(70 days)
The PROXIMATE® Curved and Straight Intraluminal Staplers have application throughout the alimentary tract for end to end, end to side and side to side anastomoses including application throughout the anal canal to perform surgical treatment for hemorrhoidal disease.
All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510 (k) #940967.
This document does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is a 510(k) summary for the PROXIMATE® Curved and Straight Intraluminal Staplers, stating that its performance and characteristics are identical to a previously cleared device (K940967).
Therefore, specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for this specific submission (K983536) are not present. The submission relies on establishing substantial equivalence to a predicate device.
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510(k) Summary of Safety and Effectiveness (App. A)
| Contact | Edwin O. Billips, Senior Associate Regulatory AffairsEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242Telephone (513) 786-7162Fax (513) 786-7134 |
|---|---|
| Date | October 3, 1998 |
| Device | Name: PROXIMATE® Curved and Straight Intraluminal StaplersClassification Name: Endoscope and AccessoriesCommon Name: Circular StaplerTrade Name /Proprietary Name: PROXIMATE® Curved and StraightIntraluminal Staplers |
| Legallymarketeddevice | Modified ENDOPATH® ILS Circular Stapler (K940967). |
| Devicedescription | All device functions, scientific concepts, significant physical and performancecharacteristics (i.e. device design, materials, physical properties, etc.) areidentical to the design and manufacture described in 510 (k) #940967. |
| Intended use | The PROXIMATE® Curved and Straight Intraluminal Staplers haveapplication throughout the alimentary tract for end to end, end to side and sideto side anastomoses. |
| Indicationsstatement | The PROXIMATE® Curved and Straight Intraluminal Staplers haveapplication throughout the alimentary tract for end to end, end to side and sideto side anastomoses, have application throughout the anal canal to performsurgical treatment for hemorrhoidal disease. |
| Technologicalcharacteristics | The PROXIMATE® Curved and Straight Intraluminal Staplers technologicalcharacteristics are identical to those described in 510(k) #940967. |
| Performancedata | The PROXIMATE® Curved and Straight Intraluminal Staplers' performancesare identical to that described in 510 (k) #940967. |
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510(k) Summary of Safety and Effectiveness (App. A)
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1998
Edwin O. Billips, RAC Senior Associate Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
K983536 Re:
Trade Name: PROXIMATE® Curved and Straight Intraluminal Staplers Regulatory Class: II Product Code: GDW Dated: October 8, 1998 Received: October 9, 1998
Dear Mr. Billips:
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. Edwin O. Billips, RAC
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.
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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Indications for Use Statement
Statement
Following is the Indications for Use Statement:
510(k) Number: K 983536 Device Name: PROXIMATE® Curved and Straight Intraluminal Staplers
Indications for Use:
The PROXIMATE® Curved and Straight Intraluminal Staplers have application throughout the alimentary tract for end to end, end to side and side to side anastomoses including application throughout the anal canal to perform surgical treatment for hemorrhoidal disease.
pcotello
(Division Sign-Off) Division of General Restorative Devices KG 835.3 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.