(174 days)
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Not Found
No
The device is a sterilization pouch and the summary contains no mention of AI, ML, or related concepts like image processing or performance metrics associated with AI/ML models.
No
The device is a sterilization pouch used to enclose another medical device for sterilization; it does not directly treat or diagnose a medical condition.
No
The device, a sterilization pouch, is used to enclose another medical device for sterilization, not to diagnose any medical condition. Its intended use is for sterilization processes, not diagnostic procedures.
No
The device described is a physical sterilization pouch, not a software application.
Based on the provided information, the Granton Medical Sterilization Pouches are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization. This is a process related to the preparation and handling of medical devices, not for the diagnosis of disease or other conditions.
- Device Description: It's described as a "Self Seal Sterilization Pouch," which aligns with its intended use for sterilization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide diagnostic information. The Granton Medical Sterilization Pouches do not fit this description.
N/A
Intended Use / 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.
Product codes
FRG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for the U.S. Department of Health and 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 image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
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.
1
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