(72 days)
Not Found
Not Found
No
The description focuses on mechanical functions (clip feeding, approximation, closure) and does not mention any computational or data-driven processes indicative of AI/ML.
No
The device is a ligating clip applier intended for closing vessels or tissue structures, not for treating a disease or condition.
No
The device is described as a delivery device for ligating clips, used for physically ligating vessels or tissue structures in surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical, sterile, single-use automatic ligating clip applier consisting of a handle, shaft, and jaw, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ligation of vessels or tissue structures" during surgical procedures. This involves physically interacting with and modifying structures within the body.
- Device Description: The device is a surgical instrument used to apply clips to vessels or tissue. It is used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical tool used for a therapeutic purpose (ligation).
N/A
Intended Use / Indications for Use
Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. 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 structures to be ligated such that the clip completely encompasses the vessel or tissue structure.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The Weck device is a sterile, single use, automatic ligating clip applier consisting of a handle, shaft containing 15 Hem-o-lok® locking polymer clips, and jaw. The major functions of the device are clip feeding, approximation (positioning the clip around the vessel), and closure. The applier is discarded after the surgical procedure whereas the applied non-absorbable polymer clips remain in the patient. Two models are offered: endoscopic and open surgery.
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
Not Found
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)
The results of bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K021808
PART 9 SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY
Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Weck submits this summary of safety and effectiveness.
-
Submitter Name, Address, and Date of Submission 1.
Brian Young Sr. Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, NC 27709 Telephone: (919) 361-4041 Facsimile: (919) 361-3914 May 13, 2002 Prepared: -
Name of the Device, Common, Proprietary (if known), and Classification 2. Implantable clip Classification Name: Common Name: Ligating clip Weck Hem-o-Lok® Automatic Ligating Clip Applier Proprietary Name:
-
Identification of the legally marketed device to which the submitter claims 3. equivalence
The clips delivered by the proposed automatic applier described in this submission are substantially equivalent to Weck Hem-o-lok® clips. The delivery mechanism is substantially equivalent to the U.S.S.C. AutoSuture® Endoclip 5mm Disposable Clip Applier, and Weck reusable ligating clip appliers.
4. Description of the Device
The Weck device is a sterile, single use, automatic ligating clip applier consisting of a handle, shaft containing 15 Hem-o-lok® locking polymer clips, and jaw. The major functions of the device are clip feeding, approximation (positioning the clip around the vessel), and closure. The applier is discarded after the surgical procedure whereas the applied non-absorbable polymer clips remain in the patient. Two models are offered: endoscopic and open surgery.
5. Intended Use of the Device
Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures.
1
Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.
Summary of Technological Characteristics 6.
The technological characteristics are equivalent to the predicate devices. The results of bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
AUG 1 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Weck James Lucky
Vice-President, Regulatory Affairs and Quality Assurance 2917 Weck Drive Durham, North Carolina 27709
Re: K021808
Trade/Device Name: Hem-o-Lok™ Automatic Ligating Clip Applier Regulation Number: 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: May 31, 2002 Received: June 3, 2002
Dear Mr. Lucky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
3
Page 2 – Mr. James Lucky .
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 ia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO21808
INDICATION FOR USE
Statement of Indications For Use
New Application 510(k) Number (if known):
Hem-o-lok™ Automatic Ligating Clip Appliers Device Name:
Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeone should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.
- Note: The indications section of the labeling for the endoscopic model will refer to endoscopic use.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CRF 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Stupt. Rhodes
on of General. Restorative
510(k) Number K021808