GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM

K012931 · Allegiance Healthcare Corp. · FRG · Aug 20, 2002 · General Hospital

Device Facts

• Record ID: K012931
• Device Name: GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
• Applicant: Allegiance Healthcare Corp.
• Product Code: FRG · General Hospital
• Decision Date: Aug 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

A sterilization container system is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in STERRAD® 50, STERRAD® 100 and STERRAD® 100S, ethylene oxide and pre-vacuum sterilization processes.

Device Story

Reusable rigid sterilization container system; includes various container sizes, inner baskets, and platforms. Used by healthcare providers to house medical instruments during sterilization cycles. Compatible with STERRAD, ethylene oxide, and pre-vacuum sterilization processes. Maintains sterility of enclosed instruments post-sterilization until point of use. Protects instruments during transport and storage.

Clinical Evidence

No clinical data. Evidence based on bench testing, including sterilization performance studies and event-related shelf-life sterility testing (30-day and 180-day). All acceptance criteria met.

Technological Characteristics

Rigid, reusable sterilization container system; perforated base design; includes various sizes (half, mid, full, quarter, mini) and depths. Compatible with STERRAD, ethylene oxide, and pre-vacuum sterilization. Materials and specific standards not detailed in provided text.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during sterilization processes (STERRAD, ethylene oxide, pre-vacuum) and to maintain sterility of the enclosed devices until use.

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

• SteriTite perforated base rigid reusable sterilization container system (K991023)

Submission Summary (Full Text)

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AUG 2 0 2002

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Genesis™ STERRAD® Compatible Reusable Sterilization Container System

Manufacturer:

.. .

Regulatory Affairs Contact

Telephone:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification:

Predicate Device: (K991023)

Description:

Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL 60085

Lance Marconi 1500 Waukegan Road McGaw Park, Illinois 60085

[phone]

August 30, 2001

Genesis™ STERRAD® Compatible Reusable Sterilization Container System

Sterilization Container

Sterilization Wrap

SteriTite perforated base rigid reusable sterilization container system

The Allegiance Genesis™ STERRAD® Compatible Reusable Sterilization Container System is a reusable device which features an assortment of container designs and sizes, and inner basket and platform types.

Allegiance Healthcare Corporation Genesis™ STERRAD Compatible Reusable Sterilization Container System V. Mueller Business Unit

# 198

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### Intended Use:

A sterilization container system, is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

This container system is intended to be used in STERRAD®, ethylene oxide and pre-vacuum sterilization processes.

The Allegiance Genesis™ STERRAD® Compatible Reusable Sterilization Container System is substantially equivalent to the SteriTite perforated base rigid reusable sterilization container system with SCF02-polypropylene non-woven disposable filter by Case Medical, Inc in that the:

- Intended use is the same ●
- . Performance attributes are the same

Sterilization Performance studies were conducted for the Genesis™ STERRAD® Compatible Reusable Sterilization Container System and all acceptance criteria were met.

Thirty-Day and One Hundred Eighty-Day Event Related Shelf Life Sterility tests were conducted. Results demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use.

Allegiance Healthcare Corporation Genesis™ STERRAD® Compatible Reusable Sterilization Container System V. Mueller Business Unit

## Summary of Testing:

Substantial Equivalence:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2002

Mr. Lance Marconi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road McGraw Park, Illinois 60085

Re: K012931

Trade/Device Name: GenesisTM STERRAD® Compatible Reusable Sterilization Container System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: June 5, 2002 Received: June 7, 2002

Dear Mr. Marconi:

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.

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.

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Page 2 - Mr. Marconi

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Puare
Timothy A. Ulatowski

Timothy A. Ulatowski 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 (if known): | K012931 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Genesis™ STERRAD® Compatible Reusable Sterilization Container System |
| Indications For Use: | A sterilization container system is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.<br>This container system is intended to be used in STERRAD® 50, STERRAD® 100 and STERRAD® 100S, ethylene oxide and pre-vacuum sterilization processes. |

| Model Number: | Model Description: |
|---------------|-------------------------------------------------------------|
| CD1-4ST | Bottom, Half-Length, Perforated, 4", Lid, Half-Length |
| CD1-5ST | Bottom, Half-Length, Perforated, 5", Lid, Half-Length |
| CD1-6ST | Bottom, Half-Length, Perforated, 6", Lid, Half-Length |
| CD2-4ST | Bottom, Mid-Length, Perforated, 4", Lid, Mid-Length |
| CD2-5ST | Bottom, Mid-Length, Perforated, 5", Lid, Mid-Length |
| CD2-6ST | Bottom, Mid-Length, Perforated, 6", Lid, Mid-Length |
| CD3-4ST | Bottom, Full-Length, Perforated, 4", Lid, Full-Length |
| CD3-5ST | Bottom, Full-Length, Perforated, 5", Lid, Full-Length |
| CD3-6ST | Bottom, Full-Length, Perforated, 6", Lid, Full-Length |
| CD0-3ST | Bottom, Mini, Perforated, 3", Lid, Mini |
| CD0-4ST | Bottom, Quarter-Length, Perforated, 4", Lid, Quarter-Length |
| CD4-3ST | Bottom, Small Shallow, Perforated, 3", Lid, Small |
| CD4-5ST | Bottom, Small, Perforated, 5-1/2", Lid, Small |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | or | Over-The Counter Use |
|-------------------------------------------------------------------------------------------------------|---------|----------------------|
| (Per 21 CFR 801.109) | | |
| <div><img alt="signature" src="signature.png"/></div> | | |
| (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 6 | | |
| 510(k) Number: | K012931 | |