The HALO360 Energy Generator 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 Energy Generator model 1100C-115B with a disposable single-use HALO®60 Coagulation Catheter, output cable, and an optional footswitch. The HALO360 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO360 Coagulation System, and Stellartech Coagulation System 2.

There are no changes associated to the HALO360+ Coagulation Catheter.

The HALO360 Energy Generator model 1100C-115B is configured with an output cable (model CCC-001B), an optional footswitch (model FS-100B), and a power cord.

There are no changes to the hardware associated to HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. There are minor changes implemented to the software version of the generator.

This submission addresses software changes for HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy.

AI/ML Overview

This 510(k) summary describes a device modification, not a study establishing new acceptance criteria or performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided document.

The submission focuses on minor software changes to the HALO360 Energy Generator and demonstrates substantial equivalence to previously cleared devices. It confirms that "These minor changes implemented to the software version of the generator did not raise any new questions of safety or efficacy."

Here's a breakdown of what can be extracted from the document based on your request:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission states that the differences were evaluated on bench, implying functional testing was performed to ensure the software changes did not negatively impact performance, but specific acceptance criteria and detailed performance results are not reported. The primary claim is substantial equivalence based on the absence of new safety or efficacy questions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench" evaluation, which typically involves laboratory testing rather than testing on a "test set" of patient data as might be relevant for AI/diagnostic devices.

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)

This information is not provided in the document. This is not applicable as the submission is about a software update for an electrosurgical generator, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document and is not applicable for this type of device modification submission.

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

This information is not provided in the document and is not applicable. The device is an energy generator for coagulation, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided in the document. This is not directly applicable. The device is a hardware generator with software control, not a standalone algorithm. Its performance is demonstrated through its function, not through an "algorithm only" evaluation in the context of an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. The ground truth for such a device would typically be its ability to perform its intended coagulation function safely and effectively, which would be assessed through engineering and bench testing, not expert consensus or pathology in this context.

8. The sample size for the training set

This information is not provided in the document. This concept is not applicable as the device is not an AI algorithm that undergoes "training" on a dataset in the conventional sense. The "software changes" were likely developed and tested internally rather than trained on a distinct dataset.

9. How the ground truth for the training set was established

This information is not provided in the document and is not applicable.

Summary

{0}------------------------------------------------

OCT 0 8 2008

510(k) SUMMARY

BÂRRX Medical's HALO360 Energy Generator

Submitter's Name, Address, Telephone Number, Contact 1. 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, 2008

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

HALO360 Energy Generator

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

3. Common or Usual Name(s):

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

{1}------------------------------------------------

Koszco 3

20f 3

5. Predicate Devices

HALO360 Energy Generator model 1100C-115B software version 4.2 (K051168) manufactured by Stellartech Research;

Stellartech Coagulation System 2, model 1100C-115A (K050831) manufactured by Stellartech Research;

6. Intended Use / Indications for Use

The HALO360 Energy Generator intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

Technological Characteristics 7.

HALO360+ Coagulation Catheter

There are no changes associated to the HALO360+ Coagulation Catheter.

HALO360 Energy Generator

The HALO360 Energy Generator model 1100C-115B is configured with an output cable (model CCC-001B), an optional footswitch (model FS-100B), and a power cord.

There are no changes to the hardware associated to HALO360 Energy Generator cleared by the 510(k) K050831 and K051168. There are minor changes implemented to the software version of the generator.

{2}------------------------------------------------

KO82203

$
3.4
$

Substantial Equivalence

The HALO360 Energy Generator model 1100C-115B (software version V4.5) and the predicate devices HALO360 Energy Generator model 1100C-115B (software version 4.2), and Stellartech Energy Generator 2 have the same intended use, indications for use, technological characteristics, and principles of operation. The technological differences between the HALO360 Energy Generator model 1100C-115B software version 4.5 and its predicates are:

Modification of the coagulation catheter operating pressure .

The differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

OCT 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K082202

Trade/Device Name: The HALO360 Energy Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 5, 2008 Received: September 9, 2008

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. Ilsting 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.

{4}------------------------------------------------

Page 2 - Ms. 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 vours.

Mark N. Mulhern

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

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically "KO82202". The characters are handwritten and appear to be part of a code or identifier. A line is drawn underneath the sequence of characters.

$\theta \cdot 1 \circ + 1$

Indications for Use Statement

510(k) Number (if known):

Device Name:

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 Evaluation (ODE)

N.L.R.R. Ryden for mkm

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

510(k) Number K082202 Page 1 of 1

HALO360 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.