(60 days)
No
The device description and performance studies focus on the physical components and chemical properties of a cryogen spray system, with no mention of AI or ML.
Yes
The device is indicated for use in the "treatment" of several conditions, which directly aligns with the definition of a therapeutic device.
No
The device is used for treatment, specifically for freezing off benign skin lesions, not for diagnosing them.
No
The device description clearly states it consists of an aerosol-filled canister and parts within the canister, along with accessories like swabs. This indicates a physical, hardware-based device for cryotherapy, not a software-only solution.
Based on the provided information, the CryoDose H is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of various skin lesions by applying a cryogen spray. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a cryogen spray system used to freeze and destroy skin lesions. It does not involve testing samples of human origin (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CryoDose H's function is to physically treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The CryoDose H indications for use as follows: CryoDose H is indicated for use in the treatment of actinic keratosis, genital warts, lentigo, mulluscum contagiosum, sebortheic keratosis, skin tags, verruca vulgaris, and verruca plana.
Product codes
GEH
Device Description
The proposed device, CryoDose H, is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. The device consists of an aerosol-filled canister and parts within the canister. The canister is sold within a kit with accessories including: Directions for Use, swabs, and packaging materials.
The treatment methodology is simple and has remained virtually unchanged for decades. The aerosol is sprayed onto a foam covered cotton swab that is then placed upon the benign lesion (e.g. wart) for 15-40 seconds. This procedure is used and accepted by physicians using commonly accepted procedures and techniques. It utilizes a decades-old, standard cryogen composition profile to freeze common skin lesions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional
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)
- Biocompatibility Testing: Performed on all patient contact device accessories (foam tipped swab applicators) based on ISO 10993. Tests included cytotoxicity, sensitization, and irritation. The foam tip swab applicators were categorized and tested as an external, short term contact with the skin (
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2016
Nuance Medical, LLC Mr. Marc Lieberman CEO 5931 Sea Lion Place, Suite 113 Carlsbad, California 92010
Re: K161337
Trade/Device Name: CryoDose H Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: May 7, 2016 Received: May 13, 2016
Dear Mr. Lieberman:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 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 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.
Sincerely yours,
Jennifer R. Stevenson -A
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161337
Device Name CryoDose H
Indications for Use (Describe)
The CryoDose H indications for use as follows: CryoDose H is indicated for use in the treatment of actinic keratosis, genital warts, lentigo, mulluscum contagiosum, sebortheic keratosis, skin tags, verruca vulgaris, and verruca plana.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
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"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."
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5. 510(k) Summary
Nuance Medical, LLC - CryoDose H
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
I. SUBMITTER
| Owner: | Nuance Medical, LLC.
5931 Sea Lion Place, Suite 113
Carlsbad, CA 92010
(760) 585-4849 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marc S. Lieberman
Nuance Medical, LLC.
5931 Sea Lion Place, Suite 113
Carlsbad, CA 92010
760-585-9548 (Direct) |
| Date Prepared: | May 7, 2016 |
II. DEVICE
| Name of Device: | CryoDose H |
|---|---|
| Common Name: | Cryogen Spray: |
| Dimethyl Ether, Propane, Isobutane | |
| Classification Name: | Unit, Cryosurgical Accessories (21CFR 878.4350) |
Product Code: GEH
III. PREDICATE DEVICE
Primary:
Histofreezer Orasure Technologies, Inc. K990877 Legally marketed medical device This predicate has not been subject to a design-related or other recall.
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References: As a reference for the reviewer, other predicate devices utilizing the identical ingredients (95% dimethyl ether, 2% propane, 3% isobutane) or similar ingredients and cleared by the FDA include: Histofreezer (K911420, K924114, and K971392), Histofreezer (K023487-OTC), CryoNize (K103310), Dr. Scholl's Freeze Away (K031697 - OTC), Wartner Wart Removal (K011708 - OTC).
IV. DEVICE DESCRIPTION
The predicate is a legally marketed device.
The proposed device, CryoDose H, is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. The device consists of an aerosol-filled canister and parts within the canister. The canister is sold within a kit with accessories including: Directions for Use, swabs, and packaging materials.
The treatment methodology is simple and has remained virtually unchanged for decades. The aerosol is sprayed onto a foam covered cotton swab that is then placed upon the benign lesion (e.g. wart) for 15-40 seconds. This procedure is used and accepted by physicians using commonly accepted procedures and techniques. It utilizes a decades-old, standard cryogen composition profile to freeze common skin lesions.
V. INDICATIONS FOR USE
The Indications for Use is identical to the predicate device.
The CryoDose H indications for use as follows: CryoDose H is indicated for use in the treatment of the following:
- actinic keratosis -
- genital warts -
- lentigo -
- mulluscum contagiosum
- seborrheic keratosis -
- skin tags
- verruca plantaris -
- verruca vulgaris -
- verruca plana
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The proposed device has the same technical characteristics as the predicate device including materials, design, and energy source. There are no technological differences between the predicate and the submitted device.
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The cryogen used in the proposed device. CryoDose H, is dimethyl ether (95%), propane (2%), isobutane (3%) is identical in chemical composition as the predicate device, Histofreezer.
All other elements of CryoDose H have the same technical characteristics as the predicate device including:
- । Canister
- -Valve
- Actuator -
- Cover Cap -
- Foam Tipped Swabs -
The method for delivering the cryogen is identical to the predicate.
Substantial Equivalence:
The predicate device, Histofreezer is a legally marketed device. The proposed device (CryoDose H) has the same intended use (Indications for Use) as the predicate device (Histofreezer). CFR 800.100(b)(1)
The proposed device (CryoDose H) has the same technological characteristics as the predicate device (Histofreezer). There are no technological differences, including no changes in the materials, design, energy source, or other features of the device from those of the predicate device. CFR 800.100(b)(2)(i)
The proposed device and the predicate device use an identical (substantially equivalent) chemical composition by type and percent of components: dimethyl ether (95%), propane (2%), and isobutane (3%).
The proposed device and the predicate device use the same design, energy source, materials, and other features. When the liquid is dispensed, it saturates the foam tip. The foam tip is then applied directly to the desired area of treatment. Subsequently, the thermal energy is removed from the freezing of the skin lesion. Kits include a canister filled with the cryogen and foam tip applicators.
Differences, if any, would be limited to discussion and promotion of product, marketing materials, cosmetic labeling, etc. only.
The proposed device does not raise questions of safety and effectiveness efficacy different from the predicate device.
Labeling:
The labeling of CryoDose H has been prepared to ensure the medical professional has adequate and clear instructions for safety and usage. It includes canister labeling, instructions for use, safety and warning statements and are substantially equivalent to the predicate.
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Thus, CryoDose H is substantially equivalent to the predicate device.
VII. PERFORMANCE DATA
Tests were performed to ensure the proposed device's output performance was substantially similar to the predicate.
Biocompatibility Testing
Biocompatibility testing was performed on all patient contact device accessories: the foam tipped swab applicators to ensure that the finished device is biocompatible. Studies were conducted based on the requirements of ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The battery of test included cytotoxicity, sensitization and irritation. The foam tip swab applicators are categorized and were tested as an external, short term contact with the skin (