(87 days)
982941
Not Found
No
The device description and intended use describe a manually applied hemostatic clip made of polyacetal, with no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is a hemostatic clip used for ligation of vessels or tissue structures, which aids in healing by connecting internal tissues, but it does not directly treat a disease or condition in the way a therapeutic device typically would.
No
Explanation: The device is described as a ligating clip used for hemostasis, which is a therapeutic function, not a diagnostic one. It is used to connect internal tissues and ligate vessels or tissue structures.
No
The device description clearly states it is a manually applied hemostatic clip made of polyacetal, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Hem-O-Lok® ligating clips are used in vivo (within the body) for ligating vessels or tissue structures during surgical procedures.
- IVDs are used to provide information for diagnosis, monitoring, or treatment. While the clips aid in hemostasis during surgery, they are a surgical tool for physical ligation, not a diagnostic or monitoring device that analyzes biological samples.
The description focuses on the physical application and function of the clip within the body, which is characteristic of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Product codes
FZP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or tissue structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
982941
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Premarket Notification [510(k)] Summary for Hem-O-Lok® Ligation Clips
Submitter Name, Address, and Date of Submission 1.
Brian Young Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, NC 27709
Telephone: (919) 361-4041 Facsimile: (919) 361-3914
August 26, 1999 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-Loke clips cleared under Weck's previous 510(k) filing number 982941.
4. Description of the Device
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
Intended Use of the Device ನ.
Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, which is a common symbol used by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1999
Mr. Brian J. Young Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, North Carolina 27709
K993157 Re: Trade Name: Hem-O-Lok SMX Polymer Clips, Model 544220 Regulatory Class: II Product Code: FZP Dated: September 7, 1999 Received: September 21, 1999
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 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. Brian J. Young
This letter will allow you to begin marketing vour 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.
Neil R.P. Ogden
James E. Dillard I Acting 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:
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 o box "higating onps should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
NRO for
(Division Sior Off)
Division of Ceneral Restorative Devices
510(k) Number K993157
Concurrence of CDRH, Office of Device Evaluation (ODE)
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X Prescription use