(308 days)
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.
The Dermal Cooling System is intended to be used by trained healthcare professionals.
The Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips.
The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.
This document describes a 510(k) premarket notification for the Dermal Cooling System and its accessory, R2 Dermabrasion Tips. The primary purpose of the submission is to expand the indications for use of the Dermal Cooling System to include general dermabrasion, scar revision, acne scar revision, and tattoo removal when used with the R2 Dermabrasion Tips.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Test Method/Requirement | Acceptance Criteria | Results |
|---|---|---|---|
| Accessories Validation | |||
| Dermabrasion Performance Test | 3 subjects tested with the R2 Dermabrasion Tips (20 Amps EDM) and 3 subjects tested with (80 Amps EDM) | No unexpected side effects observed immediately post test, and 2-days post test | Passed |
| Thermal Insulation Test | 3 subjects tested with the R2 Dermabrasion Tips (20 Amps EDM and 80 Amps EDM) | Skin temperature to remain at or above +20 °C for the full duration | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Dermabrasion Performance Test: 6 subjects (3 at 20 Amps EDM, 3 at 80 Amps EDM)
- Thermal Insulation Test: 6 subjects (3 at 20 Amps EDM, 3 at 80 Amps EDM)
- Data Provenance: The document does not specify the country of origin of the data. It appears to be a prospective study as tests were conducted on subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for the test set. The acceptance criteria for the performance tests (e.g., "no unexpected side effects observed") would likely have been evaluated by the researchers or medical staff conducting the study.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the device (Dermal Cooling System with R2 Dermabrasion Tips) itself, not on the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This device is not an AI algorithm. It is a physical medical device (Dermal Cooling System with R2 Dermabrasion Tips). The performance tests described demonstrate the device's physical functionality and safety, not an algorithm's standalone performance.
7. The Type of Ground Truth Used
The ground truth for the performance tests was based on direct observation of subjects for:
- Absence of unexpected side effects (Dermabrasion Performance Test).
- Maintenance of skin temperature above a certain threshold (Thermal Insulation Test).
This is akin to objective clinical observations rather than established "ground truth" in the context of image analysis or diagnostic AI.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML device that requires a training set.
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August 5, 2021
R2 Technologies, Inc. Ragan Reppond Sr. Director, HR & Corporate Affairs 2603 Camino Ramon. Suite 200 San Ramon, California 94583
Re: K203006
Trade/Device Name: Dermal Cooling System Regulation Number: 21 CFR 878. 4340 Regulation Name: Contact Cooling System for Aesthetic Use Regulatory Class: Class II Product Code: QPZ, GED Dated: June 9, 2021 Received: June 11,2021
Dear Ragan Reppond:
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/cdth/cfdocs/cfpmn/pmn.cfm identifies coombination 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.
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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 (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Leam (https://www.fda.gov/training-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/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
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Indications for Use
510(k) Number (if known) K203006
Device Name Dermal Cooling System
Indications for Use (Describe)
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.
The Dermal Cooling System is intended to be used by trained healthcare professionals.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K203006
510(k) Summary
- I. SUBMITTER R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 Bishop Ranch 3 San Ramon, CA 94583
- Contact: Ms. Ragan Reppond Vice President of Corporate Affairs & Compliance R2 Technologies, Inc. Phone: 925-378-4400
Date Prepared: July 29, 2021
II. SUBJECT DEVICE and ACCESSORY
| Device Name: | Dermal Cooling System |
|---|---|
| Device Common Name: | Contact cooling for skin lesion pain relief |
| Accessory Name: | R2 Dermabrasion Tips |
| Accessory Common Name: | Brush, Dermabrasion, Manual |
| Regulatory Class : | II |
| Product Code : | QPZ, GED |
| Regulation : | 21 CFR 878.4340, 21 CFR 878.4800 |
III. PREDICATE AND REFERENCE DEVICES
The predicate device is the Dermal Cooling System, K201260.
| Name of Device: | Dermal Cooling System |
|---|---|
| Common Name: | Cryosurgical unit and accessories |
| Regulatory Class: | II |
| Product Code: | GEH, MLY |
| Regulation: | 21 CFR 878.4350 |
The reference device is the Derma Paddle (Livra) attachment (Class I, 510(k) exempt), manufactured by Procell Therapies.
IV. DEVICE DESCRIPTION
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K203006
The Dermal Cooling System is identical to the device cleared in K201260. The Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lowerthe temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips.
The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.
V. INDICATIONS FOR USE
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.
The Dermal Cooling System is intended to be used by trained healthcare professionals.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
The predicate device, the Dermal Cooling System, has not been modified for use with the R2 Dermabrasion Tips and proposed expanded indication, i.e., general dermabrasion, scar revision, acne scar revision, and tattoo removal.
The reference device, the Derma Paddle (Livra) attachment, is included to substantiate the proposed expanded indications for use for the R2 Dermabrasion Tips as the intended use for the Derma Paddle (Livra) attachment (510(k) exempt) includes "general dermabrasion, scar revision, acne scar revision, and tattoo removal". The R2 Dermabrasion Tips and the Derma Paddle (Livra) attachment have these same fundamental scientific technological elements:
The R2 Dermabrasion Tips and the reference device, Derma Paddle (Livra) attachment have these similarities:
- used for aesthetic purposes;
- fabricated from metal; ●
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- textured surface (roughness);
- intended for manual dermabrasion;
- classification (generic description)
The key differences between the R2 Dermabrasion Tips and the Derma Paddle (Livra) attachment are:
- geometry
- mechanism of attachment
The differences do not raise new questions of safety and effectiveness with respect to the R2 Dermabrasion Tips and proposed expanded indication.
VII. PERFORMANCE DATA
Performance data is provided in support of the substantial equivalence determination, as summarized in the table below.
Dermabrasion performance test demonstrated the R2 Dermabrasion Tips can perform its intended use safely and effectively when used with the Dermal Cooling System, while the thermal insulation test supported the conclusion no additional risk was introduced when the R2 Dermabrasion Tips are used with the Dermal Cooling System.
| Test | Test method/Requirement | Acceptance criteria | Results |
|---|---|---|---|
| AccessoriesValidation | Dermabrasion Performance Test:3 subjects tested with the R2Dermabrasion Tips (20 AmpsEDM) and 3 subjects tested with(80 Amps EDM) | No unexpected side effectsobserved immediately post test,and 2-days post test | Passed |
| Thermal Insulation Test:3 subjects tested with the R2Dermabrasion Tips (20 AmpsEDM and 80 Amps EDM) | Skin temperature to remain at orabove +20 °C for the full duration | Passed |
No preclinical or clinical testing was performed.
VIII. CONCLUSIONS
An optional accessory, manual dermabrasion tips, is added to the Dermal Cooling System cleared in K201260. Performance tests demonstrated the dermabrasion tips can perform as intended when used with the Dermal Cooling System without introducing additional risks for the intended use. No new question of safety or effectiveness is raised. The subject device is therefore considered as substantially equivalent to the predicate device K201260.
§ 878.4340 Contact cooling system for aesthetic use.
(a)
Identification. A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.