HALO360' COAGULATION CATHETER

K071543 · Barrx Medical, Incorporated · GEI · Jun 29, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071543
• Device Name: HALO360' COAGULATION CATHETER
• Applicant: Barrx Medical, Incorporated
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HALO360+ Coagulation Catheter model is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract. The HALO360+ Coagulation Catheter 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, Dieulafov Lesions, and Angiodysplasia.

Device Story

HALO360+ Coagulation Catheter is a single-use disposable device used with the HALO360 Coagulation System (including HALO460 Energy Generator, HALO300 Sizing Balloon, and optional footswitch). Device delivers electrosurgical energy to coagulate bleeding and non-bleeding sites in the gastrointestinal tract. Operated by clinicians in a clinical setting. System provides controlled thermal energy to tissue; output affects clinical decision-making by enabling treatment of identified GI lesions. Benefits include effective coagulation of various GI pathologies.

Clinical Evidence

Bench testing and animal model testing performed to evaluate changes in materials and manufacturing processes. No clinical data provided.

Technological Characteristics

Electrosurgical coagulation catheter; single-use disposable. System includes energy generator, sizing balloon, output cable, and footswitch. Operates via electrosurgical 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)
• HALO360 Coagulation Catheter (K062225)

Submission Summary (Full Text)

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K071543

Page 1 of 2

### 510(k) SUMMARY

# BARRX Medical's HALO360+ Coagulation Catheter

JUN 2 9 2007

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

BARRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

Phone: [phone] Facsimile: [phone]

Contact Person: Viorica Filimon

Date Prepared: June 4, 2007

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

HALO360+ Coagulation Catheter

BARRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

### Common or Usual Name(s):

Electrosurgical Coagulation Catheter

#### 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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K 071543

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Predicate Device(s)

K051168 HALO360 Coagulation System-BARRX Medical Inc. K062225 HALO360 Coagulation Catheter-BÂRRX Medical Inc.

### Intended Use / Indications for Use

The HALO360+ Coagulation Catheter model is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO360+ Coagulation Catheter 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, Dieulafov Lesions, and Angiodysplasia.

#### Technological Characteristics

The HALO360 Coagulation System consists of the HALO460 Energy Generator with a disposable single-use HALO360+ Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation System comprising catheter model 32041-XX performance and mode of operation is substantially equivalent to the already cleared HALO300 Coagulation System comprising catheter models 31041-XX and/or 31041-XXBR.

#### Substantial Equivalence

The HALO360+ Coagulation Catheter model 32041-XX and the predicate device HALO360 Coagulation Catheter models 31041-XXBR and 31041-XX manufactured by BARRX Medical Inc and Stellartech Research Co. respectively have the same intended use, indications for use, technological characteristics, and principles of operation. The technological differences between the HALO360+ Coagulation Catheter model 32041-XX and its predicates are:

- 1) Changes in materials for manufacturability
- 2) Changes in manufacturing processes

All these differences were evaluated on the bench and in the animal model and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized human figure with three heads and three sets of arms, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BARRX Medical % Ms. Viorica Filimon 540 Oakmead Parkway Sunnyvale, California 94085

JUN 2 9 2007

Re: K071543

Trade/Device Name: HALO360+ Coagulation Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 5, 2007 Received: June 5, 2007

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 (PMA), 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.

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 (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.

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

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Page 2 - Ms. Viorica Filimon

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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,

P.O.M.
Mark N. Melkerson

Director Division of General, Restorativ and Neurological 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): K071543

Device Name: HALO360+ Coagulation Catheter

Indications for Use:

The HALO360* Coagulation Catheter 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 _X (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)

| (Division Sign-Off) | |
|-----------------------------------|--------|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | 10715B |
| Page | of |

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