(84 days)
Not Found
No
The description focuses on the mechanical function of an automatic ligating clip applier and does not mention any AI or ML capabilities.
No
Explanation: This device is a surgical tool used for ligating vessels or tissue structures; it does not directly treat or manage a disease or condition for therapeutic effect.
No
This device is described as a delivery device for ligating clips used to ligate vessels or tissue structures during surgical procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines a physical, disposable hardware device (applier) with mechanical components (trigger, turn knob, jaws) designed for delivering ligating clips. It does not mention any software 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 the ligation of vessels or tissue structures during surgical procedures. This is an in-vivo application (within the living body).
- Device Description: The device is a surgical instrument (a clip applier) used by a surgeon or physician's assistant during laparoscopic procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or manipulate structures within the body during surgery.
N/A
Intended Use / Indications for Use
The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
Product codes
FZP
Device Description
The Weck Auto Endo5 Hem-o-lok Ligating Clip Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used by a surgeon or physician's assistant during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5 applier is actuated by a trigger, which is housed in a body assembly. Adjacent to the body is a turn knob that is used to rotate the applier jaws. The Auto Endo5 applier is 44 cm long with a working length of 29.7 cm. This applier can be used with a 5 or 5.5 mm cannula.
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
surgeon or physician's assistant during laparoscopic procedures
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)
Non-clinical performance testing has been conducted following product sterilization, aging, and simulated distribution in order to support a change to the dry lubricant applied to various applier components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Teleflex Medical Ms. Ashlea Ricci Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K142777
Trade/Device Name: Weck Auto Endo5 Hem-o-lok Ligating Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: August 27, 2014 Received: September 26, 2014
Dear Ms. Ricci:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1
K142777 510(k) Number:
Weck® Auto Endo5® Hem-o-lok® Ligating Clip Appliers
Indications for Use:
Device Name:
The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/1 description: The image shows the word "Teleflex" in a bold, dark blue font. The "T" in Teleflex has a unique design, with a horizontal line extending from the top of the vertical line. There is a registered trademark symbol to the right of the "x" in Teleflex.
510(k) SUMMARY
Weck® Auto Endo5® Hem-o-lok® Ligating Clip Applier
A. Name, Address. Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8065 Fax: 919-433-4996
B. Contact Person
Ashlea Ricci, RAC Senior Requlatory Affairs Specialist
Lorraine DeLong Sr. Manager RA/QE Surgical
C. Date Prepared
August 27, 2014
D. Device Name
| Trade Name: | Weck® Auto Endo5® Hem-o-lok® Ligating Clip Applier |
|---|---|
| Common Name: | Implantable Clip |
| Classification Name: | Clip, Implantable |
| Product Code: | FZP |
E. Device Description
The Weck Auto Endo5 Hem-o-lok Ligating Clip Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used by a surgeon or physician's assistant during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5 applier is actuated by a trigger, which is housed in a body assembly. Adjacent to the body is a turn knob that is used to rotate the applier jaws. The Auto Endo5 applier is 44 cm long with a working length of 29.7 cm. This applier can be used with a 5 or 5.5 mm cannula.
F. Indications for Use
The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
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Image /page/4/Picture/1 description: The image shows the word "Teleflex" in blue font. The font is bold and sans-serif. There is a registered trademark symbol to the right of the word "Teleflex". The background is white.
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 to or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
G. Contraindications
Hem-o-lok Ligating Clips are not intended for use as a contraceptive tubal occlusion device.
Hem-o-lok Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
H. Environmental Conditions
Hem-o-lok Ligating Clips are "MR Safe" and pose no known hazards in MR environments. This claim was cleared under K133202. December 30, 2013.
l. Substantial Equivalence
The proposed Weck Auto Endo5 Hem-o-lok Ligating Clip Applier is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Weck Hem-o-lok Automatic | |||
| Ligating Clip Applier | Teleflex Medical | ||
| (Weck Closure) | K021808 | 8/14/2002 |
J. Comparison To Predicate Devices
The proposed Weck Auto Endo5 Hem-o-lok Ligating Clip Applier has the same technology and functional characteristics as the predicate device. The modification proposed within this submission includes a change in the dry lubricant applied to various applier components.
K. Materials
All patient contacting materials, including those with indirect patient contact, are in compliance with ISO10993-1.
L. Technological Characteristics
A comparison of the technological characteristics of the proposed Weck Auto Endo5 Hem-o-lok Ligating Clip Applier and the predicate has been performed. The results of this comparison demonstrate that the Auto Endo5 applier is equivalent to the marketed predicate device.
M. Performance Data
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Image /page/5/Picture/1 description: The image shows the word "Teleflex" in a bold, blue font. The letters are connected to each other, and the word is slightly slanted to the right. There is a registered trademark symbol to the right of the word.
Non-clinical performance testing has been conducted following product sterilization, aging, and simulated distribution in order to support a change to the dry lubricant applied to various applier components.
N. Conclusion
Based upon the comparative test results, the proposed Weck Auto Endo5 Hem-o-lok Ligating Clip Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K021808. The modification made to the Auto Endo5 Ligating Clip Applier does not introduce any new issues of safety and effectiveness.