The HALO® ULTRA Ablation Catheter (used with the HALOEEK 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 subject device, HALO® ULTRA Ablation Catheter (hereafter referred to as "modified ULTRA") is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. It is used exclusively with HALOFES Energy Generator model 1190A-115A (cleared under K092487).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the HALO90 ULTRA Ablation Catheter. It focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and bench testing.

Therefore, the following information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the document, as it is a 510(k) submission, not a study report demonstrating clinical performance against specific acceptance criteria.

The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving a device meets new performance acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.

Here's why the requested information is absent:

Acceptance Criteria & Reported Performance: The document doesn't define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) that an AI device would typically have. It's comparing the technological characteristics and bench test results of the modified device to the predicate.
Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts relevant to studies evaluating the clinical performance of a diagnostic or AI-driven device, particularly when assessing its ability to detect or diagnose conditions. This document is for an ablation catheter, which treats conditions, and its filing is based on demonstrating safety and efficacy through equivalence to existing devices, supported by bench testing of physical characteristics.

Specifically addressed, based on the provided text:

A table of acceptance criteria and the reported device performance: Not applicable. The submission is for substantial equivalence based on technological characteristics and bench testing (migration, deflection, catheter distal integrity, detachment). No clinical performance acceptance criteria are mentioned.
Sample sized used for the test set and the data provenance: Not applicable. The "test set" refers to bench testing, not a clinical data set. The document lists the specific bench tests performed without providing sample sizes as would be relevant for clinical data, nor does it discuss data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses, often established by expert consensus or pathology. This document describes bench testing where "ground truth" would be engineering specifications or physical measurements, not expert clinical interpretation.
Adjudication method for the test set: Not applicable. Adjudication is used to resolve discrepancies in expert interpretation of clinical data. This is a bench test submission.
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: Not applicable. This is for an ablation catheter, not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for a physical medical device (catheter), not an algorithm.
The type of ground truth used: For the bench testing, the "ground truth" would be the expected physical properties and performance metrics of the catheter as measured against engineering standards. This is not explicitly detailed but is implied by the nature of bench tests like "Migration," "Deflection," "Catheter Distal Integrity," and "Detachment."
The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/algorithm-based device.
How the ground truth for the training set was established: Not applicable. See point 8.

Summary of Device and Evidence Presented in the 510(k):

The HALO90 ULTRA Ablation Catheter is a modification of an existing device (original ULTRA). The submission aims to prove substantial equivalence to its predicate devices, not to establish new performance criteria through a de novo clinical study.

Evidence presented for substantial equivalence:

Technological Characteristics: The modified ULTRA has the "same construction, principles of operation, materials and energy density" as the original ULTRA. The differences are described as "a slight change in the manufacturing process of the endoscope mounting strap, as well as dimensional modification on the pivot mechanism components."
Bench Testing: The minor differences were evaluated via the following bench tests to ensure no new questions of safety and effectiveness were raised:
1. Migration
2. Deflection
3. Catheter Distal Integrity
4. Detachment

Summary

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K1204/31

510(K) SUMMARY OF SAFETY & EFFECTIVENESS BÂRRX's HALO90 ULTRA Ablation Catheter

MAY - 3 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} 328-7357 (same as phone#) Contact: Dawn Chang, Regulatory Affairs Manager Date Prepared: February 10, 2012

NAME OF SUBJECT DEVICE AND NAME/ADDRESS OF SPONSOR

HALO30 ULTRA Ablation Catheter (model 90-9200) BÂRRX 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

Primary predicate device:

HALO® ULTRA Ablation Catheter (model 90-9200, cleared under K101111), . hereafter referred to as "original ULTRA".
Secondary predicate device:
HALO® Ablation Catheter (model 90-9300, cleared under K112545), hereafter . referred to as "HALO60".

DEVICE DESCRIPTION

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K120431

TECHNOLOGICAL CHARACTERISTICS

The modified ULTRA is a modification of the original ULTRA. Both catheters have the same construction, principles of operation, materials and energy density. The differences between the modified ULTRA and the original ULTRA include a slight change in the manufacturing process of the endoscope mounting strap, as well as dimensional modification on the pivot mechanism components.

PRINCIPLES OF OPERATION

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

The modified ULTRA 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 HALO® ULTRA Ablation Catheter (used with the HALOffer 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).

SUBSTANTIAL EQUIVALENCE DISCUSSION AND CONCLUSION

The modified ULTRA and the predicate devices, the original ULTRA and HALO®, are identical in the intended use, principle of operations, energy type, materials, packaging and sterilization method. The minor differences in component dimension are evaluated via the following bench testing: (1) Migration; (2) Deflection; (3) Catheter Distal Integrity; (4) Detachment. No new questions of safety and effectiveness were raised. The subject and the predicate devices are substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird, with three curved lines forming its body and wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAY - 3 2012

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

Re: K120431

Trade/Device Name: HALO90 ULTRA Ablation Catheter model 90-9200 Regulation Number: 21 CFR§ 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, KNS Dated: February 10, 2012 Received: February 13, 2012

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 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

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Page 2 -

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,

Benjamin R. Civiletti

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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K 120 431

Indications for Use Statement

510(k) Number (if known): To be determined

Device Name:

HALO® ULTRA Ablation Catheter model 90-9200 .

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) . - please go to page 2

Concurrence of CDRH, Office of Device Evaluation (ODE).

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120431

HALO90 ULTRA Ablation Catheter 510(k) 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.