The HALO360 is indicated for use in the coagulation of bleeding and non-bleeding lesions 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 consists of a Generator; a Sizing Catheter; a Coagulation Catheter; and a Catheter Connection Cable. A mains power cord and optional footswitch are also available.

AI/ML Overview

This document does not contain an acceptance criteria table, device performance data, details of a specific study proving the device meets acceptance criteria, or information on AI/ML components.

The submission is a 510(k) summary for the BARRX HALO360 Coagulation System. The manufacturer has claimed substantial equivalence to a predicate device, the Stellartech Coagulation System 2, rather than submitting performance data against specific acceptance criteria.

Here's the relevant information extracted from the document:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states that due to the HALO360 System being "technologically identical" to the cleared Stellartech Coagulation System, "no performance testing was conducted."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new performance testing was conducted. The submission refers to "Clinical recording:3, as provided to Instructions contained in the Instructions for Use for the HALO360 Coagulation Catheter. That data Instructions for Oscillaccordance with those instructions, the HALO360 uemonstrated that, When wive as the Stellartech Coagulation System for the treatment of Barrett's Esophagus." This seems to refer to instructions for use and not a clinical study to establish performance against acceptance criteria for the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No new performance testing was conducted requiring ground truth experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is an electrosurgical coagulation system, not an AI/ML-driven diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an electrosurgical hardware system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Based on the provided text, the core of the submission is a claim of substantial equivalence:

"The HALO360 System is technologically identical to the cleared Stellartech Coagulation System 2. Accordingly, no performance testing was conducted."

"The HALO360 is as safe and effective as the Stellartech Coagulation System. The HALO has the same intended use, indications for use, technological characteristics, and principle of operation as the predicate device. The addition of physician's final decision recommending specific power settings for the treatment of Barrett's Esophagus (a cleared indication for use of the predicate device) is based on clinical recording:3 and does not change the device's indications for use. Thus, the HALO360 is substantially equivalent."

Summary

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JUN 2 9 2005

51168 510(k) SUMMARY

Page 1 of 2

BARRX's HALO360 Coagulation System

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

BARRX Medical, Inc. 1334 Bordeaux Drive Sunnyvale, CA 94089

(408) 745-8000 Phone: Facsimile: (408) 745-7406

Contact:, David S. Utley, M.D.

Date Prepared: May 5, 2005

Name of Device and Name/Address of Sponsor

HALO360 Coagulation System

BARRX Medical, Inc. 1334 Bordeaux Drive Sunnyvale, CA 94089

Common or Usual Name

Electrosurgical Coagulation System

Classification Name

Electrosurgical Cutting or Coagulation Device

... .

Predicate Devices

Stellartech Research Corporation's Stellartech Coagulation System 2

Intended Use / Indications for Use

The HALO360 is indicated for use in the coagulation of bleeding and non-bleeding I he firms - 11 million in tract including but not limited to the esophagus.

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Page 2 of (2

Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Indications increate Loophagear - Esophagus, Dieulafoy Lesions, and Angiodysplasia.

Technological Characteristics

The HALO360 consists of a Generator; a Sizing Catheter; a Coagulation Catheter; The HALO™ connection Cable. A mains power cord and optional footswitch also and a Cathewer Colliestion Cashnological characteristics and principles of are available. The 111115 - - comittee cleared Stellartech Coagulation System 2.

Performance Data

The HALO360 System is technologically identical to the cleared Stellartech The HALO® System. Accordingly, no performance testing was conducted. Clinical Coagulation bystem. Trecording:3, as provided to Instructions contained in the Instructions for Use for the HALO360 Coagulation Catheter. That data Instructions for Osciol accordance with those instructions, the HALO360 uemonstrated that, When wive as the Stellartech Coagulation System for the treatment of Barrett's Esophagus.

Substantial Equivalence

The HALO360 is as safe and effective as the Stellartech Coagulation System. The The THISS - Is as as antended use, indications for use, technological ITALO … ias the same investion as the predicate device. The addition of Characteristics, and printerprommending specific power settings for the treatment of I hysician's finol acon (a cleared indication for use of the predicate device) is Darrews Hoophiagas (a taxand does not change the device's indications for use. Thus, the HALO360 is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Barrx Medical Incorporated C/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 13th Street, NW Washington, District of Columbia 20004

Re: K051168

Trade/Device Name: HALO360 Coagulation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 5, 2005 Received: May 5, 2005

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ruch. An

Miriam C. Provost, Ph.D. Acting 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

KOS 1168 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The HALO360 Coagulation System is indicated for use in the coagulation of bleeding Inc IIIIo - Goagains in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Coophiague. Thateations, 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)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number K031168

\\DC - 88747/0001 - 2115261 v5

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.