The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).

Device Description

The Barrx™ Anorectal RFA Wand is a sterile, single-use, bipolar device used to deliver radiofrequency (RF) energy to treatment tissue in the anal canal and rectum. The Barrx™ Anorectal RFA Wand consists of a cap with electrode, EEPROM, a proximal shaft and a rigid distal shaft with handle. The device is used exclusively in connection with the Barrx™ Flex RFA Energy Generator (K092487). Once the device is connected, the EEPROM is read by the generator, recognizes the device, and determines the operation parameters.

AI/ML Overview

This document is a 510(k) summary for the Barrx™ Anorectal RFA Wand, seeking to include Anal Intraepithelial Neoplasia (AIN) as a specific indication for use, with clinical information from three AIN-related studies. However, the document explicitly states that no performance testing was conducted for the device itself because it is technologically identical to a previously cleared predicate device (K150251) and a reference predicate device (K112454).

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria, as such a study was not performed as part of this 510(k) submission for the device itself.

Instead, the submission relies on clinical studies demonstrating the use of the Barrx™ Anorectal RFA Wand for AIN, implying these studies serve as the basis for the extended indication. However, the document does not detail the methodology, acceptance criteria, or specific results of these AIN-related clinical studies. It only mentions their existence and that they support the substantial equivalence claim for the new indication.

Based on the provided text, I can answer some of your questions regarding the AIN-related clinical studies, but not for the device's technical performance validation:

Regarding the AIN-related clinical studies mentioned in the 510(k) submission:

A table of acceptance criteria and the reported device performance:
- Not provided. The document states that clinical studies were referenced to demonstrate the device's use for AIN, but it does not detail any specific acceptance criteria or performance metrics for these studies.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "three AIN related clinical studies" but does not specify their sample sizes, data provenance, or whether they were retrospective or prospective.
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):
- Not provided. The document does not describe how ground truth was established for the AIN-related clinical studies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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 RFA wand, not an AI-based diagnostic or assistive device for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not provided. For the AIN-related clinical studies, the specific type of ground truth used (e.g., histological confirmation of AIN resolution, clinical improvement) is not detailed.
The sample size for the training set:
- Not applicable / Not provided. The device is not an AI algorithm; therefore, it does not have a "training set" in the context of machine learning. If "training set" refers to data used to inform the design or understanding of the device's use for AIN, this information is not provided.
How the ground truth for the training set was established:
- Not applicable / Not provided. As above, the concept of a training set ground truth, as typically defined for AI, does not apply here.

Summary regarding the device's technical performance:

No new performance testing was conducted for the Barrx™ Anorectal RFA Wand for this submission.
The manufacturer stated that the subject device is "technologically identical" to its predicate devices (K150251 and K112454).
The basis for the new indication (AIN) relies on "clinical studies referenced within this submission" that "demonstrate the Barrx™ Anorectal RFA Wand may be used for anal intraepithelial neoplasia." However, the details of these clinical studies (methodology, results, acceptance criteria, sample sizes, etc.) are not included in this 510(k) summary.

Summary

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

January 24, 2017

Covidien LLC Rachel Silva Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield. MA 02048

Re: K162802 Trade/Device Name: Barrx Anorectal RFA Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 9, 2016 Received: December 12, 2016

Dear Rachel Silva,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Benjamin R. Fisher -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

510(k) Number (if known) K162802

Device Name Barrx™ Anorectal RFA Wand

Indications for Use (Describe)

The Barry™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).

Type of Use (Select one or both, as applicable):

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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5 510(k) SUMMARY

Submitter's Name and Address:

Covidien Ilc 15 Hampshire Street Mansfield, MA 02048

Contact Person:

Rachel Silva Senior Regulatory Affairs Specialist Phone: (408) 328-7359 Fax: (408) 328-7359

Date Prepared: October 3, 2016

Name of Device:

Proprietary Name: Barrx™ Anorectal RFA Wand Common/Usual Name: Electrosurgical Coagulation Catheter Classification Panel: General & Plastic Surgery Device Regulation: 21 CFR 878.4400, Class II Product Code: GEI

Establishment Registration Number, Owner/Operator Number:

Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497

Predicate Devices:

K150251 Barrx™ Anorectal RFA Wand by Covidien K112454 Barrx™ 60 RFA Focal Catheter by Covidien

Reason for 510(k) Submission

The purpose of this submission is to include a specific indication for use, which is Anal Intraepithelial Neoplasia (AIN), and include clinical information in the labeling resulting from three AIN related clinical studies. The intent of this 510(k) submission aligns with information stated in the FDA Guidance document titled "Guidance for Industry: General/Specific Intended Use" dated November 4, 1998 as AIN is a specific type of tissue which has been treated by the clinical community under the generic indications for use of coagulating bleeding and nonbleeding sites within the gastrointestinal tract. Also, AIN is found within a narrow target population that falls within the broader population for the products intended use.

Device Description:

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Energy Generator (K092487). Once the device is connected, the EEPROM is read by the generator, recognizes the device, and determines the operation parameters.

Indications for Use:

The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding and nonbleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiomata, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).

The Indication for Use statement for the subject device, Barrx™ Anorectal RFA Wand is not identical to the predicate device, however the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both, the subject and the predicate devices have intended use for the ablation of soft tissue using RF energy.

Technological Characteristics of the Device Compared to Predicate Device

The Barrx™ Anorectal RFA Wand has identical technological characteristics to the predicate device cleared under K150251 as well as the secondary predicate device cleared under K112454. There have been minor changes to the Barrx™ Anorectal RFA Wand that did not require a submission and were documented in a letter to file.

Performance Data

The Barrx™ Anorectal RFA Wand subject device is technologically identical to the predicate device cleared under K150251 and reference predicate cleared under K112454. Accordingly, no performance testing was conducted.

Conclusion

Clinical studies referenced within this submission demonstrate the Barrx™ Anorectal RFA Wand may be used for anal intraepithelial neoplasia and is substantially equivalent to the primary predicate and reference predicate devices.

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.