CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED

K172049 · Cry IQ AB · GEH · Aug 30, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172049
• Device Name: CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
• Applicant: Cry IQ AB
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Aug 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

CryoIQ Multi LINE is a reusable cryosurgical device for tissue destruction. It utilizes a replaceable nitrous oxide (N2O) cartridge (16g, 25g, or 40g) attached to a unit body. Operation involves pressing a lever to dispense a continuous stream of liquid N2O through a capillary tube/applicator tip. The device achieves a constant temperature of -89°C (-128°F) at the treatment site via heat evaporation upon phase transition, causing cellular necrosis. Used by physicians or medical professionals in clinical settings. The device is handheld and mechanical; no software or electronic components are involved. Benefits include precise, controlled application of extreme cold for lesion removal.

Clinical Evidence

Bench testing only. Testing included freezing effect verification, mechanical integrity, and gas consumption analysis. The device complies with ASTM F882-84 for Cryosurgical Medical Instruments. No clinical data was required or provided.

Technological Characteristics

Materials: brass, stainless steel, gold-plated components, borosilicate glass 3.3 (DURAN) tips, PTFE/acrylonitrile-butadiene-rubber seals. Energy source: pressurized N2O gas (50 bar/725 psi). Principle: heat evaporation via phase transition. Form factor: handheld unit with lever actuator and interchangeable tips (1mm-4mm, angled, long). Compliance: ASTM F882-84. No software or electronic connectivity.

Indications for Use

Indicated for the destruction of tissue during surgical procedures by applying extreme cold, including treatment of genital lesions, molluscum contagiosum, verruca plantaris, verruca plana, actinic keratosis, seborrheic keratosis, skin tags, and lentigo.

Regulatory Classification

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.

Predicate Devices

• CryoSuccess (K091721)

Reference Devices

• CryoProbe-C (K024009)
• CryOmega (K102006)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

## 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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 1<br>439 32 Onsala<br>Sweden |

| Contact person: | Stefan Skafte, President |
|-----------------|--------------------------|
| Phone number: | [phone] |
| Fax number: | [phone] |

## 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 |
|----------------------|---------|----------------------------------|-------------|
| Primary<br>predicate | K091721 | New Medical Technologies<br>GmbH | 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.

{4}------------------------------------------------

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)<br>sponsor | CryolQ AB | New Medical<br>Technologies<br>GmbH | H&O<br>Equipments<br>NV/SA | STC<br>Consulting<br>LLC | |
| Device<br>Name | CryolQ MULTI<br>line | CryoSuccess | CryoProbe-C | CryOmega | |
| Models | CryolQ DERM<br>CryolQ PRO<br>CryolQ EquiMed<br>Std tip (ø 1mm)<br>Dermatology tip<br>(ø 2mm)<br>Dermatology tip<br>(ø 3mm)<br>Dermatology tip<br>(ø 4mm)<br>Derm. tip, White<br>(ø 1mm)<br>Derm. tip, Blue<br>(ø 2mm)<br>Derm. tip, Green<br>(ø 3mm)<br>Long tip 13 cm<br>Angled tip 45° | CryoSuccess<br>Std tip (ø 1mm)<br>Std tip (ø 2mm)<br>Std tip (ø 3mm)<br>Std tip (ø 4mm)<br>Gynecology tip | CryoProbe I c<br>CryoProbe I x | CryOmega | |
| | Subject device | Predicate Device | Reference devices | | S.E |
| 510(k) | No number yet | K091721 | K024009 | K102006 | |
| 510(K)<br>sponsor | CryolQ AB | New Medical<br>Technologies<br>GmbH | H&O<br>Equipments<br>NV/SA | STC<br>Consulting<br>LLC | |
| Indication for<br>use | To destroy tissue<br>during surgical<br>procedures by<br>applying extreme<br>cold. | To destroy tissue<br>during surgical<br>procedures by<br>applying extreme<br>cold | To destroy<br>tissue during<br>surgical<br>procedures<br>by applying<br>extreme cold | Surgical<br>destruction of<br>target tissue<br>by applying<br>cryogenic<br>gases at<br>extreme low<br>temperatures.<br>The list below<br>shows<br>examples of<br>the type of<br>lesions that<br>can be<br>treated:<br>-Genital<br>lesions<br>-Molluscum<br>Contagiosum<br>-Verruca<br>Plantaris<br>-Verruca<br>Plana<br>-Actinic<br>Keratosis<br>-Seborrheic<br>Keratosis<br>-Skin Tags<br>-Lentigo | Yes |
| Type of<br>lesions to be<br>treated | -Genital lesions<br>-Molluscum<br>Contagiosum<br>-Verruca<br>Plantaris<br>-Verruca Plana<br>-Actinic Keratosis<br>-Seborrheic<br>Keratosis<br>-Skin Tags<br>-Lentigo | Not stated | Not stated | -Genital<br>lesions<br>-Molluscum<br>Contagiosum<br>-Verruca<br>Plantaris<br>-Verruca<br>Plana<br>-Actinic<br>Keratosis<br>-Seborrheic<br>Keratosis<br>-Skin Tags<br>-Lentigo | Yes |
| Nitrogen | Nitrous Oxide<br>(N2O, laughing<br>gas). Available in<br>16 g, 25 g and 40<br>g cartridge. | Nitrous Oxide<br>(N2O, laughing<br>gas). Available in<br>23.5 g cartridge. | Nitrous Oxide<br>(N2O,<br>laughing<br>gas).<br>Available in 8<br>g or 16 g<br>cartridges. | Nitrous Oxide<br>(N2O,<br>laughing<br>gas).<br>Available in<br>16 g<br>cartridge. | Yes |
| | Cartridge<br>pressure: 50 bar<br>(725 psi) | Cartridge<br>pressure: 50 bar<br>(725 psi) | Cartridge<br>pressure: 50<br>bar (725 psi) | Cartridge<br>pressure: 50<br>bar (725 psi) | Yes |
| | Subject device | Predicate Device | Reference devices | | S.E |
| 510(k) | No number yet | K091721 | K024009 | K102006 | |
| 510(K)<br>sponsor | CryolQ AB | New Medical<br>Technologies<br>GmbH | H&O<br>Equipments<br>NV/SA | STC<br>Consulting<br>LLC | |
| | Shelf life: 2 years | Shelf life: 2 years | Shelf life: 2<br>years | Shelf life: 2<br>years | Yes |
| Shelf life<br>Device | 5 years | 5 years (with 2<br>years warranty) | 2 years | Disposable<br>unit, is<br>discarded<br>after liquefied<br>gas is<br>emptied | Yes |
| Treatment<br>Temperature | Liquid freezing:<br>-89°C/-128°F<br>constant temp. | Liquid freezing:<br>-89°C/-128°F<br>constant temp. | Liquid<br>freezing:<br>-89°C/-128°F<br>constant<br>temp. | Liquid<br>freezing:<br>-89°C/-128°F<br>constant<br>temp. | Yes |
| Material | Housing:<br>Cryo device has<br>no housing.<br>The device<br>material is brass<br>and stainless<br>steel,<br>gold plated | Housing:<br>Cryo device has<br>no housing.<br>The device<br>material is brass<br>and stainless<br>steel,<br>gold plated | Housing:<br>Aluminum | Housing:<br>plastic | Yes |
| | Cryo tip: metal,<br>gold plated, cryo<br>tip in borosilicate<br>glass 3.3 (such<br>as DURAN) | Cryotip: metal,<br>gold plated,<br>cryotip in<br>borosilicate glass<br>3.3 (such as<br>DURAN) | Micro-<br>Applicator:<br>Unknown | Micro-<br>Applicator:<br>Unknown | Yes |
| | Lock cap:<br>Plastic | Protective Cap:<br>Thermoplastic<br>rubber | Lock cap:<br>Plastic | Lock cap:<br>Unknown | Yes |
| | Filter:<br>Stainless steel | Filter:<br>Stainless steel | Filter:<br>Unknown | Filter:<br>Plastic | Yes |
| | O-rings/Seals<br>PTFE and<br>acrylonitrile-<br>butadiene-rubber | O-rings/Seals<br>PTFE and<br>acrylonitrile-<br>butadiene-rubber | O-<br>rings/Seals:<br>Unknown | O-rings/Seals<br>Butadiene-<br>rubber | Yes |
| | Nitrous oxide<br>cartridges:<br>Metal | Nitrous oxide<br>cartridges:<br>Metal | Nitrous oxide<br>cartridges:<br>Metal | Nitrous oxide<br>cartridges:<br>Metal | Yes |
| Mode of Use | Apply spray<br>topically | Apply spray<br>topically | Apply spray<br>topically | Apply spray<br>topically | Yes |
| Storage<br>Conditions | Protect the unit<br>against heat and<br>exposure to<br>direct sunlight.<br>The storage<br>temperature is<br>between - | Protect the unit<br>against heat and<br>exposure to direct<br>sunlight. The<br>storage<br>temperature is<br>between - | Store in a<br>cool dry<br>place and<br>keep out of<br>reach of<br>children,<br><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)<br>sponsor | CryolQ AB | New Medical<br>Technologies<br>GmbH | H&O<br>Equipments<br>NV/SA | STC<br>Consulting<br>LLC | |
| | max.<br>50°C/122°F | 10°C/14°F and<br>max. 45°C/113°F. | | | |
| Cleaning | The unit body<br>and cryo tip can<br>be cleaned and<br>disinfected with<br>an alcohol-based<br>disinfectant or<br>alcohol. | The unit body and<br>cryo tip can be<br>cleaned and<br>disinfected with<br>an alcohol-based<br>disinfectant or<br>alcohol. | All external<br>parts can be<br>wiped with a<br>cloth soaked<br>in any non-<br>corrosive<br>sterilization<br>solution or<br>alcohol. | Unknown | Yes |
| Sterilization | N/A | Steam sterilize<br>applicators at<br>134°C/273°F,<br>according to the<br>instruction in the<br>manual of your<br>steam sterilizer<br>and according to<br>the country<br>specific law | N/A | N/A | Yes |
| Safety | Complies with<br>ASTM: F882-84<br>for Cryosurgical<br>Medical<br>Instrument | Complies with<br>ASTM: F882-84<br>for Cryosurgical<br>Medical<br>Instrument | Complies<br>with ASTM:<br>F882-84 for<br>Cryosurgical<br>Medical<br>Instrument | Complies<br>with ASTM:<br>F882-84 for<br>Cryosurgical<br>Medical<br>Instrument | Yes |
| Operating<br>Principle | CryolQ functions<br>by means of heat<br>evaporation upon<br>phase transition<br>where liquid<br>nitrous oxide<br>(N₂O, laughing<br>gas) is applied to<br>the treatment<br>area by means of<br>a capillary tube<br>(applicator, tip) at<br>a constant<br>temperature of -<br>89°C/-128°F<br>(cold<br>performance)<br>followed by<br>evaporation.<br>This results in<br>cellular<br>destruction<br>(necrosis) in the<br>treatment area.<br>The amount of<br>gas dispensed is<br>controlled by the<br>medical<br>professional | Cryosuccess<br>functions by<br>means of heat<br>evaporation upon<br>phase transition<br>where liquid<br>nitrous oxide<br>(N₂O, laughing<br>gas) is applied to<br>the treatment<br>area by means of<br>a capillary tube<br>(applicator, tip) at<br>a constant<br>temperature of -<br>89°C/-128°F (cold<br>performance)<br>followed by<br>evaporation. This<br>results in cellular<br>destruction<br>(necrosis) in the<br>treatment area.<br>The amount of<br>gas dispensed is<br>controlled by the<br>medical<br>professional<br>Pressing the lever<br>of the device. | The patented<br>principle of<br>the<br>CryoProbe is<br>based upon<br>the direct<br>flow of N₂O in<br>liquid phase<br>for the<br>purpose of<br>freezing with<br>resulting in<br>necrosis of<br>tissue in the<br>practice of<br>medicine. To<br>achieve this<br>phenomenon<br>an<br>economical<br>gas cartridge<br>is used. The<br>cartridge is<br>filled with<br>liquid N₂O<br>(83%) and<br>the rest with<br>N₂O gas. The<br>liquid N₂O is<br>the | Gas<br>dispensed<br>using<br>actuator<br>lever. Spray<br>controlled by<br>on/off<br>actuator. | Yes |
| | Subject device | Predicate Device | Reference devices | | S.E |
| 510(k) | No number yet | K091721 | K024009 | K102006 | |
| 510(K)<br>sponsor…