(75 days)
The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
- Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty 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
- . Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX and 100 NX 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 PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems and the following STERRAD Sterilizers and cycles. 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 (K222440) 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 also described as accessories.
The provided text describes the PRO-LITE Sterilization Tray, which is a device used to contain medical instruments for sterilization. The submission aims to add or expand claims for the use of these tray models specifically in the V-PRO maX 2 Specialty Cycle.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cycle specific test articles shall be reproducibly sterilized under ½ cycle conditions for the V-PRO maX 2 Specialty Cycle | All tested articles were reproducibly sterilized under ½ cycle conditions for the V-PRO maX 2 Specialty Cycle. |
| Conclusion: PASS | Conclusion: PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set (number of trays or instruments tested).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given this is an FDA 510(k) submission, it's customary for such performance data to be collected specifically for the submission, implying a prospective study conducted by the manufacturer (STERIS Corporation, based in Mentor, OH, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or their qualifications for establishing ground truth for the test set. For sterilization validation, the ground truth is typically established through direct microbial inactivation (sterilization) testing using biological indicators or test articles inoculated with specific microorganisms, rather than expert consensus on images or observations.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for a test set. This is consistent with the nature of sterilization efficacy testing, which relies on objective measurements of microbial kill.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or similar AI applications where human interpretation is involved. For a sterilization tray, the primary performance is objective sterilant penetration and microbial inactivation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This question is not applicable to the device described. The device is a physical sterilization tray, not an algorithm. The "performance" being evaluated is the ability of the tray to facilitate sterilization in specific cycles, which is a standalone performance of the device in conjunction with a sterilizer, without any human-in-the-loop "algorithm" performance.
7. Type of Ground Truth Used
The ground truth used for this type of sterilization study is typically:
- Microbial Inactivation/Sterility: This is established by demonstrating a specific sterility assurance level (SAL), often through the successful inactivation of highly resistant biological indicators (e.g., Geobacillus stearothermophilus spores) placed within the test articles. The "½ cycle conditions" mentioned indicate a stringent test designed to challenge the sterilization process.
8. Sample Size for the Training Set
The document does not describe a "training set" as this term primarily applies to the development of AI/ML algorithms. This device is a physical product, not an AI model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for a physical sterilization tray.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 7, 2023
STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K231501
Trade/Device Name: PRO-LITE Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: May 22, 2023 Received: May 24, 2023
Dear Jennifer Nalepka:
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.
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
{1}------------------------------------------------
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 medical devices and radiation-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).
Sincerelv.
Christopher K. Dugard -S
for Clarence W. Murray, III, Ph.D. 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) K231501
Device Name PRO-LITE Sterilization Trays
Indications for Use (Describe)
- The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
- · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast, and Specialty 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 Loads for Tray Models: VP0045, VP0047, VP0048, VP0049, 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:
- · 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
- · 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
- · Single or dual channeled devices with stainless steel lumens that are:
-
· ≥ 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 endoscopes 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
or
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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 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 Cycles and Intended Tray Loads for Tray Models: VP0045, VP0047, VP0049, VP0049
V-PRO s2 Fast Cycle:
• Nor-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 endoscopes, with the following configurations:
- · 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
- · Triple channeled devices with stainless steel lumens
- · > 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
Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053
V-PRO 1, 1 Plus, maX, and maX 2 Lumen Cycle:
-
Non-lumened instruments 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
-
· Instruments 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:
• Nor-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
Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050
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V-PRO maX 2 Fast 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 2 Specialty Cycle:
Patient-specific surgical guides (eg. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures .* or
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes. **
*The validation studies were conducted using a validation load consisting of pouched guide(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material.
** The validation studies were conducted using a validation load consisting of one pouched intrument try or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 lbs (5kg).
| Material | Manufacturer | Specialty Cycle | Lumens |
|---|---|---|---|
| Surgical Guide Resin | Formlabs | F | ≥ 3 mm ID and ≤ 30 mm L |
| Biomed Amber Resin | Formlabs | F | ≥ 3 mm ID and ≤ 30 mm L |
| Dental LT Clear V2 Resin | Formlabs | D | ≥ 3 mm ID and ≤ 30 mm L |
| Biomed Clear Resin | Formlabs | D | ≥ 3 mm ID and ≤ 30 mm L |
| Biocompatible Clear MED610 | Stratasys | E | ≥ 3 mm ID and ≤ 20 mm L |
| Biocompatible Opaque Med615RGD | Stratasys | E | ≥ 3 mm ID and ≤ 20 mm L |
| Veroglaze MED620 | Stratasys | E | ≥ 3 mm ID and ≤ 20 mm L |
Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0047, VP0048, VP0048, VP0048, 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 Loads for Tray Models: VP0045, VP0048, VP0049
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 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:
{5}------------------------------------------------
· ≥ 1 mm ID and ≤ 500 mm in length
· single channel polyethylene and Teflon (polytetrafluoroethylene)
- · ≥ 1mm ID and ≤ 850 mm in length
Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0047, VP0048, VP0048, 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:
· > 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:
D I LIGHTS and roometal devices 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 (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
Instrument organizers are optional accessories intended to stabilize cylindrical instruments within the Sterilization Trays.
| Model | Description |
|---|---|
| VP0054 | Blank, Tall |
| VP0055 | Blank, Short |
| VP0063 | 3 mm - 7 mm, Tall |
| VP0064 | 7 mm - 11 mm, Tall |
| VP0065 | 11 mm - 15 mm, Tall |
| VP0066 | 15 mm - 19 mm, Tall |
| VP0067 | 3 mm - 7 mm, Short |
| VP0068 | 7 mm - 11 mm, Short |
| VP0069 | 11 mm - 15 mm, Short |
| VP0070 | 15 mm - 19 mm, Short |
Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.
| Model | Description (to fit Length" x Width" Tray) |
|---|---|
| VP0071 | 13 x 4.5 |
| VP0072 | 19 x 4.5 |
| VP0073 | 25 x 4.5 |
| VP0074 | 13 x 7.75 |
| VP0075 | 19 x 7.75 |
| VP0076 | 27 x 7.75 |
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| VP0077 | 12 x 11.75 |
|---|---|
| VP0078 | 25 x 11.75 |
| VP0079 | 25 x 14 |
Type of Use (Select one or both, as applicable)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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STERIS®
510(k) Summary For K231501 PRO-LITE™ Sterilization Tray
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Jennifer Nalepka Contact: Manager, Regulatory Affairs
Telephone: (440) 392-7458 e-mail: jennifer nalepka(@steris.com
August 3, 2023 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| 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 |
2. Predicate Device
PRO-LITE Sterilization Tray, K222440
3. Description of Device
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems:
- V-PRO 1 Low Temperature Sterilization System,
- V-PRO 1 Plus Low Temperature Sterilization System, ●
- V-PRO maX Low Temperature Sterilization System, ●
- V-PRO maX 2 Low Temperature Sterilization System ●
- V-PRO 60 Low Temperature Sterilization System and ●
- V-PRO s2 Low Temperature Sterilization System ●
and the following STERRAD Sterilizers and cycles:
- STERRAD 100S Sterilizer Default Cycle ●
- STERRAD NX with and without ALLClear Technology Sterilizer Standard ● and Advanced Cycles
- STERRAD 100NX with and without ALLClear Technology Sterilizer ● Standard, Flex Scope, Express and Duo Cycles
The trays are available in various sizes, outlined in Table 5-1, to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K222440) 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.
{9}------------------------------------------------
| Model | Description (in) | Model | Description (in) |
|---|---|---|---|
| VP0045 | 13 x 4.5 x 2.25 | VP0050 | 27 x 7.75 x 4 |
| VP0046 | 19 x 4.5 x 2.25 | VP0051 | 12 x 11.75 x 4 |
| VP0047 | 25 x 4.5 x 2.25 | VP0052 | 25 x 11.75 x 4 |
| VP0048 | 13 x 7.75 x 2.25 | VP0053 | 25 x 14 x 5 |
| VP0049 | 19 x 7.75 x 2.25 |
| Table 5-1. External Dimensions of Tray Line |
|---|
| --------------------------------------------- |
Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 5-2 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 5.2. 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 |
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 5-3 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) |
|---|---|---|---|
| VP0071 | 13 x 4.5 | VP0076 | 27 x 7.75 |
| VP0072 | 19 x 4.5 | VP0077 | 12 x 11.75 |
| VP0073 | 25 x 4.5 | VP0078 | 25 x 11.75 |
| VP0074 | 13 x 7.75 | VP0079 | 25 x 14 |
| VP0075 | 19 x 7.75 |
Table 5-3. Silicone Mat Model Numbers
The purpose of this submission is to add or expand claims for the use of these tray models in the following sterilizer cycles V-PRO maX 2 Specialty Cycle. No changes have been made to the device for this claim other than labeling.
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4. 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, Fast and Specialty 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
- . Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX and 100 NX 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.
| TrayModels | IntendedSterilizationCycles | Intended Tray Load | |
|---|---|---|---|
| VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052 | V-PRO 60 ands2 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 and semi-rigid endoscopes with the following configurations: Single or dual lumen devices with stainless steel lumens that are: $\geq$ 0.77 mm ID and $\leq$ 410 mm in length $\geq$ 1.8 mm ID and $\leq$ 542 mm in length Triple lumen devices with stainless steel lumens $\geq$ 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 60 ands2 Non LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with | ||
| TrayModels | IntendedSterilizationCycles | Intended Tray Load | |
| V-PRO 60 ands2 FlexibleCycle | diffusion-restricted spaces such as the hinged portion of forcepsand scissors.Load 1: One flexible surgical endoscope or bronchoscope witha light cord (if not integral to endoscope) and mat without anyadditional 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 deviceswith diffusion-restricted areas such as the hinged portion offorceps 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 | ||
| VP0045VP0046VP0047VP0048VP0049 | V-PRO s2 FastCycle | 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 single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single or dual lumen channeled devices with stainless steel lumens ≥ 0.77 mm ID and ≤ 410 mm in length ≥ 1.8 mm ID and ≤ 542 mm in length 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 | |
| VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052VP0053 | V-PRO 1, 1Plus, maX, andmaX 2 LumenCycle | Non-lumened instruments 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 Instruments 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 | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with | ||
| TrayModels | IntendedSterilizationCycles | Intended Tray Load | |
| 2 Non LumenCycle | diffusion-restricted spaces such as the hinged portion of forcepsand scissors. | ||
| V-PRO maX,and maX 2Flexible Cycle | Load 1: Single or dual lumen surgical flexible endoscopes(such as those used in ENT, Urology and Surgical care) andbronchoscopes with a light cord (if not integral to endoscope)and mat with no additional load. The flexible endoscopes maycontain either a single or dual lumen that is $\ge$ 1 mm ID and $\le$1050 mm in lengthLoad 2:Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened deviceswith diffusion-restricted spaces such as the hinged portionof forceps and scissors Single, dual or triple stainless steel lumens that are $\ge$ 0.48mm ID and $\le$ 100 mm in length | ||
| V-PRO maX 2Fast Non LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigidand flexible endoscopes and non-lumened devices withdiffusion-restricted spaces such as the hinged portion of forcepsand scissors. | ||
| VP0045VP0046VP0047VP0048VP0049VP0050 | V-PRO maX 2Specialty Cycle | Patient-specific surgical guides (e.g. osteotomy, shoulder, hip,knee, spine) or anatomical models fabricated via additivemanufacturing (3D printing) processes and intended for single-use during operative procedures.orNon-lumened instruments including non-lumened generalmedical instruments, non-lumened rigid, semi-rigid and flexibleendoscopes.** The validation studies were conducted using a validation loadconsisting of pouched guide(s)/model(s) (with or without tray)for a total weight of 5 lbs (2.3kg) 3D printed material.**The validation studies were conducted using a validationload consisting of one pouched instrument tray or one pouchwith guide(s)/model(s) (with or without tray) for a total weightof 11 lbs (5kg). | |
| Material | Manufacturer | SpecialtyCycle | Lumens |
| Surgical GuideResin | Formlabs | F | $\ge$ 3 mm ID x $\le$ 30mm L |
| BioMedAmber Resin | Formlabs | F | $\ge$ 3 mm ID x $\le$ 30mm L |
| Dental LTClear V2Resin | Formlabs | D | $\ge$ 3 mm ID x $\le$ 30mm L |
| BioMed ClearResin | Formlabs | D | $\ge$ 3 mm ID x $\le$ 30mm L |
| TrayModels | IntendedSterilizationCycles | Intended Tray Load | |
| BiocompatibleClearMED610Stratasys E ≥3 mm ID x ≤20 mm L | |||
| BiocompatibleOpaqueMED615RGDStratasys E ≥3 mm ID x ≤20 mm L | |||
| VeroGlaze™MED620Stratasys E ≥3 mm ID x ≤20 mm L | |||
| VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052 | STERRAD100S DefaultCycle | Metal and nonmetal medical devices including instrumentswhich have diffusion-restricted spaces, such as the hingedportion of forceps and scissors.Metal and nonmetal lumened instruments with• ≥ 6 mm ID and ≤ 310 mm in lengthMedical 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 | |
| VP0045VP0046VP0048VP0049 | STERRAD NXand NX withALLClearTechnologyStandard Cycle | Metal and non-metal medical devices including instrumentswhich have diffusion-restricted spaces, such as the hingedportion 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 | |
| VP0045VP0046VP0048VP0049 | STERRANDNX and NXwith ALLClearTechnologyAdvanced Cycle | Metal and non-metal medical devices including instrumentswhich have diffusion-restricted spaces, such as the hingedportion of forceps and scissorsMedical devices, including most flexible endoscopes, with:o a single stainless steel lumen with:o ≥ 1 mm ID and ≤ 500 mm in lengtho single channel polyethylene and Teflon(polytetrafluoroethylene)o > 1mm ID and ≤ 850 mm in length | |
| VP0045VP0046VP0047VP0048VP0049VP0051VP0052VP0053 | STERRAD100NX and100NX withALLClearTechnologyStandard Cycle | Metal and nonmetal medical devices including instruments withhave diffusion-restricted spaces, such as the hinged portion offorceps and scissorsMedical devices with a single stainless steel lumen with:≥ 0.7 mm ID and ≤ 500 mm in length | |
| VP0045VP0046VP0047VP0048VP0049VP0051VP0052VP0053 | STERRAD100NX and100NX withALLClearTechnology FlexScope Cycle | Metal and nonmetal medical devices including instrumentswhich have diffusion-restricted spaces, such as the hingedportion of forceps and scissors.Medical devices, including most flexible endoscopes, with:• Single channel polyethylene and Teflon(polytetrafluoroethylene)o ≥ 1mm ID and ≤ 850 mm in length | |
| VP0045VP0046VP0047VP0048VP0049VP0051VP0052VP0053 | STERRAD100NX and100NX with | Metal and nonmetal devices surfaces and instruments whichhave diffusion-restricted spaces, such as the hinged portion offorceps and scissors | |
| TrayModels | IntendedSterilizationCycles | Intended Tray Load | |
| ALLClearTechnologyExpress Cycle | |||
| STERRAD100NX and100NX withALLClearTechnology DuoCycle | Medical devices including:most flexible endoscopes with a single channel ofpolyethylene and Teflon (polytetrafluoroethylene) with≥ 1 mm ID and ≤ 875 mm in length accessory devices that are normally connected to aflexible endoscope during use flexible endoscopes without lumens |
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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 |
5. Summary of Technical Characteristics
The proposed PRO-LITE sterilization trays, sterilization mats and instrument organizers are identical in composition to the claimed predicate devices. The technical characteristics are summarized below in Table 5-5.
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| Feature | PRO-LITE Sterilization Tray(proposed / K231501) | PRO-LITE Sterilization Tray(predicate / K222440) | Comparison |
|---|---|---|---|
| The PRO-LITE Sterilization Trays are usedto contain medical devices for sterilization inthe following Cycles:• Lumen, Non Lumen, Flexible, Fast NonLumen, Fast and Specialty 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• Standard, Flex Scope, Express and DUOCycles of the STERRAD 100NX and100NX with ALLClear TechnologySterilizers | The PRO-LITE Sterilization Trays are usedto contain medical devices for sterilization inthe following Cycles:• Lumen, Non Lumen, Flexible, Fast NonLumen and Fast Cycles of the V-PRO LowTemperature Sterilization Systems• Default Cycle of the STERRAD®* 100SSterilizer• Standard and Advanced Cycles of theSTERRAD NX and NX with ALLClearTechnology Sterilizers• Standard, Flex Scope, Express and DUOCycles of the STERRAD 100NX and100NX with ALLClear TechnologySterilizers | Additionalclaims havebeen addedfor the V-PRO maX 2SpecialtyCycle - allotherindications foruse are thesame | |
| IntendedUse /Indicationsfor Use | *STERRAD and ALLClear are trademarksof Advanced Sterilization ProductsPrior to placing in the Sterilizer, the traysmust either be:• wrapped with a legally marketedsterilization wrap for use in the Sterilizerslisted aboveor• placed inside a legally marketed pouch forenclosing trays in the Sterilizers listedabove.The PRO-LITE Sterilization Trays are notintended to maintain sterility; they areintended to be used in conjunction with avalidated, FDA-cleared sterilization wrap orpouch in order to maintain sterility of theenclosed medical instruments.Intended Sterilization Cycles and IntendedTray Loads for Tray Models: VP0045,VP0046, VP0047, VP0048, VP0049,VP0050, VP0051, VP0052 | *STERRAD and ALLClear are trademarksof Advanced Sterilization ProductsPrior to placing in the Sterilizer, the traysmust either be:• wrapped with a legally marketedsterilization wrap for use in the Sterilizerslisted aboveor• placed inside a legally marketed pouch forenclosing trays in the Sterilizers listedabove.The PRO-LITE Sterilization Trays are notintended to maintain sterility; they areintended to be used in conjunction with avalidated, FDA-cleared sterilization wrap orpouch in order to maintain sterility of theenclosed medical instruments.Intended Sterilization Cycles and IntendedTray 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 hinged portionof forceps and scissors | V-PRO 60 and s2 Lumen Cycle:• Non-lumened devices with diffusion-restricted spaces such as the hinged portionof forceps and scissors | ||
| Feature | PRO-LITE Sterilization Tray(proposed / K231501) | PRO-LITE Sterilization Tray(predicate / K222440) | Comparison |
| • Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual andtriple channeled rigid and semi-rigidendoscopes with the followingconfigurations:o Single or dual channeled devices withstainless steel lumens that are:■ $\geq$ 0.77 mm ID and $\leq$ 410 mm in length■ $\geq$ 1.8 mm ID x $\leq$ 542 mm in lengtho Triple channeled devices with stainlesssteel 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 lengthor■ $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | • Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual andtriple channeled rigid and semi-rigidendoscopes with the followingconfigurations:o Single or dual channeled devices withstainless steel lumens that are:■ $\geq$ 0.77 mm ID and $\leq$ 410 mm in length■ $\geq$ 1.8 mm ID x $\leq$ 542 mm in lengtho Triple channeled devices with stainlesssteel lumens that are:■ $\geq$ 1.2 mm ID and $\leq$ 275 mm in length■ $\geq$ 1.8 mm ID and $\leq$ 310 mm in lengthor■ $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | ||
| V-PRO 60 and s2 Non Lumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spaces such as the hingedportion of forceps and scissors. | V-PRO 60 and s2 Non Lumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spaces such as the hingedportion of forceps and scissors. | ||
| V-PRO 60 and s2 Flexible Cycle:Load 1: One flexible surgical endoscope orbronchoscope with a light cord (if notintegral to endoscope) and mat without anyadditional load. The flexible endoscope maybe a:• Single or dual lumen device with lumensthat are $\geq$ 1 mm ID and $\leq$ 990 mm in lengthLoad 2: Non-lumened devices includingnon-lumened rigid, semi-rigid, and flexibleendoscopes and non-lumened devices withdiffusion-restricted areas such as the hingedportion of forceps or scissors. Medicaldevices, including rigid and semi-rigidendoscopes with the followingconfigurations:• $\geq$ 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 | V-PRO 60 and s2 Flexible Cycle:Load 1: One flexible surgical endoscope orbronchoscope with a light cord (if notintegral to endoscope) and mat without anyadditional load. The flexible endoscope maybe a:• Single or dual lumen device with lumensthat are $\geq$ 1 mm ID and $\leq$ 990 mm in lengthLoad 2: Non-lumened devices includingnon-lumened rigid, semi-rigid, and flexibleendoscopes and non-lumened devices withdiffusion-restricted areas such as the hingedportion of forceps or scissors. Medicaldevices, including rigid and semi-rigidendoscopes with the followingconfigurations:• $\geq$ 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 Cycles and IntendedTray Loads for Tray Models: VP0045,VP0046, VP0047, VP0048, VP0049 | Intended Sterilization Cycle and IntendedTray Load for Tray Models: VP0045,VP0046, VP0047, VP0048, VP0049 | ||
| Feature | PRO-LITE Sterilization Tray(proposed / K231501) | PRO-LITE Sterilization Tray(predicate / K222440) | Comparison |
| V-PRO s2 Fast Cycle: | V-PRO s2 Fast Cycle: | ||
| • Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes, and non-lumened devices withdiffusion-restricted areas such as thehinged portion of forceps and scissors. | • Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes, and non-lumened devices withdiffusion-restricted areas such as thehinged portion of forceps and scissors. | ||
| • Medical devices, including single, dual andtriple channeled rigid and semi-rigidendoscopes, with the followingconfigurations: | • Medical devices (including single, dualand triple channeled rigid and semi-rigidendoscopes) with the followingconfigurations: | ||
| o Single or dual channeled devices withstainless steel lumens | o Single or dual channeled devices withstainless steel lumens | ||
| ■ ≥ 0.77 mm ID and ≤ 410 mm in length | ■ ≥ 0.77 mm ID and ≤ 410 mm in length | ||
| ■ ≥ 1.8 mm ID and ≤ 542 mm in length | ■ ≥ 1.8 mm ID and ≤ 542 mm in length | ||
| o Triple channeled devices with stainlesssteel lumens | o Triple channeled devices with stainlesssteel lumens that are either | ||
| ■ ≥ 1.2 mm ID and ≤ 275 mm in length | ■ ≥ 1.2 mm ID and ≤ 275 mm in length | ||
| ■ ≥ 1.8 mm ID and ≤ 310 mm in length | ■ ≥ 1.8 mm ID and ≤ 310 mm in length | ||
| ■ ≥ 2.8 mm ID and ≤ 317 mm in length | ■ ≥ 2.8 mm ID and ≤ 317 mm in length | ||
| Intended Sterilization Cycles and IntendedTray Loads for Tray Models: VP0045,VP0046, VP0047, VP0048, VP0049,VP0050, VP0051, VP0052, VP0053 | Intended Sterilization Cycles and IntendedTray Load for Tray Models: VP0045,VP0046, VP0047, VP0048, VP0049,VP0050, VP0051, VP0052, VP0053 | ||
| V-PRO 1, 1 Plus, maX, and maX 2 LumenCycle: | V-PRO 1, 1 Plus, maX, and maX 2 LumenCycle: | ||
| • Non-lumened instruments with diffusion-restricted spaces such as the hinged portionof forceps and scissors | • Non-lumened devices with diffusion-restricted spaces such as the hinged portionof forceps and scissors | ||
| • Medical devices, including single, dual ortriple channeled stainless steel lumens thatare: | • Medical devices, including single, dual ortriple channeled stainless steel lumens thatare: | ||
| o ≥ 0.77 mm ID and ≤ 527 mm in length | o ≥ 0.77 mm ID and ≤ 527 mm in length | ||
| o ≥ 0.8 mm ID and ≤ 542 mm in length | o ≥ 0.8 mm ID and ≤ 542 mm in length | ||
| o ≥ 0.48 mm ID and ≤ 100 mm in length | o ≥ 0.48 mm ID and ≤ 100 mm in length | ||
| • Medical devices with dead end stainlesssteel lumens that are ≥ 1.3 mm ID and ≤ 73mm in length | • Medical devices with dead end stainlesssteel lumens that are ≥ 1.3 mm ID and ≤ 73mm in length | ||
| • Instruments with rigid non-metallic lumens(such as those used in endoscope sheaths,take-apart forceps and trocars) that are: | • Devices with rigid non-metallic lumens(such as those used in endoscope sheaths,take-apart forceps and trocars) that are: | ||
| o ≥ 3 mm ID and ≤ 298 mm in length | o ≥ 3 mm ID and ≤ 298 mm in length | ||
| o ≥ 4 mm ID and ≤ 424 mm in length | o ≥ 4 mm ID and ≤ 424 mm in length | ||
| V-PRO 1 Plus, maX, and maX 2 Non LumenCycle: | V-PRO 1 Plus, maX, and maX 2 Non LumenCycle: | ||
| Feature | PRO-LITE Sterilization Tray(proposed / K231501) | PRO-LITE Sterilization Tray(predicate / K222440) | Comparison |
| Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spaces such as the hingedportion of forceps and scissors | Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spaces such as the hingedportion of forceps and scissors | ||
| V-PRO maX, and maX 2 Flexible Cycle:Load 1: Single or dual lumen surgicalflexible endoscopes (such as those used inENT, Urology and Surgical Care) andbronchoscopes with a light cord (if notintegral to endoscope) and mat with noadditional load.The flexible endoscopes may contain either asingle or dual lumen that is ≥ 1 mm ID and ≤1050 mm in lengthLoad 2:• Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spaces such as thehinged portion of forceps and scissors• Single, dual or triple channel stainless steellumens that are ≥ 0.48 mm ID and ≤ 100mm in lengthIntended Sterilization Cycles and Intended | V-PRO maX, and maX 2 Flexible Cycle:Load 1: Single or dual lumen surgicalflexible endoscopes (such as those used inENT, Urology and Surgical Care) andbronchoscopes with a light cord (if notintegral to endoscope) and mat with noadditional load.The flexible endoscopes may contain either asingle or dual lumen that is ≥ 1 mm ID and ≤1050 mm in lengthLoad 2:• Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spaces such as thehinged portion of forceps and scissors• Single, dual or triple channel stainless steellumens that are ≥ 0.48 mm ID and ≤ 100mm in length | ||
| Tray Loads for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050 | |||
| V-PRO maX 2 Fast Non Lumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spaces such as the hingedportion of forceps and scissors. | V-PRO maX 2 Fast Non Lumen Cycle:Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spaces such as the hingedportion of forceps and scissors. | ||
| V-PRO maX 2 Specialty Cycle:Patient-specific surgical guides (e.g.osteotomy, shoulder, hip, knee, spine) oranatomical models fabricated via additivemanufacturing (3D printing) processes andintended for single-use during operativeprocedures. *orNon-lumened instruments including non-lumened general medical instruments, non- | |||
| Feature | PRO-LITE Sterilization Tray(proposed / K231501) | PRO-LITE Sterilization Tray(predicate / K222440) | Comparison |
| lumened rigid, semi-rigid and flexibleendoscopes.** | |||
| * The validation studies were conductedusing a validation load consisting of pouchedguide(s)/model(s) (with or without tray) for atotal weight of 5 lbs (2.3kg) 3D printedmaterial. | |||
| **The validation studies were conductedusing a validation load consisting of onepouched instrument tray or one pouch withguide(s)/model(s) (with or without tray) for atotal weight of 11 lbs (5kg). | |||
| • Formlabs Surgical Guide Resin, SpecialtyCycle F, Lumens $\ge$ 3 mm ID x $\le$ 30 mm L• Formlabs BioMed Amber Resin, SpecialtyCycle F, Lumens $\ge$ 3 mm ID x $\le$ 30 mm L• Formlabs Dental LT Clear V2 Resin,Specialty Cycle D, Lumens $\ge$ 3 mm ID x $\le$30 mm L• Formlabs BioMed Clear Resin, SpecialtyCycle D, Lumens $\ge$ 3 mm ID x $\le$ 30 mm L• Stratasys Biocompatible Clear MED610,Specialty Cycle E, Lumens $\ge$ 3 mm ID x $\le$20 mm L• Stratasys Biocompatible Clear MED610,Specialty Cycle E, Lumens $\ge$ 3 mm ID x $\le$20 mm L• Stratasys Biocompatible Opaque MED615RGD, Specialty Cycle E, Lumens $\ge$ 3 mmID x $\le$ 20 mm L Stratasys VeroGlazeMED620, Specialty Cycle E, Lumens $\ge$ 3mm ID x $\le$ 20 mm L | |||
| Intended Sterilization Cycles and IntendedTray Loads for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052 | Intended Sterilization Cycles and IntendedTray Load for Tray Models: VP0045,VP0046, VP0047, VP0048, VP0049,VP0050, VP0051, VP0052 | ||
| STERRAD 100S Default Cycle:Metal and nonmetal medical devicesincluding instruments which have diffusion-restricted spaces, such as the hinged portionof forceps and scissors. Metal and nonmetallumened instruments with• $\ge$ 6 mm ID and $\le$ 310 mm in length | STERRAD 100S Default Cycle:Metal and nonmetal medical devicesincluding instruments which have diffusion-restricted spaces, such as the hinged portionof forceps and scissors. Metal and nonmetallumened instruments with• $\ge$ 6 mm ID and $\le$ 310 mm in length | ||
| Feature | PRO-LITE Sterilization Tray(proposed / K231501) | PRO-LITE Sterilization Tray(predicate / K222440) | Comparison |
| Medical devices with a single stainless steellumen 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 | Medical devices with a single stainless steellumen 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 IntendedTray Loads for Tray Models:VP0045, VP0046, VP0048, VP0049 | Intended Sterilization Cycles and IntendedTray Load for Tray Models: VP0045,VP0046, VP0048, VP0049 | ||
| STERRAD NX and NX with ALLClearTechnology Standard Cycle:Metal and non-metal medical devicesincluding instruments which have diffusion-restricted spaces, such as the hinged portionof forceps and scissors.Medical devices with a single stainless steellumen with:• ≥ 1 mm ID and ≤ 150 mm in length• ≥ 2 mm ID and ≤ 400 mm in length | STERRAD NX and NX with ALLClearTechnology Standard Cycle:Metal and non-metal medical devicesincluding instruments which have diffusion-restricted spaces, such as the hinged portionof forceps and scissors.Medical devices with a single stainless steellumen with:• ≥ 1 mm ID and ≤ 150 mm in length• ≥ 2 mm ID and ≤ 400 mm in length | ||
| STERRAND NX and NX with ALLClearTechnology Advanced Cycle:Metal and non-metal medical devicesincluding instruments which have diffusion-restricted spaces, such as the hinged portionof forceps and scissorsMedical devices, including most flexibleendoscopes, with:o a single stainless steel lumen with:○ ≥ 1 mm ID and ≤ 500 mm in lengtho single channel polyethylene and Teflon(polytetrafluoroethylene)○ ≥ 1mm ID and ≤ 850 mm in length | STERRAND NX and NX with ALLClearTechnology Advanced Cycle:Metal and non-metal medical devicesincluding instruments which have diffusion-restricted spaces, such as the hinged portionof forceps and scissorsMedical devices, including most flexibleendoscopes, with:o a single stainless steel lumen with:○≥ 1 mm ID and ≤ 500 mm in lengtho single channel polyethylene and Teflon(polytetrafluoroethylene)○ ≥ 1mm ID and ≤ 850 mm in length | ||
| Intended Sterilization Cycles and IntendedTray Loads for Tray Models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0051, VP0052, VP0053 | Intended Sterilization Cycles and IntendedTray Load for Tray Models: VP0045,VP0046, VP0048, VP0049, VP0051,VP0052, VP0053 | ||
| STERRAD 100NX and 100NX withALLClear Technology Standard Cycle:Metal and nonmetal medical devicesincluding instruments with have diffusion-restricted spaces, such as the hinged portionof forceps and scissorsMedical devices with a single stainless steellumen with: | STERRAD 100NX and 100NX withALLClear Technology Standard Cycle:Metal and nonmetal medical devicesincluding instruments with have diffusion-restricted spaces, such as the hinged portionof forceps and scissorsMedical devices with a single stainless steellumen with: | ||
| Feature | PRO-LITE Sterilization Tray(proposed / K231501) | PRO-LITE Sterilization Tray(predicate / K222440) | Comparison |
| • ≥ 0.7 mm ID and ≤ 500 mm in length | • ≥ 0.7 mm ID and ≤ 500 mm in length | ||
| STERRAD 100NX and 100NX withALLClear Technology Flex Scope Cycle:Metal and nonmetal medical devicesincluding instruments which have diffusion-restricted spaces, such as the hinged portionof forceps and scissors.Medical devices, including most flexibleendoscopes, with:• Single channel polyethylene and Teflon(polytetrafluoroethylene)○ ≥ 1mm ID and ≤ 850 mm in length | STERRAD 100NX and 100NX withALLClear Technology Flex Scope Cycle:Metal and nonmetal medical devicesincluding instruments which have diffusion-restricted spaces, such as the hinged portionof forceps and scissors.Medical devices, including most flexibleendoscopes, with:• Single channel polyethylene and Teflon(polytetrafluoroethylene)○ ≥ 1mm ID and ≤ 850 mm in length | ||
| STERRAD 100NX and 100NX withALLClear Technology Express Cycle:Metal and nonmetal devices surfaces andinstruments which have diffusion-restrictedspaces, such as the hinged portion of forcepsand scissors. | STERRAD 100NX and 100NX withALLClear Technology Express Cycle:Metal and nonmetal devices surfaces andinstruments which have diffusion-restrictedspaces, such as the hinged portion of forcepsand scissors. | ||
| STERRAD 100NX and 100NX withALLClear Technology Duo Cycle:Medical devices including:• most flexible endoscopes with a singlechannel of polyethylene and Teflon(polytetrafluoroethylene) with ≥ 1 mm IDand ≤ 875 mm in length• accessory devices that are normallyconnected to a flexible endoscope duringuse• flexible endoscopes without lumens | STERRAD 100NX and 100NX withALLClear Technology Duo Cycle:Medical devices including:• most flexible endoscopes with a singlechannel of polyethylene and Teflon(polytetrafluoroethylene) with ≥ 1 mm IDand ≤ 875 mm in length• accessory devices that are normallyconnected to a flexible endoscope duringuse• flexible endoscopes without lumens | ||
| Vent toVolumeRatio | All trays are the same:0.135 in-1 | All trays are the same:0.135 in-1 | Same |
| TrayComposition | Mineral-filled polypropylene, stainless steel | Mineral-filled polypropylene, stainless steel | Same |
| InstrumentOrganizerComposition | Medical Grade Silicone, USP grade VI | Medical Grade Silicone, USP grade VI | Same |
| MatComposition | Medical Grade Silicone, USP grade VI | Medical Grade Silicone, USP grade VI | Same |
Table 5-5. Summary of Tray Physical Description and Technological Properties
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6. Summary of Non-clinical Tests
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Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-5 below.
| Test | Result | Conclusion |
|---|---|---|
| Demonstrationof EffectiveSterilantPenetration | Cycle specific test articles shall be reproduciblysterilized under ½ cycle conditions for the V-PROmaX 2 Specialty Cycle | PASS |
Table 5-5. Summary of Non-clinical Testing
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K222440), 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).