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 Description

The HALO® Coagulation System consists of the HALO90 Energy Generator model 90-9000 with a disposable single-use HALO® Coagulation Catheter, output cable, and a footswitch. The HALO® Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO® Coagulation System, HALO360 Coagulation System, and Stellartech Coagulation System 2.

The HALO® Energy Generator model 90-9000 is configured with an output cable (model 90-9010), a footswitch (model 90-9020) and a power cord.

The HALO® Coagulation Generator supplies up to 150 watts of radiofrequency power at 460 kHz in a bipolar mode under power control while continuously monitoring and displaying power density, and energy density. Energy density and power are displayed to allow homogeneous energy delivery equivalent to the HALO90 Energy Generator model 1100C-115C.

AI/ML Overview

The provided text is a 510(k) summary for the BARRX Medical's HALO® Coagulation System. This type of submission focuses on establishing substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials and detailed acceptance criteria studies.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

A table of acceptance criteria and reported device performance.
Sample sizes (for test or training sets), data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
The type of ground truth used or how it was established for training sets.

The submission primarily focuses on demonstrating that the technological characteristics of the new HALO90 Energy Generator are substantially equivalent to previously cleared predicate devices (HALO® Energy Generator model 1100C-115C, HALO360 Energy Generator model 1100C-115B, and Stellartech Coagulation System 2). The "study" mentioned is limited to bench testing to evaluate the differences in the new generator, such as:

Simplification of the generator and elimination of unused pneumatic systems.
Changes in hardware for optimum RF power output for the defined impedance range.
Minor modification of generator software.
Change of design and manufacturing facility.

The document explicitly states: "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent."

Essentially, for a 510(k) submission, the "acceptance criteria" for the new device are that its performance, as demonstrated through bench testing (and sometimes limited clinical data if significant changes, though not explicitly detailed here), does not raise new questions of safety or effectiveness compared to the predicate device. The "study" proving this is often a comparison of technical specifications and performance characteristics through bench testing.

Summary

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K06244/

510(k) SUMMARY

Page 1 of 3

BARRX Medical's HALO® Coagulation System

Submitter's Name, Address, Telephone Number, Contact 1. Person and Date Prepared:

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

NOV 1 4 2006

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

Viorica Filimon Contact Person:

Date Prepared: August 19, 2006

Name of device and Name/Address of Sponsor: 2.

HALO90 Coagulation System HALO®0 Coagulation Catheter HALO90 Energy Generator

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

Common or Usual Name(s): 3.

Electrosurgical Coagulation System

Classification Name: 4.

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

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Page 2 of 3

5. Predicate Devices

HALO® Energy Generator model 1100C-115C (K060169) manufactured by . Stellartech Research;
HALO360 Energy Generator model 1100C-115B (K051168) manufactured by . Stellartech Research;
Stellartech Coagulation System 2, model 1100C-115A (K050831) . manufactured by Stellartech Research;

Intended Use / Indications for Use 6.

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

Technological Characteristics 7.

HALO® Coagulation Catheter

There are no changes associated with the HALO® Coagulation Catheter model 1520F.

HALO90 Energy Generator

The HALO® Energy Generator model 90-9000 is configured with an output cable (model 90-9010), a footswitch (model 90-9020) and a power cord.

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density and power are displayed to allow homogeneous energy delivery equivalent to the HALO90 Energy Generator model 1100C-115C.

8. Substantial Equivalence

The HALO® Coagulation System (generator model 90-9000) and the predicate devices: HALO® Coagulation System (generator model 11000-1150), 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 HALO90 Coagulation System and its predicates are:

(1) Simplification of the generator and elimination of the unused pneumatic systems for inflation/deflation capability;

(2) Changes in the hardware implemented to establish an optimum RF power output for the impedance range defined for the clinical application;

(3) Minor modification of the generator software to support the changes in the hardware design.

(4) Change of the design and manufacturing facility to the Aubrey Group;

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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510(K) SUMMARY v.

The Company's 510(k) Summary is provided in pages 19-21 below.

HALO® Energy Generator

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BARRX Medical, Inc. % Hogan & Hartson, L.L.P. Mr. Jonathan S. Kahan 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

NOV 1 4 2006

Re: K062441

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: October 17, 2006 Received: October 17, 2006

Dear Mr. Kahan:

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.

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Page 2 – Mr. Jonathan S. Kahan

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 (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 yours,

Mark A. Millman

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 1.

510(k) Number (if known):

Device Name:

Indications for Use:

Prescription Use __ V_ (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)

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

510(k) Number. K062441 Page _ of _

HALO
Energy Generator

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.