(161 days)
The indications statement for the New Device and the Predicate Devices is the same. All of the devices are used for approximating tissue and affixing prosthetic material. Both endoscopic and open procedures.
The GSI Fixation System and the predicate devices are endoscopic multi-fire, fastening systems. The New Device and the Predicate Devices are single patient use, disposable and supplied sterile, with the exception of the Origin Tacker System which is supplied in two parts: the fastener cartridge is single use, disposable and the handle is reusable.
I am sorry, but the provided text does not contain specific acceptance criteria or details about a study proving the device meets them. The document is a 510(k) summary for a "Fixation System," primarily focusing on its substantial equivalence to predicate devices and its intended use. It does not include information about performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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K1983318
Appendix 3 510(k) Summary
SUMMARY: 510(k) Summary of Information Supporting Safety and Effectiveness SUBMITTER: General Surgical Innovations, Inc. 10460 Bubb Road Cupertino, CA 95014 (408) 863 - 2500 CONTACT PERSON: Ferolyn Powell DATE PREPARED: September 15, 1998 CLASSIFICATION Endoscope and/or Accessories NAME: COMMON NAME: Fixation System PROPRIETARY NAME: Not yet determined DEVICE DESCRIPTION: The GSI Fixation System and the predicate devices are endoscopic multi-fire, fastening systems. The New Device and the Predicate Devices are single patient use, disposable and supplied sterile, with the exception of the Origin Tacker System which is supplied in two parts: the fastener cartridge is single use, disposable and the handle is reusable. Origin Tacker TM System PREDICATE DEVICES: SUTURE™ AUTO Modified Endoscopic Fascia Stapler Endoscopic Multifeed Stapler The New Device is intended for the same use as INTENDED USE: the Predicate Devices. All of these devices are intended for use either in minimally invasive, endoscopic or open surgical procedures. The indications statement for the New Device and the Predicate Devices is the same. All of the
affixing prosthetic material.
devices are used for approximating tissue and
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Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 1999
Mr. Ferolyn Powell Vice President, Regulatory Affairs and Quality Assurance General Surgical Innovations 10460 Bubb Road Cupertino, California 95014
Re: K983318 Trade Name: Fixation System Regulatory Class: II Product Code: GDW Dated: December 16, 1998 Received: December 17, 1998
Dear Mr. Powell:
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 requirement, as set forth in the Quality System Regulation (QS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -- Mr. Ferolyn Powell
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 vour 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,
Jacolle for
-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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8.1 Statement of Indications for Use
510(k) Number (If known): _
Device Name:
Fixation System
Indications for Use:
The indications statement for the New Device and the Predicate Devices is the same. All of the devices are used for approximating tissue and affixing prosthetic material. Both endoscopic and open procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
(Optional Format 1-2-96)
Hoccer D
(Division Sign-Off) Division of General Restorative Devices 1483318 510(k) Number
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.