(354 days)
No
The description focuses on a physical sterilization container system and its performance in sterilization processes, with no mention of AI or ML.
No
The device is a sterilization container system, which is used to sterilize and maintain sterility of other medical devices. It does not directly treat or diagnose a disease or condition in a patient.
No.
The device is a sterilization container system, not a diagnostic device. Its purpose is to hold medical devices for sterilization and maintain their sterility, not to diagnose medical conditions or analyze patient data.
No
The device description clearly states it is a "reusable device which features 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 used to enclose and sterilize other medical devices. It is a container system for sterilization processes.
- Device Description: The description reinforces that it's a reusable container system with various designs and sizes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. It doesn't involve analyzing biological samples.
IVD devices are specifically designed for testing biological samples (like blood, urine, tissue) to provide diagnostic information. This sterilization container system is a device used in the process of preparing other medical devices for use, not for diagnostic testing.
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 STERRAD® 50, STERRAD® 100 and STERRAD® 100S, ethylene oxide and pre-vacuum sterilization processes.
Product codes
FRG
Device Description
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a plus-shaped symbol made up of small squares. Below the word "Allegiance" is the phrase "- Cardinal Health company" in a smaller font.
AUG 2 0 2002
Image /page/0/Figure/25 description: The image shows a close-up of a dark, textured surface. The surface appears to be rough and uneven, with small, irregular patterns covering the entire area. The lighting is somewhat dim, which accentuates the texture and creates shadows that add depth to the image. There is also an arrow pointing down.
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
(847) 578-3312
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
1
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:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 that resembles three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
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 (301) 594-4618. Additionally, for questions on the promotion and advertising 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 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 (800) 638-2041 or (301) 443-6597 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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Image /page/4/Picture/0 description: The image contains the logo for Allegiance, a Cardinal Health company. The logo features a stylized cross made of dots to the left of the word "Allegiance" in a bold, italicized font. Below the main logo is the text "a Cardinal Health company" in a smaller, non-italicized font.
| 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. |
| 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) | ||
| (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 6 | ||
| 510(k) Number: | K012931 |