(60 days)
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.
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 aerosol is sprayed onto a foam covered cotton swab that is then placed upon the benign lesion (e.g. wart) for 15-40 seconds.
The provided document describes the acceptance criteria and study for the Nuance Medical, LLC CryoDose H device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured by) | Reported Device Performance and Methodology |
|---|---|
| Biocompatibility: Absence of cytotoxicity, sensitization, and irritation from patient contact materials (foam-tipped swab applicators). (ISO 10993 Part 1) | Biocompatibility testing performed on foam-tipped swab applicators, categorized as external, short-term contact (< 24 hours). Tests included cytotoxicity, sensitization, and irritation. Outcome: Compliant (ensures finished device is biocompatible). |
| Chemical Composition: Identical chemical composition of cryogen (95% dimethyl ether, 2% propane, 3% isobutane) to the predicate device. | Chemical composition confirmed for the proposed device's aerosol upon receipt from the supplier to ensure it matches the predicate: 95% dimethyl ether, 2% propane, and 3% isobutane. |
| Structural and Parts Composition: Canisters, valves, and caps are identical or substantially equivalent to the predicate device. | Engineering verification measurements and visual inspections were made to determine that the canisters, valves, and caps were identical or substantially equivalent between the predicate and the proposed device. |
| Instructions for Use (Clinical Use) Application and Methodology: Substantial equivalence of instructions for use and product claims to the predicate device. | Side-by-side comparison of Instructions for Use from the predicate device and the proposed device. Outcome: No substantial differences exist between the predicate and proposed device's Instructions for Use. |
| Cryogen Performance (Output Temperature): Substantially similar output temperature of the cryogen from the canister, on the applicator foam tips, and formation of an "ice ball". | Comparative Cryogen Performance testing was conducted. Measures included: 1. Output nozzle exit temperature of the cryogen from the canister. 2. Cryogen-saturated applicator foam tips temperature. 3. Visual confirmation for "ice ball" on neoprene-backed practice pads. Outcome: Practical test assessments determined substantial equivalence to the predicate device. |
| Stability and Shelf Life: Maintenance of identity, strength, quality, and purity throughout the labeled dating period. | A stability protocol was developed. Testing assessments were conducted under controlled conditions at room temperature and under accelerated conditions. Outcome: Protocol developed to ensure product is maintained throughout its labeled dating period. (Implied successful completion as part of the overall conclusion of safety and effectiveness). |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not explicitly state a specific numerical sample size for each test (e.g., number of foam tips tested for biocompatibility, number of cans for chemical composition, number of devices for temperature testing). The description indicates "Tests were performed" and "Studies were conducted" which implies samples were used.
- Data Provenance: Not explicitly stated. However, given this is an FDA 510(k) submission, the studies would have been conducted by or for Nuance Medical, LLC, likely in a controlled laboratory setting. There is no mention of country of origin for data, nor if it was retrospective or prospective in a clinical sense, as the studies are primarily bench and lab-based (biocompatibility, chemical, structural, temperature performance).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable or not specified. The tests described are primarily objective, bench-top engineering, chemical, and biological assessments, not requiring expert human interpretation of observational data to establish ground truth in the typical clinical sense.
- Qualifications of Experts: Not applicable or not specified for these types of tests. The tests would be performed by qualified laboratory personnel following established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests involve objective measurements (e.g., chemical analysis, temperature readings, visual inspections, biological assay results) and comparisons to predetermined criteria or the predicate device, rather than subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is a cryosurgical unit (cryogen spray and applicators), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device for cryosurgical treatment and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for this device is primarily established by:
- Predicate Device Equivalence: The safety and effectiveness of CryoDose H are established by demonstrating substantial equivalence to the legally marketed predicate device, Histofreezer. This means the predicate device's established safety and efficacy serve as the "ground truth" for the new device.
- Objective Criteria: For specific tests, the ground truth is based on objective, measurable criteria:
- Biocompatibility: Established ISO 10993 standards and pass/fail criteria for cytotoxicity, sensitization, and irritation.
- Chemical Composition: Quantitative chemical analysis results matching the specified formula.
- Structural/Functional Equivalence: Engineering specifications, measurements, and visual inspection confirming identity or substantial equivalence.
- Temperature Performance: Objective temperature measurements and visual confirmation of physical effects (ice ball).
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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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.
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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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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 113Carlsbad, CA 92010(760) 585-4849 |
|---|---|
| Contact Person: | Marc S. LiebermanNuance Medical, LLC.5931 Sea Lion Place, Suite 113Carlsbad, CA 92010760-585-9548 (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 (< 24 hours).
Chemical Composition Confirmation
Both systems use identical aerosols profiles: dimethyl ether (95%), propane (2%), and isobutane (3%). The proposed device's aerosol is checked and verified upon receipt from the aerosol supplier to ensure the same chemical profile as the predicate.
Structural and Parts Composition
Engineering verification measurements were taken and visual inspections were made to determine the canisters, valves, and caps were identical or substantially equivalent between the predicate and the proposed device.
Instructions for Use (Clinical Use) Application and Methodology:
Side-by-side Instructions for Use from the predicate device and the proposed device clinical use and product claims made to determine substantial equivalence. No substantial differences exist between the predicate and proposed device's Instructions for Use.
Side-by-Side Temperature Bench Testing
Comparative Cryogen Performance testing was conducted to determine the output temperature of the predicate and proposed devices. The output temperature was measured in three tests: (1) the output nozzle exit of the cryogen from the canister, (2) the cryogen-saturated applicator foam tips, and (3) visual confirmation for "ice ball" on neoprene-backed practice pads. Practical tests assessments to determine substantial equivalence were conducted.
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Stability Protocol and Shelf Life Testing
A stability protocol was developed to ensure that the identity, strength, quality, and purity of the product is maintained throughout its labeled dating period. Testing assessments conducted under controlled conditions at room temperature and under accelerated conditions.
Summary
Based on the testing performance conducted the proposed device, CryoDose H, was found to have a safety and effectiveness profile that is similar, if not identical, to the predicate device, Histofreezer.
CONCLUSION VIII.
Based on the information presented above and within this submission, it is concluded that the CryoDose H is safe and effective for its intended use and is substantially equivalent to the predicated device. Also, the labeling is substantially equivalent to the predicate device.
§ 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.