ALLEGIANCE GENESIS CONTAINER SYSTEM

K983299 · Allegiance Healthcare Corp. · FRG · Aug 4, 2000 · General Hospital

Device Facts

• Record ID: K983299
• Device Name: ALLEGIANCE GENESIS CONTAINER SYSTEM
• Applicant: Allegiance Healthcare Corp.
• Product Code: FRG · General Hospital
• Decision Date: Aug 4, 2000
• 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 prevacuum steam and ethylene oxide sterilization processes.

Device Story

The Allegiance Genesis™ Container System is a reusable sterilization container designed to house medical instruments during sterilization and storage. It consists of various container designs, sizes, inner baskets, and platforms. Used by healthcare providers in clinical settings, the system facilitates the sterilization of enclosed instruments via prevacuum steam or ethylene oxide processes. The container maintains the sterility of the instruments post-sterilization until they are required for use. By providing a protective, sterile barrier, the system ensures that instruments remain ready for clinical procedures, thereby supporting infection control protocols.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including sterilization performance studies and 30-day and 90-day event-related shelf-life sterility tests, which met all acceptance criteria.

Technological Characteristics

Reusable sterilization container system comprising various designs, sizes, inner baskets, and platforms. Designed for prevacuum steam and ethylene oxide sterilization processes. Maintains sterility via a closed-container barrier system.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices during sterilization processes (prevacuum steam and ethylene oxide) 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

• C.A.S.E.™ Container System (K844652)

Reference Devices

• Aesculap Sterilization Container

Submission Summary (Full Text)

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us 4, 2000

K983299

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Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS

Manufacturer.

Alleglance Healthcare Corporation V. Mueller Business Unit 1435 Lake Cook Road Deerfield, Illinols 60015

Patricia Sharpe-Gregg 1500 Waukegan Road McGaw Park, Illinois 60085

[phone]

September 2, 1998

Allegiance Genesis™ Container System

Sterilization Container

Sterilization Wrap

C.A.S.E.m. Container System

The Allegiance Genesis™ Container System is a reusable device which features an assortment of container designs and sizes, and Inner basket and platform types.

The Alleglance Genesis™ Container 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 prevacuum steam and ethylene oxide sterilization processes.

Regulatory Affairs Contact

Telephone:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification:

Predicate Device: (K844652)

Description:

Intended Use:

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# Allegiance

Allegiance Healthcare Corporation 1500 Waukagan Road McGaw Park, IL 60085 847.473.1500 FAX: [phone]

Substantial Equivalence:

The Allegiance Genesis™ Container Is substantially equivalent to the Allegiance C.A.S.E™ Container System, Dental, Medical Instrument Cases & Cassettes by Sterilization Cassette Systems, Inc. and the Aesculap Sterilization Container In that the:

- Intended use is the same

- performance attributes are the same

Sterilization performance studies were conducted and all acceptance criteria were mat.

Thirty-Day and Ninety-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.

## Summary of Testing:

Page 2 of 2

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Image /page/2/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 of three abstract shapes, possibly representing human figures or waves, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2000 AUG

Ms. Patricia Sharpe-Gregg Director Allegiance Healthcare Corporation 1500 Waukegan Road, Building MPWM McGaw Park, Illinois 60085

Re : K983299 Allegiance Genesis Container System Trade Name: Regulatory Class: II Product Code: FRG May 22,2000 Dated: May 23, 2000 Received:

Dear Ms. Gregg:

We have reviewed your Section 510(k) notification of intent to we have referenced above and we have determined the marker is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use beated in the chirterstate 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). provisions of the roading the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provisions of the ino 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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#### Page 2 - Ms. Gregg

This letter will allow you to begin marketing your device as This lecter will arrow your market notification. The FDA described in your 510\x) premaince of your device to a legally
finding of substantial equivalence of your activerier for your marketed predicate device results in a classification for your marketed predicate device rebares in a created to the market.

If you desire specific advice for your device on our labeling If you desire specific advice readitionally 809.00 for in regulacion (21 crk raros) , please contact the Office of Compliance at [phone]. Additionally, for questions on Compliance at (501) 554 ising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premarket nocification - (archilities under the Act may be information on your responsible manufacturers "Assistance obtained from the Drvibion or billing [phone] or at its internet address

115 Incerner addrop>/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word, there is a graphic of vertical lines of varying heights, resembling a sound wave or a stylized representation of a building. The overall design is simple and professional, likely representing a company or organization named Allegiance.

60085 USA

510(k) Notification Genesis Montalner System V. Muoller Business Unit Page 1 of 1

### 510(k) Number (if known):

Unknown

Device Name:

Indications For Use:

Allegiance Genesis™ Container System

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 prevacuum steam and ethylene oxide sterilization processes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | or | Over-The Counter Use X |
|---------------------------------------|----|------------------------|
|---------------------------------------|----|------------------------|

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices

| 510(k) Number | K983299 |
|---------------|---------|
|---------------|---------|

220/700 'd

196748117877441

datas surgeicht 86:81 (201)0002-10-904