(29 days)
No
The summary describes a mechanical device using acoustic waves and mentions only minor hardware and software changes that do not alter the fundamental technology. There is no mention of AI, ML, image processing, or data sets for training or testing.
Yes.
The device is used to facilitate black ink tattoo removal, which is a therapeutic intervention.
No
The device is described as an accessory for tattoo removal and its function involves releasing pigment particles and dissipating laser-induced whitening to allow multiple laser passes. It does not mention any diagnostic capabilities.
No
The device description explicitly states it is composed of three hardware parts: the Console, the Hand Piece, and the connecting Cable. It also mentions hardware changes and hardware verification/validation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description clearly states the device is an "accessory to laser treatments for tattoo removal." It works by generating acoustic waves that interact directly with the skin and the tattoo ink within the skin.
- Intended Use: The intended use is "for black ink tattoo removal in Fitzpatrick Skin Type I-III patients." This is a cosmetic or therapeutic procedure performed directly on the patient's body, not on a specimen taken from the body.
The device's function and intended use are entirely focused on a procedure performed on the living patient, which is characteristic of a therapeutic or cosmetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rapid Acoustic Pulse Device (RAP) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
Product codes
GEX
Device Description
The Soliton Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments for tattoo removal. The RAP uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in fewer office visits.
The RAP is composed of three parts: the Console, the Hand Piece and the connecting Cable. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent Window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the tattoo to be removed, penetrates the skin to the typical depth of tattoo ink.
The RAP is a modification to the company's Acoustic Wave Device (AWD) that has already been cleared for the same indications for use (K190542). Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device. Specifically, the shape, frequency and repetition rate of the acoustic waves are not changed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
In accordance with Soliton's design control procedures, risk analysis was conducted to assess the impact of the modifications on the device. Verification testing using the same methods as used for the predicate device demonstrates that the RAP functions as specified and is as safe and effective as its predicate device.
Electrical safety and electromagnetic compatibility (EMC) testing was repeated for the RAP device by an independent test laboratory in accordance with IEC 60601-1. Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
The biocompatibility of RAP device is established based on the evaluation of the AWD. No new materials are used on the surface of the device that contacts the patient skin.
Software verification testing was conducted and the testing results were found acceptable for the software changes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Soliton Acoustic Wave Device (K190542)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font, and "ADMINISTRATION" in a smaller font below it, also in blue.
Soliton Inc. % Janice Hogan Regulatory Counsel Hogan Levells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
March 10, 2020
Re: K200331
Trade/Device Name: Rapid Acoustic Pulse Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: February 10, 2020 Received: February 10, 2020
Dear Janice Hogan:
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/cfpmn/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.
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
1
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 Advice (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.
Neil R.P. Ogden, MS Assistant Director, THT4A4 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: June 30, 2020 See PRA Statement on last page
510(k) Number (if known) K200331
Device Name
Rapid Acoustic Pulse Device
Indications for Use (Describe)
The Rapid Acoustic Pulse Device (RAP) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Rapid Acoustic Pulse Device
| Submitted by: | Soliton, Inc.
5304 Ashbrook Drive
Houston, TX 77081 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leslie Honda
VP, Regulatory Affairs and Quality Systems
Tel: 206.375.8586 |
| Date Prepared: | March 9, 2020 |
| Trade Name: | Rapid Acoustic Pulse Device |
| Common Name: | Dermatology Laser System |
| Classification: | Class II
Laser surgical instrument for use in general and plastic surgery and in
dermatology (21 CFR 878.4810)
Product Code GEX |
| Predicate Devices: | Soliton Acoustic Wave Device (K190542) (Predicate device) |
Intended Use / Indications for Use:
The Rapid Acoustic Pulse Device (RAP) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
Summary of Technological Characteristics
The Soliton Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments for tattoo removal. The RAP uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in fewer office visits.
The RAP is composed of three parts: the Console, the Hand Piece and the connecting Cable. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent Window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the tattoo to be removed, penetrates the skin to the typical depth of tattoo ink.
The RAP is a modification to the company's Acoustic Wave Device (AWD) that has already been cleared for the same indications for use (K190542). Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device. Specifically, the shape, frequency and repetition rate of the acoustic waves are not changed.
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Performance Data
In accordance with Soliton's design control procedures, risk analysis was conducted to assess the impact of the modifications on the device. Verification testing using the same methods as used for the predicate device demonstrates that the RAP functions as specified and is as safe and effective as its predicate device.
Electrical safety and electromagnetic compatibility (EMC) testing was repeated for the RAP device by an independent test laboratory in accordance with IEC 60601-1. Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
The biocompatibility of RAP device is established based on the evaluation of the AWD. No new materials are used on the surface of the device that contacts the patient skin.
Software verification testing was conducted and the testing results were found acceptable for the software changes.
Conclusions
The RAP device is as safe and effective as the predicate AWD device previously cleared in K190542. RAP and its predicate device have the same intended use and indications for use, and similar technological characteristics and principles of operation. The minor differences in the newer device version (the subject device) do not alter the fundamental technological characteristics or present different questions of safety or effectiveness as compared to the predicate device. Thus, RAP is substantially equivalent to the predicate device.