(261 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the cryogen spray system, with no mention of AI or ML.
Yes
The device is described as being "For the treatment of verruca (warts) including plantar warts, sehorrheic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granualpma." This statement directly indicates its use in treating medical conditions, classifying it as a therapeutic device.
No
The device is described as being used "in the treatment of skin lesions" and its intended use is "For the treatment of verruca (warts) including plantar warts..." There is no mention of diagnosis.
No
The device description clearly states it is a "cryogen spray system" and describes its chemical composition and physical properties, indicating it is a hardware device that delivers a cryogen.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a cryogen spray system used to treat skin lesions by freezing them. It is applied directly to the patient's skin.
- Intended Use: The intended use is for the treatment of various skin conditions, not for the diagnosis or detection of these conditions through analysis of samples.
- Mechanism of Action: The device works by physically freezing the tissue, not by analyzing biological markers in a sample.
Therefore, the device falls under the category of a therapeutic device used for direct treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the treatment of verruca (warts) including plantar warts, sehorrheic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granualpma.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The Subject Device is used in the practice of dermatology in the treatment of skin lessons using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a cryogen composition profile to freeze common skin lessons that is has a lower global warming potential then the predicate device and is safe and provide equivalent performance.
The chemical composition is a blend of HFC-32 and HFO-1234ze. HFC-32, difluoromethane, is a colorless gas typically used as a refrigerant. HFO-1234ze, trans-1,3,3,3-tetrafluoroprop-1-ene, is a colorless gas and a new generation hydrofluoroolefin developed for its low global warming potential.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Adults
Intended User / Care Setting
Used in the practice of dermatology by physicians.
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)
Assessments were performed that includes the following:
- Temperature
- Flammability/Ignition
- Spray Rate
- Pressure
- Visual Freezing
As indicated in the above comparison chart, the Subject Devices in non-flammable, deliveries similar temperatures at the application site, and the spray weight is identical than that of the predicate.
Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use.
The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the predicate as it pertains to the indications for use and device performance.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 22, 2021
Nuance Medical, Inc. Mr. Neal Hartman Regulatory Affair/Quality Assurance 5931 Sea Lion Place, Suite 113 Carlsbad, California 92010
Re: K210310
Trade/Device Name: CryoDose V50/50 Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: October 8, 2021 Received: October 12,2021
Dear Mr. Hartman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210310
Device Name CryoDose V 50/50
Indications for Use (Describe)
For the treatment of verruca (warts) including plantar warts, sehorrheic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granualpma.
| Type of Use (Select one or both, as applicable) | ☑ Research Use (Part 21 CFR 321.3, Level I) ☐ Over-The-Counter Use (21 CFR 331.3, Level I) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K210310
Nuance Medical
510(K) SUMMARY
Submitter Information
| Company Name: | Nuance Medical, Inc. |
|---|---|
| Company Address: | Nuance Medical, Inc. |
| 5931 Sea Lion Place, Suite 113 | |
| Carlsbad, CA 92010 | |
| Company Phone: | (760) 585-9548 |
| Company Facsimile: | (760) 235-4572 |
| Contact Person No. 1: | Marc S. Lieberman |
| Chief Executive Officer | |
| marc@cryodose.com | |
| Contact Person No. 2: | Neal Hartman |
| Regulatory Affairs/ Quality Assurance | |
| 892 Summer Moon Road | |
| San Marcos, CA 92078 | |
| 858.382.6550 | |
| nealenhartman@gmail.com | |
| Date: | October 16, 2021 |
Device Identification
| Device Trade Name: | CryoDose V50/50 |
|---|---|
| Common Name: | Cryogen Spray |
| Classification Name(s): | Cryosurgical unit and accessories |
| Requlation(s): | 878.4350 |
| Device Class: | Class II |
| Product Code(s): | GEH |
| Advisory Panel: | General & Plastic Surgery |
ldentification of Predicate Devices
The System Device is substantially equivalent to the following device:
| Device Name | Classification Regulation | Product
Code | 510(K)
Number | Clearance
Date |
|-------------------------------|----------------------------------------------|-----------------|------------------|-------------------|
| Nuance Freeze
Spray System | 878.4350 - Cryosurgical unit and accessories | GEH | K130995 | 6/14/2013 |
4
K210310
Device Description
The Subject Device is used in the practice of dermatology in the treatment of skin lessons using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a cryogen composition profile to freeze common skin lessons that is has a lower global warming potential then the predicate device and is safe and provide equivalent performance.
The chemical composition is a blend of HFC-32 and HFO-1234ze. HFC-32, difluoromethane, is a colorless gas typically used as a refrigerant. HFO-1234ze, trans-1,3,3,3-tetrafluoroprop-1-ene, is a colorless gas and a new generation hydrofluoroolefin developed for its low global warming potential.
Indications for Use
For the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granuloma.
| Comparison Feature | Subject Device | Predicate Device |
|---|---|---|
| Device name | CryoDose V50/50 | Nuance Freeze Spray System |
| Manufacturer | Nuance Medical, Inc. | Nuance Medical, Inc. |
| Indications for Use | For the treatment of verruca (warts) | |
| including plantar warts, seborrheic | ||
| keratoses, actinic keratosis, | ||
| achrochorodon, molluscum, | ||
| contagiosum, age spots, dermatofibroma, | ||
| small keltoids, granuloma annulare, | ||
| porokeratosis plantaris, angiomas, | ||
| keratoacanthoma, chrondrodermatitis, | ||
| epithelial nevus, leukoplakia, granuloma | ||
| pyogenicum, and pyrogenic granuloma. | 1,1,1,2-tetrafluoroethane, | |
| pentafluoroethane, and 1,1,1-trifluorethane | ||
| is to be used for the treatment of verruca | ||
| (warts) including plantar warts, seborrheic | ||
| keratoses, actinic keratosis, | ||
| achrochorodon, molluscum, contagiosum, | ||
| age spots, dermatofibroma, small keltoids, | ||
| granuloma annulare, porokeratosis | ||
| plantaris, angiomas, keratoacanthoma, | ||
| chrondrodermatitis, epithelial nevus, | ||
| leukoplakia, granuloma pyogenicum, and | ||
| pyrogenic granuloma. | ||
| Target Population | Adults | Adults |
| Anatomical Sites | Skin | Skin |
| Chemical Name | HFC-32/HFO-1234ze Blend | HFC blend (R-404a) |
| Chemical Composition | difluoromethane (50%) | |
| trans-1,3,3,3-tetrafluoroprop-1-ene (50%) | 1,1,2-tetrafluoroethane (4%) | |
| pentafluoroethane (44%) | ||
| 1,1,1-trifluoroethane (54%). | ||
| Molecular Weight | 97.6 | 71.4 |
| Bolling Point | -47.8°C | -46.2°C |
| Liquid Density @ 25°C | ~1.13 g/cc | 1.05 g/cc |
| Heat of Vaporization | ~233 kj/kg | 202.1 kj/kg |
| Global Warning Potential | ||
| (CO2=1) | ~340 | 3260 |
| Flammability | Non-flammable | Non-flammable |
Comparison of Technological Characteristics with Predicate and Reference Devices
5
| Comparison Feature | Subject Device | Predicate Device |
|---|---|---|
| Mechanism of Action | Freezing by application of cryogen | Freezing by application of cryogen |
| Application Method | Handheld spray cannister with | |
| applicators | Handheld spray cannister with applicators | |
| Temperature at | ||
| application site @ 3- & 7- | ||
| seconds spray /3" | ||
| distance | Surface: -60°C | |
| Subcutaneous -5°C | ||
| Intramuscular: 30°C | Surface: -60°C | |
| Subcutaneous -5°C | ||
| Intramuscular: 30°C | ||
| Temperature at | ||
| application site @ 7 | ||
| seconds spray/ 6" | ||
| distance | Surface: -60°C | |
| Subcutaneous -5°C | ||
| Intramuscular: 28°C | Surface: -65°C | |
| Subcutaneous -8°C | ||
| Intramuscular: 32°C | ||
| Spray weight with 5 | ||
| second spray | 0.015 lb. | 0.015 lb. |
| Mechanical Safety | Positive shut-off release | Positive shut-off release |
| Cannister Fill Size | 175, 236 ml | 162, 236 ml |
| Kit Components | Device cannister, Cones, Swabs | Device cannister, Cones, Swabs |
| EMI Radiation Safety | N/A | N/A |
Technically, the Subject Device has similar mechanical properties to the predicate as well as its performance. The same patient population and use indications applies between the devices. Identical cannister components and applicators are used with both devices. The main differences between the Subject Device and predicate is that the global warning potential is significantly less with the Subject Device. The differences in the Subject Device does not impact safety, effectiveness, or performance.
Summary of Testing Performed
Assessments were performed that includes the following:
- Temperature
- Flammability/Ignition ●
- Spray Rate
- Pressure
- Visual Freezing ●
As indicated in the above comparison chart, the Subject Devices in non-flammable, deliveries similar temperatures at the application site, and the spray weight is identical than that of the predicate.
Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use.
Conclusions Drawn from Nonclinical Evaluation
The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the predicate as it pertains to the indications for use and device performance.