(174 days)
The Granton Medical Sterilization Pouches are to be used to enclose another medical device that is to be 121°C gravity steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 OR ST-41 sterilization recommendations.
Self Seal Sterilization Pouch
This is a 510(k) clearance letter for a medical device called "Self Seal Sterilization Pouch". This document is an administrative letter from the FDA and unfortunately, it does not contain the specific information you are requesting about acceptance criteria and device performance studies.
The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. However, it does not provide details about the performance criteria, study design, or results typically found in full submissions or scientific publications.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set or its data provenance.
- Number of experts used or their qualifications for ground truth.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Granton Medical Limited C/O Mr. E. J. Smith Smith & Associates P.O. Box 4341 Crofton, Maryland 21114
MAR 0 4 2003
Re: K023025
Trade/Device Name: Self Seal Sterilization Pouch Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: December 12, 2002 Received: December 16, 2002
Dear Mr. Smith:
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.
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Page 2 - Mr. Smith
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. 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 (OS) 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Punrer
Susan Runner, DDS, MA Interim 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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510(k) Number:
Device Name: Self Seal Sterilization Pouch
Classification Panel: 80 KCT
Indications for Use:
The Granton Medical Sterilization Pouches are to be used to enclose another medical device that is to be 121°C gravity steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 OR ST-41 sterilization recommendations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter Use
Qun Si hin
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control. Dental Devices
510(k) Number. K023025
§ 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).