(84 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 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 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 V-PRO ● or STERRAD Sterilization Systems. or
- . placed inside a legally marketed pouch for enclosing trays in the V-PRO or STERRAD Sterilization Systems.
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 (K172755) 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PRO-LITE Sterilization Tray:
The document (K183402) is not a multi-reader multi-case comparative effectiveness study nor does it describe a standalone algorithm performance study. It's a 510(k) premarket notification for a medical device (sterilization tray) aiming to demonstrate substantial equivalence to a predicate device. Therefore, questions related to AI-specific metrics, expert ground truth adjudication methods, and training set information are not applicable to this type of submission.
The study focuses on the physical and functional performance of the sterilization tray itself when used with specific sterilization systems.
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Demonstration of Effective Sterilant Penetration | Cycle-specific test articles shall be reproducibly sterilized under ½ cycle conditions for the: • STERRAD 100S Default Cycle • STERRAD NX Standard Cycle • STERRAD NX Advanced Cycle • STERRAD 100NX Standard Cycle • STERRAD 100NX Flex Scope Cycle • STERRAD 100NX Express Cycle • STERRAD 100NX Duo Cycle | PASS |
| Package Integrity Maintenance of Package Integrity | Not applicable. The Sterilization Tray meets the definition of a “tray” in ANSI/AAMI ST77:2013, “Containment devices for reusable medical device sterilization,” therefore package integrity and maintenance of package integrity testing are not applicable. | N/A (Not Applicable) |
| Demonstration of Effective Drying and Aeration | Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst-case Sterilizer Cycle conditions. | PASS |
| Demonstration of Material Compatibility | After processing through multiple worst-case sterilization cycles, the trays and accessories shall retain functionality. | PASS |
| Demonstration of Biocompatibility | Component materials shall be non-cytotoxic after exposure to worst-case Sterilizer Conditions. | PASS |
| Demonstration of Effective Cleaning | Sterilization Trays and accessories must be clean following automated and manual cleaning. | PASS |
Additional Information Not Applicable to This Document:
- Sample sizes used for the test set and the data provenance: This information is not provided in a way that relates to an "AI test set." The study involves physical testing of devices with sterilization cycles. The number of sterilization cycles and units tested for each criterion would be part of detailed test protocols, not typically summarized in this FDA 510(k) summary. Data provenance is not specified beyond being "non-clinical tests."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device is established through scientific and engineering tests (e.g., microbial log reduction for sterility, chemical analysis for residuals, functional testing for material compatibility).
- Adjudication method for the test set: Not applicable. Decisions are based on objective measurement against defined criteria, not expert adjudication of subjective assessments.
- 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. This is not an AI device or an imaging device involving human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used: For "Demonstration of Effective Sterilant Penetration," the ground truth would be based on validated biological indicator (BI) testing (e.g., showing a 10^-6 or greater sterility assurance level, typically through half-cycle challenges). For "Drying and Aeration" it's chemical analysis (residual H2O2). For "Material Compatibility" it's functional assessment and integrity checks. For "Biocompatibility" it's laboratory assays (e.g., cytotoxicity tests). For "Cleaning," it's visual inspection and potentially tests for residual soil/protein.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable. This is not an AI device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 25, 2019
STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060
Re: K183402
Trade/Device Name: PRO-LITE Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: FRG Dated: December 6, 2018 Received: December 7, 2018
Dear Jennifer Nalepka:
This letter corrects our substantially equivalent letter of March 1, 2019.
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
{1}------------------------------------------------
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183402
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 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, 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, VP0049, VP0050, VP0050, VP0051, VP0052
V-PRO 60 & s2 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 endoscopes, with the following configurations:
- · single or dual lumen devices
- · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length
- · triple lumen devices
- ≥ 1.2 mm ID and ≤ 275 mm in length
- ≥ 1.8 mm ID and ≤ 310 mm in length
- · single or dual lumen devices
-
≥ 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 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, semi-rigid, and flexible endoscopes and non-lumened devices
{3}------------------------------------------------
with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following dimensions:
- ≥ 2 mm ID and ≤ 400 mm in length
- ≥ 0.76 mm ID and < 233 mm in length
- ≥ 1.0 mm ID and ≤ 254 mm in length
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0046, VP0047, VP0049, VP0049, VP0049
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 or scissors.
- · 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
- · 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
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050, VP0050, VP0051, VP0052, VP0053
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 endoscopes, with the following configurations:
- · single or dual lumen devices
- · ≥ 0.77 mm internal diameter (ID) and ≤ 527 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
- · single or dual lumen devices
V-PRO 1 Plus, maX & maX 2 Non Lumen Cycle
Non-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
V-PRO maX & 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 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 ≥ 1 mm ID and ≤ 850 mm in length
Load 2: Non-luments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
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 stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.
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Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052
STERRAD 100S Default Cycle
- · Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Metal and non metal 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 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
- · a single stainless steel lumen with:
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0047, VP0047, VP0048, VP0049, VP0051, VP0052, VP0053
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
- · Single channel polyethylene and Teflon (polytetrafluoroethylene)
STERRAD 100NX and 100NX with ALLClear Technology Express Cycle
-
· Metal and nonmetal medical 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:
{5}------------------------------------------------
- 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 Sterlization 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 |
| 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K183402 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
Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist
Telephone: (440) 392-7458 Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com
Submission Date: December 6, 2018
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, K172755
Reference Device: PRO-LITE Sterilization Tray, K183301
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 (NOTE: the V-PRO s2 ● Low Temperature Sterilization System claims are under review in a concurrent premarket notification, K183301).
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 1, to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Trav (K172755) 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 trav is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or
{8}------------------------------------------------
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) |
|---|---|---|---|
| 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 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 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 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 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 3. Silicone Mat Model Numbers | ||
|---|---|---|
The purpose of this submission is to add claims for the use of these tray models in the following sterilizer cycles:
- STERRAD 100S Sterilizer Default Cycle
{9}------------------------------------------------
- . 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
4. 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 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 V-PRO ● or STERRAD Sterilization Systems. or
- . placed inside a legally marketed pouch for enclosing trays in the V-PRO or STERRAD Sterilization Systems.
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.
| Tray Models | IntendedSterilizationCycles | Intended Tray Load |
|---|---|---|
| VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052 | V-PRO 60and s2 LumenCycle | · Instruments with diffusion-restricted spaces such as thehinged portion of forceps and scissors· Non-lumened devices including non-lumened rigid andsemi-rigid endoscopes· Medical devices, including single, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:o single or dual lumen devices· ≥ 0.77 mm ID and ≤ 410 mm in lengtho triple lumen devices· ≥ 1.2 mm ID and ≤ 275 mm in length· ≥ 1.8 mm ID and ≤ 310 mm in lengthor· > 2.8 mm ID and ≤ 317 mm in length |
| Tray Models | IntendedSterilizationCycles | Intended Tray Load |
| V-PRO 60and s2 NonLumen 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 60and s2FlexibleCycle | Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:o single or dual lumen device with lumens that are $≥$ 1 mm ID and $≤$ 990 mm in lengthLoad 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:o $≥$ 2.0 mm ID and $≤$ 400 mm in lengtho $≥$ 1.0 mm ID and $≤$ 254 mm in lengtho $≥$ 0.76 mm ID and $≤$ 233 mm in length | |
| VP0045VP0046VP0047VP0048VP0049 | V-PRO s2Fast 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:o single or dual lumen devices▪ $≥$ 0.77 mm internal diameter (ID) and $≤$ 410 mm in lengtho 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 &maX 2Lumen 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:o single or dual lumen devices▪ $≥$ 0.77 mm ID and $≤$ 527 mm in lengtho triple lumen devices▪ $≥$ 1.2 mm ID and $≤$ 275 mm in length▪ $≥$ 1.8 mm ID and $≤$ 310 mm in lengthor▪ $≥$ 2.8 mm ID and $≤$ 317 mm in length |
| Tray Models | IntendedSterilizationCycles | Intended Tray Load |
| V-PRO 1Plus, maX &maX 2 NonLumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened deviceswith stainless steel or titanium diffusion-restricted spacessuch as the hinged portion of forceps and scissors. | |
| V-PRO maX& maX 2FlexibleCycle | Load 1: Single or dual lumen surgical flexibleendoscopes (such as those used in ENT, Urology andSurgical Care) and bronchoscopes with a light cord (if notintegral to endoscope) and mat with no additional load.The flexible endoscopes may contain either:a single lumen that is $\ge$ 1 mm ID and $\le$ 1050 mm inlength or two lumens with: one lumen that is $\ge$ 1 mm ID and $\le$ 990 mm in length and the other lumen that is $\ge$ 1 mm ID and $\le$ 850 mm in lengthLoad 2: Non-lumened instruments including instruments | |
| with diffusion-restricted areas such as the hinged portionof forceps or scissors. | ||
| V-PRO maX2 Fast NonLumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened deviceswith stainless steel or titanium diffusion-restricted spacessuch as the hinged portion of forceps and scissors. | |
| VP0045VP0046VP0047VP0048VP0049VP0050VP0051VP0052 | STERRAD100S DefaultCycle | Metal and nonmetal medical devices includinginstruments which have diffusion-restricted spaces, suchas the hinged portion of forceps and scissors.Metal and nonmetal lumened instruments with:$\ge$ 6 mm ID and $\le$ 310 mm in lengthMedical devices with a single stainless steel lumen with: $\ge$ 1 mm ID and $\le$ 125 mm in length $\ge$ 2 mm ID and $\le$ 250 mm in length $\ge$ 3 mm ID and $\le$ 400 mm in length |
| VP0045VP0046VP0048VP0049 | STERRADNX and NXwithALLClearTechnologyStandardCycle | Metal and nonmetal medical devices includinginstruments which have diffusion-restricted spaces, suchas the hinged portion of forceps and scissors.Medical devices with a single stainless steel lumen with: $\ge$ 1 mm ID and $\le$ 150 mm in length $\ge$ 2 mm ID and $\le$ 400 mm in length |
| VP0048VP0049 | STERRADNX and NXwithALLClearTechnology | Metal and nonmetal medical devices includinginstruments which have diffusion-restricted spaces, suchas the hinged portion of forceps and scissors.Medical Devices, including most flexible endoscopes,with: |
| Tray Models | IntendedSterilizationCycles | Intended Tray Load |
| AdvancedCycle | $\geq$ 1 mm ID and $\leq$ 500 mm in length Single channel polyethylene and Teflon(polytetrafluoroethylene) $\geq$ 1 mm ID and $\leq$ 850 mm in length | |
| STERRAD100NX and100NX withALLClearTechnologyStandardCycle | Metal and nonmetal medical devices includinginstruments which have diffusion-restricted spaces, suchas 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 | |
| VP0045VP0046VP0047VP0048VP0049VP0051VP0052VP0053 | STERRAD100NX and100NX withALLClearTechnologyFlex ScopeCycle | Metal and nonmetal medical devices includinginstruments which have diffusion-restricted spaces, suchas the hinged portion of forceps and scissors.Medical Devices, including most flexible endoscopes,with: Single channel polyethylene and Teflon(polytetrafluoroethylene) $\geq$ 1 mm ID and $\leq$ 850 mm in length |
| STERRAD100NX and100NX withALLClearTechnologyExpressCycle | Metal and nonmetal medical devices surfaces andinstruments which have diffusion-restricted spaces, suchas the hinged portion of forceps and scissors. | |
| STERRAD100NX and100NX withALLClearTechnologyDuo Cycle | Medical devices including: most flexible endoscopes with a single channel ofpolyethylene and Teflon (polytetrafluoroethylene)with $\geq$ 1 mm ID and $\leq$ 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 |
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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 |
ട. Technological 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.
| Table 5. Technical Characteristic Comparison Table | ||||
|---|---|---|---|---|
| -- | -- | ---------------------------------------------------- | -- | -- |
| Feature | PRO-LITE Sterilization Tray(K183402) | PRO-LITE Sterilization Tray(K172755) |
|---|---|---|
| Indicationsfor Use | The PRO-LITE Sterilization Trays areused to contain medical devices forsterilization in the following Cycles:• Lumen, Non Lumen, Flexible, FastNon Lumen and Fast Cycles of theV-PRO® Low TemperatureSterilization Systems• Default Cycle of the STERRAD*100S Sterilizer• Standard and Advanced Cycles ofthe STERRAD NX and NX withALLClear Technology Sterilizers• Standard, Flex Scope, Express andDUO Cycles of the STERRAD100NX and 100NX with ALLClearTechnology Sterilizers* STERRAD and ALLClear aretrademarks of Advanced SterilizationProductsPrior to placing in the Sterilizer, thetrays must either be:• wrapped with a legally marketedsterilization wrap for use in the V-PRO or STERRAD SterilizationSystems• placed inside a legally marketedpouch for enclosing trays in the V- | The PRO-LITE Sterilization Trays areused to contain medical devices forsterilization in the Lumen, Non Lumen,Flexible and Fast Non Lumen Cyclesof the V-PRO Low TemperatureSterilization Systems. Prior to placingin the Sterilizer, the trays must eitherbe:• wrapped with a legally marketedsterilization wrap for use in the V-PRO Low Temperature SterilizationSystems or• placed inside a legally marketedpouch for enclosing trays in the V-PRO Low Temperature SterilizationSystems. |
| Feature | PRO-LITE Sterilization Tray(K183402) | PRO-LITE Sterilization Tray(K172755) |
| PRO or STERRAD SterilizationSystems. | ||
| The PRO-LITE Sterilization Trays arenot intended to maintain sterility; theyare intended to be used in conjunctionwith a validated, FDA-clearedsterilization wrap or pouch in order tomaintain sterility of the enclosedmedical instruments. | The PRO-LITE Sterilization Trays arenot intended to maintain sterility; theyare intended to be used in conjunctionwith a validated, FDA-clearedsterilization wrap or pouch in order tomaintain sterility of the enclosedmedical instruments. | |
| Intended Sterilization Cycles andIntended Tray Loads for Tray models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052 | Intended Sterilization Cycles andIntended Tray Loads for Tray models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052 | |
| 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 | V-PRO 60 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■ ≥ 0.77 mm internal diameter (ID)and ≤ 410 mm in lengtho triple lumen devices■ ≥1.2 mm ID and ≤ 275 mm inlength■ ≥1.8 mm ID and ≤ 310 mm inlengthor■ ≥ 2.8 mm ID and ≤ 317 mm inlength | • Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes, with thefollowing configurations:> single or dual lumen devices≥ 0.77 mm ID and less than orequal to 410 mm in length> triple lumen devices≥1.2 mm ID and less than or equalto 275 mm in length≥1.8 mm ID and less than or equalto 310 mm in lengthor≥2.8 mm ID and less than or equalto 317 mm in length | |
| lengthV-PRO 60 & 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 & s2 Flexible Cycle: | to 317 mm in lengthV-PRO 60 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.V-PRO 60 Flexible Cycle | |
| Feature | PRO-LITE Sterilization Tray(K183402) | PRO-LITE Sterilization Tray(K172755) |
| Load 1: One flexible surgicalendoscope or bronchoscope with alight cord (if not integral to endoscope)and mat without any additional load.The flexible endoscope may be a:o single or dual lumen device withlumens that are $\ge$ 1 mm ID and $\le$990 mm in length | - One flexible surgical endoscope orbronchoscope with a light cord (if notintegral to endoscope) and matwithout any additional load. Theflexible endoscope may be a single ordual lumen device with lumens thatare $\ge$ 1 mm ID and less than or equal990 mm in length | |
| Load 2: Non-lumened devicesincluding non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hingedportion of forceps or scissors. Medicaldevices, including rigid and semi-rigidendoscopes, with the followingconfigurations:o $\ge$ 2 mm ID and $\le$ 400 mm in lengtho $\ge$ 0.76 mm ID and $\le$ 233 mm inlengtho $\ge$ 1.0 mm ID and $\le$ 254 mm inlength | ||
| Intended Sterilization Cycles andIntended Tray Loads for Tray models:VP0045, VP0046, VP0047, VP0048,VP0049 | ||
| V-PRO s2 Fast Cycle:• Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscope, and non-lumeneddevices with diffusion-restrictedareas such as the hinged portion offorceps or scissors• 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 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 | ||
| Feature | PRO-LITE Sterilization Tray(K183402) | PRO-LITE Sterilization Tray(K172755) |
| ■ ≥2.8 mm ID and ≤ 317 mm inlength | ||
| Intended Sterilization Cycles andIntended Tray Loads for Tray models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052,VP0053 | Intended Sterilization Cycles andIntended Tray Loads for Tray models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0050, VP0051, VP0052,VP0053 | |
| V-PRO 1, 1 Plus, maX & maX 2Lumen 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■ ≥ 0.77 mm ID and ≤ 527 mm inlengtho triple lumen devices■ ≥ 1.2 mm ID and ≤ 275 mm inlength■ ≥ 1.8 mm ID and ≤ 310 mm inlengthor■ ≥2.8 mm ID and ≤ 317 mm inlength | V-PRO 1, 1 Plus, maX, & maX 2Lumen Cycle• Instruments with diffusion-restrictedspaces such as thehinged portion of forceps andscissors• Non-lumened devices including non-lumened rigid and semi-rigidendoscopes• Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes, with the followingconfigurations:➤ single or dual lumen devices≥ 0.77 mm ID and less than orequal to 527 mm in length➤ triple lumen devices≥1.2 mm ID and less than or equalto 275 mm in length≥1.8 mm ID and less than or equalto 310 mm in lengthor≥2.8 mm ID and less than or equalto 317 mm in length | |
| V-PRO 1, 1 Plus, maX & 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 1 Plus, maX, & maX 2 NonLumen CycleNon-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 1, 1 Plus, maX & maX 2Flexible Cycle:Load 1: Single or dual lumen surgicalflexible endoscopes (such as thoseused in ENT, Urology and Surgical | V-PRO maX & maX 2 Flexible CycleLoad 1: Single or dual lumen surgicalflexible endoscopes (such as thoseused in ENT, Urology and Surgical | |
| Feature | PRO-LITE Sterilization Tray(K183402) | PRO-LITE Sterilization Tray(K172755) |
| 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 lumen that is $\ge$ 1 mm ID and $\le$ 1050 mm in length• or two lumens with:■ one lumen that is $\ge$ 1 mm ID and $\le$ 990 mm in length■ and the other lumen that is $\ge$ 1 mm ID and $\le$ 850 mm in lengthLoad 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. | bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.The flexible endoscopes may contain either:a single lumen that is $\ge$ 1 mm ID and less than or equal 1050 mm in lengthor two lumens with:one lumen that is $\ge$ 1 mm ID and less than or equal 990 mm in lengthand the other lumen that is $\ge$ 1 mm ID and less than or equal 850 mm in lengthLoad 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. | |
| 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 stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | V-PRO maX 2 Fast Non LumenNon-lumened devices including non-lumened rigids, semi-rigids and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | |
| Intended Sterilization Cycles and Intended Tray Loads for Tray models:VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052 | Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the PRO-LITE Sterilization Trays. | |
| STERRAD 100S Default Cycle:• Metal and nonmetal devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.• Metal and nonmetal lumened instruments with:○ $\ge$ 6 mm ID and $\le$ 310 mm in | Sterilization mats are optional accessories intended to cushion and stabilize instruments within the PRO-LITE Sterilization Trays. | |
| length• Medical devices with a single stainless steel lumen with:○ $\ge$ 1 mm ID and $\le$ 125 mm in length○ $\ge$ 2 mm ID and $\le$ 250 mm in length | ||
| Feature | PRO-LITE Sterilization Tray(K183402) | PRO-LITE Sterilization Tray(K172755) |
| $\geq$ 3 mm ID and $\leq$ 400 mm inlength | ||
| Intended Sterilization Cycles andIntended Tray Loads for Tray models:VP0045, VP0046, VP0048, VP0049 | ||
| STERRAD NX and NX withALLClear Technology StandardCycle : | ||
| • Metal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such asthe hinged portion of forceps andscissors. | ||
| • Medical devices with a singlestainless steel lumen with:$\circ$ $\geq$ 1 mm ID and $\leq$ 150 mm inlength$\circ$ $\geq$ 2 mm ID and $\leq$ 400 mm inlength | ||
| STERRAD NX and NX withALLClear Technology AdvancedCycle : | ||
| Metal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such as thehinged portion of forceps and scissors.Medical Devices, including mostflexible endoscopes, with:• a single stainless steel lumen with:$\circ$ $\geq$ 1 mm ID and $\leq$ 500 mm inlength• Single channel polyethylene andTeflon (polytetrafluoroethylene)$\circ$ $\geq$ 1 mm ID and $\leq$ 850 mm inlength | ||
| Intended Sterilization Cycles andIntended Tray Loads for Tray models:VP0045, VP0046, VP0047, VP0048,VP0049, VP0051, VP0052, VP0053 | ||
| STERRAD 100NX and 100NX withALLClear Technology StandardCycle : | ||
| Feature | PRO-LITE Sterilization Tray(K183402) | PRO-LITE Sterilization Tray(K172755) |
| 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 withALLClear 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 withALLClear Technology Express Cycle:Metal and nonmetal medical devices surfaces and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. | ||
| STERRAD 100NX and 100NX withALLClear 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 medical instruments with in the Sterilization Trays | ||
| Feature | PRO-LITE Sterilization Tray(K183402) | PRO-LITE Sterilization Tray(K172755) |
| Sterilization mats are optionalaccessories intended to cushion andstabilize instruments within theSterilization Trays. | ||
| Vent toVolumeRatio | All trays are the same:$0.135 \text{ in}^{-1}$ | All trays are the same:$0.135 \text{ in}^{-1}$ |
| TrayComposition | Mineral-filled polypropylene, stainlesssteel | Mineral-filled polypropylene, stainlesssteel |
| InstrumentOrganizerComposition | Medical Grade Silicone, USP grade VI | Medical Grade Silicone, USP grade VI |
| MatComposition | Medical Grade Silicone, USP grade VI | Medical Grade Silicone, USP grade VI |
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Summary of Non-clinical Tests 6.
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5 below.
Table 5. Summary of Non-clinical Testing
| Table 5. Summary of Non-clinical Testing | ||
|---|---|---|
| Test | Acceptance Criteria | Conclusion |
| Demonstrationof EffectiveSterilantPenetration | Cycle specific test articles shall be reproduciblysterilized under $\frac{1}{2}$ cycle conditions for the:• STERRAD 100S Default Cycle• STERRAD NX Standard Cycle• STERRAD NX Advanced Cycle• STERRAD 100NX Standard Cycle• STERRAD 100NX Flex Scope Cycle• STERRAD 100NX Express Cycle• STERRAD 100NX Duo Cycle | PASS |
| PackageIntegrityMaintenance ofPackageIntegrity | Not applicable. The Sterilization Tray meets the definition of a“tray” in ANSI/AAMI ST77:2013, Containment devices for reusablemedical device sterilization, therefore package integrity andmaintenance of package integrity testing are not applicable | |
| Demonstrationof EffectiveDrying andAeration | Residual hydrogen peroxide levels shall be belowacceptable levels after exposure to worst case SterilizerCycle conditions | PASS |
| Demonstrationof MaterialCompatibility | After processing through multiple worst casesterilization cycles, the trays and accessories shallretain functionality | PASS |
| DemonstrationofBiocompatibility | Component materials shall be non-cytotoxic afterexposure to worst case Sterilizer Conditions | PASS |
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| Demonstrationof EffectiveCleaning | Sterilization Trays and accessories must be cleanfollowing automated and manual cleaning | PASS |
|---|---|---|
| ------------------------------------------- | ---------------------------------------------------------------------------------------------- | ------ |
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 (K172755), 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).