REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM

K131614 · Covidien · NUJ · Aug 29, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131614
• Device Name: REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
• Applicant: Covidien
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Aug 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reprocessed ClosureFast RF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Device Story

Reprocessed ClosureFast RF Catheter is an intravascular device designed for endovascular coagulation of blood vessels. It delivers temperature-controlled radiofrequency (RF) energy to a predetermined length of superficial vessel. The device features a 7cm RF heating element, a flexible shaft, and a molded handle with an integrated start/stop switch. It is intended for use in conjunction with the ClosureRFG (RF) Generator. The device is operated by a clinician in a clinical setting to treat superficial vein reflux by inducing thermal coagulation of the vessel. The reprocessed device is functionally identical to the original predicate device.

Clinical Evidence

No clinical data. Evidence consists of bench-top verification testing and process validation testing of the cleaning process in accordance with AAMI TIR 30:2011. Manufacturing includes visual and functional testing of all units prior to release.

Technological Characteristics

Intravascular catheter with 7cm RF heating element, flexible shaft, and molded handle with start/stop switch. Energy source: RF generator (ClosureRFG). Sterilization: Reprocessing validation per AAMI TIR 30:2011. Design and materials are identical to the predicate device.

Indications for Use

Indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• ClosureFast RF Catheter (K061373)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image contains a logo and the word "COVIDIEN". The logo is a white cross on a black background. The word "COVIDIEN" is written in black, sans-serif font. The logo is on the left side of the image, and the word "COVIDIEN" is on the right side of the image.

# K131614 510(K) SUMMARY

## 1. 510(k) Owner:

Applicant:

Telephone: Fax:

Covidien 15 Hampshire Street Mansfield, MA 02048 (508) 452 - 4135 (508) 452 - 4135

AUG 2 9 2013

Contact: Title: Date Prepared: Daniel Campion Associate Director Regulatory Affairs May 31, 2013

## 2. Device:

Trade Name: Classification Name: Regulation Number: Product Code(s): Classification:

Reprocessed ClosureFast Radiofrequency (RF) Catheter Electrosurgical Cutting & Coagulation, Reprocessed 21 CFR 878.4400 nui Class II

## 3. Predicate Device:

The Reprocessed ClosureFast RF Catheter is substantially equivalent in intended use and operation to the predicate ClosureFast RF Catheter (K061373).

### 4. Device Description:

The Reprocessed ClosureFast RF Catheter relies on the delivery of radiofrequency (RF) energy via an intravascular catheter that delivers temperature controlled heat to a predetermined length of superficial vessel. The ClosureFast RF Catheter is a sterile device with a 7cm radiofrequency heating element, a molded handle with start/stop switch, a flexible shaft and an integrated instrument cable, and is designed for use with the ClosureRFG (RF) Generator.

#### 5. Intended Use:

The Reprocessed ClosureFast RF Catheters are intended for endovascular coagulation of blood vessels in patients with superficial vein reflux .

### 6. Technological Characteristics:

The Reprocessed ClosureFast RF Catheters are identical to the predicate device in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation.

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## 7. Performance Data:

1

Representative samples of Reprocessed ClosureFast RF Catheters were tested to demonstrate appropriate functional characteristics through bench top verification testing and process validation testing was performed to validate the cleaning process in line with AAMI TIR 30:2011 requirements. The manufacturing process includes visual and validated functional testing of all products produced prior to release.

### 8. Conclusion:

Covidien concludes that the Reprocessed ClosureFast RF Catheter is safe, effective, and substantially equivalent to the predicate device, ClosureFast RF Catheters K061373, as described in this premarket notification submission.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Covidien Daniel Campion Associate Director Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048

August 29, 2013

Re: K131614

Trade/Device Name: Reprocessed ClosureFast Radiofrequency (RF) Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: July 26, 2013 Reccived: July 31, 2013

Dear Mr. Campion:

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: CDRI-1 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 cither class 11 (Special Controls) or class 111 (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

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Page 2 - Daniel Campion

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

FOR

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K131614

Device Name: Reprocessed ClosureFast RF Catheter

Indications for Use:

The Reprocessed ClosureFast RF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

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