Weck Hem-o-lok Auto Endo5 Ligating Clip Applier

K142777 · Teleflexmedical, Inc. · FZP · Dec 19, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142777
• Device Name: Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
• Applicant: Teleflexmedical, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The Weck Auto Endo5 Hem-o-lok Ligating Clip Applier is a sterile, disposable, automatic endoscopic delivery device pre-loaded with 15 non-absorbable polymer ligating clips. Used by surgeons or physician assistants during laparoscopic procedures; device is 44 cm long with a 29.7 cm working length; compatible with 5/5.5 mm cannulas. Operation involves manual trigger actuation to deploy clips and a turn knob to rotate jaws. The device facilitates vessel or tissue ligation by ensuring the clip completely encompasses the target structure. Benefits include efficient, automated clip delivery during minimally invasive surgery.

Clinical Evidence

Bench testing only. Non-clinical performance testing was conducted following sterilization, aging, and simulated distribution to validate the change in dry lubricant.

Technological Characteristics

Sterile, disposable, automatic endoscopic ligating clip applier. 44 cm total length; 29.7 cm working length. Compatible with 5/5.5 mm cannulas. Patient-contacting materials compliant with ISO 10993-1. Mechanical actuation via trigger and rotation knob. MR Safe.

Indications for Use

Indicated for patients undergoing laparoscopic procedures requiring ligation of vessels or tissue structures. Contraindicated for use as a contraceptive tubal occlusion device or for ligation of the renal artery during laparoscopic donor nephrectomies.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Weck Hem-o-lok Automatic Ligating Clip Applier (K021808)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone]

# 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<br>Ligating Clip Applier | Teleflex Medical<br>(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.