(140 days)
The instrument is designed to be used for high-speed histological biopsy.
ABS® Device
This document is a 510(k) premarket notification letter from the FDA to Gallini U.S., L.L.C. for their "Gallini ABS Device" (K973152). It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The letter is a notification of substantial equivalence, which primarily means the FDA believes the device is as safe and effective as a legally marketed device and can be cleared for market. It does not typically include detailed performance study results or acceptance criteria within the letter itself. Such information would usually be found in the 510(k) submission document, which is not provided here.
Therefore, I cannot provide the requested information based on the given text.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul L. Hawthorne U.S. Representative Gallini U.S., L.L.C. 4211 Harwin Place, Suite 315 Glen Allen, Virginia 23060
JAN - 9 1998
Re: K973152 Trade Name: Gallini ABS Device Regulatory Class: II Product Code: KNW Dated: December 15, 1997 Received: December 22, 1997
Dear Mr. Hawthorne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the … current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Hawthorne
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image is a black and white logo for Gallini U.S. The logo is a circle with a cross through it. The word "GALLINI" is written across the top half of the circle, and the letters "U.S." are written across the bottom half of the circle. The text is in a bold, sans-serif font.
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510(k) Number (if known)
ABS® Device __________________________________________________________________________________________________________________________________________________________________
Unknown
Indications for Use:
Device Name:
The instrument is designed to be used for high-speed histological biopsy.
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ... ... (Per 21 CFR 801.109)
Over-the-Counter Use ... .....................................................................................................................................................
(Optional Format 1-2-96)
Deale
Digital Sign Off
OR
(Division Sign-Off) Division of General Restorative 510(k) Number
G ALLINI U.S. 4405 Cox Road, Suite 110, Glen Allen, VA 23060 Phone: 804 273-1617/ Fax: 804 273-1312
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.