The HALO90 ULTRA Ablation Catheter model 90-9200 (when used with HALOFEN System) is indicated for use in the coagulation of bleeding and nonbleeding 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® ULTRA Ablation Catheter model 90-9200 is a modification . of the predicate device HALO" Ablation Catheter model 90-9100 currently commercialized in USA. Both catheters have the same constructions, design, principle of operation, materials and energy density. The differences between HALO" ULTRA and its predicate consist in the electrode surface increase and the associated components electrode cap and base. HALO90 ULTRA Ablation Catheter model 90-9200 is used in conjunction with HALOFER Energy Generator There are no changes associated to the HALOFLEX Energy Generator software, hardware and accessories.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the HALO® ULTRA Ablation Catheter Model 90-9200. This is a submission demonstrating substantial equivalence to a predicate device, not a study designed to establish new acceptance criteria or definitively prove performance against specific clinical endpoints. Therefore, much of the requested information (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC studies, ground truth establishment) is not typically part of a 510(k) submission focused on minor modifications to an already cleared device.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific performance acceptance criteria in the typical sense of a clinical study, as it's a modification of a predicate device. Instead, the "acceptance criteria" are implied by the successful completion of a series of bench tests showcasing that the changes did not negatively impact safety and efficacy compared to the predicate. The "reported device performance" is that these tests were passed successfully, indicating equivalence.

Acceptance Criterion (Implied)	Reported Device Performance
Maintain Apposition	HALO® ULTRA Ablation Catheter Model 90-9200 Design Verification - Apposition (Passed)
Tensile Strength (Base-cap & Litz wires)	Tensile strengths of Base-cap & Litz wires (Passed)
Attachment Strength (Endoscope-elastomeric strap)	Attachment strength endoscope-elastomeric strap (Passed)
Endoscope Compatibility	Endoscope compatibility with the HALO® ULTRA Ablation Catheter Model 90-9200 (Passed)
Insertion-Retraction Performance	Insertion-Retraction performance in a tissue model (Passed)

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

The document mentions "Bench Tests." These are typically laboratory-based tests and do not involve human subjects. Therefore, the concept of a "test set" in the clinical sense with human subjects, data provenance (country of origin, retrospective/prospective), and sample sizes for clinical data are not applicable or provided here. For bench tests, sample sizes would typically refer to the number of devices or components tested, but this specific detail is not given.

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

Not applicable. Bench tests do not typically involve human expert "ground truth" establishment in the way clinical diagnostic studies do. The "ground truth" for bench tests is defined by engineering specifications and objective measurements.

4. Adjudication Method

Not applicable, as there is no clinical data or expert review process described that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study evaluates human reader performance, usually in diagnostic imaging, and is not relevant to a bench testing submission for an electrosurgical ablation catheter.

6. Standalone Performance Study

Yes, in a way. The "Bench Tests" described represent a standalone evaluation of the modified device's physical and functional characteristics. However, this is not a standalone clinical performance study, but rather a standalone engineering/design verification study. The tests evaluate the device itself without human-in-the-loop performance being the primary focus.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" would be established by:

Engineering specifications and design requirements: For tests like tensile strength, apposition, and insertion-retraction, the "truth" is whether the device meets pre-defined, measurable specifications.
Predicate device performance: The ultimate "ground truth" for demonstrating substantial equivalence is that the modified device performs similarly to or better than the legally marketed predicate device on the critical parameters.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context. The manufacturing of the device would follow established quality control processes, but that's different from an algorithm's training data.

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

Not applicable for the same reasons as point 8.

Summary

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JUN 1 8 2010

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K 101111
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510(k) SUMMARY

BARRX Medical's HALO" ULTRA Ablation Catheter Model 90-9200

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 (408) 328-7395 Facsimile:

Viorica Filimon Contact Person:

Date Prepared: April 20, 2010

Name of device and Name/Address of Sponsor:

HALO® ULTRA Ablation Catheter Model 90-9200

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

Predicate Devices 5.

HALO® Ablation Catheter model 90-9100 (K060169, K062723, K083737, and K093008) manufactured by BÂRRX Medical Inc.

HALO® ULTRA Ablation Catheter

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Intended Use / Indications for Use

Technological Characteristics 7.

HALO90 ULTRA Ablation Catheter model 90-9200 is used in conjunction with HALOFER Energy Generator There are no changes associated to the HALOFLEX Energy Generator software, hardware and accessories.

Substantial Equivalence 8.

The HALO® ULTRA Ablation Catheter model 90-9200 and the predicate devices HALO® Ablation Catheter model 90-9100 are identical in construction except electrode and associated components (electrode cap and base) length change.

These differences were evaluated by performing the following Bench Tests and did not raise questions regarding safety and efficacy. Thus the devices are equivalent.

A- HALO90 ULTRA Ablation Catheter model 90-9200 Design Verification - Apposition

B- Tensile strengths of Base-cap & Litz wires

C- Attachment strength endoscope-elastomeric strap

D- Endoscope compatibility with the HALO® ULTRA Ablation Catheter model 90-9200

E- Insertion-Retraction performance in a tissue model

HALO" ULTRA Ablation Catheter

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an eagle emblem with three lines extending from its wing.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

JUN 1 8 2010

Mr. Randall Sullivan C.O.O. BARRX Medical, Inc. 540 Oakmead Parkway SUNNYVALE CA 94085

· Re: K101111

Trade/Device Name: HALO90 ULTRA Ablation Catheter Model 90-9200 Regulation Number: 21 CFR 8878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 28, 2010 Received: June 1, 2010

Dear Mr. Sullivan:

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. 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 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 of medical device-related

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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/CDRH0ffices/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,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological 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: HALO®ULTRAAblation Catheter model 90-9200

Indications for Use:

The HALO90 ULTRA Ablation Catheter model 90-9200 (when used with HALO" 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, Angiodysplasia, Gastric Antral Vascular Ectasia (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

HALO® ULTRA Ablation Catheter

510(k) Number

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.