(75 days)
The OriGen tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues.
Not Found
This looks like a 510(k) submission for a medical device (OriGen Tissue Storage Bags) where the primary change is the sterilization method. The provided documents focus on the regulatory approval process and the substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria for an AI/machine learning device.
Therefore, most of the information requested in your prompt (about AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in these documents.
However, I can extract the following information related to acceptance criteria and the "study" demonstrating the change:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (after radiation sterilization) |
|---|---|
| Product Characteristics | No change |
| Product Performance | No change |
| EtO Residues | Eliminated (benefit of new sterilization) |
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly stated for the "physical testing," but the submission indicates "Physical testing has demonstrated..." This implies a test dataset was used, but the size, specifics, and provenance are not detailed in these regulatory summary documents. This is a change in manufacturing process for an existing device, not a new device with a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "study" here is physical testing of the device itself (likely material properties, integrity, functionality), not an assessment requiring expert human interpretation of results in the way an AI/ML diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable. The assessment would likely involve laboratory tests and measurements against predefined specifications, not expert adjudication.
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
Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The ground truth for the physical testing would be established by the pre-change device's characteristics and performance, likely through engineering specifications and quality control standards. The "physical testing" aimed to show that the new sterilization method did not alter these established characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and there is no mention of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned.
Summary of what can be inferred from the document:
The core "study" cited is "Physical testing" which aimed to demonstrate that changing the sterilization method from Ethylene Oxide (EtO) to radiation did not change the product characteristics or performance of the OriGen Tissue Storage bags. The acceptance criteria essentially were that the characteristics and performance remain the same as the original EtO-sterilized device (approved under K915471), with the added benefit of eliminating EtO residues. The details of this physical testing (e.g., sample size, specific tests, quantitative results) are not provided in this 510(k) summary letter.
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Image /page/0/Picture/0 description: The image shows the logo for OriGen Biomedical. The word "OriGen" is in a large, bold font, with a dot over the "i". Below "OriGen" is the word "BIOMEDICAL" in a smaller, sans-serif font. The logo is black and white.
AUG 0 6 2002
Koz 1702
510(k) Summary OriGen Tissue Storage bags
May 19, 2002
Common Name: Tissue Storage Bags, classification LPZ Classification Name: Tissue Freezing bag, per 21 CFR 880
OriGen Tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues. These are the same devices originally approved under K915471. This 510(k) application is being submitted to document the change of sterilization method from Ethylene Oxide to radiation. Physical testing has demonstrated that there is no change in product characteristics or performance following radiation sterilization, and there is the obvious benefit of eliminating EtO residues from the device.
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Sincerely.
Driu Snasti
Richard L. Martin President
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 6 2002
Mr. Richard Martin President OriGen Biomedical, Incorporated 9709-A Beck Circle Austin, Texas 78758
Re: K021702
Trade/Device Name: Cryobag, Model CB Regulation Number: None Regulation Name: Tissue Storage Bag Regulatory Class: Unclassified Product Code: LPZ Dated: May 21, 2002 Received: May 23, 2002
Dear Mr. Martin:
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. Martin
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,
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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Page 1 of 1
K021702 510 (k) NUMBER :
DEVICE NAME :
INDICATIONS FOR USE :
The OriGen tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter-Use _ (Optional Format 1-2-96)
Patron Lucerith
thesiology, General Hospital.
510(k) Number: K021702
N/A