BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F

K060169 · Barrx Medical, Incorporated · GEI · Apr 21, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060169
• Device Name: BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
• Applicant: Barrx Medical, Incorporated
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. The HALO® Coagulation System is indicated for use in the coagulation of bleeding and non-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

HALO90 Coagulation System provides electrosurgical coagulation for GI tract lesions. System comprises HALO Coagulation Generator, disposable single-use HALO Coagulation Catheter, output cable, and optional footswitch. Device utilizes endoscope and pivot mechanism for electrode positioning; eliminates need for sizing balloons or custom-sized catheters. Operated by clinicians in clinical settings. Generator delivers energy to catheter electrodes to coagulate tissue. Minor software modifications support catheter design changes. Benefits include precise lesion treatment and simplified procedural workflow compared to previous balloon-based systems.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical coagulation system. Components: generator, disposable single-use catheter, output cable, optional footswitch. Features endoscope-compatible pivot mechanism for electrode positioning. Software-controlled energy delivery.

Indications for Use

Indicated for coagulation of bleeding and non-bleeding GI tract sites, including esophagus. Conditions include 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

• HALO360 Coagulation System (K051168)
• Stellartech Coagulation System 2 (K050831)

Submission Summary (Full Text)

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# APR 2 1 2005

#### 510(k) SUMMARY

# BÂRRX Medical's HALO® Coagulation System

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

[phone] Phone: [phone] Facsimile:

Contact Person: Viorica Filimon

Date Prepared: January 20, 2006

## Name of device and Name/Address of Sponsor:

HALO90 Coagulation System HALO® Coagulation Catheter HALO90 Coagulation Generator

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

## Common or Usual Name(s):

Electrosurgical Coagulation System

#### Classification Name:

Product code: GEI CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II Classification panel: General & Plastic Surgery

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### Predicate Device(s)

K051168 HALO360 Coagulation System-BÂRRX Medical Inc. K050831 Stellartech Coagulation System 2-Stellartech Research Corporation

#### Intended Use / Indications for Use

The HALO® Coagulation System intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO® Coagulation System is indicated for use in the coagulation of bleeding and non-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

The HALO® Coagulation System consists of the HALO® Coagulation Generator with a disposable single-use HALO® Coagulation Catheter, output cable, and an optional footswitch. The HALO® Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO®60 Coagulation System and Stellartech Coagulation System 2.

#### Substantial Equivalence

The HALO® Coagulation System and the predicate devices: HALO360 Coagulation System and Stellartech Coagulation System 2 have the same or similar intended use, indications for use, technological characteristics, and principles of operation. The technological differences between the HALO® Coagulation System and its predicates are: (1) use of an endoscope and pivot mechanism for electrode positioning; (2) elimination of the sizing balloon and the need to select a custom size coagulation catheter; (3) additional materials; and (4) minor modification of the generator software to support the changes in the catheter design. All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 2 1 2006

Ms. Viorica Filimon Vice President of Quality/Regulatory Affairs BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085

Re: K060169

Trade/Device Name: HALO® Coagulation System Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 20, 2006 Reccived: January 27, 2006

Dear Ms. Filimon:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

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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); good manufacturing practice requirements as set 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological 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): K060 0 69

Device Name: HALO90 Coagulation System

Indications for Use:

The HALO® Coagulation System is indicated for use in the coagulation of bleeding and non-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 _> (Part 21 C.F.R. 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device System Evaluation (ODE)

T. Henry C. Broderick

(Division Sign-Off Division of Reproductive, Abdominal and Radiological Device 510(k) Number.

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