The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the type of lesions that can be treated.

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

Device Description

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the CryOmega device. It focuses on demonstrating substantial equivalence to a predicate device (Cryoprobe-C) rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically found for AI/software-as-a-medical-device (SaMD) clearances.

Therefore, much of the requested information regarding AI device testing (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an algorithm) is not applicable to this document. The CryOmega is a physical cryosurgical unit, not an AI/software device.

However, I can extract information related to the device's characteristics and the basis for its substantial equivalence.

Here's a breakdown of the requested information based only on the provided text:

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

Since this is a 510(k) for a physical device, the "acceptance criteria" are not framed as statistical performance metrics for an algorithm but rather as characteristics demonstrating substantial equivalence to a predicate device. The "reported device performance" is essentially a comparison of its characteristics to the predicate.

Characteristic / "Acceptance Criteria"	Predicate Device (Cryoprobe-C K024009)	CryOmega (Reported Device Performance)
Intended Use	To destroy tissue during surgical procedures by applying extreme cold.	Disposable device intended for surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. Examples of treatable lesions listed: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratosis, Lentigo.
Cryogen Characteristics	Nitrous Oxide, N2O at 50 bar pressure. 8g or 16g cartridges.	Nitrous Oxide, N2O at 50 bar pressure. 16g cartridge.
Materials	Housing: Aluminum; Micro-Applicator: unknown; Lock Cap: Plastic; Filter: Unknown; O-rings: Unknown; Cartridge: Metal.	Housing: Plastic; Filter: Plastic; O-rings: Butadiene-rubber; Cartridge: Metal.
Mode of Use	Apply Spray Topically.	Apply Spray Topically.
Mechanism of action	N2O gas is delivered to the treatment site at -89°C to effect cellular destruction.	N2O gas is delivered to the treatment site at -89°C to effect cellular destruction.
Storage Conditions	<50°C	<50°C
Safety (ASTM Standard)	Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.	Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.
Gas Cartridge Safety	Cartridge can expel unused gas under pressure during cartridge replacement.	Unit is discarded after liquefied gas is emptied (implying increased safety due to inaccessibility of high-pressure cartridge).
Treatment Procedure	Suggests Freezing of target tissue by spray.	Same.
Operation	Spray begins when gas cartridge is engaged. Continuous spray unless capped.	Gas dispensed using actuator lever. Spray controlled by on/off actuator.
Disposal	Main Unit is reusable with replaceable gas cartridges.	Whole Unit is disposable after liquefied gas is emptied from the cartridge.
Defined Operators	Physician or Licensed Practitioner.	Same.
Service/Repair	Return to Manufacturer.	Disposable once liquefied gas is emptied. No Servicing.

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

This information is not applicable as the document describes a physical medical device (cryosurgical unit), not a software or AI device requiring a test set of data. The "testing" mentioned refers to engineering and safety verifications, not clinical performance studies with 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)

This information is not applicable. Ground truth for image interpretation or diagnosis is not relevant for this type of device submission.

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

This information is not applicable.

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

This information is not applicable. This is not an AI-assisted device.

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

This information is not applicable.

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

This information is not applicable. The "ground truth" relevant to this submission is the established performance and characteristics of the legally marketed predicate device (Cryoprobe-C) to which the CryOmega is being compared for substantial equivalence.

8. The sample size for the training set

This information is not applicable.

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

This information is not applicable.

Summary

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K102006

CryOmega

PREMARKET NOTIFICATION SUMMARY

I. Device Name:

Proprietary Name - CryOmega Usual Name - Cryosurgical unit and accessories Classification Name - Class II, GEH

QCT 6 2010

II. Establishment Registration Number:

This 510(k) is submitted by STC Consulting LLC. The product will be manufactured by CryoConcepts LLP, a company owned by STC Consulting LLC.

III. Device Classification:

The CryOmcga is a Class II device according to Cryosurgical unit and accessories (21 CFR 878.4350) and has been assigned a product code of GEH.

IV. Performance Standards:

To date, no performance standards have been finalized which affect the CryOmega device.

. .

V. Proposed Labels, Labeling, Advertisements and Enginecring Drawings:

This document contains the proposed Instruction Manual for the CryOmega device

VI. Statement of Similarities and Differences to Legally Marketed Devices:

A summary of the substantial equivalence ("SE") analysis for the CryOmega versus the Cryoprobe-C is provided in the following table.

510k PredicateCharacteristic	Cryoprobe-CPredicateK024009	CryOmega-SubstantialEquivalence
Cryoprobe-CK024009-Intended UseStatement	Intended use: Todestroy tissueduring surgicalprocedures byapplying extremecold	The CryOmega is adisposable deviceintended for thesurgicaldestruction oftarget tissue byapplying cryogenicgases at extreme

		low temperatures.
		The list below
		shows examples of
		the type of
		lesions that can
		be treated.

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


Cryoprobe-C	Nitrous Oxide, N20	Nitrous Oxide, N20
K024009	at 50 bar pressure.	at 50 bar
-Cryogen	8g or 16g	pressure. 16g
Characteristics	cartridges	cartridge

Cryoprobe-C	Housing: Aluminum	Housing: Plastic
K024009	Micro-Applicator:	Filter: Plastic
-Materials	unknown	O-rings:
	Lock Cap: Plastic	Butadiene-rubber
	Filter: Unknown	Cartridge: Metal
	O-rings: Unknown
	Cartridge: Metal
Cryoprobe-C	Apply Spray	Apply Spray
K024009	Topically	Topically
-Mode of Use

Cryoprobe-C	N20 qas is	N20 gas is
K024009	delivered to the	delivered to the
-Mechanism of	treatment site at -	treatment site at
action	89C to effect	-89C to effect
	cellular	cellular
	destruction	destruction
Cryoprobe-C	<50°C	<50°C
K024009
-Storage
Conditions
	Complies with ASTM:	Complies with
Cryoprobe-C	F882-84 (96) for	( 96)ASTM: F882-84
K024009
-Safety	CryosurgicalMedical Instruments	for CryosurgicalMedicalInstruments
Cryoprobe-CK024009-Gas CartridgeSafety	Cartridge can expelunused gas underpressure duringcartridgereplacement	Unit is discardedafter liquefiedgas is emptied.
Cryoprobe-CK024009-TreatmentProcedure	Suggests Freezingof target tissue byspray	Same
Cryoprobe-CK024009-Operation	Spray begins whengas cartridge isengaged. Continuousspray unless capped	Gas dispensedusing actuatorlever. Spraycontrolled byon/off actuator
Cryoprobe-CK024009-Disposal	Main Unit isreusable withreplaceable gascartridges	Whole Unit isdisposable afterliquefied gas isemptied from thecartridge.
Cryoprobe-CK024009-Defined Operators	Physician orLicensedPractitioner	Same
Cryoprobe-CK024009-Service/Repair	Return toManufacturer	Disposable onceliquefied gas isemptied. NoServicing

P. i/4

. * . * *

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$\rho_{2/4}$

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It is believed that the data presented in the Testing Section of this submission is sufficient to demonstrate substantial equivalence between the predicate and CryOmega Device.

Intended Use

3/6

-Genital Lesions -Molluscum Contagiosum -Seborrheic Keratoses -Skin Tags -Verruca Plantaris -Verruca Vulgaris -Verruca Plana

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-Actinic Keratosis -Lentigo

Technological Characteristics

The CryOmega device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device contains a 16g cartridge of nitrous oxide that is dispensed once the device is activated. Physicians or medical professionals can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C). Unlike the predicate device, the CryOmega is designed to be self contained and disposable after all of the liquefied gas has been dispensed. It is believed that this feature increases the safety of the device since operators cannot replace or access the high pressure gas cartridge. Additionally because the device is disposable there is no servicing or maintenance of the CryOmega device.

CONCLUSION

In summary, the CryOmega's path through the 510(k) flowchart ` is as follows:

The CryOmega has the same intended use as the predicate 피 cryogenic device that is intended for the destruction of tissue using nitrous oxide.
The CryOmega has the same technological characteristics as . the Cryoprobe-C Device which sprays liquid nitrous oxide gas.
Both the CryOmega and Predicate using valves to dispense . nitrous oxide gas. Therefore technological differences between the CryOmega and its predicate devices do not raise new questions of safety or efficacy.
The 510(k) notice includes data and literature to verify that the 다 nitrous oxide in the CryOmega device can safely and effectively cause destruction when used as instructed.

Therefore, STC Consulting believes that FDA can find the CryOmega to be substantially equivalent to the Cryoprobe-C device.

'FDA Guidance-Format for Traditional & Abbreviated 510k's 2005

P4/4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 resembling an eagle or bird in flight, composed of three stylized lines.

Public Health Service

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

STC Consulting LLC % R. Sam Niedbala, Ph.D. 4093 Maulfair Drive Allentown, Pennsylvania 18103

OCT 6 2010

Re: K102006

Trade/Device Name: CryOmega™ Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: September 03, 2010 Received: September 13, 2010

Dear Dr. 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 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

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Page 2 - R. Sam Niedbala, Ph.D.

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 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.

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,

Peter Der Dik

Mark N. Melkers Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K102006

Device Name: CryOmega ™

Indications For Use:

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

AND/OR Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE QNTINUE ON ANOTHER - Kis PAGE IF (Division Sign-Off) NEEDED) Division of Surgical. Orthopede, and Restorative Devices 2006

Concurrence of CDRH, Office of Device

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.