The Accurett® is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold gas, carbon dioxide (CO2). The device design is based on direct application of carbon dioxide in the liquid phase to the selected area. The CO2 gas is delivered to the treatment site at -79°C to effect cellular destruction. The hand-held device is shaped like a pencil to afford maximum user comfort. Prior to use, a commercially available 16g CO2 gas cylinder cartridge is loaded into the Accurett® device. The flow of gas is controlled by a trigger on the unit. Mode of operation: Joule-Thompson Principle to cool the gas.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Accurett® cryosurgical unit and accessories. It focuses on demonstrating substantial equivalence to a predicate device (CryoProbe™). The information primarily outlines the device, its intended use, and the comparison to the predicate, with a specific mention of performance testing to address the change in cryogen.

Based on the provided text, here is a summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that performance testing was conducted to assure the use of CO2 gas was "appropriate, safe and effective." However, it does not explicitly state specific acceptance criteria or quantitative performance results for attributes like freezing rate, tissue destruction depth, or any other performance metric. It only states the output temperature for CO2.

Performance Metric	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Output Temperature (CO2)	Not explicitly stated	-79°C
Output Temperature (N2O)	Not explicitly stated (for predicate)	-89°C (for predicate)

2. Sample Size Used for the Test Set and Data Provenance

The document states that "design verification testing was performed" but does not specify the sample size used for this testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth as this is a device submission for substantial equivalence based on performance testing related to a change in cryogen, not a diagnostic AI study.

4. Adjudication Method for the Test Set

This is not applicable as the document describes performance testing for a cryosurgical device, not a diagnostic study requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done, as this document pertains to a medical device submission, not an AI-assisted diagnostic system.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done as this document refers to a cryosurgical device, not an AI algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, expert consensus) is not directly applicable here. The "proof" focuses on demonstrating the safety and effectiveness of the device with the new cryogen, likely through engineering and functional testing rather than clinical ground truth as defined in diagnostic studies. The document states "design verification testing was performed to assure the use of the CO2 gas was appropriate, safe and effective for the intended use."

8. Sample Size for the Training Set

There is no mention of a training set as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set mentioned in the document.

Summary of the Study Proving Device Meets Acceptance Criteria (as described in the document):

The study referenced is "performance testing" conducted as part of "design verification testing." The motivation for this testing was a "Risk Analysis ... according to ISO 14971:2012" to assess the impact of changing the cryogenic gas from N2O to CO2. The objective of this testing was "to assure the use of the CO2 gas was appropriate, safe and effective for the intended use."

The document states that "The result of use of the different gas is the output temperature: for the CO2 it is -79ºC while for the N2O it is -89°C." This implies that the temperature achieved by the new cryogen (CO2 at -79°C) was considered acceptable for "destroying tissue during surgical procedures by applying extreme cold," which is the stated indication for use.

In essence, the "study" was a series of design verification tests, including measuring output temperature, to ensure the modified device (Accurett® with CO2) performed as intended and was safe and effective, thereby demonstrating substantial equivalence to the predicate device (CryoProbe™ with N2O). Specific quantitative acceptance criteria or detailed test results are not provided in this summary document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines beneath them.

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

August 23, 2016

H&O Equipments, nv/sa % Ms. Patsy Trisler Qserve Group US, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, MD 20815

Re: K161615

Trade/Device Name: Accurett ® Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: August 2, 2016 Received: August 3, 2016

Dear Ms. Trisler:

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 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 yours,

Christopher J. Ronk -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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161615

Device Name

Accurett®

Indications for Use (Describe)

To destroy tissue during surgical procedures by applying extreme cold.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

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510(k) SUMMARY— Accurett®

K161615

I. SUBMITTER
Submitter Name:	H&O Equipments nv/sa
Submitter Address:	Rue des Journaliers 17822 GhislenghienBELGUIM
Contact Person:Telephone #:	Aline Frank, Quality Manager+32 68 26 86 00
US Contact:	Patsy Trisler, Regulatory Consultant, Qserve Group US301.652.5344
Date Prepared:	7 June 2016
II. DEVICE
Device Trade Name:	Accurett®
Common andClassification Name(s):	Cryosurgical Unit and Accessories
Classification #:	21 CFR 878.4350
Product Code	GEH
Regulatory Class	2
Review Panel	General and Plastic Surgery
III. PREDICATE DEVICE	K024009, CryoProbe™
IV. DEVICE DESCRIPTION
	The Accurett® is a hand-held cryosurgical instrument fordestroying tissue during surgical procedures by applyingextreme cold gas, carbon dioxide (CO2). The devicedesign is based on direct application of carbon dioxide inthe liquid phase to the selected area. The CO2 gas isdelivered to the treatment site at -79°C to effect cellulardestruction.
	The hand-held device is shaped like a pencil to affordmaximum user comfort. Prior to use, a commerciallyavailable 16g CO2 gas cylinder cartridge is loaded intothe Accurett® device. The flow of gas is controlled by atrigger on the unit.
	Mode of operation: Joule-Thompson Principle to coolthe gas.
DESCRIPTION OF DEVICEMODIFICATIONS	The only modification to the marketed predicateCryoProbe is the cryogen source, from N2O gas to CO2gas.
V. INDICATIONS FOR USE	To destroy tissue during surgical procedures by applyingextreme cold.
VI. COMPARISON OFTECHNOLOGICALCHARACTERISTICSWITH THE PREDICATEAND REFERENCEDEVICES	The Accurett® has the same intended use as thepredicate and reference devices.There are no technological differences between themarketed CryoProbe predicate and the Accurett®. Theonly modification, as noted, is the use of the alternativecryogen, CO2 gas. To address this difference,performance testing was provided.The Accurett® and the predicate have the same mode ofoperation: Joule-Thompson.The result of use of the different gas is the outputtemperature: for the CO2 it is -79ºC while for the N₂O itis -89°C.
VI. SUMMARY OFPERFORMANCE DATAAND DESIGNCONTROLS	A Risk Analysis was performed according to ISO14971:2012 and documentation was included in the510(k) to assess the impact of the change of cryogenicgases.As a result, design verification testing was performed toassure the use of the CO2 gas was appropriate, safe andeffective for the intended use.
VIII. CONCLUSION OFSUBSTANTIALEQUIVALENCE	The information and data provided in this Special 510(k)establish that H&O Equipment's modified cryosurgicalinstrument, the Accurett®, is substantially equivalent inthe intended use, design, principle of operation,technology, materials, specifications and performance tothe CryoProbe predicate.

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Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.