(148 days)
No
The device description and performance studies focus on the physical properties and sterilization efficacy of a tray and its accessories, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The V-PRO Sterilization Tray is used to contain medical devices for sterilization and stabilize them; it is not intended to treat or diagnose patients.
No
The V-PRO Sterilization Tray is used for containment of medical devices during sterilization, not for diagnostic purposes. Its function is to facilitate the sterilization process and maintain sterility of enclosed instruments, which is a treatment/processing function, not a diagnostic one.
No
The device description clearly details physical components such as trays, lids, handles, holes, instrument organizers, and sterilization mats, indicating it is a hardware device.
Based on the provided information, the V-PRO Sterilization Tray is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the tray is used to "contain medical devices for sterilization" and to "maintain sterility of the enclosed medical instruments" in conjunction with sterilization wrap. This is a function related to the processing and storage of medical devices, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics of the tray, its accessories (instrument organizers and mats), and how they function to hold and protect instruments during sterilization. There is no mention of any components or functions related to analyzing biological samples.
- Performance Studies: The nonclinical tests described evaluate the tray's ability to facilitate sterilant penetration, its biocompatibility after sterilization, and its durability after multiple sterilization cycles. These are all relevant to a device used in the sterilization process, not an IVD.
In summary, the V-PRO Sterilization Tray is a medical device used in the sterilization process of other medical devices. It does not perform any diagnostic function on biological specimens, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer. The V-PRO Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDAcleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
| Proposed Tray Model | Intended Sterilization Cycles | Intended Tray Load |
|---|---|---|
| VP0040 VP0041 VP0042 VP0043 VP0044 | V-PRO 60 Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors |
| • Non-lumened devices including non-lumened rigid and semi-rigid endoscopes | ||
| • Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: | ||
| o single or dual lumen devices | ||
| • 0.77 mm ID and 410 mm in length | ||
| o triple lumen devices | ||
| • 1.2 mm ID and 275 mm in length | ||
| • 1.8 mm ID and 310 mm in length | ||
| or | ||
| • 2.8 mm ID and 317 mm in length | ||
| V-PRO 60 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 60 Flexible Cycle | 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 |
§ 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).
0
Image /page/0/Picture/0 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with the trademark symbol to the upper right of the word. Below the word is a graphic of several horizontal lines that are slightly curved, resembling waves.
JUL 2 5 2014
510(k) Summary For V-PRO Sterilization Tray
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Repackager/Relabeler Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Tony Piotrkowski Contact: Manager, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
Summary Date: July 25, 2014
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 T
1
Device Name 1.
| Trade Name: | V-PRO Sterilization Trays |
|---|---|
| Common/usual Name: | Sterilization Trays, cassettes and other accessories |
| Classification Name: | Sterilization Wrap |
| 21 CFR 880.6850 | |
| Class II | |
| Product Code KCT |
2. Predicate Device
VHP® 136 Tray (renamed V-PRO Sterilization Tray) K070769 Sterilization Mat K103226
3. Description of Device
The V-PRO Sterilization Tray is available in various sizes, 10"x 10" x 27" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with clamping mechanisms for securing to the trav. There are numerous holes in the tray and larger holes in the lids for sterilant penetration. The purpose of this premarket submission is to modify the trays by adding a longer tray to the existing product line (10' x 27"), to increase the vent area of the tray lid, and to extend indications for use of the tray to include the V-PRO 60 Low Temperature Sterilization System.
Optional instrument organizers are provided as accessories to the tray and are intended to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attaches to the V-PRO Sterilization Trav. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device that requires stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock. The organizers are identical to those previously cleared under K070769.
Sterilization mats are provided as optional accessories to the trav and are identical to those previously cleared under K103226 for use in V-PRO Low Temperature Sterilizers' Lumen, Non Lumen and Flexible Cycles. A larger mat sized to fit into the new 10" x 27" tray has been added to the existing product line. The sterilization mats are intended to cushion and stabilize devices placed into the V-PRO.
2
Sterilization Trays. The mats are available in sizes to fit the five V-PRO 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 V-PRO Sterilization Trays.
4. Intended Use
The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer. The V-PRO sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDAcleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
| Proposed
Tray
Model | Intended
Sterilization
Cycles | Intended Tray Load |
|------------------------------------------------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VP0040
VP0041
VP0042
VP0043
VP0044 | V-PRO 60
Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged
portion of forceps and scissors
• Non-lumened devices including non-lumened rigid and semi-
rigid endoscopes
• Medical devices, including single, dual and triple channeled
rigid and semi-rigid endoscopes, with the following
configurations:
o single or dual lumen devices
■ 0.77 mm ID and 410 mm in length
o triple lumen devices
■ 1.2 mm ID and 275 mm in length
■ 1.8 mm ID and 310 mm in length
or
■ 2.8 mm ID and 317 mm in length |
| | V-PRO 60
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 60
Flexible
Cycle | • 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 **VP0044 | 10 x 27 | 10 x 27 | VP0034 ** |
Table 5-3. V-PRO Sterilization Tray and Mat Sizes
*Sizes are approximated for ease of reference.
** The 10" x 27" size is being added in this submission
Models and sizes of V-PRO Sterilization Tray Instrument Organizers are included in Table 5-4. The sizes and model numbers are identical to the predicate VHP® 136 Tray (K070769).
Table 5-4. Instrument Organizers Available Sizes
| Stem Length
(mm) | Diameter*
(mm) | Part
Number | Stem Length
(mm) | Diameter*
(mm) | Part
Number |
|---------------------|-------------------|----------------|---------------------|-------------------|----------------|
| 6 | 5 | 99101 | 6 | 14 | 99110 |
| 13 | 5 | 99102 | 13 | 14 | 99111 |
| 25 | 5 | 99103 | 25 | 14 | 99112 |
| 6 | 9 | 99104 | 6 | 17 | 99113 |
| 13 | 9 | 99105 | 13 | 17 | 99114 |
| 25 | 9 | 99106 | 25 | 17 | 99115 |
| 6 | 11 | 99107 | 6 | 19 | 99116 |
| 13 | 11 | 99108 | 13 | 19 | 99117 |
| 25 | 11 | 99109 | 25 | 19 | 99118 |
| Lock Base | | 99120 | | | |
*Sizes are approximated for ease of reference.
7
ર. Summary of Nonclinical Tests
The sterilization trays, sterilization mats and instrument organizers are identical in composition and have the same or similar intended use as compared to the predicate device. The only substantial difference is the claim of using the subject device with the V-PRO 60 Low Temperature Sterilization System (subject of a separate, concurrent submission). Therefore, performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-5 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Demonstration of | ||
| Effective Sterilant | ||
| Penetration | Worst case test article packaged in the trays shall | |
| be reproducibly sterilized under worst case ½ cycle | ||
| conditions. | PASS | |
| Demonstration of | ||
| Biocompatibility | Component materials shall be non cytotoxic after | |
| exposure to worst case V-PRO 60 Sterilizer Cycle | ||
| conditions. | ||
| Residual hydrogen peroxide levels shall be below | ||
| acceptable levels after exposure to worst case | ||
| V-PRO 60 Sterilizer Cycle conditions. | PASS | |
| Demonstration of | ||
| Sterilant | ||
| Compatibility | After processing through multiple worst case | |
| sterilization cycles, the trays and accessories shall | ||
| retain functionality. | PASS |
Table 5-5. Instrument Organizers Available Sizes
7. Conclusion
The V-PRO Sterilization Trays have been validated to meet the established performance criteria. The results of the verification studies demonstrate that the sterilization trays and accessories perform as intended and based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices, Class II (21 CFR 880.6850, Product code KCT.
8
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, with three curved lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
STERIS Corporation Mr. Tony Piotrkowski Manager, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060
Re: K140494
Trade/Device Name: V-PRO Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Containers, Trays, Cassettes and other accessories Regulatory Class: II Product Code: KCT Dated: June 20, 2014 Received: June 23, 2014
Dear Mr. Piotrkowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
9
Page 2 - Mr. Tony Piotrkowski
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit
Clinical Deputy Director
DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Sincerely yours.
10
Indications for Use
510(k) Number (if known): K140494
Device Name:
V-PRO Sterilization Tray
Indications For Use:
The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer. The V-PRO Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
| Proposed
Tray
Model | Intended
Sterilization
Cycles | Intended Tray Load |
|------------------------------------------------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VP0040
VP0041
VP0042
VP0043
VP0044 | V-PRO 60
Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged
portion of forceps and scissors
• Non-lumened devices including non-lumened rigid and semi-
rigid endoscopes
• Medical devices, including single, dual and triple channeled
rigid and semi-rigid endoscopes, with the following
configurations:
o single or dual lumen devices
• 0.77 mm ID and 410 mm in length
o triple lumen devices
• 1.2 mm ID and 275 mm in length
• 1.8 mm ID and 310 mm in length
or
• 2.8 mm ID and 317 mm in length |
| | V-PRO 60
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 60
Flexible
Cycle | 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