The CryoIQ devices consist of a unit body with a lever and an applicator (capillary tube, tip). A disposable cartridge filled with nitrous oxide (N₂O, laughing qas) will be attached to the unit body by slightly screwing into it. The cartridge has a build-in valve for safety storage and release of the gas. The CryoIQ designed to dispense a continuous stream of liquid nitrous oxide when actuated by pressing the lever. The device functions by means of heat evaporation upon phase transition where the nitrous oxide is applied to the treatment area by means of the applicator (capillary tube, tip) at a constant temperature of -89°C/-128°F (cold performance) followed by evaporation. Physicians or medical professionals can use the gas in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C/-128°F).

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or specific studies that prove the device meets these criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a Cryosurgical unit and accessories (CryoIQ MULTI LINE). This is a traditional medical device, not an AI/ML device.

Therefore, I cannot extract the following requested information:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
If a standalone (algorithm only without human-in-the-loop performance) was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

The document discusses performance testing for the CryoIQ MULTI LINE based on the standard ASTM: F882-84 for Cryosurgical Medical Instruments, which includes:

Freezing Effect Evidence
PPM test report
Mechanical Integrity test report

It concludes that the subject devices meet the requirements of the standard and that the freezing effect is comparable to the predicate device due to using the same technology. However, these are mechanical and performance tests for a cryosurgical device, not AI/ML performance metrics.

Summary

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

August 30, 2017

Cry IO AB % Ms. Cherita James Regulatory Consultant M Squared Associates. Inc 515 Eight Avenue, St. 1212 New York, New York 10018

Re: K172049

Trade/Device Name: CryoIQ MULTI LINE Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: July 5, 2017 Received: July 6, 2017

Dear Ms. James:

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 Actinclude 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

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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 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 (DICE) 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 (DICE) 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.

Sincerelv.

Jennifer R. Stevenson -S3

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)

K172049

Device Name CryoIQ Multi LINE

Indications for Use (Describe)

The CryoIQ Multi LINE are reusable devices intended 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)

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K172049

In accordance with 21 CFR 807.92, the following information constitutes the CryolQ AB summary for the CryolQ Multi LINE.

I. Submission Date

August 28, 2017

II. Submitter

Name:	CryoIQ AB
Address:	Apelröds vägen 1439 32 OnsalaSweden

Contact person:	Stefan Skafte, President
Phone number:	+46 31-400 500
Fax number:	+46 300-56 94 99

III. Device

Name of device:	CryolQ MULTI line
Common or usual name:	Cryosurgical unit & accessories
Classification name:	Cryosurgical unit & accessories
Regulatory class:	Class II per regulations 878.4350
Classification code:	GEH
Panel:	General & plastic surgery

IV. Predicate devices

	510(k)	Company	Device
Primarypredicate	K091721	New Medical TechnologiesGmbH	CryoSuccess
Reference	K024009	H&O Equipments NV/SA	CryoProbe-C
	K102006	STC Consulting LLC	CryOmega

V. Device Description

The CryolQ devices consist of a unit body with a lever and an applicator (capillary tube, tip). A disposable cartridge filled with nitrous oxide (N₂O, laughing qas) will be attached to the unit body by slightly screwing into it. The cartridge has a build-in valve for safety storage and release of the gas.

The CryolQ designed to dispense a continuous stream of liquid nitrous oxide when actuated by pressing the lever.

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The device functions by means of heat evaporation upon phase transition where the nitrous oxide is applied to the treatment area by means of the applicator (capillary tube, tip) at a constant temperature of -89°C/-128°F (cold performance) followed by evaporation. Physicians or medical professionals can use the gas in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C/-128°F).

VI. Intended use

The CryoIQ Multi LINE are reusable devices intended to destroy tissue during surgical procedures by applying extreme cold.

VII. Comparisons of the technological characteristics with the predicate device

CryolQ MULTI line exists of 3 devices, CryolQ DERM, CryoIQ PRO, CryolQ EquiMed. They all have the same intended use to destroy tissue during surgical procedures by applying extreme cold, same technical features but they differ in design.

	Subject device	Predicate Device	Reference devices		S.E
510(k)	No number yet	K091721	K024009	K102006
510(K)sponsor	CryolQ AB	New MedicalTechnologiesGmbH	H&OEquipmentsNV/SA	STCConsultingLLC
DeviceName	CryolQ MULTIline	CryoSuccess	CryoProbe-C	CryOmega
Models	CryolQ DERMCryolQ PROCryolQ EquiMedStd tip (ø 1mm)Dermatology tip(ø 2mm)Dermatology tip(ø 3mm)Dermatology tip(ø 4mm)Derm. tip, White(ø 1mm)Derm. tip, Blue(ø 2mm)Derm. tip, Green(ø 3mm)Long tip 13 cmAngled tip 45°	CryoSuccessStd tip (ø 1mm)Std tip (ø 2mm)Std tip (ø 3mm)Std tip (ø 4mm)Gynecology tip	CryoProbe I cCryoProbe I x	CryOmega
	Subject device	Predicate Device	Reference devices		S.E
510(k)	No number yet	K091721	K024009	K102006
510(K)sponsor	CryolQ AB	New MedicalTechnologiesGmbH	H&OEquipmentsNV/SA	STCConsultingLLC
Indication foruse	To destroy tissueduring surgicalprocedures byapplying extremecold.	To destroy tissueduring surgicalprocedures byapplying extremecold	To destroytissue duringsurgicalproceduresby applyingextreme cold	Surgicaldestruction oftarget tissueby applyingcryogenicgases atextreme lowtemperatures.The list belowshowsexamples ofthe type oflesions thatcan betreated:-Genitallesions-MolluscumContagiosum-VerrucaPlantaris-VerrucaPlana-ActinicKeratosis-SeborrheicKeratosis-Skin Tags-Lentigo	Yes
Type oflesions to betreated	-Genital lesions-MolluscumContagiosum-VerrucaPlantaris-Verruca Plana-Actinic Keratosis-SeborrheicKeratosis-Skin Tags-Lentigo	Not stated	Not stated	-Genitallesions-MolluscumContagiosum-VerrucaPlantaris-VerrucaPlana-ActinicKeratosis-SeborrheicKeratosis-Skin Tags-Lentigo	Yes
Nitrogen	Nitrous Oxide(N2O, laughinggas). Available in16 g, 25 g and 40g cartridge.	Nitrous Oxide(N2O, laughinggas). Available in23.5 g cartridge.	Nitrous Oxide(N2O,laughinggas).Available in 8g or 16 gcartridges.	Nitrous Oxide(N2O,laughinggas).Available in16 gcartridge.	Yes
	Cartridgepressure: 50 bar(725 psi)	Cartridgepressure: 50 bar(725 psi)	Cartridgepressure: 50bar (725 psi)	Cartridgepressure: 50bar (725 psi)	Yes
	Subject device	Predicate Device	Reference devices		S.E
510(k)	No number yet	K091721	K024009	K102006
510(K)sponsor	CryolQ AB	New MedicalTechnologiesGmbH	H&OEquipmentsNV/SA	STCConsultingLLC
	Shelf life: 2 years	Shelf life: 2 years	Shelf life: 2years	Shelf life: 2years	Yes
Shelf lifeDevice	5 years	5 years (with 2years warranty)	2 years	Disposableunit, isdiscardedafter liquefiedgas isemptied	Yes
TreatmentTemperature	Liquid freezing:-89°C/-128°Fconstant temp.	Liquid freezing:-89°C/-128°Fconstant temp.	Liquidfreezing:-89°C/-128°Fconstanttemp.	Liquidfreezing:-89°C/-128°Fconstanttemp.	Yes
Material	Housing:Cryo device hasno housing.The devicematerial is brassand stainlesssteel,gold plated	Housing:Cryo device hasno housing.The devicematerial is brassand stainlesssteel,gold plated	Housing:Aluminum	Housing:plastic	Yes
	Cryo tip: metal,gold plated, cryotip in borosilicateglass 3.3 (suchas DURAN)	Cryotip: metal,gold plated,cryotip inborosilicate glass3.3 (such asDURAN)	Micro-Applicator:Unknown	Micro-Applicator:Unknown	Yes
	Lock cap:Plastic	Protective Cap:Thermoplasticrubber	Lock cap:Plastic	Lock cap:Unknown	Yes
	Filter:Stainless steel	Filter:Stainless steel	Filter:Unknown	Filter:Plastic	Yes
	O-rings/SealsPTFE andacrylonitrile-butadiene-rubber	O-rings/SealsPTFE andacrylonitrile-butadiene-rubber	O-rings/Seals:Unknown	O-rings/SealsButadiene-rubber	Yes
	Nitrous oxidecartridges:Metal	Nitrous oxidecartridges:Metal	Nitrous oxidecartridges:Metal	Nitrous oxidecartridges:Metal	Yes
Mode of Use	Apply spraytopically	Apply spraytopically	Apply spraytopically	Apply spraytopically	Yes
StorageConditions	Protect the unitagainst heat andexposure todirect sunlight.The storagetemperature isbetween -	Protect the unitagainst heat andexposure to directsunlight. Thestoragetemperature isbetween -	Store in acool dryplace andkeep out ofreach ofchildren,<50°C/122°F	<50°C/122°F	Yes
	Subject device	Predicate Device	Reference devices		S.E
510(k)	No number yet	K091721	K024009	K102006
510(K)sponsor	CryolQ AB	New MedicalTechnologiesGmbH	H&OEquipmentsNV/SA	STCConsultingLLC
	max.50°C/122°F	10°C/14°F andmax. 45°C/113°F.
Cleaning	The unit bodyand cryo tip canbe cleaned anddisinfected withan alcohol-baseddisinfectant oralcohol.	The unit body andcryo tip can becleaned anddisinfected withan alcohol-baseddisinfectant oralcohol.	All externalparts can bewiped with acloth soakedin any non-corrosivesterilizationsolution oralcohol.	Unknown	Yes
Sterilization	N/A	Steam sterilizeapplicators at134°C/273°F,according to theinstruction in themanual of yoursteam sterilizerand according tothe countryspecific law	N/A	N/A	Yes
Safety	Complies withASTM: F882-84for CryosurgicalMedicalInstrument	Complies withASTM: F882-84for CryosurgicalMedicalInstrument	Complieswith ASTM:F882-84 forCryosurgicalMedicalInstrument	Complieswith ASTM:F882-84 forCryosurgicalMedicalInstrument	Yes
OperatingPrinciple	CryolQ functionsby means of heatevaporation uponphase transitionwhere liquidnitrous oxide(N₂O, laughinggas) is applied tothe treatmentarea by means ofa capillary tube(applicator, tip) ata constanttemperature of -89°C/-128°F(coldperformance)followed byevaporation.This results incellulardestruction(necrosis) in thetreatment area.The amount ofgas dispensed iscontrolled by themedicalprofessional	Cryosuccessfunctions bymeans of heatevaporation uponphase transitionwhere liquidnitrous oxide(N₂O, laughinggas) is applied tothe treatmentarea by means ofa capillary tube(applicator, tip) ata constanttemperature of -89°C/-128°F (coldperformance)followed byevaporation. Thisresults in cellulardestruction(necrosis) in thetreatment area.The amount ofgas dispensed iscontrolled by themedicalprofessionalPressing the leverof the device.	The patentedprinciple oftheCryoProbe isbased uponthe directflow of N₂O inliquid phasefor thepurpose offreezing withresulting innecrosis oftissue in thepractice ofmedicine. Toachieve thisphenomenonaneconomicalgas cartridgeis used. Thecartridge isfilled withliquid N₂O(83%) andthe rest withN₂O gas. Theliquid N₂O isthe	Gasdispensedusingactuatorlever. Spraycontrolled byon/offactuator.	Yes
	Subject device	Predicate Device	Reference devices		S.E
510(k)	No number yet	K091721	K024009	K102006
510(K)sponsor	CryolQ AB	New MedicalTechnologiesGmbH	H&OEquipmentsNV/SA	STCConsultingLLC
	Pressing thelever of thedevice.		refrigerantand theN₂O gas isthepropellant.Theinnovation oftheCryoProbe isthe ability toachieve aconstant flowof liquid N₂Oout of themicro-applicator tip.This is madepossible bymaintainingthe pressurelevel withintheinstrumentuntil the liquidN2O leavesthe tip of themicro-applicator,whereupon itwillimmediatelyexpand.
	Apply spraytopicallyN₂O gas isdelivered to thetreatment site at -89°C/-128°F inorder to causecellulardestruction.	Apply spraytopicallyN₂O gas isdelivered to thetreatment site at -89°C/-128°F to inorder to causecellulardestruction.	Apply spraytopicallyN₂O gas isdelivered tothe treatmentsite at -89°C/-128°F to inorder tocause cellulardestruction.	Apply spraytopicallyN₂O gas isdelivered tothe treatmentsite at -89°C/-128°F to inorder tocause cellulardestruction.	Yes
Maintenance	No maintenancerequired, repairsmay only beexecuted by alicenseddistributor ordealer.	No maintenancerequired, repairsmay only beexecuted by alicenseddistributor ordealer.	Change filterwith eachcartridge,exchange O-rings afterfrequent use.	Disposableonce liquefiedgas isemptied. Noservicing.	Yes
Disposal	Unit body (Mainunit) is reusablewit replaceablegas cartridge.	Main unit isreusable withreplaceable gascartridge.	Main unit isreusable withreplaceablegas cartridge,	Whole unit isdisposableafter liquefiedgas is	Yes
	Subject device	Predicate Device	Reference devices		S.E
510(k)	No number yet	K091721	K024009	K102006
510(K)sponsor	CryolQ AB	New MedicalTechnologiesGmbH	H&O EquipmentsNV/SA	STC ConsultingLLC
			be replacedwhenchanging gascartridge.	emptied fromthe cartridge.

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K172049

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VIII. Performance testing

The CryolQ has the same intended use as the predicate cryogenic devices that is intended for the destruction of tissue during surgical procedures by applying extreme cold caused by the use of nitrous oxide. The CryolQ has the same technological characteristics as the predicate cryogenic device which sprays liquid nitrous oxide gas.

The predicate cryogenic device is using a lever to dispense the nitrous oxide gas from a cartridge thru a capillary tube. Therefore, technological differences between CryolQ and its predicate device do not raise new questions about safety and efficacy.

The 510(k) notice includes data to verify that nitrous oxide in the CryolQ device can safely and effectively cause destruction when used as instructed.

The CryolQ Multiline performance has been tested according to Standard ASTM: F882-84 for Cryosurgical Medical Instruments.:

Freezing Effect Evidence ●
PPM test report ●
Mechanical Integrity test report .

The subject devices meet the requirements of the standard.

The freezing effect with the predicate device is comparable as same technology is used to dispense the nitrous oxide gas in liguid form. Bench performance test liguid freezing and gas consumption confirmed comparable performance when compared to the predicate.

IX. Conclusions

The information provided supports that the CryolQ Multi LINE is substantially equivalent in function, composition, and intended use to the predicate device. The proposed device raise no new issues of safety and effectiveness. The non-clinical testing performed demonstrates that the proposed device met all test specifications and is suitable and safe for its intended use.

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.