The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of 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 subject device, the Barry™ Barrx FLEX RFA Energy Generator is intended to be used with the listed catheters to deliver radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheters include:

HALO360 Ablation Catheter and Sizing Ballon (K093855)
. HALO90 Ablation Catheter (K093008)
HALO60 Ablation Catheter (K112454) ●
HALO® ULTRA Ablation Catheter (K120431) ●
. Barrx Channel RFA Endoscopic Catheter (K130623)

The Barrx FLEX RFA Energy Generator is an electrosurgical device that utilizes bipolar RF energy to coagulate biological tissue. The Generator is provided with a footswitch that can initiate inflation of the balloon and initiate or cease delivery of RF energy. The Barrx FLEX RFA Energy Generator is designed to function with a family of single use, disposable Ablation Catheters and Sizing Balloons to deliver the intended therapy.

AI/ML Overview

This document describes a 510(k) premarket notification for the Barrx FLEX RFA Energy Generator. The submission is for a labeling change only, meaning the device itself has not undergone design or material changes, and its technological characteristics and principles of operation are identical to its predicate device (K092487). The main difference is the addition of clinical information to the labeling, derived from two published peer-reviewed clinical studies.

Given this context, the request for acceptance criteria and a study proving device performance as typically understood for a new or modified device's technical capabilities is not directly applicable in the same way. This submission focuses on the clinical evidence supporting the expanded indications for use on the label, which are based on previously established device performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the typical sense of new performance metrics for the device hardware itself. Instead, the "acceptance criteria" here relate to the successful inclusion of expanded indications for use based on clinical evidence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a labeling change based on clinical studies, there aren't new device performance criteria. The "performance" being evaluated implicitly is the Barrx FLEX RFA Energy Generator's ability to effectively coagulate tissue for the expanded indications listed, as demonstrated by the previously published clinical studies.

Acceptance Criteria (Implied for Labeling Change)	Reported Device Performance (as supported by clinical studies and previous clearances)
Device functions as intended for tissue coagulation.	Barrx FLEX RFA Energy Generator delivers radiofrequency (RF) energy for coagulation of soft tissue.
Clinical evidence supports the expanded indications for use.	Two published peer-reviewed clinical studies provide clinical information justifying the expanded indications to include specific gastrointestinal bleeding sites and conditions: Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Device remains substantially equivalent to predicate devices.	The device has identical technological characteristics, design, and materials as the predicate device (K092487). Minimal software changes were documented via Letter to File and did not require a new submission.
Safety and effectiveness for existing and expanded indications are maintained.	The device cleared previous 510(k) submissions, establishing its underlying safety and effectiveness for tissue coagulation. The clinical studies support its safety and effectiveness for the newly added conditions.

Regarding the "study that proves the device meets the acceptance criteria":

The document explicitly states: "The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K092487) is the addition of clinical information to the labeling resulting from two published peer-reviewed clinical studies."

Therefore, the "studies" that "prove" the device meets the (expanded indication) acceptance criteria are these two published peer-reviewed clinical studies. The document does not provide details about these studies themselves (e.g., their titles, methodology, specific results, sample sizes, etc.). It only references their existence and their role in justifying the labeling changes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details about the sample sizes, data provenance (country, retrospective/prospective nature) of the two referenced clinical studies. It only states they are "published peer-reviewed clinical studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide any information about experts or their qualifications for establishing ground truth within the context of the clinical studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not provide any information about adjudication methods for the clinical studies.

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

The Barrx FLEX RFA Energy Generator is an electrosurgical device for tissue coagulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This is an electrosurgical device, not a standalone algorithm. Its function inherently involves human operation. Therefore, a "standalone algorithm only" performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not provide specifics on the type of ground truth used in the two clinical studies. Given the nature of the device (coagulation of soft tissue for various gastrointestinal conditions), it is highly probable that the ground truth would involve:

Clinical outcomes (e.g., cessation of bleeding, healing of ulcers, eradication of Barrett's epithelium).
Endoscopic assessment by qualified endoscopists.
Potentially histopathology/pathology for conditions like Barrett's Esophagus.

8. The sample size for the training set

The document does not mention a "training set" as this device is not an AI/machine learning algorithm that requires training. The clinical studies (referred to as "two published peer-reviewed clinical studies") would involve patient cohorts, but these are not "training sets" in the AI sense.

9. How the ground truth for the training set was established

As explained above, there is no "training set" in the context of this device.

Summary

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

August 21, 2014

Covidien LLC Mr. Tim Thomas Vice President, Medical and Regulatory Affairs 540 Oakmead Parkway Sunnyvale, California 94085

Re: K141357

Trade/Device Name: Barrx FLEX RFA Energy Generator Regulation Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 22, 2014 Received: May 23, 2014

Dear Me. Thomas:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Sincerely vours.

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

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

Device Name:

Barrx FLEX RFA Energy Generator

Indications for Use:

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.

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)

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510(k) Summary

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

Covidien IIc 540 Oakmead Parkway Sunnyvale, CA 94085 Phone: (770) 662-0870 ext. 1006 Facsimile: (508) 452-1941 Contact: Date Prepared: May 22, 2014

NAME OF SUBJECT DEVICE AND NAME

Barrx FLEX RFA Energy Generator

ESTABLISHMENT REGISTRATION NUMBER/OWNER OPERATOR NUMBER

Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497 Legal Manufacturer: Covidien, Ilc 15 Hampshire Street Mansfield, MA 02048 Manufacturing Facility: Covidien, Formerly BÂRRX Medical, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

COMMON OR USUAL NAME

Electrosurgical cutting and coagulation device and accessories

REGULATION DESCRIPTION

Classification: Class II, 21 CFR 876.4400 Product Code: GEI

PREDICATE DEVICES

Barrx™HALOFLEX Energy Generator, 510(k) K092487 HALO360 Energy Generator, 510(k) K093855 HALO® Energy Generator, 510(k) K093008

DEVICE DESCRIPTION

HALO360 Ablation Catheter and Sizing Ballon (K093855)
. HALO90 Ablation Catheter (K093008)
HALO60 Ablation Catheter (K112454) ●
HALO® ULTRA Ablation Catheter (K120431) ●
. Barrx Channel RFA Endoscopic Catheter (K130623)

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INDICATION FOR USE

The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue.

TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICE

As the subject of this submission is a labeling change only, the Barrx FLEX RFA Energy Generator has identical technological characteristics as compared to the predicate, K092487. There have been no design or material changes to the generator since the predicate was cleared on November 10, 2009. There have been minor software changes since the clearance of the K092487 however they did not require a submission and were documented via Letter to File. The difference between the proposed Barrx FLEX RFA Energy Generator and the predicate device (K092487) is the addition of clinical information to the labeling resulting from two published peer-reviewed clinical studies.

PRINCIPLES OF OPERATION

As the subject of this submission is a labeling change only, the principles of operation of the Barrx FLEX RFA Energy Generator are unchanged and remain identical to the predicate device, K092487, cleared on November 10, 2009.

HALO360 Ablation Catheter and Sizing Ballon (K093855)
. HALO90 Ablation Catheter (K093008)
HALO60 Ablation Catheter (K112454) ●
HALO® ULTRA Ablation Catheter (K120431)
Barrx Channel RFA Endoscopic Catheter (K130623)

CONCLUSION

As the subject of this submission is a labeling change only, Covidien, Ilc considers the Barrx FLEX RFA Energy Generator to be substantially equivalent to legally marketed predicates: Barrx™ HALOFEK Energy Generator (K092487), HAL0380 Energy Generator (K093855) and HAL090 Energy Generator (K093008).

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.