STERILIZATION MATS

K103226 · STERIS Corporation · KCT · Feb 18, 2011 · General Hospital

Device Facts

• Record ID: K103226
• Device Name: STERILIZATION MATS
• Applicant: STERIS Corporation
• Product Code: KCT · General Hospital
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The sterilization mats are intended to be used in conjunction with the V-PRO™ Sterilization Trays (K070769) to cushion and stabilize instruments during sterilization in the Amsco® V-PRO Low Temperature Sterilization Systems.

Device Story

Sterilization mats consist of silicone diamond-grid structures with integrated fingers; designed to cushion and stabilize delicate surgical instruments within V-PRO Sterilization Trays. Used in clinical settings by sterile processing staff during instrument preparation for low-temperature sterilization. Mats prevent instrument movement during packaging, sterilization, and storage. Device facilitates sterilization of cleaned/dried medical devices, including lumened and non-lumened instruments, and flexible endoscopes, by ensuring proper positioning within the tray. Benefits include protection of delicate instruments from damage and maintenance of load integrity during processing cycles.

Clinical Evidence

Bench testing only. Validation studies confirmed effective sterilant penetration, biocompatibility (non-cytotoxic), and compatibility with VAPROX HC sterilant and cleaning agents across all three V-PRO cycles (Lumen, Non Lumen, Flexible). Load testing performed with maximum validated weights (up to 24.0 lbs) and instrument configurations.

Technological Characteristics

Silicone material; diamond grid design with stabilizing fingers; dimensions sized to fit V-PRO Sterilization Trays. Passive device; no energy source or connectivity. Sterilization via V-PRO Low Temperature Sterilization Systems.

Indications for Use

Indicated for use as a cushioning and stabilization accessory for medical instruments during sterilization in Amsco V-PRO Low Temperature Sterilization Systems (Lumen, Non Lumen, and Flexible cycles). Compatible with V-PRO Sterilization Trays.

Regulatory Classification

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.

Predicate Devices

• APTIMAX Instrument Tray, Instrument Tray Holder, and Instrument Tray Mat (K013003)

Reference Devices

• V-PRO Sterilization Trays (K070769)
• V-PRO Lumen Cycle (K062297)
• V-PRO Non Lumen Cycle (K083097)
• V-PRO Flexible Cycle (K102330)

Submission Summary (Full Text)

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K103226/S001 STERIS Response to 12/23/10 Request for Additional Information Sterilization Mats for use in V-PRO Sterilizers

STERIS®

FEB 1 8 2011

# 510(k) Summary For Sterilization Mat use in V-PRO Sterilizers

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Robert F. Sullivan Contact: Senior Director, FDA Regulatory Affairs

Telephone: [phone] Fax No: [phone]

Summary Date:

January 17, 2010

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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### 1. Device Name

| Trade Name: | Sterilization Mats |
|----------------------|---------------------------------------------------------------------|
| Common/usual Name: | Sterilization Mats |
| Classification Name: | Sterilization Tray Accessory<br>21 CFR 880.6850<br>Product Code KCT |

### 2. Predicate Device

APTIMAX Instrument Tray, Instrument Tray Holder, and Instrument Tray Mat (K013003)

### 3. Description of Device

The sterilization mats are used to cushion and stabilize devices placed into the V-PRO Sterilization Trays (K070769). The mats are available in sizes to fit the four 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 Trays.

The mats are designed to allow sterilization of cleaned and dried medical devices during the V-PRO Lumen (K062297), Non Lumen (K083097) and Flexible (K102330) Cycles in the V-PRO Sterilizers.

#### 4. Intended Use

The sterilization mats are intended to be used in conjunction with the V-PRO™ Sterilization Trays (K070769) to cushion and stabilize instruments during sterilization in the Amsco® V-PRO Low Temperature Sterilization Systems.

#### ડ. Summary of Nonclinical Tests

The sterilization mats have the same or similar intended use and the same technological characteristics as compared to the predicate device. Performance testing to demonstrate substantial equivalence to the predicate is summarized in the table below.

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### K103226/S001 STERIS Response to 12/23/10 Request for Additional Information Sterilization Mats for use in V-PRO Sterilizers

| Test | Acceptance Criteria | Conclusion |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Demonstration of<br>Effective Sterilant<br>Penetration | Worst case test article for each of the three V-PRO<br>Sterilization Cycles must be reproducibly sterilized<br>under worst case ½ cycle conditions. | PASS |
| Demonstration of<br>Biocompatibility | Silicone shall be non cytotoxic after exposure to<br>worst case V-PRO Cycle conditions.<br>Residual hydrogen peroxide levels must be below<br>acceptable levels after exposure to worst case<br>V-PRO Cycle conditions. | PASS |
| Demonstration of<br>Sterilant and<br>Cleaning Agent<br>Compatibility | After processing through multiple cleaning and<br>worst case sterilization cycles, the mats must not<br>display any incompatibilities with VAPROX HC<br>sterilant and typical cleaning agents. | PASS |
| Cleaning Evaluating | The mats must be easy to clean using either a<br>manual or an automated process. | PASS |

### 6. Conclusion

The sterilization mats have been validated to meet the established performance criteria. The results of the verification studies demonstrate that the sterilization mats perform as intended and the proposed device is substantially equivalent to the predicate.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert F. Sullivan Senior Director, FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

FEB: 1 8 201

Re: K103226

Trade/Device Name: Sterilization Mats Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 17, 2011 Received: January 18, 2011

Dear Mr. Sullivan:

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.

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Page 2- Mr. Sullivan

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 go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony D. Ams

Anthony D. Watson, B.S., M.S., M.S., M.B. A., Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K103226 510(k) Number (if known):

Device Name: Sterilization Mats

Indications For Use:

The sterilization mats are intended to be used in conjunction with the V-PRO™ Sterilization Trays (K070769) to cushion and stabilize instruments during sterilization in the Amsco V-PRO Low Temperature Sterilization Systems.

The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO 1 Sterilizer), Non Lumen Cycle, and Flexible Cycle]. The critical parameters for each of these cycles are listed below.

| Sterilization<br>Cycle | Sterilant<br>Injection<br>(g) | # of<br>Injections | Sterilant<br>Exposure<br>Time (min) | Chamber<br>Pressure<br>Prior to<br>Injection<br>(Torr) | Chamber/<br>Vaporizer<br>Temperature<br>(°C) |
|------------------------|-------------------------------|--------------------|-------------------------------------|--------------------------------------------------------|----------------------------------------------|
| Lumen | 2.1 | 4 | 32 | 0.4 | 50/60 |
| Non Lumen | 2.1 | 4 | 12 | 1 | 50/60 |
| Flexible | 2.1 | 4 | 12 | 0.4 | 50/60 |

The Lumen Cycle, cleared under K062297, can sterilize:2

- . Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Medical devices with a single stainless steel lumen with: .
- an inside diameter of 1 mm or larger and a length of 125 mm or shorter o
- an insider diameter of 2 mm or larger and a length of 250 mm or shorter o
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter o
- a The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays (containing two mats and 20 instrument organizers) and two pouches for a total weight of 19.65 lbs.

The Non Lumen Cycle, cleared under K083097, can sterilize: 6

Non-lumened instruments including non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

- d The validation studies were conducted using a validation load consisting of two instrument trays containing two mats, and 20 instrument organizers and two pouches for a total weight of 19.65 lbs.
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### The Flexible Cycle, subject of K102330, can sterilize:

Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations:

- 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:

- a single Teflon lumen with an inside diameter of 1 mm or larger and a � length of 1050 mm or shorter
- . or two Teflon lumens with:
- one lumen having an inside diameter of 1 mm or larger and a length . of 998 mm or shorter
- . and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
- C The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat, 20 instrument organizers and light cord (if not integral to endoscope).
- -2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. 9 The flexible endoscope can contain either:
- a single Teflon lumen with an inside diameter of 1 mm or larger and a . length of 1050 mm or shorter
- . or two Teflon lumens with:
- one lumen having an inside diameter of 1 mm or larger and a length . of 998 mm or shorter
- . and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
- d The validation studies were conducted with a flexible endoscope in a tray with silicone mat, 20 instrument organizers and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray (containing a mat and 20 instrument organizers) and one pouch for a total load weight of 24.0 lbs.

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Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation) (ODE)

| (Division Sign-Off) | |
|----------------------------------------------|---------|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K103226 |