BARRX FLEX RFA ENERGY GENERATOR

K141357 · Covidien Iic · GEI · Aug 21, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141357
• Device Name: BARRX FLEX RFA ENERGY GENERATOR
• Applicant: Covidien Iic
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 21, 2014
• 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 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 ablation catheters; footswitch-controlled; used by clinicians in endoscopic procedures to coagulate soft tissue and bleeding sites; output affects tissue via thermal coagulation; benefits include treatment of various GI lesions and Barrett's Esophagus.

Clinical Evidence

No new clinical testing performed for this submission. Substantial equivalence is based on identical technological characteristics to the predicate. Labeling update is supported by two previously published peer-reviewed clinical studies.

Technological Characteristics

Electrosurgical generator; bipolar RF energy delivery; footswitch interface; compatible with specific single-use disposable ablation catheters and sizing balloons; identical to predicate K092487.

Indications for Use

Indicated for coagulation of soft tissue and bleeding sites in the gastrointestinal tract, including esophagus, in patients with Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and 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™HALOFLEX Energy Generator (K092487)
• HALO360 Energy Generator (K093855)
• HALO® Energy Generator (K093008)

Reference Devices

• HALO60 Ablation Catheter (K112454)
• HALO® ULTRA Ablation Catheter (K120431)
• Barrx Channel RFA Endoscopic Catheter (K130623)

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

August 21, 2014

Covidien LLC Mr. Tim Thomas Vice President, Medical and Regulatory Affairs 540 Oakmead Parkway Sunnyvale, California 94085

Re: K141357

Trade/Device Name: Barrx FLEX RFA Energy Generator Regulation Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 22, 2014 Received: May 23, 2014

Dear Me. Thomas:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 vours.

# David Krause -S

for

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

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#### Indications for Use Statement

## 510(k) Number (if known): To be determined

Device Name:

- 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 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 (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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] ext. 1006 Facsimile: [phone] Contact: Date Prepared: May 22, 2014

#### NAME OF SUBJECT DEVICE AND NAME

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, Formerly BÂRRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

#### COMMON OR USUAL NAME

Electrosurgical cutting and coagulation device and accessories

#### REGULATION DESCRIPTION

Classification: Class II, 21 CFR 876.4400 Product Code: GEI

#### PREDICATE DEVICES

Barrx™HALOFLEX Energy Generator, 510(k) K092487 HALO360 Energy Generator, 510(k) K093855 HALO® Energy Generator, 510(k) K093008

#### DEVICE DESCRIPTION

The subject device, the Barry™ 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:

- HALO360 Ablation Catheter and Sizing Ballon (K093855)
- . HALO90 Ablation Catheter (K093008)
- HALO60 Ablation Catheter (K112454) ●
- HALO® ULTRA Ablation Catheter (K120431) ●
- . Barrx Channel RFA Endoscopic Catheter (K130623)

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# 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 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.

# 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, K092487. There have been no design or material changes to the generator since the predicate was cleared on November 10, 2009. There have been minor software changes since the clearance of the K092487 however they did not require a submission and were documented via Letter to File. The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K092487) is the addition of clinical information to the labeling resulting from two published peer-reviewed clinical studies.

# PRINCIPLES OF OPERATION

As the subject of this submission is a labeling change only, the principles of operation of the Barrx FLEX RFA Energy Generator are unchanged and remain identical to the predicate device, K092487, cleared on November 10, 2009.

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 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:

- HALO360 Ablation Catheter and Sizing Ballon (K093855)
- . HALO90 Ablation Catheter (K093008)
- HALO60 Ablation Catheter (K112454) ●
- HALO® ULTRA Ablation Catheter (K120431)
- Barrx Channel RFA Endoscopic Catheter (K130623)

# 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 predicates: Barrx™ HALOFEK Energy Generator (K092487), HAL0380 Energy Generator (K093855) and HAL090 Energy Generator (K093008).