Barrx Anorectal RFA Wand

K150251 · Covidien, LLC · GEI · Jul 28, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150251
• Device Name: Barrx Anorectal RFA Wand
• Applicant: Covidien, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding and non-bleeding sites in the anal and rectum, including but not limited to, arteriovenous malformations, angiodysplasia, and radiation proctitis (RP).

Device Story

Barrx Anorectal RFA Wand is a sterile, single-use, bipolar electrosurgical device designed for targeted coagulation of tissue in the anal canal and rectum. It functions by delivering radiofrequency (RF) energy to treatment sites. The device features a rigid distal shaft and handle for manual manipulation by a clinician. It operates exclusively when connected to the Barrx Flex RFA Energy Generator (K092487). Upon connection, the generator reads an integrated EEPROM within the wand to identify the device and automatically configure operational parameters. The clinician uses the device to ablate targeted tissue, which can help manage conditions like radiation proctitis and vascular malformations. The system provides controlled energy delivery to achieve specific ablation depths, aiding in the coagulation of bleeding or non-bleeding lesions.

Clinical Evidence

Bench testing only. Evidence includes in-vitro functional testing, biocompatibility, sterilization assessment, packaging validation, shelf life testing, electrical safety testing, and user validation. Results demonstrate performance equivalence to the predicate device.

Technological Characteristics

Sterile, single-use, bipolar electrosurgical catheter. Features rigid distal shaft and handle. Energy source: RF energy via Barrx™ Flex RFA Energy Generator. Includes EEPROM for device recognition and parameter storage. Connectivity: Wired connection to generator. Sterilization: Not specified.

Indications for Use

Indicated for coagulation of bleeding and non-bleeding sites in the anal canal and rectum, including arteriovenous malformations, angiomata, angiodysplasia, and radiation proctitis.

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

• Barrx™ 60 RFA Focal Catheter (K112454)

Reference Devices

• Barrx™ Flex RFA Energy Generator (K092487)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, overlapping each other to create a sense of depth and connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 28, 2015

Covidien LLC Rachel Silva Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048

Re: K150251 Trade/Device Name: Barrx Anorectal RFA Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: June 25, 2015 Received: June 26, 2015

Dear Rachel Silva,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Benjamin R. Fisher -S

Benjamin R. Fisher, PhD Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K150251

Device Name Barrx™ Anorectal RFA Wand

#### Indications for Use (Describe)

The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding and non-bleeding sites in the anal and rectum, including but not limited to, arteriovenous malformations, angiodysplasia, and radiation proctitis (RP).

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 5 510(k) Summary

Submitter's Name and Address: Covidien Ilc 15 Hampshire Street Mansfield. MA 02048

## Contact Person:

Rachel Silva Senior Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

Date Prepared: July 2, 2015

## Name of Device:

Proprietary Name: Barrx™ Anorectal RFA Wand Common/Usual Name: Electrosurgical Coagulation Catheter Classification Panel: General & Plastic Surgery Device Regulation: 21 CFR 878.4400, Class II Product Code: GEI

# Establishment Registration Number, Owner/Operator Number:

Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497

## Predicate Device(s):

K112454 Barrx™ 60 RFA Focal Catheter by Covidien, Formerly BÂRRX MEDICAL, Inc.

## Device Description:

The Barrx™ Anorectal RFA Wand is a sterile, single-use, bipolar device used to deliver radiofrequency (RF) energy to treatment tissue in the anal and rectum. The design of the Barrx™ Anorectal RFA Wand is a modification to the legally marketed Barrx ™ 60 RFA Focal Catheter predicate device. The Barrx™ Anorectal RFA Wand design has a rigid distal shaft with handle which allows for targeted use in the anal canal and rectum. The device is used exclusively with the Barrx™ Flex RFA Energy Generator (K092487).

## Indications for Use:

The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding and nonbleeding sites in the anal canal and rectum, including but not limited to, arteriovenous malformations, angiomata, angiodysplasia, and radiation proctitis (RP).

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# Technological Characteristics of the Device Compared to Predicate Device

The Barrx™ Anorectal RFA Wand has the same technological characteristics as the predicate device; Barrx™ 60 RFA Focal Catheter. Both devices are sterile, single use, bipolar devices that have Electrically Erasable Programmable Read-Only Memories (EEPROMs) which connect to the Barrx™ Flex RFA Energy Generator. Both devices have similar construction, energy type, and principles of operation.

# Principles of Operation

The Barrx™ Anorectal RFA Wand is used in connection with the Barrx™ Flex RFA Energy Generator. Once the device is connected, the EEPROM is read by the generator, recognizes the device, and determines the operation parameters.

The Barrx™ Anorectal RFA Wand has the same principle of operation as the Barrx™ 60 RFA Focal Catheter predicate device. Both devices use the same cap with electrode, use RF energy, and achieve similar ablation depths. Both devices are used with the Barrx™ Flex RFA Energy Generator where the operational settings are the same. Operation parameters for each device are stored in the device EEPROM connector.

# Performance Data

Performance testing for the Barrx™ Anorectal RFA Wand consisted of in-vitro functional testing, biocompatibility testing, sterilization assessment, packaging validation, shelf life testing, electrical safety testing, and user validation. Results of performance testing demonstrate performance equivalence for the Barrx™ Anorectal RFA Wand when evaluated against the predicate device.

# Conclusion

Covidien IIc considers the Barrx™ Anorectal RFA Wand to be substantially equivalent to legally marketed predicate device Barrx™ 60 RFA Focal Catheter (K112454). Test results and compliance to applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.