The HALO360+ Ablation 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 System consists of the following components:

HALO360 Energy Generator model 1100C-115B and 1100C-230B . and accessories (output cable, and an optional footswitch).
A single use HALO360 Sizing Balloon model 3441B,
A single use HALO360+ Ablation Catheter model 32041-xx with an optional accessory HALO Cap

The HALO360 System performance and mode of operation did not change. This 510 (k) addresses the addition of the optional accessory HALO Cap.

There are no changes in construction, materials, principle of operation, intended use and indications for use, for the HALO360+ Ablation catheter model 32041-xx when compared with the predicate device HALO360+ Coagulation Catheter model 32041-xx. The following changes are subject to this 510k submission:

Based on feedback received from the physician-user, BARRX Medical identified the need for an optional accessory HALO Cap for the use with HALO30 + Coagulation Catheter. This accessory will-facilitate removal of biological debris.after treatment and as result minimize the time;of the ¿ procedure.
HALO360+ Coagulation Catheter model 32041-xx was marketed in Europe and Canada as HALO360+ Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO360+ Coagulation Catheter to HALO360+ Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.

AI/ML Overview

This 510(k) summary (K083711) for the BARRX Medical HALO360+ Ablation Catheter does not describe a study to prove acceptance criteria with specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a modified version of an existing device.

Here's an breakdown of why the requested information cannot be fully provided from this document and what can be extracted:

The primary purpose of this 510(k) submission is to:

Introduce an optional accessory, the HALO Cap, for the HALO360+ Ablation Catheter to facilitate debris removal and reduce procedure time.
Change the device name from "HALO360+ Coagulation Catheter" to "HALO360+ Ablation Catheter" for international and domestic labeling consistency.

The submission explicitly states: "All these differences were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent." This indicates that the regulatory pathway relied on demonstrating that the changes did not negatively impact the existing device's safety and efficacy, rather than conducting a new clinical study to establish performance against pre-defined acceptance criteria for the entire device.

Therefore, many of the requested details related to a clinical study (like sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance) are not present in this document because such a study was not deemed necessary for this particular submission.

Here's what can be extracted and inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable. Since this 510(k) is for demonstrating substantial equivalence based on minor modifications (an accessory and a name change), there are no specific, quantitative acceptance criteria and corresponding performance metrics presented in this document for the device as a whole or for the new accessory's performance. The "acceptance criteria" here implicitly relate to demonstrating that the addition of the HALO Cap does not degrade the safety and effectiveness of the existing device.

Acceptance Criteria	Reported Device Performance
Implicit: No adverse impact on existing safety and efficacy of the HALO360+ Ablation Catheter due to:	Claimed: "All these differences [inclusion of HALO Cap, name changes] were evaluated on bench and did not raise questions regarding safety and efficacy. Thus the devices are equivalent."
1. Inclusion of optional HALO Cap accessory	Bench testing indicated no safety/efficacy concerns.
2. Name change from "Coagulation Catheter" to "Ablation Catheter"	No change in intended use, indications for use, or principle of operation.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable/Not specified. The document states "evaluated on bench," implying non-clinical testing rather than patient-based clinical testing. No specific number of samples or tests is provided.
Data Provenance: Not applicable. The evaluation was "on bench," suggesting laboratory or engineering testing, not data from human subjects or clinical settings, either retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. No expert ground truth establishment for a test set is described. The evaluation was "on bench," likely performed by engineers or technical personnel rather than clinical experts establishing ground truth in a diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described, as there was no clinical test set requiring expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not conducted or mentioned. This type of study focuses on human reader performance with and without AI, which is not relevant to this submission for a physical device and its accessory.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. This device is a physical electrosurgical catheter, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

Not applicable. Given that the evaluation was "on bench" for changes to a physical device and an accessory, the "ground truth" would likely relate to engineering specifications, material properties, electrical performance, and mechanical function, rather than clinical outcomes, pathology, or expert consensus. No specific type of "ground truth" (e.g., pathology, outcomes) is mentioned.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device and an accessory, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set or associated ground truth establishment is relevant to this device submission.

Summary

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K083711

FEB -2 2009

510(k) SUMMARY

BÂRRX Medical's HALO860+ Ablation Catheter

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:

December 11, 2008 Date Prepared:

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

HALO360+ Ablation Catheter

BÂRRX Medical Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

Common or Usual Name(s): 3.

Electrosurgical Coagulation System

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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K083711

5. Predicate Devices

HALO360+ Coagulation Catheter model 32041-xx (K071543) manufactured by BARRX Medical Inc;

HALO® Coagulation Catheter model 90-9100 (K062723) manufactured bv BÂRRX Medical Inc:

6. Intended Use / Indications for Use

The HALO360+ Ablation Catheter intended use is for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.

Technological Characteristics 7.

The HALO360 System consists of the following components:

HALO360 Energy Generator model 1100C-115B and 1100C-230B . and accessories (output cable, and an optional footswitch).
A single use HALO360 Sizing Balloon model 3441B,
A single use HALO360+ Ablation Catheter model 32041-xx with an optional accessory HALO Cap

The HALO360 System performance and mode of operation did not change. This 510 (k) addresses the addition of the optional accessory HALO Cap.

HALO360+ Coagulation Catheter

Based on feedback received from the physician-user, BARRX Medical identified the need for an optional accessory HALO Cap for the use with HALO30 + Coagulation Catheter. This accessory will-facilitate removal of biological debris.after treatment and as result minimize the time;of the ¿ procedure.
HALO360+ Coagulation Catheter model 32041-xx was marketed in Europe and Canada as HALO360+ Ablation Catheter, under the same indications for use for tissue coagulation. For unifying the international and domestic labeling we request FDA to allow the name change for HALO360+ Coagulation Catheter to HALO360+ Ablation Catheter. There are no changes associated with the intended use, indication for use or the principle of operation.

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KO83711

Page 3 of (3)

HALO360 Energy Generator

There are no changes associated to the HALO360 Energy Generator.

છે. Substantial Equivalence

The HALO360+ Ablation Catheter model 32041-XX and the predicate devices HALQ360+ Coagulation Catheter model 32041-xx and HALO90 Coagulation Catheter model 90-9100 are similar in construction except:

Inclusion on an optional HALO Cap accessory .

. Name changes
- o From HALO360+ Coagulation Catheter to HALO360+ Ablation Catheter
- o From HALO360 Coagulation System to HALO360 System.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design that resembles an abstract representation of a human figure.

Public Health Service

FEB = 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BARRX Medical, Inc. % Ms. Viorica Filimon 530 Oakmead Parkway Sunnyvale, California 94085

Re: K083711

Trade/Device Name: HALO360+ Ablation Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 11, 2008 Received: January 12, 2009

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.

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Page 2 - Ms. Viorica Filimon

This letter will allow you to begin marketing your device as described in your Section 510(k) prematket 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 N Millican

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):_ |< 0 8 3 7 11

Device Name: HALO360+ Ablation Catheter

Indications for Use:

The HALO460+ Ablation 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 tearn, Arteriovenous Malformations, 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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number 16837

Page _ of _.

HALO800+ Ablation Catheter with HALO Cap

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.