(23 days)
The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The SmoothSkin Pure Adapt is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use.
The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp.
Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair sharty is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
The provided document is a 510(k) Summary for the SmoothSkin Pure Adapt (SSG3) hair removal device. It details the device's intended use and compares it to a predicate device. However, it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the way you are asking about (e.g., performance metrics like sensitivity/specificity, human reader studies, or ground truth establishment).
The non-clinical and/or clinical tests summary section (page 5) lists compliance with various standards related to electromagnetic compatibility, usability, essential performance, photobiological safety, and biocompatibility. These are general safety and performance standards for medical devices, not specific performance criteria for hair removal efficacy or accuracy that would involve a test set, ground truth, or expert review in the way you described for AI/CAD systems.
Therefore, I cannot provide answers to most of your numbered points based on the information given. The document focuses on showing substantial equivalence to a legally marketed predicate device by demonstrating similar technological characteristics and compliance with recognized safety and performance standards.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- The document primarily demonstrates compliance with various safety and performance standards (e.g., IEC 60601 series, ISO 10993 series), rather than specifying quantitative performance acceptance criteria for hair removal efficacy in terms of metrics like sensitivity or specificity.
- For hair removal efficacy, the acceptance criterion implicitly comes from showing substantial equivalence to the predicate device, which is also indicated for "permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime." The document states "Same indications for use," implying the device is expected to achieve similar results as the predicate. However, no specific performance data (e.g., percentage reduction in hair regrowth) is provided from a study to meet this.
2. Sample size used for the test set and the data provenance:
- Not provided. No specific test set for hair removal efficacy is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving expert-established ground truth for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is an IPL hair removal device, not an AI/CAD system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for the types of studies you are referring to. The device's "ground truth" for its intended use is likely based on the clinical outcomes of the predicate device.
8. The sample size for the training set:
- Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through technological comparisons and compliance with recognized standards, rather than detailing a specific clinical performance study with defined acceptance criteria and test sets for efficacy.
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December 20, 2023
CyDen Limited Adam Stephens Regulatory Engineer Block A, Bay Studios Business Park Fabian Way, SA1 8QB Swansea, United Kingdom
Re: K233782
Trade/Device Name: SmoothSkin Pure Adapt (SSG3) 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: OHT Dated: November 27, 2023 Received: November 27, 2023
Dear Adam Stephens:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Digitally signed by Shlomit Shlomit Halachmi -S Date: 2023.12.20 14:39:00 Halachmi -S -05'00
For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices
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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
Submission Number (if known)
Device Name
SmoothSkin Pure Adapt (SSG3)
Indications for Use (Describe)
The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared on: 2023-11-27
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | CyDen Limited | ||
|---|---|---|---|
| Applicant Address | Block A, Bay Studios Business Park Fabian Way, SA1 8QB SwanseaUnited Kingdom | ||
| Applicant Contact Telephone | +44 1792 274009 | ||
| Applicant Contact | Mr. Adam Stephens | ||
| Applicant Contact Email | astephens@cyden.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | SmoothSkin Pure Adapt (SSG3) | ||
| Common Name | Laser surgical instrument for use in general and plastic surgery and indermatology | ||
| Classification Name | Light Based Over-The-Counter Hair Removal | ||
| Regulation Number | 878.4810 | ||
| Product Code | OHT | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K200184 | SmoothSkin Pure / SmoothSkin Pure Fit | OHT | |
| K143003 | SmoothSkin Gold | OHT | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The SmoothSkin Pure Adapt is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use.
The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp.
Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair sharty is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs reasured at 6, 9 and 12 months after the completion of a treatment regime.
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Indications for Use Comparison
Same indications for use.
Technological Comparison
The SmoothSkin Pure Adapt has the same following technical characteristics:
- The same indicated use,
- Operates with the same mode of action,
- Has the same technological characteristics,
- Has the same Materials,
- Has the same shelf-life,
- Is manufactured and packed in the same manner,
- Has similar output parameters to the predicate device,
- Has the same safety features.
The following changes have been made to the device: - Contour Adapters: 2 spring loaded moving paddles on the front of the device for improved skin contact to the user.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The device is compliant with the following Electromagnetic Compatibility standards.
- AAM / IEC 60601-1 : Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance 2) IEC 60601-1-6 : Medical Electrical Equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability 3) EC 60601-2-57 : Medical Electrical Equipment : Part 2-57 : Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use 4) EC 60601-2-83 : Medical Electrical Equipment Part 2-83: Particular requirement for the basic safety and essential performance of home light therapy equipment 5) EC 60601-1-2 : Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests 6) IEC 62471 : Photobiological safety of lamps and lamp systems The device is compliant with the following Biocompatibility standards 1) ISO 10993-1 : Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process 2) ISO 10993-5 : Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity 3) ISO 10993-10 : Biological evaluation of medical devices Part 10: Tests for skin sensitization
21 CFR 807.92(a)(6)
§ 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.