Barrx FLEX RFA Energy Generator

K160360 · Covidien, LLC · GEI · Apr 5, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160360
• Device Name: Barrx FLEX RFA Energy Generator
• Applicant: Covidien, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue. The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions and Angiodysplasia.

Device Story

Electrosurgical generator delivering bipolar radiofrequency (RF) energy to gastrointestinal tissue via compatible single-use catheters/balloons; operated by physician via footswitch to control balloon inflation/deflation and RF energy delivery; used in clinical settings to coagulate soft tissue and treat specific GI lesions/conditions; output affects tissue coagulation; benefits include therapeutic management of esophageal and GI pathologies.

Clinical Evidence

No new clinical testing performed for this submission. Evidence consists of a literature review of one peer-reviewed clinical study (Wolf WA et al., 2015) regarding the incidence of esophageal adenocarcinoma and mortality after radiofrequency ablation of Barrett's Esophagus, used to support labeling updates.

Technological Characteristics

Electrosurgical generator; bipolar RF energy output; compatible with various single-use disposable ablation catheters and sizing balloons; footswitch-controlled; identical to predicate (K141357).

Indications for Use

Indicated for coagulation of soft tissue and bleeding/nonbleeding GI tract sites (esophagus, ulcers, Mallory-Weiss tears, AVMs, angiomata, Barrett's esophagus, Dieulafoy lesions, angiodysplasia).

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 FLEX RFA Energy Generator (K141357)

Reference Devices

• Barrx 360 RFA Balloon Catheter and Barrx Soft Sizing Balloon (K093855)
• Barrx 90 RFA Focal Catheter (K093008)
• Barrx 60 RFA Focal Catheter (K112454)
• Barrx ULTRA Long RFA Focal Catheter (K120431)
• Barrx Channel RFA Endoscopic Catheter (K130623)
• Barrx RFA Self Sizing Balloon Catheter (K142364)
• Barrx Anorectal RFA Wand (150251)

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

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

April 5, 2016

Covidien LLC Gloria Dy Regulatory Affairs Specialist 540 Oakmead Parkway Sunnvvale, CA 94085

Re: K160360 Trade/Device Name: Barrx FLEX RFA Energy Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 5, 2016 Received: February 9, 2016

Dear Gloria Dy,

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,

**Herbert P. Lerner -S**

for 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 Statement

## 510(k) Number (if known):

K160360

### Device Name:

- X Barrx FLEX RFA Energy Generator
### Indications for Use:

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions and Angiodysplasia.

Prescription Use _ X __

AND/OR

Over-The-Counter Use

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

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## 510(k) Summary

## SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED

Covidien IIc 540 Oakmead Parkway Sunnyvale, CA 94085 Phone: Phone: [phone] Facsimile: [phone] Contact: Gloria Dy

Date Prepared: January 29, 2016

## NAME OF SUBJECT DEVICE

Barrx FLEX RFA Energy Generator

### ESTABLISHMENT REGISTRATION NUMBER/OWNER OPERATOR NUMBER

Establishment Registration Number: 3004904811

Owner/Operator Number: 1282497

Legal Manufacturer: Covidien, Ilc

15 Hampshire Street

Mansfield, MA 02048

Manufacturing Facility:

Covidien, Ilc

540 Oakmead Parkway

Sunnyvale, CA 94085

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# COMMON OR USUAL NAME

Electrosurgical cutting and coagulation device and accessories

## REGULATION DESCRIPTION

Classification: Class II, 21 CFR 878.4400

Product Code: GEI

## PREDICATE DEVICES

Barrx FLEX RFA Energy Generator, 510(k) K141357

## DEVICE DESCRIPTION

The subject device, the Barrx™ FLEX RFA Energy Generator is intended to be used with the listed catheters to deliver radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheters include:

- . Barrx™ 360 RFA Balloon Catheter and Barrx™ Soft Sizing Balloon (K093855)
- Barrx™ 90 RFA Focal Catheter (K093008)
- Barrx™ 60 RFA Focal Catheter (K112454)
- Barrx™ ULTRA Long RFA Focal Catheter (K120431)
- Barrx™ Channel RFA Endoscopic Catheter (K130623) ●
- Barrx™ RFA Self Sizing Balloon Catheter (K142364) ●
- o Barrx™ Anorectal RFA Wand (150251)

### INDICATION FOR USE

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions and Angiodysplasia.

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# TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICE

As the subject of this submission is a labeling change only, the Barrx FLEX RFA Energy Generator has identical technological characteristics as compared to the predicate Barrx FLEX RFA Energy Generator (K141357). There have been no design or material changes to the generator since the predicate was cleared on. There has been a minor software change since the K141357 however, it did not require a submission and was documented via Letter to File to K141357. The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K141357) is the addition of clinical information to the labeling resulting from one published peer-reviewed clinical study:

- Wolf WA, Pasricha S, Cotton C, et al. Incidence of Esophageal Adenocarcinoma and Causes of Mortality After Radiofrequency Ablation of Barrett's Esophagus. Gastroenterology 2015; Aug 28. [Epub ahead of print]
# PRINCIPLES OF OPERATION

As the subject of this submission is a labeling change only, the principleof operation of the Barrx FLEX RFA Energy Generator is unchanged and remains identical to the predicate device, K141357, cleared on August 21, 2014.

The Barrx FLEX RFA Energy Generator is an electrosurgical device that utilizes bipolar RF energy to coagulate biological tissue. The Generator is provided with a footswitch that can initiate inflation or deflation of the balloon and initiate or cease delivery of RF energy. The Barrx FLEX RFA Energy Generator is designed to function with a family of single use, disposable Ablation Catheters and Sizing Balloons to deliver the intended therapy. The family of catheters includes:

- Barrx™ 360 RFA Balloon Catheter and Barrx™ Soft Sizing Balloon (K093855)
- Barrx™ 90 RFA Focal Catheter (K093008)
- Barrx™ 60 RFA Focal Catheter (K112454)
- Barrx™ ULTRA Long RFA Focal Catheter (K120431)
- . Barrx™ Channel RFA Endoscopic Catheter (K130623)
- Barrx™ RFA Self Sizing Balloon Catheter (K142364)
- Barrx™ Anorectal RFA Wand (150251)

## CONCLUSION

As the subject of this submission is a labeling change only, Covidien, Ilc considers the Barrx FLEX RFA Energy Generator to be substantially equivalent to legally marketed predicate: Barrx FLEX RFA Energy Generator (K141357).