HALO360 + Sizing Balloon model 3441C is indicated for 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

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sizing accuracy	Met the same specifications as predicate devices.
Structural strength	Met the same specifications as predicate devices.
Material compatibility	Met the same specifications as predicate devices.
Sterility	Met the same specifications as predicate devices.
Esophageal diameter measurement capability	Increased to measure diameters higher than 33.7 mm (allowing identification of migration into the stomach).

Note: The document explicitly states the modified device "met the same specifications requirements as the HALO360 Sizing Balloon and HALO360+ Ablation Catheter" for the first four criteria. The fifth criterion is a noted improvement in capability.

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

The provided text does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The information provided focuses on the device's technical specifications and a comparison to predicate devices, rather than a clinical study.

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

The provided text does not contain information about the number of experts used or their qualifications to establish ground truth. As this appears to be a submission based on engineering and performance criteria for substantial equivalence, clinical expert assessment for ground truth is not detailed.

4. Adjudication Method

The provided text does not contain information about any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence based on material and performance specifications, not on comparing human reader performance with or without AI assistance.

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

This question is not applicable. The HALO360+ Sizing Balloon is a medical device, not an AI algorithm. Therefore, a standalone performance study in the context of AI is not relevant. The device itself is designed to be used by a human operator (a physician) to size the esophagus and select a coagulation catheter.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance appears to be established through engineering specifications and testing based on the predicate devices. For example, "sizing accuracy" would be compared against a known, precise measurement standard in a laboratory or simulated environment, rather than a clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

The provided text does not contain information about a training set since this is not an AI/machine learning device. The testing described appears to be for device validation against established specifications.

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

This question is not applicable as there is no mention of a training set for an AI algorithm.

Summary

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510(k) SUMMARY

5093855
JAN 1 5 2010

BARRX Medical's [MODIFIED DEVICE]

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

BARRX Medical Inc. 540 Oakmead Pkwv Sunnyvale, CA 94085

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

Contact Person: Viorica Filimon

Date Prepared: December 20, 2009

Name of Device and Name/Address of Sponsor

HALO360+ Sizing Balloon

BARRX Medical Inc. 540 Oakmead Pkwy Sunnyvale, CA 94085

Common or Usual Name

Sizing Balloon

Classification Name

Product code: GEI CFR Section: 878.4400 Electrosurgical, cutting & coagulation & accessories Device Class: II Classification panel: General & Plastic Surgery

Predicate Devices

HALO360 Sizing Balloon model 3441B (K051168) HALO360+ Ablation Catheter model 32041-XX (K083711, K071543)

Purpose of the Special 510(k) notice.

The HALO360+ Sizing Balloon model 3441C is a modification to HALO360 Sizing Balloon model 3441B and HALO360+ Ablation Catheter model 32041-XX the predicate devices.

Intended Use

510(k) HALO360+ Sizing Balloon Model 3441C

Page 93

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The HALO360+ Sizing Balloon model 3441C is intended to be used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. The HALO660+ Sizing Balloon model 3441C is indicated for use for 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, and Angiodysplasia.

Technological Characteristics

The HALO360+ Sizing Balloon model 3441C is used in conjunction with either the HALO360 Energy Generator models 1100C-115B (or 1100C-230B), or HALORLEX Energy Generator model 1190A-115A (or 1190A-230A) for assessing the size of the esophageal lumen, and facilitate the selection of the disposable single-use HALO360+ Coagulation Catheter. The HALO360+ Sizing Balloon model 3441C, like the predicate device HALO360 Sizing Balloon model 3441B is comprised of a sizing balloon, a catheter shaft with markings, and an electrical connector. The HALO360+ Sizing Balloon model 3441B is substantially equivalent in design, performance, and mode of operation with the already cleared predicate devices: HALO360 Sizing Balloon model 3441B and HALO360+ Ablation Catheter model 32041-XX.

Performance Data

The HALO360+ Sizing Balloon model 3441C met the same specifications requirements as the HALO360 Sizing Balloon and HALO360+ Ablation Catheter for the following characteristics:

0 Sizing accuracy
Structural strength .
Material compatibility
Sterility .

Substantial Equivalence

HALO360+ Sizing Balloon model 3441C has the same intended use and indications, principles of operation, and technological characteristics as HALO360 Sizing Balloon model 3441B and HALO360+ Ablation Catheter model 32041-XX. The minor differences in the HALO360+ Sizing Balloon model 3441C are:

. Changes in the balloon material
Increase the sizing balloon capability to measure esophageal diameter . higher than 33.7 mm and as result identify when the balloon migrates in the stomach.

These changes do not raise any new questions of safety or effectiveness. Performance data demonstrates that the HALO360+ Sizing Balloon is as safe and effective as HALO360 Sizing Balloon model 3441B and HALO360+ Ablation catheter model 32041-XX. Thus, the HALO360+ Sizing Balloon model 3441B is substantially equivalent to its predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

BARRX Medical, Inc. % Ms. Viorica Filimon Vice President of Quality/Regulatory Affairs 540 Oakmead Parkway Sunnyvale, California 94085

JAN 1 5 2010

Re: K093855

Trade/Device Name: HALO360 + Sizing Balloon Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 15, 2009 Received: December 16, 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 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 (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.

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Page 2 - Ms. Viorica Filimon

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/ResourcesforYou/Industry/default.htm.

Singular

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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 + Sizing Balloon

Indications for Use:

Prescription Use X (Per 21 C.F.R. 801.109) Subpart C)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093855

510(k) HALO360+ Sizing Balloon Model 3441C

Page 99

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.