Barrx Anorectal RFA Wand

K162802 · Covidien, LLC · GEI · Jan 24, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162802
• Device Name: Barrx Anorectal RFA Wand
• Applicant: Covidien, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Barrx Anorectal RFA Wand is a sterile, single-use, bipolar device designed to deliver radiofrequency (RF) energy to tissue within the anal canal and rectum. The device features a cap with an electrode, an EEPROM chip, a proximal shaft, and a rigid distal shaft with a handle. It is used exclusively with the Barrx Flex RFA Energy Generator. Upon connection, the generator reads the device's EEPROM to identify the device and establish operational parameters. The device is operated by clinicians to perform tissue coagulation for conditions such as AIN, arteriovenous malformations, and radiation proctitis. By delivering controlled RF energy, the device enables the ablation of soft tissue, providing a therapeutic benefit for patients with these anorectal conditions.

Clinical Evidence

No new bench or performance testing was conducted as the device is technologically identical to the predicates. The submission references three clinical studies regarding the use of the device for Anal Intraepithelial Neoplasia (AIN) to support the expanded indication.

Technological Characteristics

Sterile, single-use, bipolar RF ablation device. Components include a cap with electrode, EEPROM for generator communication, proximal shaft, and rigid distal shaft with handle. Operates via RF energy delivered by the Barrx Flex RFA Energy Generator. No changes to technological characteristics compared to predicate.

Indications for Use

Indicated for coagulation of bleeding and nonbleeding sites in the anal canal and rectum, including arteriovenous malformations, angiomata, angiodysplasia, radiation proctitis, and anal intraepithelial neoplasia (AIN).

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™ Anorectal RFA Wand (K150251)
• Barrx™ 60 RFA Focal Catheter (K112454)

Reference Devices

• Barrx™ Flex RFA Energy Generator (K092487)

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

January 24, 2017

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

Re: K162802 Trade/Device Name: Barrx Anorectal RFA Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 9, 2016 Received: December 12, 2016

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,

# Benjamin R. Fisher -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K162802

Device Name Barrx™ Anorectal RFA Wand

#### Indications for Use (Describe)

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

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

| <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------------|
| <span> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: October 3, 2016

#### 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 Devices:

K150251 Barrx™ Anorectal RFA Wand by Covidien K112454 Barrx™ 60 RFA Focal Catheter by Covidien

#### Reason for 510(k) Submission

The purpose of this submission is to include a specific indication for use, which is Anal Intraepithelial Neoplasia (AIN), and include clinical information in the labeling resulting from three AIN related clinical studies. The intent of this 510(k) submission aligns with information stated in the FDA Guidance document titled "Guidance for Industry: General/Specific Intended Use" dated November 4, 1998 as AIN is a specific type of tissue which has been treated by the clinical community under the generic indications for use of coagulating bleeding and nonbleeding sites within the gastrointestinal tract. Also, AIN is found within a narrow target population that falls within the broader population for the products intended use.

#### 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 canal and rectum. The Barrx™ Anorectal RFA Wand consists of a cap with electrode, EEPROM, a proximal shaft and a rigid distal shaft with handle. The device is used exclusively in connection with the Barrx™ Flex RFA

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Energy Generator (K092487). Once the device is connected, the EEPROM is read by the generator, recognizes the device, and determines the operation parameters.

### 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, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).

The Indication for Use statement for the subject device, Barrx™ Anorectal RFA Wand is not identical to the predicate device, however the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both, the subject and the predicate devices have intended use for the ablation of soft tissue using RF energy.

#### Technological Characteristics of the Device Compared to Predicate Device

The Barrx™ Anorectal RFA Wand has identical technological characteristics to the predicate device cleared under K150251 as well as the secondary predicate device cleared under K112454. There have been minor changes to the Barrx™ Anorectal RFA Wand that did not require a submission and were documented in a letter to file.

#### Performance Data

The Barrx™ Anorectal RFA Wand subject device is technologically identical to the predicate device cleared under K150251 and reference predicate cleared under K112454. Accordingly, no performance testing was conducted.

#### Conclusion

Clinical studies referenced within this submission demonstrate the Barrx™ Anorectal RFA Wand may be used for anal intraepithelial neoplasia and is substantially equivalent to the primary predicate and reference predicate devices.