(683 days)
Not Found
No
The summary describes a sterilization container system, a purely mechanical device for holding instruments during sterilization. There is no mention of any software, data processing, or intelligent capabilities.
No.
The device is a sterilization container system, which is used to sterilize and maintain the sterility of other medical devices. It does not directly treat or diagnose a disease or condition in a patient.
No
Explanation: The device is a sterilization container system, designed to enclose and maintain sterility of other medical devices. Its intended use focuses on sterilization processes and sterility maintenance, not on diagnosing medical conditions or diseases.
No
The device description clearly states it is a "reusable device" with "an assortment of container designs and sizes, and Inner basket and platform types," indicating it is a physical hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "sterilization container system" used to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body.
- Device Description: The description reinforces that it's a reusable container system for holding other devices.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or assays.
The device's function is purely related to the physical process of sterilizing and storing other medical devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The Allegiance Genesis™ Container System is a reusable device which features an assortment of container designs and sizes, and Inner basket and platform types.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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