(37 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
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: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2, V-PRO 60 and V-PRO s2 Low Temperature Sterilization Systems. 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 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 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 are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. 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.
The provided text describes the PRO-LITE Sterilization Tray and its performance in various sterilization cycles. There is no information about an AI/ML device in the document. Therefore, I cannot provide details on sample size for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies, as these are not relevant to the described device.
However, I can provide the acceptance criteria and reported device performance based on the provided "Summary of Non-clinical Tests" table.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Demonstration of Effective Sterilant Penetration | ||
| V-PRO s2 Sterilizer Fast Cycle | Worst case stainless steel lumen test articles shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Fast Cycle. | PASS |
| Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Fast Cycle. | PASS | |
| Contact points between medical devices and tray accessories shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Fast Cycle. | PASS | |
| Worst case surface sterilization test articles shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Fast cycle. | PASS | |
| V-PRO 60 & s2 Sterilizer Non Lumen Cycle, diffusion-restricted spaces claims | Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Non Lumen Cycle. | PASS |
| V-PRO 60 & s2 Sterilizer Flexible Cycle, diffusion-restricted spaces claims | Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Flexible Cycle. | PASS |
| V-PRO 60 & s2 Sterilizer Flexible Cycle Extended Claims | Stainless steel test articles shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Flexible Cycle. | PASS |
| 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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes the performance testing for a sterilization tray, which does not typically involve test sets, data provenance, or data types like those associated with AI/ML or clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document and is not relevant to the type of device described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document and is not relevant to the type of device described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document and is not relevant to the type of device described, which is a sterilization tray, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document and is not relevant as it is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Demonstration of Effective Sterilant Penetration" tests, the ground truth is implicitly defined by the ability to achieve "reproducible sterilization" of test articles/spaces under specified worst-case conditions. This is a direct measurement of sterility, likely using biological indicators or similar validated methods, rather than expert consensus or pathology in a clinical sense. For other tests like drying, material compatibility, biocompatibility, and cleaning, the ground truth involves objective measurements against established engineering and regulatory standards (e.g., residual hydrogen peroxide levels below acceptable levels, retention of functionality, non-cytotoxicity, visual cleanliness, etc.).
8. The sample size for the training set
This information is not provided in the document and is not relevant as it is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided in the document and is not relevant as it is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
January 3, 2019
STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K183301
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: November 26, 2018 Received: November 27, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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.
Elizabeth F. Claverie -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) K183301
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
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
or
- ≥ 2.8 mm ID and ≤ 317 mm in length
V-PRO 60 & s2 Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with 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 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
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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 ≤ 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
- Or
- ≥ 2.8 mm ID and ≤ 317 mm in length
- · single or dual lumen devices
V-PRO 1, 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 1, 1 Plus, 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:
The flexible endoscopes may contain either:
-
1-lumen with 1 > ID > 1050
-
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-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.
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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 |
| 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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STE
510(k) Summary For K183301 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: Senior Regulatory Affairs Specialist
Telephone: (440) 392-7458 Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com
Submission Date: November 26, 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
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, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2, V-PRO 60 and V-PRO s2 Low Temperature Sterilization Systems. 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 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 tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material.
| Model | Description (in) | Model | Description (in) |
|---|---|---|---|
| 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.
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| 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 |
Table 5.2. Instrument Organizer Model Numbers
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.
Table 5-3. Silicone Mat Model Numbers
| 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 |
The purpose of this submission is to add claims for the use of tray models in the V-PRO Sterilizers for:
- Qualification for use with devices having stainless steel lumens of the following configurations:
- o > 2.0 mm ID and ≤ 400 mm in length
- o ≥1.0 mm ID and ≤ 254 mm in length
- o > 0.76 mm ID and ≤ 233 mm in length
in the V-PRO 60 and V-PRO s2 Sterilizer Flexible Cycle
- Qualification of use with diffusion-restricted spaces in addition to stainless ● steel and titanium when used in the V-PRO 60 and V-PRO s2 Sterilizer Non Lumen Cycle and Flexible Cycle.
- Oualification of use in the V-PRO s2 Sterilizer Fast Cycle
- Addition of the V-PRO s2 Sterilizer to the indications for use in the Lumen ● Cycle
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| Cycle | Most RecentPremarketNotificationClearance | V-PRO 60 | V-PRO s2 |
|---|---|---|---|
| Lumen Cycle | X | X | |
| Non Lumen Cycle | K172319 | X | X |
| Flexible Cycle | X | X | |
| Fast Cycle | ConcurrentSubmission(K182528) | X |
| Table 5-4: V-PRO Cycles Provided V-PRO 60 and s2 Sterilizers | |
|---|---|
| -------------------------------------------------------------- | -- |
- Shaded cell indicates that the V-PRO Sterilizer does not include the identified cycle.
NOTE: V-PRO Sterilizer cycles are pre-set and thus the name of the cycle describes the cycle conditions.
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
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 &s2 LumenCycle | • Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeledrigid and semi-rigid endoscopes, with the followingconfigurations:o single or dual lumen devices• ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in lengtho triple lumen devices |
| TrayModels | IntendedSterilizationCycles | Intended Tray Load |
| ≥1.2 mm ID and ≤ 275 mm in length ≥1.8 mm ID and ≤ 310 mm in length or≥2.8 mm ID and ≤ 317 mm in length | ||
| V-PRO 60 &s2 NonLumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps andscissors. | |
| V-PRO 60 &s2 FlexibleCycle | Load 1: One flexible surgical endoscope or bronchoscope with alight 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 IDand ≤ 990 mm in lengthLoad 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices withdiffusion-restricted areas such as the hinged portion of forceps orscissors. Medical devices, including rigid and semi-rigidendoscopes, with the following configurations:○ ≥ 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 | |
| VP0045VP0046VP0047VP0048VP0049 | V-PRO s2Fast Cycle | Non-lumened devices including non-lumened rigid, semi-rigidand flexible endoscope, and non-lumened devices withdiffusion-restricted areas such as the hinged portion of forceps orscissors Medical devices, including single, dual and triple channeledrigid and semi-rigid endoscopes, with the followingconfigurations: 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 or≥2.8 mm ID and ≤ 317 mm in length |
| TrayModels | IntendedSterilizationCycles | Intended Tray Load |
| 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:○ single or dual lumen devices■ $\ge$ 0.77 mm ID and $\le$ 527 mm in length○ triple lumen devices■ $\ge$ 1.2 mm ID and $\le$ 275 mm in length■ $\ge$ 1.8 mm ID and $\le$ 310 mm in lengthor■ $\ge$ 2.8 mm ID and $\le$ 317 mm in length |
| V-PRO 1Plus, maX &maX 2 NonLumen 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 2FlexibleCycle | 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 $\ge$ 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. | |
| V-PRO maX2 Fast NonLumen 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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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 Characteristic Comparison Table
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.
| Feature | PRO-LITE SterilizationTray (proposed) | PRO-LITE SterilizationTray (K172755) | Comparison |
|---|---|---|---|
| IntendedUse | The PRO-LITE SterilizationTrays are used to containmedical devices forsterilization in the followingCycles:Lumen, Non Lumen, Flexible, Fast Non Lumenand Fast Cycles of the V-PRO® Low TemperatureSterilization Systems Prior to placing in theSterilizer, the trays musteither be:wrapped with a legallymarketed sterilizationwrap for use in theSterilizers listed above. or placed inside a legallymarketed pouch forenclosing trays in theSterilizers listed above. The PRO-LITE SterilizationTrays are not intended tomaintain sterility; they areintended to be used inconjunction with a validated, | The PRO-LITE SterilizationTrays are used to containmedical devices forsterilization in the Lumen, NonLumen, Flexible and Fast NonLumen Cycles of the V-PROLow Temperature SterilizationSystems. Prior to placing in theSterilizer, the trays must eitherbe:wrapped with a legallymarketed sterilization wrapfor use in the V-PRO LowTemperature SterilizationSystems or placed inside a legallymarketed pouch forenclosing trays in the V-PROLow TemperatureSterilization Systems. The PRO-LITE SterilizationTrays are not intended tomaintain sterility; they areintended to be used inconjunction with a validated, | Identical exceptfor:The additionof the FastCycle of theV-PRO s2Sterilizer.The FastCycle is anew cycle inthe V-PRO s2LowTemperatureSterilizer,subject of aconcurrentsubmission(K182568). The extensionof claims inthe V-PRO60 & s2SterilizersFlexibleCycle. |
| Feature | PRO-LITE SterilizationTray (proposed) | PRO-LITE SterilizationTray (K172755) | Comparison |
| wrap or pouch in order tomaintain sterility of theenclosed medicalinstruments. | or pouch in order to maintainsterility of the enclosedmedical instruments. | ||
| Intended Sterilization Cyclesand Intended Tray Loads forTray models: VP0045,VP0046, VP0047, VP0048,VP0049, VP0050, VP0051,VP0052 | Intended Sterilization Cyclesand Intended Tray Loads forTray models: VP0045,VP0046, VP0047, VP0048,VP0049, VP0050, VP0051,VP0052 | ||
| V-PRO 60 & s2 LumenCycle:• Instruments with diffusion-restricted spaces such asthe hinged portion offorceps and scissors• Non-lumened devicesincluding non-lumenedrigid and semi-rigidendoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:o single or dual lumendevices■ ≥ 0.77 mm internaldiameter (ID) and ≤410 mm in lengtho triple lumen devices■ ≥1.2 mm ID and ≤ 275mm in length■ ≥1.8 mm ID and ≤ 310mm in lengthor■ ≥ 2.8 mm ID and ≤317 mm in length | V-PRO 60 Lumen Cycle• Instruments with diffusion-restricted spaces such as thehinged portion of forcepsand scissors• Non-lumened devicesincluding non-lumened rigidand semi-rigid endoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:► single or dual lumendevices≥ 0.77 mm ID and lessthan or equal to 410 mm inlength► triple lumen devices≥1.2 mm ID and less thanor equal to 275 mm inlength≥1.8 mm ID and less thanor equal to 310 mm inlengthor≥2.8 mm ID and less thanor equal to 317 mm inlength | ||
| Feature | PRO-LITE SterilizationTray (proposed) | PRO-LITE SterilizationTray (K172755) | Comparison |
| V-PRO 60 & s2 Non LumenCycle:Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumened devices withdiffusion-restricted spacessuch as the hinged portion offorceps and scissors. | V-PRO 60 Non Lumen Cycle- Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps and scissors. | ||
| V-PRO 60 & s2 FlexibleCycle:Load 1: One flexiblesurgical endoscope orbronchoscope with a lightcord (if not integral toendoscope) and mat withoutany additional load. Theflexible endoscope may be a:• single or dual lumendevice with lumens thatare ≥ 1 mm ID and ≤990 mm in lengthLoad 2: Non-lumeneddevices including non-lumened rigid, semi-rigid,and flexible endoscopes andnon-lumened devices withdiffusion-restricted areassuch as the hinged portion offorceps or scissors. Medicaldevices, including rigid andsemi-rigid endoscopes, withthe following configurations:• ≥ 2 mm ID and ≤ 400mm in length• ≥ 0.76 mm ID and ≤ 233mm in length• ≥ 1.0 mm ID and ≤ 254mm in length | V-PRO 60 Flexible Cycle- One flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to endoscope) andmat without any additionalload. The flexible endoscopemay be a single or dual lumendevice with lumens that are ≥1 mm ID and less than orequal 990 mm in length | ||
| Feature | PRO-LITE SterilizationTray (proposed) | PRO-LITE SterilizationTray (K172755) | Comparison |
| Intended Sterilization Cyclesand Intended Tray Loads forTray models: VP0045,VP0046, VP0047, VP0048,VP0049 | |||
| V-PRO s2 Fast Cycle:• Non-lumened devicesincluding non-lumenedrigid, semi-rigid andflexible endoscope, andnon-lumened devices withdiffusion-restricted areassuch as the hinged portionof forceps or scissors• Medical devices,including single, dual andtriple channeled rigid andsemi-rigid endoscopes,with the followingconfigurations:o single or dual lumendevices■ ≥ 0.77 mm internaldiameter (ID) and ≤410 mm in lengtho triple lumen devices■ ≥1.2 mm ID and ≤ 275mm in length■ ≥1.8 mm ID and ≤ 310mm in lengthor | |||
| ■ ≥2.8 mm ID and ≤ 317mm in length | |||
| Intended Sterilization Cyclesand Intended Tray Loads forTray models: VP0045,VP0046, VP0047, VP0048,VP0049, VP0050, VP0051,VP0052, VP0053 | Intended Sterilization Cyclesand Intended Tray Loads forTray models: VP0045,VP0046, VP0047, VP0048,VP0049, VP0050, VP0051,VP0052, VP0053 | ||
| V-PRO 1, 1 Plus, maX &maX 2 Lumen Cycle:• Instruments with diffusion-restricted spaces such asthe hinged portion offorceps and scissors | V-PRO 1, 1 Plus, maX, &maX 2 Lumen Cycle• Instruments with diffusion-restricted spaces such as thethe hinged portion of forcepsand scissors | ||
| Feature | PRO-LITE Sterilization | PRO-LITE Sterilization | Comparison |
| Tray (proposed) | Tray (K172755) | ||
| • Non-lumened devicesincluding non-lumenedrigid and semi-rigidendoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:o single or dual lumendevices■ ≥ 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 ≤ 317mm in length | • Non-lumened devicesincluding non-lumened rigidand semi-rigid endoscopes· Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:> single or dual lumendevices≥ 0.77 mm ID and lessthan or equal to 527 mm inlength> triple lumen devices≥1.2 mm ID and less thanor equal to 275 mm inlength≥1.8 mm ID and less thanor equal to 310 mm inlengthor≥2.8 mm ID and less thanor equal to 317 mm inlength | ||
| V-PRO 1, 1 Plus, maX &maX 2 Non Lumen Cycle:Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumened devices withstainless steel or titaniumdiffusion-restricted spacessuch as the hinged portion offorceps and scissors. | V-PRO 1 Plus, maX, & maX 2Non Lumen Cycle- Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps and scissors. | ||
| V-PRO 1, 1 Plus, maX &maX 2 Flexible Cycle:Load 1: Single or duallumen surgical flexibleendoscopes (such as thoseused in ENT, Urology andSurgical Care) andbronchoscopes with a lightcord (if not integral toendoscope) and mat with noadditional load. | V-PRO maX & maX 2Flexible CycleLoad 1: Single or dual lumensurgical flexible endoscopes(such as those used in ENT.Urology and Surgical Care)andbronchoscopes with a lightcord (if not integral toendoscope) and mat with noadditional load. | ||
| Feature | PRO-LITE SterilizationTray (proposed) | PRO-LITE SterilizationTray (K172755) | Comparison |
| The flexible endoscopes maycontain either:• a single lumen that is ≥ 1mm ID and ≤ 1050 mm inlength• or two lumens with:■ one lumen that is ≥ 1mm ID and ≤ 990 mm inlength■ and the other lumen thatis ≥ 1 mm ID and ≤ 850mm in lengthLoad 2: Non-lumenedinstruments includinginstruments with diffusion-restricted areas such as thehinged portion of forceps orscissors. | The flexible endoscopes maycontain either:a single lumen that is ≥ 1 mmID and less than or equal 1050mm in lengthor two lumens with:one lumen that is ≥ 1 mm IDand less than or equal 990 mmin lengthand the other lumen that is ≥ 1mm ID and less than or equal850 mm in lengthLoad 2: Non-lumenedinstruments includinginstruments with diffusion-restricted areas such as thehinged portion of forceps orscissors. | ||
| V-PRO maX 2 Fast NonLumen Cycle:Non-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumened devices withstainless steel or titaniumdiffusion-restricted spacessuch as the hinged portion offorceps and scissors. | V-PRO maX 2 Fast NonLumenNon-lumened devicesincluding non-lumened rigids,semi-rigids and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps and scissors. | ||
| Instrument organizers areoptional accessoriesintended to stabilizecylindrical medicalinstruments with in theSterilization Trays. | Instrument organizers areoptional accessories intendedto stabilize cylindrical medicalinstruments within the PRO-LITE Sterilization Trays. | ||
| Sterilization mats areoptional accessoriesintended to cushion andstabilize instruments withinthe Sterilization Trays. | Sterilization mats are optionalaccessories intended to cushionand stabilize instruments withinthe PRO-LITE SterilizationTrays. | ||
| Vent toVolumeRatio | All trays are the same:$0.135 \text{ in}^{-1}$ | All trays are the same:$0.135 \text{ in}^{-1}$ | Identical. |
| TrayComposition | Mineral-filledpolypropylene, stainlesssteel | Mineral-filled polypropylene,stainless steel | Identical. |
| Feature | PRO-LITE SterilizationTray (proposed) | PRO-LITE SterilizationTray (K172755) | Comparison |
| InstrumentOrganizerComposition | Medical Grade Silicone,USP grade VI | Medical Grade Silicone, USPgrade VI | Identical. |
| MatComposition | Medical Grade Silicone,USP grade VI | Medical Grade Silicone, USPgrade VI | Identical. |
Table 5-5. Summary of Tray Physical Description and Technological Properties
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6. Summary of Non-clinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-5 below.
| Test | Acceptance Criteria | Conclusion | |
|---|---|---|---|
| Demonstrationof EffectiveSterilantPenetration | V-PRO s2Sterilizer FastCycle | Worst case stainless steel lumen testarticles shall be reproduciblysterilized under worst case 1/2 cycleconditions for the Fast CycleDiffusion-restricted spaces shall bereproducibly sterilized under worstcase 1/2 cycle conditions for the FastCycleContact points between medicaldevices and tray accessories shall bereproducibly sterilized under worstcase 1/2 cycle conditions for the FastCycleWorst case surface sterilization testarticles shall be reproduciblysterilized under worst case 1/2 cycleconditions for the Fast cycle | PASS |
| V-PRO 60 & s2Sterilizer NonLumen Cycle,diffusion-restricted spacesclaims | Diffusion-restricted spaces shall bereproducibly sterilized under worstcase 1/2 cycle conditions for the NonLumen Cycle | PASS | |
| V-PRO 60 & s2SterilizerFlexible Cycle,diffusion-restricted spacesclaims | Diffusion-restricted spaces shall bereproducibly sterilized under worstcase 1/2 cycle conditions for theFlexible Cycle | PASS | |
| V-PRO 60 & s2SterilizerFlexible CycleExtendedClaims | Stainless steel test articles shall bereproducibly sterilized under worstcase 1/2 cycle conditions for theFlexible Cycle | PASS |
Table 5-5. Summary of Non-clinical Testing
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| 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 | |
|---|---|---|
| Maintenance of Package Integrity | ||
| 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 |
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).