(90 days)
Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should match clip size to the size of the vessel or tissue structure to be ligated.
Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal. The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10 . The blister packs are fitted into an overpack carton which serves as the sales unit.
This document is a 510(k) Premarket Notification for the Hem-O-Lok® Ligation Clips. It states that the device is substantially equivalent to a previously cleared device (K941972) and details its intended use and technological characteristics. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information from the provided text. The document is primarily a notification to the FDA for market clearance, focusing on substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.
{0}------------------------------------------------
HECK MKTG NOV 1 9 1998
Image /page/0/Picture/3 description: The image shows the logo for "WECK CLOSURE SYSTEMS". The text is in a bold, sans-serif font and is stacked on top of each other. To the right of the text is a circular graphic with horizontal lines and a dark, filled-in area at the bottom.
Premarket Notification [510(k)] Summary for Hem-O-Lok® Ligation Clips
- Submitter Name, Address, and Date of Submission 1..
Mr. Brian J. Young Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, NC 27709
Telephone: (919) 361-4041 (919) 361-3914 Facsimile:
July 24, 1998 Submitted:
Name of the Device, Common, Proprietary (if known), and Classification 2.
| Classification Name: | Implantable clip |
|---|---|
| Common Name: | Ligating clip |
| Proprietary Name: | Hem-O-Lok® Ligating clip |
Identification of the legally marketed device to which the submitter claims 3. equivalence
The Weck Closure Systems Hem-O-Lok® clip is substantially equivalent to Hem-O-Lok® clips cleared under Weck's previous 510(k) filing number K941972.
Description of the Device 4.
Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal.
The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10 . The blister packs are fitted into an overpack carton which serves as the sales unit.
{1}------------------------------------------------
Page 2 / Hem-O-Lok® 510(k) Summary
રાં Intended Use of the Device
Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should match clip size to the size of the vessel or tissue structure to be ligated.
Summary of Technological Characteristics 6.
The technological characteristics are the same as or equivalent to the predicate device. The polyacetal material used in the clips is shown to be biocompatible.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1998
Mr. Brian J. Young Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, North Carolina 27709
Re: K982944 Trade Name: Hem-O-Lok® Ligating clips Regulatory Class: II Product Code: FZP Dated: July 30, 1998 Received: August 21, 1998
Dear Mr. Young:
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 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). 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 (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.
{3}------------------------------------------------
Page 2 - Mr. Brian J. Young
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/dsma/dsmamain.html".
Sincerely yours,
Pcoeydo
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
{4}------------------------------------------------
2 Statement of indications for use
510(k) Number (if assigned): Device Name:
K982944 Hem-O-Lok® ligating clips
INDICATIONS FOR USE
Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or Tion -0-20x "Ifgating only memore clip size to the size of the vessel or tissue structure to be ligated.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rx Prescriptum
bcoollute
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.