The Freezpoint device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses an 8g or 16g cartridge of nitrous oxide. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N20 (-89ºC).

AI/ML Overview

The Freezpoint device is a cryosurgical unit that uses liquid nitrous oxide to destroy tissue by applying cryogenic gases at extremely low temperatures. The following information outlines the acceptance criteria and the study conducted to prove the device meets these criteria, as derived from the provided 510(k) summary.

I. Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Freezpoint device, based on its comparison to the predicate device CryOmega, revolved around demonstrating equivalent performance in key functional aspects: the amount of cryogen dispensed and the temperature achieved.

Acceptance Criteria	Reported Device Performance (Freezpoint)	Predicate Device Performance (CryOmega)
Amount of gas dispensed per unit of time	Calculated as <0.01g different from the predicate device during a 5-second spray. (Considered negligible difference).	Calculated as <0.01g different from the Freezpoint device during a 5-second spray.
Temperature attained at the treatment site	All replicate measurements of gas sprayed onto a thermocouple were less than -89°C. This substantiates the low boiling point of nitrous oxide (-89°C).	All replicate measurements of gas sprayed onto a thermocouple were less than -89°C, aligning with the expected low boiling point of nitrous oxide (-89°C).
Compliance with ASTM standards for devices	Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.	Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.

II. Sample Size and Data Provenance for the Test Set

Sample Size: The document refers to "replicate sprays" for both the Freezpoint and CryOmega devices for both weighing and temperature measurements. The exact number of replicates is not specified.
Data Provenance: The data was generated through bench testing conducted by the device manufacturer (Bovie Medical Corp./CryoConcepts LP). The country of origin is not explicitly stated but can be inferred to be the United States, given the FDA submission. The nature of the testing is prospective as it involves new measurements of the Freezpoint device and direct comparison to the predicate.

III. Number of Experts and Qualifications for Ground Truth

This type of bench testing for a cryosurgical device does not typically involve human experts to establish "ground truth" in the same way clinical trials for diagnostic devices would. The performance metrics (gas dispensed and temperature) are objectively measured using scientific instruments.
The qualifications of the individuals who performed the bench testing and analyzed the data are not detailed in the provided summary. However, it's implied that they possess the necessary technical expertise to conduct such measurements.

IV. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) was used as this was a bench testing study, not a study involving human interpretation or clinical outcomes that would require such a process. The measurements are objective and quantitative.

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

No MRMC comparative effectiveness study was done. This device is a cryosurgical tool, not an imaging or diagnostic device that requires human interpretation. The study focused on the physical performance characteristics of the device.

VI. Standalone Performance Study

Yes, a standalone performance study was done. The bench testing focused on the intrinsic performance of the Freezpoint device itself (amount of gas dispensed, temperature attained) and compared it directly to the predicate device. This was an "algorithm only" equivalent for a physical device, establishing its performance parameters without human interaction influencing the core function being measured.

VII. Type of Ground Truth Used

The "ground truth" used for this study was based on objective physical measurements rather than expert consensus, pathology, or outcomes data.
- For the amount dispensed criterion, the ground truth was the accurate weight measurement of the dispensed gas.
- For the temperature criterion, the ground truth was the temperature reading from a thermocouple.
- The comparison was against the established performance of a legally marketed predicate device (CryOmega) and the known physical properties of nitrous oxide (-89°C boiling point).

VIII. Sample Size for the Training Set

This device is a physical cryosurgical unit, not an AI or machine learning algorithm. Therefore, the concept of a "training set" is not applicable. The device's manufacturing and design are based on established engineering principles for cryosurgical units.

IX. How the Ground Truth for the Training Set was Established

As there is no "training set" for this type of physical medical device, this question is not applicable. The device's functionality is determined by its mechanical design and the physical properties of the cryogen.

Summary

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March 21, 2018

Bovie Medical Corp. % Sam Niedbala CEO CryoConcepts LP 205 Webster Street Bethlehem, Pennsylvania 18015

Re: K180211

Trade/Device Name: Freezpoint Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: January 13, 2018 Received: January 25, 2018

Dear Sam Niedbala:

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, 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 device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, 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) K180211

Device Name Freezpoint

Indications for Use (Describe)

The Freezpoint device is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.

The List below shows examples of the types of lesions that may be treated:

Molluscum Contagiosum
· Skin Tags
Actinic Keratosis
· Lentigo
Verruca Plana
· Verruca Vulgaris
Verruca Plantaris
· Genital Lesions
· Seborrheic Keratosis

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

Research Use (Part 21 CFR 201.321, Subpart B)
Over-The-Counter Use (21 CFR 201.66, Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. SUBMITTER

Bovie Medical Corp. 5115 Ulmerton Road Clearwater, Florida 33760 Prepared January 08, 2018

Send Correspondence To: Sam Niedbala, Ph.D. Phone: 855-355-2796 sam(@cryoconcepts.com

II. DEVICE

Name of Device: Freezpoint Usual Name – Cryosurgical unit and accessories Classification Name -General & Plastic Surgery (21CFR 878.4350) Regulatory Class: II Product Code: GEH

III. PREDICATE DEVICE

CryOmega-K102006

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Freezpoint is intended for the surgical destruction of tissue of target tissue by applying cryogenic gases at extreme low temperatures.

The List below shows examples of the types of lesions that may be treated:

Molluscum Contagiosum ●
Skin Tags ●
Actinic Keratosis ●
Lentigo
Verruca Plana ●
Verruca Vulgaris ●
Verruca Plantaris

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Genital Lesions .
. Seborrheic Keratosis

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A summary of the technological characteristics for the Freezpoint versus the CryOmega predicate is provided in the following table.

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VII. PERFORMANCE DATA

The following bench testing data was provided in support of the substantial equivalence determination.

The Freezpoint and predicate CryOmega devices both utilize liquid nitrous oxide. Bench testing therefore focused on demonstrating the equivalency of gas dispensed per unit of time and the temperature attained.

Replicate sprays of each device were performed, weighing the devices before and after a 5 second spray. The amount dispensed for the Freezpoint and CryOmega were calculated and found to be <0.01g different. The difference in amount dispensed was therefore negligible. Additionally replicate measurements of gas sprayed onto a thermocouple from each device were all less than -89°C substantiating the low boiling point of the dispensed liquid nitrous oxide for its intended use.

VIII. CONCLUSIONS

Nitrous oxide is well established as a gas used in cryosurgical products. The comparison bench testing shown between the Freezpoint and CryOmega show that the temperatures attained and amount dispensed are substantially the same. The data therefore supports the substantial equivalence between the Freezpoint and the predicate.

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.

Technological	Freezpoint	Predicate
Characteristics		CryOmega-K102006
-Intended UseStatement	Intended Use: TheFreezepoint is adisposable device with aspray applicator intendedfor the surgicaldestruction of targettissue by applyingcryogenic gases atextreme lowtemperatures	Intended Use: TheCryOmega is a disposabledevice with a sprayapplicator intended forthe surgical destructionof target tissue byapplying cryogenic gasesat extreme lowtemperatures
-CryogenCharacteristics	Nitrous Oxide, N2O at 50bar pressure. 16gcartridge	Nitrous Oxide, N2O at 50bar pressure. 16gcartridge
-Materials	Housing: PlasticFilter: PlasticO-rings: Butadiene-rubberGas Cartridge: Metal	Housing: PlasticFilter: PlasticO-rings: Butadiene-rubberGas Cartridge: Metal
-Mode of Use	Apply Spray Topically	Apply Spray Topically
-Mechanism of action	N2O gas is delivered tothe treatment site at -89Cto effect cellulardestruction	N2O gas is delivered tothe treatment site at -89Cto effect cellulardestruction
-Storage Conditions	<50°C	<50°C
-Safety	Complies with ASTM:F882-84 (96) forCryosurgical Medical	Complies with ASTM:F882-84 (96) forCryosurgical Medical
	Instruments	Instruments
-Gas Cartridge Safety	Unit is discarded after cartridge gas is emptied.	Unit is discarded after cartridge gas is emptied.
-Treatment Procedure	Freezing of target tissue by open spray	Freezing of target tissue by open spray
-Operation	Gas dispense control using actuator lever.Spray controlled by on/off actuator	Gas dispense control using actuator lever.Spray controlled by on/off actuator
-Disposal	Whole Unit is disposable after gas is emptied from the cartridge.	Whole Unit is disposable after gas is emptied from the cartridge.
-Defined Operators	Licensed Practitioner	Licensed Practitioner
-Service/Repair	Dispose of once gas cartridge is emptied. No Servicing	Dispose of once gas cartridge is emptied. No Servicing