The Barry™ Channel RFA Endoscopic Catheter 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, the Barrx™ Channel RFA Endoscopic Catheter is a sterile single-use bipolar device that delivers radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheter is used exclusively with the HALOFEN Energy Generator (cleared under 510(k) K092487).

AI/ML Overview

The provided text describes a medical device, the Barrx™ Channel RFA Endoscopic Catheter, and its 510(k) summary for FDA clearance. However, it does not include detailed information about acceptance criteria or a specific study proving the device meets those criteria, as typically seen in AI/ML device submissions.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics, principles of operation, and various bench and safety tests.

Therefore, I cannot extract the requested information like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, or standalone algorithm performance, as these are not present in the provided text.

Based on the available text, here's what can be provided:

Acceptance Criteria and Device Performance

The document describes several types of tests performed for verification and validation, implying that the device was expected to meet certain performance standards in these areas. However, specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly stated. The summary only lists the tests conducted.

Acceptance Criteria Category	Reported Device Performance
Bench Testing:	(Specific criteria and performance values not provided in document)
1. Catheter length testing	Assumed to meet design specifications.
2. Shaft revolution testing	Assumed to meet design specifications.
3. Endoscope articulation testing	Assumed to meet design specifications for compatibility.
4. Push force testing	Assumed to meet design specifications.
5. Retraction force testing	Assumed to meet design specifications.
6. Electrode deflection force testing	Assumed to meet design specifications.
7. Torque force and stability testing	Assumed to meet design specifications.
8. Bend radius testing	Assumed to meet design specifications for flexibility.
9. Electrical insulation testing	Assumed to meet safety standards.
10. Apposition testing	Assumed to demonstrate proper tissue contact.
11. Simulated use testing	Assumed to perform as intended in simulated scenarios.
12. Esophageal damage test	Assumed to demonstrate safe operation without unintended damage.
13. Tensile force test	Assumed to meet durability requirements.
Biocompatibility Testing	Assumed to meet ISO 10993 standards.
Sterilization	Assumed to meet sterility assurance level (SAL).
Packaging Validation	Assumed to ensure product integrity during transport and storage.
Shelf Life Testing	Assumed to meet specified shelf life.
EMC and Electrical Safety Testing	Assumed to comply with relevant safety standards (e.g., IEC 60601 series).
User Validation	Assumed to be acceptable for intended user operation.

Detailed Information (Not available in the provided text)

Sample size used for the test set and the data provenance: Not specified in the document. The tests performed are primarily bench and engineering tests, not clinical studies with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document describes engineering and safety tests, not studies requiring expert ground truth in a diagnostic context.
Adjudication method for the test set: Not applicable.
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 device is an electrosurgical catheter, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not have a standalone algorithm component.
The type of ground truth used: For the bench and safety tests, the "ground truth" would be established engineering specifications, material standards, and regulatory safety limits. For instance, in electrical insulation testing, the ground truth is that there should be no electrical leakage above a certain threshold.
The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Conclusion from the document:
The provided document concludes that the Barrx™ Channel RFA Endoscopic Catheter is "substantially equivalent to legally marketed predicates" and that "The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use." This indicates that the device met the internal and regulatory performance expectations, even if specific numerical criteria are not detailed in this summary.

Summary

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510(k) Summary

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

Covidien IIc 15 Hampshire Street Mansfield, MA 02048 Phone: (408) 328-7342 Facsimile: (408) 328-7342 (same as phone#) Contact: Richelle Hover Date Prepared: March 7, 2013

JUL 2 6 2013

NAME OF SUBJECT DEVICE AND NAME

Barrx™ Channel RFA Endoscopic Catheter

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 Coagulation Catheter

REGULATION DESCRIPTION

Classification: Class II, 21 CFR 876.4300 Product Code: GEI, KNS

PREDICATE DEVICES

HALO® Catheter cleared under 510(k) K112454 HALO90 Catheter cleared under 510(k) K093008

DEVICE DESCRIPTION

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INDICATION FOR USE

The Barry " Channel RFA Endoscopic Catheter 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).

TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMAPRED TO PREDICATE DEVICE

The Barry " Channel RFA Endoscopic Catheter, the HALO" catheter, and the HALO" catheter have similar technological characteristics. All catheters are single-use, have similar construction, similar principles of operation, control mechanism, similar materials, same packaging, and the same energy type.

The main difference between the Barrx™ Channel RFA Endoscopic Catheter and the HALO® and HALO® catheters is the channel through which the catheter is delivered. The HALO® and HALO® catheters are delivered to the target tissue by mounting the device to the endoscope, whereas the Barrx™ Channel RFA Endoscopic Catheter is delivered through an endoscope. The Barrx™ Channel RFA Endoscopic Catheter is compatible with the Flex RFA Energy Generator only (K092487). The HALO'ER Energy Generator will be brand marketed as Flex RFA Energy Generator. No software change has been made to the Flex RFA Energy Generator in order to accommodate the Barrx™ Channel RFA Endoscopic Catheter.

PRINCIPLES OF OPERATION

The Barry" Channel RFA Endoscopic Catheter follows the same principles of operation as compared to the predicates HALO® (K112454) and HALO® catheters (K093008). The Barrx™ Channel RFA Endoscopic Catheter is connected to the Flex RFA Energy Generator using an output cable. Once connected, the Generator will recognize the catheter based on a unique identification in the plug and set the appropriate power density and energy density range.

The Barry " Channel RFA Endoscopic Catheter is introduced into the esophagus through the working channel of an endoscope. 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.

SUMMARY OF TESTING PERFORMED

Verification and validation activity for the Barry " Channel RFA Endoscopic Catheter consisted of bench testing, biocompatibility testing, sterilization, packaging validation, shelf life testing, EMC and electrical safety testing, and user validation. Bench testing for the Barry" Channel RFA Endoscopic Catheter consisted of the following tests: (1) catheter length testing (2) shaft revolution testing (3) endoscope articulation testing (4) push force testing (5) retraction force testing (6) electrode deflection force testing (7) torque force and stability testing (8) bend radius testing (9) electrical insulation testing (10) apposition testing (11) simulated use testing (12) esophageal damage test (13) tensile force test.

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CONCLUSION

Covidien, Ilc considers the Barry™ Channel RFA Endoscopic Catheter to be substantially equivalent to legally marketed predicates: HALO® Catheter cleared under 510(k) K112454 and HALO® catheters cleared under 510(k) K093008.

The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

Public Health Service

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

July 26, 2013

Covidien, LLC % Richelle Hover Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048

Re: K130623

Trade/Device Name: Barrx™ Channel RFA Endoscopic Catheter; Models TTS-1100 and TTS-1500 Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS, GEI Dated: June 20, 2013 Received: June 21, 2013

Dear Richelle Hover,

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.

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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.

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,

Image /page/4/Picture/7 description: The image shows the name "Benjamin" in large, bold letters. The letters "R" and "A" are stylized with a decorative pattern. The last name "Fisher" is also present, followed by the letter "S".

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): K130623

Device Name:

Barry™ Channel RFA Endoscopic Catheter; Models TTS-1100 and TTS-1500 .

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2013.07.26 14:52:22 -04'00'

Barry™ Channel RFA Endoscopic Catheter - Traditional 510(k) Covidien, Ilc

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130623 510(k) Number _

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).