(683 days)
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.
The Allegiance Genesis™ Container System is a reusable device which features an assortment of container designs and sizes, and Inner basket and platform types.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization performance | "all acceptance criteria were met." |
| Thirty-Day Event Related Shelf Life Sterility | "demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use." |
| Ninety-Day Event Related Shelf Life Sterility | "demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set. It also doesn't provide information about the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies conducted are described as "Sterilization performance studies" and "Thirty-Day and Ninety-Day Event Related Shelf Life Sterility tests," which typically involve laboratory testing against established standards rather than expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. The studies appear to be performance tests against objective standards rather than studies requiring human adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication of an MRMC comparative effectiveness study being done. The device is a sterilization container system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a physical sterilization container, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The "sterilization performance studies" and "shelf life sterility tests" can be considered as standalone tests of the device's physical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "sterilization performance studies" and "shelf life sterility tests" would be based on established standards and scientific methods for sterility validation and shelf-life testing. These would likely involve microbiological assays (e.g., spore-kill assays for sterilization, microbial challenge tests for sterility maintenance) and physical testing to confirm integrity and barrier function over time. The document states that the product is "in compliance with established standards."
8. The sample size for the training set
This information is not applicable and not provided. The device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/machine learning product.
{0}------------------------------------------------
us 4, 2000
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
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).