Vesocclude Polymer Ligating Clip

K152082 · Vesocclude Medical, LLC · FZP · Feb 26, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152082
• Device Name: Vesocclude Polymer Ligating Clip
• Applicant: Vesocclude Medical, LLC
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Feb 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vesocclude Polymer Ligation Clips are in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Device Story

Non-absorbable, non-active implantable polymer ligating clips; used for ligation of vessels or tissue structures. Available in medium/large, large, and x-large sizes. Clips are housed in color-coded cartridges; applied using compatible clip appliers designed for general or endoscopic procedures. Operated by surgeons in clinical settings. Device functions by mechanically encompassing and compressing vessels or tissue to achieve ligation. Benefits include secure vessel/tissue closure during surgery.

Clinical Evidence

Bench testing only. Performance data included dimensional analysis, clip applier compatibility, post-aging performance, and functional testing for resistance to leakage and migration. Biocompatibility testing was conducted in accordance with ISO 10993-1 standards.

Technological Characteristics

Material: Acetal homopolymer. Form factor: Three sizes (medium/large, large, x-large) in color-coded cartridges. Mechanical ligation principle. Single-use. Sterile. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for ligation of vessels or tissue structures in surgical procedures. Contraindicated for use as a fallopian contraceptive tubal occlusion device and 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

• Teleflex Medical Hem-o-lok® Ligating Clips (K030311, K003337, K993157, K902108)

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

February 26, 2016

Vesocclude Medical, LLC Mr. Freddy Cannady President and Founder 7429 ACC Blvd., Suite 101 Raleigh, NC 27617

Re: K152082

Trade/Device Name: Vesocclude Polymer Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: December 5, 2015 Received: January 28, 2016

Dear Mr. Cannady:

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,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

510(k) Number (if known) K152082

Device Name Polymer Ligating Clip

#### Indications for Use (Describe)

Intended Use: The Vesocclude Polymer Ligation Clips are in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Contraindications: Vesocclude polymer ligs are not intended for use as a fallopian contraceptive tubal occlusion device. Vesocclude polymer ligation clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary (Per 21 CFR 807.92)

| Date: | February 13th 2016 |
|--------------------|------------------------------------------------------------------------------------|
| Company Name: | Vesocclude Medical, LLC |
| Company Address: | 7429 ACC BLVD<br>Suite 101<br>Raleigh, NC 27617 |
| Contact Person: | Freddy Cannady<br>President and Founder<br>919-201-3142 |
| Device Trade Name: | Vesocclude™ Polymer Ligating Clip |
| Regulation Name: | Implantable Clip |
| Regulation Number: | 21 CFR 878.4300 |
| Product Code: | FZP |
| Predicate Device: | Teleflex Medical Hem-o-lok® Ligating Clips<br>(K030311, K003337, K993157, K902108) |

Device Description: The Vesocclude™ ligating clips are non-absorbable, nonactive implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.

Intended Use: The Vesocclude Polymer Ligation 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.

Contraindications: Vesocclude polymer ligation clips are not intended for use as a fallopian contraceptive tubal occlusion device. Vesocclude polymer ligation clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.

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Technological Characteristics: The technological characteristics of the proposed device are similar or the same as those of the predicate devices. The shape, sizes offered, material, method of application and mechanical function of the Vesocclude clip are the same as the predicate device.

Performance Data (Nonclinical): Performance testing consisting of dimensional analysis, clip applier compatibility, post aging performance and functional testing for resistance to leakage and migration were completed and demonstrate equivalence to the predicate device. And biocompatibility testing in accordance to ISO 10993-1 standards was conducted.

Statement of Substantial Equivalence: The Vesocclude™ Polymer Ligating Clips are substantially equivalent to their predicate device; the Teleflex Medical Hem-olok® Ligating Clips, based upon similarities in intended use, design, principles of operation and performance specifications.