The HALO360 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 Description

The HALO360 Coagulation System consists of the HALO360 Coagulation Generator and with a disposable single-use HALO360 Coagulation Catheter, output cable, and optional footswitch.

AI/ML Overview

This 510(k) submission (K062225) for the HALO360 Coagulation Catheter does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance against those criteria.

This document is a Summary of Substantial Equivalence, which focuses on demonstrating that a new device is "substantially equivalent" to one or more legally marketed predicate devices. It does not typically include detailed performance study results or acceptance criteria in the manner you've described for a device performance evaluation.

Here's a breakdown of what is and is not in the provided text:

Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document states that the performance and mode of operation are "substantially equivalent to the already cleared HALO®360 Coagulation Catheter and Stellartech Coagulation Catheter 2." This is a regulatory statement of equivalence, not a report of specific performance metrics against defined acceptance criteria.
Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set: All of these details, which relate to a detailed performance study, are not provided in this 510(k) summary. The summary focuses on comparing technological characteristics to predicates and stating that the differences "do not raise questions regarding safety and efficacy."

In summary, the provided text establishes the substantial equivalence of the HALO360 Coagulation Catheter to existing predicate devices based on intended use, indications for use, technological characteristics, and principles of operation, but it does not contain the specific performance study details, acceptance criteria, or expert review information you are seeking.

Summary

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AUG 2 8 2006 510(k) SUMMARY

Page 1 of 2

BARRX Medical's HALO360 Coagulation Syste <062225

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

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

Phone: (408) 328-7302 Facsimile: (408) 328-7395

Contact Person: Viorica Filimon

Date Prepared: August 1, 2006

Name of device and Name/Address of Sponsor:

HALO360 Coagulation Catheter

BÂRRX 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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622225

Predicate Device(s)

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

Intended Use / Indications for Use

The HALO360 Coagulation System intended use is for the coagulation of bleeding The TITLE -- Coagites in the gastrointestinal tract.

The HALO®60 Coagulation System is indicated for use in the coagulation of bleeding The HALOwo Coagunation System is including but not linited to, the and non-bleeding sites in the gasts geal Ulcers, Mallory-Weiss tears, esophaguis. Indications Include Esophagear Oleers, Escore, Security
Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Technological Characteristics

The HALO360 Coagulation System consists of the HALO360 Coagulation Generator The HALOws Coagulation Dystem conclose of ation Catheter, output cable, and and with a disposable single-use HALO - Coagulation Catheter performance and mode of optional footswitch. The IIIDO - Coag and already cleared HALO®® Coagulation
operation is substantially equivalent to the already cleared by Stallertsch operation is substantially Cquirvation Catheter 2 manufactured by Stellartech Research Co.

Substantial Equivalence

The HALO360 Coagulation Catheter manufactured by BÂRRX Medical Inc and the The HALO™ Coagulation Outliever tion catheter and Stellartech Coagulation
predicate devices: HALO360 Coagulation catheter and Stellartes and selection predicate devices. IIIIDO - Ooagalaxe, indications for use, technological Catherer 2 have the same intended act; incation. The technological differences between characteristics, and principies of open its predicates are: (1) increase in balloon the HAD®® Coagulador System and 1.0 personal in the electrode liner; non active length for improved manufacturability; (2) changes in materials; (4) changes to the
surface for improved manufacturability; (3) changes in materials; (4) changes to the Suriate for iniproved manufacturalizes and (5) change in the manufacturing location. All Instructions for use for clarity, and (), and (), and (), and mot raise questions regarding safety and efficacy. Thus the devices are equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2006

BARRX Medical Inc. % Ms. Viorica Filimon Vice President of Quality/Regulatory Affairs 540 Oakmead Parkway Sunnyvale, California 94085

Re: K062225

Trade/Device Name: HALO360 Coagulation Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 1, 2006 Received: August 3, 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 (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 (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

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Page 2 - Ms. Viorica Filimon

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

fa Pelo Vz

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

X062225 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: HALO360 Coagulation Catheter

Indications for Use:

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 System Evaluation (ODE)

Peter Haas

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page

§10(k) Number K062225

BÅRRX Medical Inc 510k

Page: 18

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.