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.

Device Description

The HALO360 Coagulation System consists of the HALO300 Energy Generator with a disposable single-use ablation catheter HALO360+ Coagulation Catheter and HALO360 Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation Catheter comprises models 31041-XX and 32041-XX equivalent in performance and mode of operation. There are no changes to the design, principle of operations for any of the products included in the HALO360 System.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that Barrx Medical's HALO360 Coagulation Catheter and HALO360+ Coagulation Catheter meet such criteria.

The document is a 510(k) summary for a premarket notification to the FDA. It does contain:

Device Name: HALO360 Coagulation Catheter and HALO360+ Coagulation Catheter.
Intended Use/Indications for Use: Coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific conditions like Esophageal Ulcers, Mallory-Weiss tears, etc.
Technological Characteristics: Describes the system components (Energy Generator, disposable catheters, sizing balloon, cable, footswitch) and states no changes to design or principle of operations.
Substantial Equivalence: The submission is primarily about Instructions for Use (IFU) changes (adding a contraindication for "Eosinophilic esophagitis" and clarifying instructions) for devices that did not undergo product or process changes. It asserts that these changes do not affect device use or performance and do not raise questions about safety and efficacy, thus concluding substantial equivalence to existing predicate devices (K071543 HALO360+ Coagulation Catheter and K062225 HALO360 Coagulation Catheter).
FDA Clearance: The letter from the FDA confirms market clearance based on substantial equivalence.

The document explicitly states that the devices did not undergo any product or process changes and that the submission addresses only changes to the instructions for use. Therefore, there is no discussion of new acceptance criteria, performance studies, or data related to the device's technical specifications or clinical effectiveness to demonstrate meeting those criteria in this document.

For the information you requested regarding acceptance criteria and performance studies, you would typically need to refer to a different type of document, such as a PMA (Premarket Approval) submission, clinical trial results, or a more detailed technical report which are not present in this 510(k) summary.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K080557" at the top, with a line underneath it. Below the line, the text "510(k) SUMMARY" is written in a larger font size. The text appears to be part of a document or label, possibly related to a product or regulatory submission.

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BARRX Medical's Instructions for Use changes for HALO360+ Coagulation Catheter and HALO360 Coagulation Catheter

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

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

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

Contact Person: Viorica Filimon

Date Prepared: February 27, 2008

Name of device and Name/Address of Sponsor:

HALO360+ Coagulation Catheter 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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K 080557

Predicate Device(s)

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K071543 HALO360+ Coagulation Catheter-BÂRRX Medical Inc. K062225 HALO360 Coagulation Catheter-BARRX Medical Inc.

Intended Use / Indications for Use

The HALO30 Coagulation Catheter is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

The HALO36 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.

Technological Characteristics

Substantial Equivalence

The HALO360+ Coagulation Catheter model 32041-XX and HALO360 Coagulation Catheter model 31041-XX did not undergo any product or process changes, and have the same intended use, indications for use, technological characteristics, and principles of operation. This submission addresses instructions for use changes which consist of the following:

Adding a contraindication "Eosinophilic esophagitis" 2) Provide clarifications to the instructions for use to improve the use of the device

All these changes are not affecting the use of the device or its performance 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with flowing ribbons, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2008

Barrx Medical, Inc. % Viorica Filimon VP, Quality/Regulatory Affairs 540 Oakmead Parkway Sunnyvale, California 94085

Re: K080557

Trade/Device Name: HALO360 Coagulation Catheter and 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: February 27, 2008 Received: March 4, 2008

Dear Viorica 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.

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Page 2 - Viorica Filimon

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M. 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HALO360 Coagulation Catheter and HALO3604 Coagulation Catheter Indications for Use:

The HALO366 Coagulation Catheter is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

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)

Neil keogh for mxn

Division of General, Restorative, and Neurological Devices

510(k) Number K08557

Page: 15

BARRX Medical Inc 510(k)

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.