The HALO® Ablation Catheter (used with the HALOFER Energy Generator, model 1190A-115A) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

Device Description

The HALO® (subject device) is a single-use bipolar device that delivers radiofrequency energy to the treatment tissue within the gastrointestinal tract. It is used solely with the HALOFES Energy Generator (model 1190A-115A), which provides the radiofrequency energy.

AI/ML Overview

The HALO60 Ablation Catheter is a modification of the HALO90 Ablation Catheter, primarily involving a reduction in the copper electrode surface area. The submission is a Special 510(k) as the modification does not change the intended use or alter the fundamental scientific technology.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the HALO60 Ablation Catheter. Instead, it focuses on demonstrating substantial equivalence to a predicate device (HALO90 Ablation Catheter) based on the absence of new questions of safety or effectiveness.

The "performance" is implicitly demonstrated through the modifications and the conclusion of substantial equivalence.

Acceptance Criteria	Reported Device Performance
No new questions of safety or effectiveness raised by the modifications	The primary modification (dimensional reduction of copper electrode surface area from 2.6cm² to 1.5cm²) and secondary modifications (dimensional reduction of supporting components) do not raise new questions of safety or effectiveness.
Same intended use as predicate device	The HALO60 Ablation Catheter has the same intended use as the HALO90 Ablation Catheter.
Same fundamental scientific technology as predicate device	The HALO60 Ablation Catheter has the same fundamental scientific technology as the HALO90 Ablation Catheter.
Compatible with HALOFER Energy Generator	The HALO60 Ablation Catheter is compatible with the HALOFER Energy Generator. No changes were made to the generator's software for HALO60.
Materials remained unchanged	The materials used in the HALO60 Ablation Catheter are unchanged from the predicate device.
Amount of energy delivered remained unchanged	The amount of energy delivered by the HALO60 Ablation Catheter is unchanged from the predicate device.
Depth of tissue treated remained unchanged	The depth of tissue treated by the HALO60 Ablation Catheter is unchanged from the predicate device.
Design verification activities demonstrate meeting design input requirements	Design verification activities were conducted to demonstrate that the design outputs of the modified device meet the design input requirements.

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

The document does not describe a specific clinical "test set" with a sample size in the traditional sense of evaluating a new device's performance against clinical endpoints. The submission relies on design verification activities and a comparison to the predicate device's established safety and effectiveness.

Sample Size for Test Set: Not applicable as a clinical test set for performance evaluation is not described.
Data Provenance: Not applicable as a clinical test set for performance evaluation is not described. The document pertains to regulatory submission data.

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

This information is not applicable to this submission. The document focuses on engineering and design verification rather than clinical outcomes requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to this submission as a clinical test set requiring adjudication is not described.

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 applicable. The HALO60 Ablation Catheter is a medical device for radiofrequency energy delivery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable. The HALO60 Ablation Catheter is a physical medical device, not an algorithm, and operates with human intervention during its use.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through design verification activities against design input requirements, and based on the established safety and effectiveness of the predicate device (HALO90). The document highlights:

Design Input Requirements: The modified device's design outputs were verified to meet these.
Predicate Device's Established Performance: The HALO90's prior clearances (K093008, K083737, K062723) serve as the basis for demonstrating substantial equivalence.
Failure Modes, Effects, and Criticality Analysis (FMECA): Used to analyze risks, implying that safety standards and risk mitigation served as a form of "ground truth" for design decisions.

8. The Sample Size for the Training Set

This information is not applicable. The HALO60 Ablation Catheter is a physical medical device; there is no "training set" of data in the context of machine learning or AI.

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

This information is not applicable for the reasons stated in point 8.

Summary

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510(K) SUMMARY OF SAFETY & EFFECTIVENESS -BÂRRX's HALO60 Ablation Catheter

JAN - 5 2012

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED

BÂRRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085 Phone: (408) 328-7357 Facsimile: (408) 328-7395 Contact: Dawn Chang, Regulatory Affairs Manager Date Prepared: August 24, 2011

NAME OF SUBJECT DEVICE AND NAME/ADDRESS OF SPONSOR

HALO60 Ablation Catheter (model 90-9300) BÄRRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

ESTABLISHMENT REGISTRATION NUMBER

3004904811

COMMON OR USUAL NAME

Electrosurgical Coagulation Catheter

REGULATION DESCRIPTION

Electrosurgical Cutting and Coagulation Devices and Accessories (21 CFR 878.4400, Product Code GEI)

PREDICATE DEVICE

HALO90 Ablation Catheter (model 90-9100, cleared by the FDA under K093008, K083737, and K062723).

OVERVIEW

The HALO® Ablation Catheter (subject device, hereafter referred to as "HALO®") is a single-use bipolar device that delivers radiofrequency energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The HALO" is a modification of the HALO® Ablation Catheter (predicate device, cleared by the FDA under K093008, K083737, and K062723, hereafter referred to as "HALO""). The

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K112454
Pg. 2 of 3

primary modification is a dimensional reduction of the copper electrode surface area, from 2.6cm- (1.3cm x 2.0cm, HALO90) to 1.5cm- (1.0cm x 1.5cm, HALO80). Secondary modifications include dimensional reduction of the copper electrode supporting components.

The electrode surface area of the subject device is reduced to approximately 60% of the predicate device, hence the product name HALO60. This new product provides an option for physicians to treat smaller diseased area. The modification neither changes the intended use nor alters the fundamental scientific technology of the original device; therefore this submission is a Special 510(k).

DEVICE DESCRIPTION

PRINCIPLES OF OPERATION

Same as the HALO90, the HALO® is connected to the HALOFER Energy Generator using an output cable. Once connected, the Generator will recognize the catheter based on a unique ID and set the appropriate power density and energy density range.

The HALO® is introduced into the esophagus under endoscopic visualization. Once the targeted treatment area is identified, the catheter electrode is positioned against the tissue by deflecting the endoscope. The energy activation is performed by depressing either a front panel switch on the generator or the foot-pedal. After the energy is delivered, the coagulation effect can be verified endoscopically.

INDICATION FOR USE STATEMENT

The HALO60 Ablation Catheter (used with the HALOFER Energy Generator, model 1190A-115A) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

510(k) HALO" Ablation Catheter BÂRRX Medical, Inc. -

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K112454
pg. 30f.3

SUBSTANTIAL EQUIVALENCE DISCUSSION

As mentioned earlier, the HALO® (subject device) is a modification of the HALO90 (predicate device), cleared by the FDA under K093008, K083737, and K062723. The primary modification is a dimensional reduction of the copper electrode surface area, from 2.6cm² (1.3cm x 2.0cm, HALO90) to 1.5cm² (1.0cm x 1.5cm, HALO90) and the secondary modifications include dimensional reduction of the copper electrode supporting components. There is no change in the materials, amount of energy being delivered and the depth of the tissue being treated.

Both the subject and the predicate devices have the same intended use and fundamental scientific technology. Both devices are compatible with the HALO「EEX Energy Generator. No changes have been made to the HALOFER Energy Generator software in order to accommodate the HALO60.

SUMMARY OF DESIGN CONTROL ACTIVITIES

Failure Modes, Effects, and Criticality Analysis (FMECA) was used to analyze the risks associated with the design modification. Design verification activities demonstrate that the design outputs of the modified device meet the design input requirements.

CONCLUSION

In summary, the company's HALO® Ablation Catheter has the same intended use as all of the previously cleared HALO90 Ablation Catheter (K093008, K083737, K062723). In addition, the HALO® Ablation Catheter has identical indications, technological characteristics, and principles of operation as its predicate devices.

The minor differences between the HALO® Ablation Catheter model 90-9300 and its predicate device HALO90 Ablation Catheter model 90-9100 do not raise new questions of safety or effectiveness. Thus, the HALO® Ablation Catheter model 90-9300 is substantially equivalent.

510(k) HALO60 Ablation Catheter BÂRRX Medical, Inc.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Dawn Chang Regulatory Affairs Manager BÂRRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085

JAN - 5 2012

Re: K112454

Trade/Device Name: HALO60 Ablation Catheter, Model 90-9300 Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Codes: GEI, KNS Dated: December 8, 2011 Received: December 9, 2011

Dear Ms. Chang:

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. - Please note: CDRH does not evaluate-information related-to contract-liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

C. Herbert Lemon w

Benjamin R. Fisher, Ph D., Director Division of Reproductive, Gastro-Renal, and Urological 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): K112454

Device Name:

HALO® Ablation Catheter model 90-9300 .
Indications for Use:

The HALO® Ablation Catheter (used with the HALO' เช่น Energy Generator, model 11904-115A) is The HALU" Ablation Catherer (used with the mass on the gastrointesting sites in the gastrointesting the indicated for use in the coagulation of bleating and not and new and one of the mallory-Weiss tears,
including but not limited to the esophagus. Indications include Escophag including but not illinited to the Esophagus, Thanks in Submatoy Lesions, Angiodysplasia,
Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angi Arcchovenous Manoas Manova (GAVE) and Radiation Proctitis (RP).

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) – please go to page 2

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Simon

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112454

510(k) HALO60 Ablation Catheter BÂRRX Medical, Inc.

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.