The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room.

The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (< 24 hours) with tissue. The Wi-3 Arm (made of Aluminum Alloy) and Wi-3 Fixation Nut (made of polyphenylsulfone and acetal) are surface devices having limited contact duration (< 24 hours) with skin.

AI/ML Overview

This document is a 510(k) premarket notification for the Wi-3 HAL-RAR System and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner requested. The document outlines non-clinical testing performed, but does not provide specific acceptance criteria or performance results in a quantifiable way for clinical efficacy.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance cannot be extracted from this document.

Here's what can be extracted:

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

This information is not provided in the document. The document states that "non-clinical testing" was performed, but does not specify acceptance criteria or quantitative performance results for clinical efficacy. The types of non-clinical tests mentioned are:

Biocompatibility: Compliant to ISO 10993-1.
Software Verification: Compliant to IEC 60601-1 and IEC 60601-1-4.
Electromagnetic Compatibility and Electrical Safety: Compliant to IEC 60601-1-2 and IEC 60601-2-37.

For these non-clinical tests, the "reported device performance" is simply that the device was found to be "in compliance" or "tested in compliance" with the stated standards. No specific performance metrics or quantitative results are given.

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

Not applicable. The document discusses non-clinical testing of the device itself (biocompatibility, software, electrical safety) rather than clinical performance data from a test set of patient data.

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)

Not applicable. This document does not describe a study involving expert review for ground truth establishment.

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

Not applicable. This document does not describe a study involving adjudication of a test set.

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

Not applicable. The device described, the Wi-3 HAL-RAR System, is a surgical tool for detecting and ligating hemorrhoidal arteries. It is not an AI-based diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device or document.

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

Not applicable. The Wi-3 HAL-RAR System is a physical medical device (ultrasound system for surgery) used by a human operator, not a standalone algorithm.

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

Not applicable. As noted, the testing described is non-clinical and related to device safety and compliance with standards, not diagnostic or therapeutic efficacy requiring ground truth from clinical data.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an algorithm using a training set.

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

Not applicable. This document does not describe the development or training of an algorithm using a training set.

Summary

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

June 12, 2015

Agency for Medical Innovations GmbH % Dr. Allison C. Komiyama, Ph. D., R.A.C. AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego, California 92104

Re: K150718

Trade/Device Name: Wi-3 HAL-RAR System Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: FHN, IYN Dated: March 18, 2015 Received: March 19, 2015

Dear Dr. Komiyama:

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/ResourcesforYou/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 yours.

Jennifer R. Stevenson -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

Enclosure

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Indications for Use

510(k) Number (if known) K150718

Device Name Wi-3 HAL-RAR System

Indications for Use (Describe)

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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510(k) Summary K150718

DATE PREPARED

March 18, 2015

MANUFACTURER AND 510(k) OWNER

Agency for Medical Innovations GmbH Im Letten 1, 6800 Feldkirch, Vorarlberg, Austria +43 5522 90505-0 Telephone: Fax: +43 5522 90505-4006 Official Contact: Stefanie Hoellger, Quality Assurance & Regulatory Affairs

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: akomiyama@acknowledge-rs.com Email:

PROPRIETARY NAME OF SUBJECT DEVICE

Wi-3 HAL-RAR System

COMMON NAME

Hemorrhoidal ligator

DEVICE CLASSIFICATION

Hemorrhoidal ligator (21 CFR 876.4400, Product Code FHN, Class II) Ultrasonic pulsed Doppler imaging system (21 CFR 892.1550, Product Code IYN, Class II)

INDICATIONS FOR USE

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DEVICE DESCRIPTION

PREDICATE DEVICE IDENTIFICATION

The Wi-3 HAL-RAR System is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K061831	MedChannel HTS System* / MedChannel, LLC	✓
K081429	THD Slide / THD S.p.A
K131282	Nexus™ Hemorrhoid Ligator / inx Medical

The MedChannel HTS System was purchased by A.M.I and rebranded as the HAL-RAR System.

SUMMARY OF NON-CLINICAL TESTING

Biocompatibility: Patient contacting material was subjected to biocompatibility testing in compliance to ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process: cytotoxicity, sensitization, and irritation.

Software Verification: The software development and testing was executed in compliance to IEC 60601-1 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance and IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems.

Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests and IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

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510(k) Summary

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EQUIVALENCE TO PREDICATE DEVICES

The subject device has a similar design and dimensions, and uses similar or identical materials as the device cleared in K061831. The new material (PBT) used in the Sleeve component of the subject device has undergone testing to ensure it is biocompatible for its contact duration (< 24 hours) and contact type (tissue). The subject device has the same intended use and similar technological characteristics (i.e. the Doppler is connected via a Bluetooth module instead of a cable, and the batteries are now incorporated into the handpiece of the device instead of the console) to the devices cleared in K061831, K081429, and K131282. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates.

CONCLUSION

Based on the testing performed, including biocompatibility, software verification testing, electrical safety, and electromagnetic compatibility testing, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Wi-3 HAL-RAR System are assessed to be substantially equivalent to the predicate devices. The device is considered safe and effective for its intended use.

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.