MEDICOM SELF-SEALING STERILIZATION POUCH

K070428 · A.R. Medicom, Inc. · KCT · Jul 17, 2007 · General Hospital

Device Facts

• Record ID: K070428
• Device Name: MEDICOM SELF-SEALING STERILIZATION POUCH
• Applicant: A.R. Medicom, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jul 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 100 - 120 minutes at 50 °C with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

Device Story

Sterilization pouch consisting of medical-grade paper thermally sealed to laminated film; features adhesive strip for closure. Used by healthcare workers to enclose medical devices prior to steam or EO sterilization. External chemical ink indicators change color to confirm exposure to sterilization process. Pouch maintains sterility of contents for up to one year. Device provides physical barrier for sterile storage and visual confirmation of processing.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included sterilant penetration, drying time, aeration, biocompatibility, package integrity, material compatibility, sterility maintenance, and chemical indicator efficacy per ISO 11140-1:2005.

Technological Characteristics

Medical-grade paper thermally sealed to laminated film; adhesive strip closure. External chemical ink indicators. Compatible with steam (121°C) and EO (50°C, 60-85% RH, 600 mg/L) sterilization. Complies with ISO 11140-1:2005 for chemical indicators.

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization via steam autoclave or Ethylene Oxide (EO) and to maintain sterility for up to one year post-sterilization.

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

• Winner® Self Seal Sterilization pouch (K051242)

Submission Summary (Full Text)

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K070428
ary

## 510 (K) Summary

JUL 1 7 2007

| 5.1 Device Trade Name: | Medicom Self Sealing – Sterilization Pouch |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.2 Named and Address of<br>Manufacturer: | A.R. Medicom Inc.<br>1200 55th Avenue,<br>Lachine, Quebec<br>H8T 3J8 Canada |
| Establishment<br>Registration Number: | 9680179 |
| Contact Person: | Jason Ludivg<br>Senior Quality & Regulatory Writer |
| | Tel: [phone] x 2222<br>Fax: [phone]<br>E-mail: [e-mail] |
| 5.3 Device Classification<br>Names: | 1) sterilization wrap containers, trays, cassettes &<br>accessories.<br>2) indicator, Physical/Chemical Sterilization<br>Process |
| Classification/Panel: | Class II, §880.6850 & 880.2800 |
| Classification Advisory<br>Committee: | General Hospital |
| Product Code: | 1) KCT 2) JOJ |
| Recognized Performance<br>Standard | ISO 11140-1:2005 (JOJ) |
| 5.4 Predicate Devices | Winner® Self Seal Sterilization pouch |
| 510(k) Number | K051242 |
| 5.5 Intended Use | The self-sealing sterilization pouches<br>are intended to provide health care workers with an<br>effective method to enclose devices intended for<br>sterilization in steam auto claves and via Ethylene<br>Oxide (EO). The recommended steam sterilization<br>cycle parameters are 30 minutes at 121°C. The<br>recommended EO sterilization cycle is 100 - 120<br>minutes at 50 °C with a relative humidity between<br>60 - 85% and a sterilant concentration of 600 mg/L.<br>Furthermore, the sterilization pouch maintains the<br>enclosed devices sterile up until one year post<br>sterilization. Lastly, the pouch's external chemical<br>ink indicators are designed to indicate to the user<br>that the pouch has undergone either a steam or EO<br>sterilization process. |
| 5.6 510(k) Statement | A 510(k) statement for the new device, as required<br>by 21 CFR 93, is replaced with this 510(k)<br>summary. |
| 5.7 Proposed Labeling | A comparison with the predicate labeling confirms<br>our claim of substantial equivalence with the<br>predicate. A draft copy of the proposed and<br>predicate device labeling may be found in Section<br>11. |
| 5.8 Device Description | The pouches are manufactured from a medical<br>grade paper that is thermally sealed to a laminated<br>film on the left, right, and bottom of pouch. The<br>fourth side has an adhesive strip that is used to seal<br>the paper to the film prior to sterilization of the<br>enclosed medical device. The pouches contain<br>external indicators used to indicate the pouches<br>were processed via steam or EO sterilization. See<br>Section 7 for a detailed device description including<br>shelf life, sterility achievement and compatibility<br>with steam and EO sterilization processes. |
| 5.9 Comparison Testing | Side by side testing was conducted on the The<br>Medicom Self Sealing sterilization pouch and the<br>Winner® Self Seal pouch to determine substantial<br>equivalence. Sterilant Penetration, Drying Time,<br>Aeration, Biocompatibility, Package Integrity. |

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Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy (recognized standard ISO 11140-1:2005) were the parameters used to determine substantial equivalence and validate the safety and efficacy of the device. See sections 6 for the complete substantial equivalence comparison table.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2007

Mr. Jason Ludvig Senior Quality and Regulatory Writer A.R. Medicom, Incorporated 1200 55" Avenue Lachine, Quebec H8T 318 CANADA

Re: K070428

Trade/Device Name: Medicom Self Sealing Sterilization Pouch Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 19, 2007 Received: June 21, 2007

Dear Mr. Ludvig:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Ludvig

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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510(k) Number: K070428

Device Name: Medicom Self Sealing Sterilization Pouch

Indications For Use:

The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121℃. The recommended EO sterilization cycle is 100 - 120 minutes at 50 ℃ with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

Prescription Use Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter

(2

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula R. Murphy, MD

(Division Sign-Off)

livision of Anesthesiology, General Hospital Infection Control, Dental Devices

10(k) Number: K070428