HALO90 COAGULATION CATHETER

K062723 · Barrx Medical, Incorporated · GEI · Nov 9, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062723
• Device Name: HALO90 COAGULATION CATHETER
• Applicant: Barrx Medical, Incorporated
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

HALO Coagulation System comprises HALO90 Coagulation Generator, disposable single-use HALO90 Coagulation Catheter (model 90-9100), output cable, and optional footswitch. Device functions as electrosurgical coagulation system for GI tract. Operated by clinicians in clinical setting. Generator delivers energy to catheter to coagulate bleeding or non-bleeding tissue sites. Output allows physician to treat specific GI pathologies; benefits include controlled tissue coagulation for conditions like Barrett's esophagus and vascular lesions.

Technological Characteristics

Electrosurgical coagulation system. Components: HALO90 Generator, disposable single-use catheter (model 90-9100), output cable, optional footswitch. Energy source: Electrosurgical. Classification: 21 CFR 878.4400, Product Code GEI.

Indications for Use

Indicated for coagulation of bleeding and non-bleeding GI tract sites, including esophagus. Conditions include esophageal ulcers, Mallory-Weiss tears, AVMs, 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

• HALO90 Coagulation System (catheter model 1520F)

Submission Summary (Full Text)

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K06-2723

NOV - 9 2006

## 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] Facsimile: [phone]

Contact Person: Viorica Filimon

Date Prepared: September 11, 2006

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

HALO® Coagulation System HALO90 Coagulation Catheter HALO® 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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69 HALO® Coagula

## l Use / Indications for Use

e HALO® Coagulation System intended use is for the
l non-bleeding sites in the gastrointestinal tract

ne HALO® Coagulation System is indicated for use in the coagulation of bleeding
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terior inglodySplasia.

# ological Characteristics

The **HALO**90 Coagulation System consists of the **HALO**90 Coagulation Generator
with a disposable single-use **HALO**90 Coagulation Catheter model 90-9100, output
cable, and an optional footswitch. The **HALO**90 Coagulation System performance
and mode of operation is substantially equivalent to the already cleared **HALO**90
Coagulation System (with catheter model 1520F).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Viorica Filimon VP Regulatory/Quality BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085

## NOV - 9 2006

Re: K062723

> Trade/Device Name: BÂRRX HALO® Coagulation Catheter, Model 90-9100 Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 14, 2006 Received: October 18, 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.

Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006 FDA Centennial" arranged around the perimeter. In the center of the seal, the letters "FDA" are prominently displayed in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial".

Protecting and Promoting Public Health

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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 Ictter 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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

Sincerely vours.

Nancy Chrogdon

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): K062723

Device Name: HALO® 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 V (Part 21 C.F.R. 801 Subpart D)

ANDIOR

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 System Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-O Division of Reproductive, Abdominal. and Radiological Devie 510(k) Number

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