(308 days)
Derma Paddle (Livra) attachment
No
The summary describes a cryosurgical device using thermoelectric cooling and mechanical dermabrasion tips. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies are basic safety and functional tests.
Yes
The device is intended for the removal of benign lesions and for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, which are therapeutic applications.
No
The device is described as a cryosurgical instrument and a cooling system for the removal of benign lesions and temporary reduction of pain/swelling, and for dermabrasion. Its functions are therapeutic/procedural, not diagnostic.
No
The device description explicitly mentions hardware components like a thermoelectric cooler (TEC), an integrated aluminum plate, a handpiece, and optional R2 Dermabrasion Tips. It is a physical device that performs cooling and potentially dermabrasion.
Based on the provided information, the Dermal Cooling System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for direct treatment of the skin (cryosurgery for lesion removal, cooling for pain/swelling reduction, dermabrasion). IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that applies cooling and/or facilitates mechanical abrasion to the skin surface. This is a therapeutic/procedural device, not a diagnostic one.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
- Anatomical Site: The device is applied directly to the skin, which is consistent with a therapeutic device.
Therefore, the Dermal Cooling System falls under the category of a therapeutic or procedural medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
QPZ, GED
Device Description
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.
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
trained healthcare 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
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: Accessories Validation: Dermabrasion Performance Test
Test method/Requirement: 3 subjects tested with the R2 Dermabrasion Tips (20 Amps EDM) and 3 subjects tested with (80 Amps EDM)
Acceptance criteria: No unexpected side effects observed immediately post test, and 2-days post test
Results: Passed
Test: Thermal Insulation Test
Test method/Requirement: 3 subjects tested with the R2 Dermabrasion Tips (20 Amps EDM and 80 Amps EDM)
Acceptance criteria: Skin temperature to remain at or above +20 °C for the full duration
Results: Passed
No preclinical or clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Derma Paddle (Livra) attachment
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 |
|---|---|---|---|
| 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 |
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.