClearTechnology Standard CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors | ||
| Feature | PRO-LITE Sterilization TraysModified Vis-U-All Low TemperatureSterilization Pouch (proposed) K222440 | Vis-U-All Low TemperatureSterilization Pouch (K183401) | Comparison |
| Medical devices with a single stainlesssteel lumen with:• ≥ 1 mm ID and ≤ 150 mm in length• ≥ 2 mm ID and ≤ 400 mm in length | Medical devices with a single stainlesssteel lumen with:• ≥ 1 mm ID and ≤ 150 mm in length• ≥ 2 mm ID and ≤ 400 mm in length | ||
| STERRAD NX and NX with ALLClearTechnology Advanced CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors. | STERRAD NX and NX with ALLClearTechnology Advanced CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors. | ||
| Medical Devices, including most flexibleendoscopes, with:• a single stainless steel lumen with:○ ≥ 1 mm ID and ≤ 500 mm inlength• Single channel polyethylene andTeflon (polytetrafluoroethylene)○ ≥1 mm ID and ≤ 850 mm in length | Medical Devices, including most flexibleendoscopes, with:• a single stainless steel lumen with:• ≥ 1 mm ID and ≤ 500 mm inlength• Single channel polyethylene andTeflon (polytetrafluoroethylene)• ≥1 mm ID and ≤ 850 mm in length | ||
| STERRAD 100NX and 100NX withALLClear Technology Standard CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Medical devices with a single stainlesssteel lumen with:• ≥ 0.7 mm ID and ≤ 500 mm in length | STERRAD 100NX and 100NX withALLClear Technology Standard CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Medical devices with a single stainlesssteel lumen with:• ≥ 0.7 mm ID and ≤ 500 mm in length | ||
| STERRAD 100NX and 100NX withALLClear Technology Flex Scope CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Medical Devices, including most flexibleendoscopes, with:• Single channel polyethylene andTeflon (polytetrafluoroethylene)• ≥ 1 mm ID and ≤ 850 mm inlength | STERRAD 100NX and 100NX withALLClear Technology Flex Scope CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Medical Devices, including most flexibleendoscopes, with:Single channel polyethylene andTeflon (polytetrafluoroethylene)• ≥ 1 mm ID and ≤ 850 mm inlength | ||
| STERRAD 100NX and 100NX withALLClear Technology Express CycleMetal and nonmetal medical devices(surfaces sterilization only) andinstruments which have diffusion- | STERRAD 100NX and 100NX withALLClear Technology Express CycleMetal and nonmetal medical devices(surfaces sterilization only) and | ||
| PRO-LITE Sterilization Trays | |||
| Feature | Modified Vis-U-All Low TemperatureSterilization Pouch (proposed) K222440 | Vis-U-All Low TemperatureSterilization Pouch (K183401) | Comparison |
| restricted spaces, such as the hingedportion of forceps and scissors.STERRAD 100NX and 100NX withALLClear Technology Duo CycleMedical devices including:most flexible endoscopes with asingle channel of polyethylene andTeflon (polytetrafluoroethylene) with$\geq$ 1 mm ID and $\leq$ 875 mm in length accessory devices that are normallyconnected to a flexible endoscopeduring use flexible endoscopes without lumens | instruments which have diffusion-restricted spaces, such as the hingedportion of forceps and scissors.STERRAD 100NX and 100NX withALLClear Technology Duo CycleMedical devices including:most flexible endoscopes with asingle channel of polyethylene andTeflon (polytetrafluoroethylene) with$\geq$ 1 mm ID and $\leq$ 875 mm in length accessory devices that are normallyconnected to a flexible endoscopeduring use flexible endoscopes without lumens | ||
| DeviceFeatures | Chevron end of pouches for ease ofopeningChemical process indicator for EO | Chevron end of pouches for ease ofopeningChemical process indicator for EO | Identical |
| Maintenanceof Sterility | 1 year | 1 year | Identical |
| Materials ofConstruction | Tyvek and plastic | Tyvek and plastic | Identical |
| Types | Self Seal, Heat Seal, Tubing | Self Seal, Heat Seal, Tubing | Identical |
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6. Summary of Performance Testing
Table 3 summarizes the testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing to demonstrate that the proposed pouch is qualified for use in V-PRO Low temperature Sterilization Systems.
Table 3. Performance Test Summary
| Test | Result | Conclusion |
|---|---|---|
| ½ CycleVerification ofMated Surfaces | Sterile efficacy was demonstrated for mated surfaces under worst case conditions in the V-PRO Sterilizer cycles. | PASS |
| ½ Cycle Efficacy | The standard injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. | PASS |
| Simulated UseTest | Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. | PASS |
| In Use Test | The in use investigation demonstrated the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. | PASS |
{19}------------------------------------------------
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K183401), Class II (21 CFR 880.6850), product code FRG.
{20}------------------------------------------------
510(k) Summary For PRO-LITE™ Sterilization Tray
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Anthony Piotrkowski Contact: Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tony piotrkowski(@steris.com
Submission Date: September 7, 2022
Premarket Notification Number: K222440
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
{21}------------------------------------------------
Device Name 7.
| Trade Name: | PRO-LITE Sterilization Tray |
|---|---|
| Common/usual Name: | Sterilization Trays, cassettes and other accessories |
| Classification Name: | Sterilization Wrap |
| Classification | 21 CFR 880.6850 |
| Class | II |
| Product Code | KCT, FRG |
8. Predicate Device
PRO-LITE Sterilization Tray, K183402
9. Description of Device
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems and STERRAD Sterilizers. The trays are available in various sizes, outlined in Table 4, to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K183402) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material.
| Model | Description (in) | Model | Description (in) | Model | Description (in) |
|---|---|---|---|---|---|
| VP0045 | 13 x 4.5 x 2.25 | VP0048 | 13 x 7.75 x 2.25 | VP0051 | 12 x 11.75 x 4 |
| VP0046 | 19 x 4.5 x 2.25 | VP0049 | 19 x 7.75 x 2.25 | VP0052 | 25 x 11.75 x 4 |
| VP0047 | 25 x 4.5 x 2.25 | VP0050 | 27 x 7.75 x 4 | VP0053 | 25 x 14 x 5 |
Table 4. External Dimensions of Trav Line
Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 5 lists the organizer sizes. The organizers are either "blank" and are used to partition the tray or have a device holding portion into which the devices are inserted. At the organizer base is a flapped groove that is used to position the organizer within a PRO-LITE Sterilization Tray.
Table 5. Instrument Organizer Model Numbers
| Model | Description | Model | Description |
|---|---|---|---|
| VP0054 | Blank, Tall | VP0055 | Blank, Short |
| VP0063 | 3 mm - 7mm, Tall | VP0067 | 3 mm - 7 mm, Short |
| VP0064 | 7 mm - 11mm, Tall | VP0068 | 7 mm - 11 mm, Short |
| VP0065 | 11 mm - 15 mm, Tall | VP0069 | 11 mm - 15 mm, Short |
| VP0066 | 15 mm - 19mm, Tall | VP0070 | 15 mm - 19 mm, Short |
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
{22}------------------------------------------------
Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes as shown in Table 6 to fit the nine PRO-LITE Sterilization Trays. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays.
| Model | Description (in) | Model | Description (in) | Model | Description (in) |
|---|---|---|---|---|---|
| VP0071 | 13 x 4.5 | VP0074 | 13 x 7.75 | VP0077 | 12 x 11.75 |
| VP0072 | 19 x 4.5 | VP0075 | 19 x 7.75 | VP0078 | 25 x 11.75 |
| VP0073 | 25 x 4.5 | VP0076 | 27 x 7.75 | VP0079 | 25 x 14 |
Tahle 6 Silicone Mat Model Numbers
The purpose of this submission is to expand claims for the use of these tray models in the following sterilizer cycles:
- V-PRO 1, 1 Plus, maX and maX 2 Lumen Cycle ●
- V-PRO 1 Plus, maX and maX 2 Non Lumen Cycle ●
- V-PRO maX and maX 2 Flexible Cycle ●
- V-PRO maX 2 Fast Non Lumen Cycle ●
- V-PRO 60 and s2 Lumen, Non Lumen and Flexible Cycles ●
- V-PRO s2 Fast Cycle
10. Intended Use/ Indications for Use
The tray indications for use are included in Table 7 which compares the proposed device to the predicate.
Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the PRO-LITE Sterilization Trays.
| Model | Description | Model | Description |
|---|---|---|---|
| VP0054 | Blank, Tall | VP0055 | Blank, Short |
| VP0063 | 3 mm - 7 mm, Tall | VP0067 | 3 mm - 7 mm, Short |
| VP0064 | 7 mm - 11 mm, Tall | VP0068 | 7 mm - 11 mm, Short |
| VP0065 | 11 mm - 15 mm, Tall | VP0069 | 11 mm - 15 mm, Short |
| VP0066 | 15 mm - 19 mm, Tall | VP0070 | 15 mm - 19 mm, Short |
Sterilization mats are optional accessories intended to cushion and stabilize instruments within the PRO-LITE Sterilization Trays.
| Model | Description (in) | Model | Description (in) | Model | Description (in) |
|---|---|---|---|---|---|
| VP0071 | 13 x 4.5 | VP0074 | 13 x 7.75 | VP0077 | 12 x 11.75 |
| VP0072 | 19 x 4.5 | VP0075 | 19 x 7.75 | VP0078 | 25 x 11.75 |
| VP0073 | 25 x 4.5 | VP0076 | 27 x 7.75 | VP0079 | 25 x 14 |
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11. Summary of Technical Characteristics
The proposed PRO-LITE sterilization trays, sterilization mats and instrument organizers are identical in composition to the claimed predicate device. The technical characteristics are summarized below in Table 7.
| Table 7. Summary of Tray Physical Description and Technological Properties |
|---|
| ---------------------------------------------------------------------------- |
| Feature | PRO-LITE Sterilization Tray (proposed) K222440 | PRO-LITE Sterilization Tray (K183402) | Comparison |
|---|---|---|---|
| Intended Use / Indications for Use | The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:• Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO Low Temperature Sterilization Systems• Default Cycle of the STERRAD®* 100S Sterilizer• Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers• Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers*STERRAD and ALLClear are trademarks of Advanced Sterilization ProductsPrior to placing in the Sterilizer, the trays must either be:• wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed aboveor• placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed | The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:• Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO Low Temperature Sterilization Systems• Default Cycle of the STERRAD®* 100S Sterilizer• Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers• Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers*STERRAD and ALLClear are trademarks of Advanced Sterilization ProductsPrior to placing in the Sterilizer, the trays must either be:• wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed aboveor• placed inside a legally marketed pouch for enclosing trays in the sterilizers listed aboveThe PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed | Identical except for:• Clarification of lumen claims for V-PRO lumen cycles• Clarification of endoscope claims for V-PRO flexible cyclesRemoval of “stainless steel or titanium” from V-PRO Non Lumen cycles. |
| Feature | PRO-LITE Sterilization Tray(proposed) K222440 | PRO-LITE Sterilization Tray(K183402) | Comparison |
| Intended Sterilization Cycles andIntended Tray Load for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052 | Intended Sterilization Cycles andIntended Tray Load for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052 | ||
| V-PRO 60 and s2 Lumen Cycle:• Non-lumened devices with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes with thefollowing configurations:o Single or dual channeled deviceswith stainless steel lumens that are:■ $\ge$ 0.77 mm ID and $\le$ 410 mm inlength■ $\ge$ 1.8 mm ID x $\le$ 542 mm inlengtho Triple channeled devices withstainless steel lumens that are:■ $\ge$ 1.2 mm ID and $\le$ 275 mm inlength■ $\ge$ 1.8 mm ID and $\le$ 310 mm inlengthor■ $\ge$ 2.8 mm ID and $\le$ 317 mm inlength | V-PRO 60 and s2 Lumen Cycle:• Instruments with diffusion-restrictedspaces such as the hinged portion offorceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes with thefollowing configurations:o Single or dual lumen devices■ $\ge$ 0.77 mm ID and $\le$ 410 mm inlength• Triple lumen devices■ $\ge$ 1.2 mm ID and $\le$ 275 mm inlength■ $\ge$ 1.8 mm ID and $\le$ 310 mm inlengthor■ $\ge$ 2.8 mm ID and $\le$ 317 mm inlength | ||
| V-PRO 60 and s2 Non Lumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces such asthe hinged portion of forceps andscissors. | V-PRO 60 and s2 Non Lumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces such asthe hinged portion of forceps andscissors. | ||
| V-PRO 60 and s2 Flexible Cycle:Load 1: One flexible surgicalendoscope or bronchoscope with a lightcord (if not integral to endoscope) andmat without any additional load. Theflexible endoscope may be a: | V-PRO 60 and s2 Flexible Cycle:Load 1: One flexible surgicalendoscope or bronchoscope with a lightcord (if not integral to endoscope) andmat without any additional load. Theflexible endoscope may be a: | ||
| Feature | PRO-LITE Sterilization Tray(proposed) K222440 | PRO-LITE Sterilization Tray(K183402) | Comparison |
| Single or dual lumen device withlumens that are $\geq$ 1 mm ID and $\leq$ 990 mm in length Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes with the following configurations: $\geq$ 0.76 mm ID and $\leq$ 233 mm in length $\geq$ 1.0 mm ID and $\leq$ 254 mm in length $\geq$ 1.8 mm ID and $\leq$ 542 mm in length Intended Sterilization Cycle and Intended Tray Load for Tray Models:VP0045, VP0046, VP0047, VP0048, VP0049 | Single or dual lumen device withlumens that are $\geq$ 1 mm ID and $\leq$ 990 mm in length Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes with the following configurations: $\geq$ 2.0 mm ID and $\leq$ 400 mm in length $\geq$ 0.76 mm ID and $\leq$ 233 mm in length $\geq$ 1.0 mm ID and $\leq$ 254 mm in length | ||
| V-PRO s2 Fast Cycle: Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes, and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps and scissors. Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: Single or dual channeled devices with stainless steel lumens $\geq$ 0.77 mm ID and $\leq$ 410 mm in length $\geq$ 1.8 mm ID and $\leq$ 542 mm in length Triple channeled devices with stainless steel lumens that are either $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | V-PRO s2 Fast Cycle: Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: Single or dual channeled devices with stainless steel lumens that are $\geq$ 0.77 mm ID and $\leq$ 410 mm in length Triple channeled devices with stainless steel lumens that are either $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | ||
| Feature | PRO-LITE Sterilization Tray(proposed) K222440 | PRO-LITE Sterilization Tray(K183402) | Comparison |
| Intended Sterilization Cycles andIntended Tray Load for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052,VP0053 | Intended Sterilization Cycles andIntended Tray Load for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0050, VP0051,VP0052, VP0053 | ||
| V-PRO 1, 1 Plus, maX, and maX 2Lumen Cycle:• Non-lumened devices with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Medical devices, including single,dual or triple channeled stainless steellumens that are:○ ≥ 0.77 mm ID and ≤ 527 mm inlength○ ≥ 0.8 mm ID and ≤ 542 mm inlength○ ≥ 0.48 mm ID and ≤ 100 mm inlength• Medical devices with dead endstainless steel lumens that are ≥ 1.3mm ID and ≤ 73 mm in length• Devices with rigid non-metalliclumens (such as those used inendoscope sheaths, take-apart forcepsand trocars) that are:○ ≥ 3 mm ID and ≤ 298 mm in length○ ≥ 4 mm ID and ≤ 424 mm in length | V-PRO 1, 1 Plus, maX, and maX 2Lumen Cycle:• Instruments with diffusion-restrictedspaces such as the hinged portions offorceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes, with thefollowing configurations:o single or dual lumen devices■ ≥ 0.77 mm ID and ≤ 410 mm inlengtho triple lumen devices■ ≥ 1.2 mm ID and ≤ 275 mm inlength■ ≥ 1.8 mm ID and ≤ 310 mm inlength■ ≥ 2.8 mm ID and ≤ 317 mm inlength | ||
| V-PRO 1 Plus, maX, and maX 2 NonLumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces such asthe hinged portion of forceps andscissors | V-PRO 1 Plus, maX, and maX 2 NonLumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith stainless steel or titaniumdiffusion-restricted spaces such as thehinged portion of forceps and scissors. | ||
| V-PRO maX, and maX 2 FlexibleCycle:Load 1: Single or dual lumen surgicalflexible endoscopes (such as those usedin ENT, Urology and Surgical Care)and bronchoscopes with a light cord (ifnot integral to endoscope) and mat withno additional load. | V-PRO maX, and maX 2 FlexibleCycle:Load 1: Single or dual lumen surgicalflexible endoscopes (such as those usedin ENT, Urology and Surgical Care)and bronchoscopes with a light cord (ifnot integral to endoscope) and mat withno additional load. | ||
| Feature | PRO-LITE Sterilization Tray(proposed) K222440 | PRO-LITE Sterilization Tray(K183402) | Comparison |
| The flexible endoscopes may containeither a single or dual lumen that is ≥ 1mm ID and ≤ 1050 mm in lengthLoad 2:• Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces suchas the hinged portion of forceps andscissors• Single, dual or triple channel stainlesssteel lumens that are ≥ 0.48 mm IDand ≤ 100 mm in length | The flexible endoscopes may containeither:• a single lumen that is ≥ 1 mm ID and≤ 1050 mm in length• or two lumens with:○ one lumen that is ≥ 1 mm ID and< 990 mm in length○ and the other lumen that is ≥ 1mm ID and ≤ 850 mm in lengthLoad 2: Non-lumened instrumentsincluding instruments with diffusion-restricted areas such as the hingedportion of forceps or scissors. | ||
| V-PRO maX 2 Fast Non Lumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith diffusion-restricted spaces such asthe hinged portion of forceps andscissors. | V-PRO maX 2 Fast Non Lumen Cycle:Non-Lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened deviceswith stainless steel or titaniumdiffusion-restricted spaces such as thehinged portion of forceps and scissors | ||
| Intended Sterilization Cycles andIntended Tray Load for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052 | Intended Sterilization Cycles andIntended Tray Load for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052 | ||
| STERRAD 100S Default Cycle:Metal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Metal and nonmetal lumenedinstruments with• ≥ 6 mm ID and ≤ 310 mm in lengthMedical devices with a single stainlesssteel lumen with:• ≥ 1 mm ID and ≤ 125 mm in length• ≥ 2 mm ID and ≤ 250 mm in length• ≥ 3 mm ID and ≤ 400 mm in length | STERRAD 100S Default Cycle:Metal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Metal and nonmetal lumenedinstruments with• ≥ 6 mm ID and ≤ 310 mm in lengthMedical devices with a single stainlesssteel lumen with:• ≥ 1 mm ID and ≤ 125 mm in length• ≥ 2 mm ID and ≤ 250 mm in length• ≥ 3 mm ID and ≤ 400 mm in length | ||
| Intended Sterilization Cycles andIntended Tray Load for Tray Models:VP0045, VP0046, VP0048, VP0049 | Intended Sterilization Cycles andIntended Tray Load for Tray Models:VP0045, VP0046, VP0048, VP0049 | ||
| STERRAD NX and NX with ALLClearTechnology Standard Cycle: | STERRAD NX and NX with ALLClearTechnology Standard Cycle: | ||
| Feature | PRO-LITE Sterilization Tray (proposed) K222440 | PRO-LITE Sterilization Tray (K183402) | Comparison |
| Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with a single stainless steel lumen with:• $\geq$ 1 mm ID and $\leq$ 150 mm in length• $\geq$ 2 mm ID and $\leq$ 400 mm in length | STERRAD NX and NX with ALLClear Technology Standard Cycle:Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with a single stainless steel lumen with:• $\geq$ 1 mm ID and $\leq$ 150 mm in length• $\geq$ 2 mm ID and $\leq$ 400 mm in length | ||
| STERRAND NX and NX with ALLClear Technology Advanced Cycle:Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors Medical devices, including most flexible endoscopes, with:o a single stainless steel lumen with:○ $\geq$ 1 mm ID and $\leq$ 500 mm in lengtho single channel polyethylene and Teflon (polytetrafluoroethylene)○ $\geq$ 1mm ID and $\leq$ 850 mm in length | STERRAND NX and NX with ALLClear Technology Advanced Cycle:Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors Medical devices, including most flexible endoscopes, with:o a single stainless steel lumen with:○ $\geq$ 1 mm ID and $\leq$ 500 mm in lengtho single channel polyethylene and Teflon (polytetrafluoroethylene)• $\geq$ 1mm ID and $\leq$ 850 mm in length | ||
| Intended Sterilization Cycles and Intended Tray Load for Tray Models:VP0045, VP0046, VP0048, VP0049, VP0051, VP0052, VP0053 | Intended Sterilization Cycles and Intended Tray Load for Tray Models:VP0045, VP0046, VP0048, VP0049, VP0051, VP0052, VP0053 | ||
| STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle:Metal and nonmetal medical devices including instruments with have diffusion-restricted spaces, such as the hinged portion of forceps and scissors Medical devices with a single stainless steel lumen with:• $\geq$ 0.7 mm ID and $\leq$ 500 mm in length | STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle:Metal and nonmetal medical devices including instruments with have diffusion-restricted spaces, such as the hinged portion of forceps and scissors Medical devices with a single stainless steel lumen with:$\geq$ 0.7 mm ID and $\leq$ 500 mm in length | ||
| STERRAD 100NX and 100NX with ALLClear Technology Flex Scope Cycle:Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices, including most flexible endoscopes with | STERRAD 100NX and 100NX with ALLClear Technology Flex Scope Cycle:Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors | ||
| Feature | PRO-LITE Sterilization Tray(proposed) K222440 | PRO-LITE Sterilization Tray(K183402) | Comparison |
| • Single channel polyethylene andTeflon (polytetrafluoroethylene)○ ≥ 1mm ID and ≤ 850 mm in length | Medical devices, including mostflexible endoscopes, with:• Single channel polyethylene andTeflon (polytetrafluoroethylene)○ ≥ 1mm ID and ≤ 850 mm in length | ||
| STERRAD 100NX and 100NX withALLClear Technology Express Cycle:Metal and nonmetal devices surfacesand instruments which have diffusion-restricted spaces, such as the hingedportion of forceps and scissors. | STERRAD 100NX and 100NX withALLClear Technology Express Cycle:Metal and nonmetal devices surfacesand instruments which have diffusion-restricted spaces, such as the hingedportion of forceps and scissors. | ||
| STERRAD 100NX and 100NX withALLClear Technology Duo Cycle:Medical devices including:• most flexible endoscopes with asingle channel of polyethylene andTeflon (polytetrafluoroethylene) with$\geq$ 1 mm ID and ≤ 875 mm in length• accessory devices that are normallyconnected to a flexible endoscopeduring use• flexible endoscopes without lumens | STERRAD 100NX and 100NX withALLClear Technology Duo Cycle:Medical devices including:• most flexible endoscopes with asingle channel of polyethylene andTeflon (polytetrafluoroethylene) with$\geq$ 1 mm ID and ≤ 875 mm in length• accessory devices that are normallyconnected to a flexible endoscopeduring use• flexible endoscopes without lumens | ||
| Vent toVolumeRatio | All trays are the same:0.135 in-1 | All trays are the same:0.135 in-1 | Identical |
| TrayComposition | Mineral-filled polypropylene, stainlesssteel | Mineral-filled polypropylene, stainlesssteel | Identical |
| InstrumentOrganizerComposition | Medical Grade Silicone, UPS grade VI | Medical Grade Silicone, UPS grade VI | Identical |
| MatComposition | Medical Grade Silicone, UPS grade VI | Medical Grade Silicone, UPS grade VI | Identical |
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Summary of Non-clinical Tests 12.
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 8 below.
| Test | Result | Conclusion |
|---|---|---|
| ½ Cycle Verification ofMated Surfaces | Sterile efficacy was demonstrated for mated surfaces underworst case conditions in the V-PRO Sterilizer cycles. | PASS |
| ½ Cycle Efficacy | The standard injection weight resulted in all sterile resultswithin the validation load used to qualify each sterilizer cycle. | PASS |
Table 8. Performance Test Summary
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| PRO-ELITE Sterilization Trays | ||
|---|---|---|
| Test | Result | Conclusion |
| Simulated Use Test | Simulated use testing verified the ability of the sterilizer cyclesto sterilize medical devices under worst-case processingconditions. | PASS |
| In Use Test | The in use investigation demonstrated the ability of the V-PROSterilizer cycles to sterilize patient-soiled, clinically-cleaned,medical instruments. | PASS |
7. Conclusion
Based on the intended us, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K183402), Class II (21 CFR 880.6850), product code KCT.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).