(75 days)
Not Found
No
The summary describes a tissue storage bag and does not mention any AI or ML capabilities.
No
The device is used for storing and freezing cells and tissues, not for treating any medical condition or disease.
No
Explanation: The device is indicated for storing and freezing cells and tissues, which is a laboratory or preservation function, not a diagnostic one. There is no mention of analysis, interpretation, or detection of disease/conditions.
No
The device is a tissue storage bag, which is a physical medical device, not software.
Based on the provided information, it is unlikely that this device is an IVD. Here's why:
- Intended Use: The intended use is "protecting, storing and freezing cells and tissues." This describes a function related to preserving biological samples, not performing diagnostic tests in vitro (outside the body).
- Lack of Diagnostic Information: There is no mention of analyzing samples, detecting substances, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro testing.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Performance Studies: The performance study mentioned focuses on the physical characteristics and performance after sterilization, which is relevant for a storage device, not typically for the analytical performance of an IVD.
- Predicate Device: The predicate device K915471 is for a "Cryopreservation Bag." This further supports the idea that the device is for storage and preservation, not in vitro diagnosis.
In summary, the intended use and the nature of the performance study strongly suggest that this device is a storage and preservation device for biological samples, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The OriGen tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues.
Product codes
LPZ
Device Description
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.
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
Not Found
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)
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.
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
Not Found
N/A
0
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
1
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.
2
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
3
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