(55 days)
No
The device description and performance studies focus on the mechanical and thermodynamic properties of the device and the cryosurgical process, with no mention of AI or ML.
Yes
The device is intended to destroy tissue during surgical procedures by applying extreme cold, which is a therapeutic action.
No
The device is intended to destroy tissue during surgical procedures by applying extreme cold, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (unit body, lever, applicator, disposable cartridge) and a mechanism involving the release and phase transition of nitrous oxide gas, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "destroy tissue during surgical procedures by applying extreme cold." This is a therapeutic or surgical application, not a diagnostic one.
- Mechanism of Action: The device works by applying extreme cold to tissue for destruction. This is a physical intervention on the body, not an analysis of samples taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The CryoIQ Multi LINE does not fit this description.
N/A
Intended Use / Indications for Use
The CryoIQ Multi LINE are reusable devices intended to destroy tissue during surgical procedures by applying extreme cold.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians or medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CryoIQ 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 liquid form. Bench performance test liquid freezing and gas consumption confirmed comparable performance when compared to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 (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
2
Indications for Use
510(k) Number (if known)
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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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 |
| 439 32 Onsala | |
| Sweden |
| 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 | |
|---|---|---|---|
| Primary | |||
| predicate | K091721 | New Medical Technologies | |
| 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) | |||||
| sponsor | CryolQ AB | New Medical | |||
| Technologies | |||||
| GmbH | H&O | ||||
| Equipments | |||||
| NV/SA | STC | ||||
| Consulting | |||||
| LLC | |||||
| Device | |||||
| Name | CryolQ MULTI | ||||
| line | CryoSuccess | CryoProbe-C | CryOmega | ||
| Models | CryolQ DERM | ||||
| CryolQ PRO | |||||
| CryolQ EquiMed | |||||
| Std 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 cm | |||||
| Angled tip 45° | CryoSuccess | ||||
| Std tip (ø 1mm) | |||||
| Std tip (ø 2mm) | |||||
| Std tip (ø 3mm) | |||||
| Std tip (ø 4mm) | |||||
| Gynecology tip | CryoProbe I c | ||||
| CryoProbe 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 Medical | |||
| Technologies | |||||
| GmbH | H&O | ||||
| Equipments | |||||
| NV/SA | STC | ||||
| Consulting | |||||
| LLC | |||||
| Indication for | |||||
| use | To destroy tissue | ||||
| during surgical | |||||
| procedures by | |||||
| applying extreme | |||||
| cold. | To destroy tissue | ||||
| during surgical | |||||
| procedures by | |||||
| applying extreme | |||||
| cold | To destroy | ||||
| tissue during | |||||
| surgical | |||||
| procedures | |||||
| by applying | |||||
| extreme cold | 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 | |||||
| -Verruca | |||||
| Plantaris | |||||
| -Verruca | |||||
| Plana | |||||
| -Actinic | |||||
| Keratosis | |||||
| -Seborrheic | |||||
| Keratosis | |||||
| -Skin Tags | |||||
| -Lentigo | Yes | ||||
| Type of | |||||
| lesions to be | |||||
| treated | -Genital lesions | ||||
| -Molluscum | |||||
| Contagiosum | |||||
| -Verruca | |||||
| Plantaris | |||||
| -Verruca Plana | |||||
| -Actinic Keratosis | |||||
| -Seborrheic | |||||
| Keratosis | |||||
| -Skin Tags | |||||
| -Lentigo | Not stated | Not stated | -Genital | ||
| lesions | |||||
| -Molluscum | |||||
| Contagiosum | |||||
| -Verruca | |||||
| Plantaris | |||||
| -Verruca | |||||
| Plana | |||||
| -Actinic | |||||
| Keratosis | |||||
| -Seborrheic | |||||
| Keratosis | |||||
| -Skin Tags | |||||
| -Lentigo | Yes | ||||
| Nitrogen | Nitrous Oxide | ||||
| (N2O, laughing | |||||
| gas). Available in | |||||
| 16 g, 25 g and 40 | |||||
| g cartridge. | Nitrous Oxide | ||||
| (N2O, laughing | |||||
| gas). Available in | |||||
| 23.5 g cartridge. | Nitrous Oxide | ||||
| (N2O, | |||||
| laughing | |||||
| gas). | |||||
| Available in 8 | |||||
| g or 16 g | |||||
| cartridges. | Nitrous Oxide | ||||
| (N2O, | |||||
| laughing | |||||
| gas). | |||||
| Available in | |||||
| 16 g | |||||
| cartridge. | Yes | ||||
| Cartridge | |||||
| pressure: 50 bar | |||||
| (725 psi) | Cartridge | ||||
| pressure: 50 bar | |||||
| (725 psi) | Cartridge | ||||
| pressure: 50 | |||||
| bar (725 psi) | Cartridge | ||||
| pressure: 50 | |||||
| bar (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 Medical | |||
| Technologies | |||||
| GmbH | H&O | ||||
| Equipments | |||||
| NV/SA | STC | ||||
| Consulting | |||||
| LLC | |||||
| Shelf life: 2 years | Shelf life: 2 years | Shelf life: 2 | |||
| years | Shelf life: 2 | ||||
| years | Yes | ||||
| Shelf life | |||||
| Device | 5 years | 5 years (with 2 | |||
| years warranty) | 2 years | Disposable | |||
| unit, is | |||||
| discarded | |||||
| after liquefied | |||||
| gas is | |||||
| emptied | Yes | ||||
| Treatment | |||||
| Temperature | Liquid freezing: | ||||
| -89°C/-128°F | |||||
| constant temp. | Liquid freezing: | ||||
| -89°C/-128°F | |||||
| constant temp. | Liquid | ||||
| freezing: | |||||
| -89°C/-128°F | |||||
| constant | |||||
| temp. | Liquid | ||||
| freezing: | |||||
| -89°C/-128°F | |||||
| constant | |||||
| temp. | Yes | ||||
| Material | Housing: | ||||
| Cryo device has | |||||
| no housing. | |||||
| The device | |||||
| material is brass | |||||
| and stainless | |||||
| steel, | |||||
| gold plated | Housing: | ||||
| Cryo device has | |||||
| no housing. | |||||
| The device | |||||
| material is brass | |||||
| and stainless | |||||
| steel, | |||||
| gold plated | Housing: | ||||
| Aluminum | Housing: | ||||
| plastic | Yes | ||||
| Cryo tip: metal, | |||||
| gold plated, cryo | |||||
| tip in borosilicate | |||||
| glass 3.3 (such | |||||
| as DURAN) | Cryotip: metal, | ||||
| gold plated, | |||||
| cryotip in | |||||
| borosilicate glass | |||||
| 3.3 (such as | |||||
| DURAN) | Micro- | ||||
| Applicator: | |||||
| Unknown | Micro- | ||||
| Applicator: | |||||
| Unknown | Yes | ||||
| Lock cap: | |||||
| Plastic | Protective Cap: | ||||
| Thermoplastic | |||||
| rubber | Lock cap: | ||||
| Plastic | Lock cap: | ||||
| Unknown | Yes | ||||
| Filter: | |||||
| Stainless steel | Filter: | ||||
| Stainless steel | Filter: | ||||
| Unknown | Filter: | ||||
| Plastic | Yes | ||||
| O-rings/Seals | |||||
| PTFE and | |||||
| acrylonitrile- | |||||
| butadiene-rubber | O-rings/Seals | ||||
| PTFE and | |||||
| acrylonitrile- | |||||
| butadiene-rubber | O- | ||||
| rings/Seals: | |||||
| Unknown | O-rings/Seals | ||||
| Butadiene- | |||||
| rubber | Yes | ||||
| Nitrous oxide | |||||
| cartridges: | |||||
| Metal | Nitrous oxide | ||||
| cartridges: | |||||
| Metal | Nitrous oxide | ||||
| cartridges: | |||||
| Metal | Nitrous oxide | ||||
| cartridges: | |||||
| Metal | Yes | ||||
| Mode of Use | Apply spray | ||||
| topically | Apply spray | ||||
| topically | Apply spray | ||||
| topically | Apply spray | ||||
| topically | Yes | ||||
| Storage | |||||
| Conditions | Protect the unit | ||||
| against heat and | |||||
| exposure to | |||||
| direct sunlight. | |||||
| The storage | |||||
| temperature is | |||||
| between - | Protect the unit | ||||
| against heat and | |||||
| exposure to direct | |||||
| sunlight. The | |||||
| storage | |||||
| temperature is | |||||
| between - | Store in a | ||||
| cool dry | |||||
| place and | |||||
| keep out of | |||||
| reach of | |||||
| children, |