← Product Code [FRG](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG) · K983299 # ALLEGIANCE GENESIS CONTAINER SYSTEM (K983299) _Allegiance Healthcare Corp. · FRG · Aug 4, 2000 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K983299 ## Device Facts - **Applicant:** Allegiance Healthcare Corp. - **Product Code:** [FRG](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG.md) - **Decision Date:** Aug 4, 2000 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6850 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. 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. ## Regulatory 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](/device/K844652.md)) ## Reference Devices - Aesculap Sterilization Container ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ us 4, 2000 K983299 Image /page/0/Picture/2 description: The image contains the word "Allegiance" in a stylized, bold, and italicized font. To the left of the word is a graphic that appears to be a stylized cross or plus sign, composed of small squares or pixels. The overall impression is that of a logo or brand name. Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2481 ## 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 (847) 578-3836 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: {1}------------------------------------------------ # Allegiance Allegiance Healthcare Corporation 1500 Waukagan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461 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 {2}------------------------------------------------ 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. {3}------------------------------------------------ #### 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 (301) 594-4692. Additionally, for questions on Compliance at (501) 554 ising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (301) 443-6597 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 {4}------------------------------------------------ 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K983299](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K983299) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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