(128 days)
The Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosecea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family devices are prescription home use, light-based skin care systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Action is to lighten or resolve lesions using light for preferentially heating. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
The provided text describes the Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family, a prescription home-use device for treating benign pigmented and vascular lesions. The document focuses on regulatory approval (510(k)) and demonstrates substantial equivalence to predicate devices.
However, the document does not contain the detailed information needed to construct a table of "acceptance criteria and reported device performance" as typically understood in a medical device study (e.g., sensitivity, specificity, accuracy, or specific clinical outcomes for lesion treatment). The acceptance criteria described are primarily related to label comprehension and safe usability in a simulated home-use environment, rather than the clinical efficacy of treating lesions.
Therefore, many of the requested fields cannot be filled directly from this document.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (From text) |
|---|---|---|
| Label Comprehension | Sufficient understanding of Instructions For Use (IFU) by consumers, including low literacy subjects. | "The results of [the label comprehension test] confirm sufficient label comprehension." |
| Usability (Safety) | Safe and appropriate use of the device by consumers in a simulated home-use environment, including low literacy subjects. | "The results of [the usability test] confirm... safe and appropriate use of the device." |
| Nonclinical Performance | Verification of performance and electrical safety through bench testing. | "Bench testing for performance verification and electrical safety testing." (Results not detailed) |
| Clinical Efficacy | (Not explicitly stated as an acceptance criterion with specific metrics in this document - established through substantial equivalence) | (Not directly reported as clinical performance outcomes for lesion treatment in this document) |
2. Sample size used for the test set and the data provenance
- Label Comprehension Test Set Sample Size: 150 subjects
- Usability Test Set Sample Size: 123 subjects
- Data Provenance: The study was a "label comprehension and usability test of consumers" and was conducted in a "simulated home-use environment." The country of origin is not specified, but the submission is to the U.S. FDA. It would be considered a prospective study for regulatory purposes. The text explicitly mentions "Both test populations included low literacy subjects."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The ground truth for label comprehension and usability would typically be established by defining correct understanding and safe operation, likely assessed by trained observers or evaluators, but no details on their number or qualifications are given.
4. Adjudication method for the test set
This information is not provided in the document. For label comprehension and usability tests, an adjudication method (like 2+1 or 3+1) is not typically used as it would for clinical diagnostic endpoints. Assessments are usually made based on objective criteria or observer ratings.
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
- No, an MRMC comparative effectiveness study was NOT done. This device is an Intense Pulsed Light System for direct treatment, not an AI-assisted diagnostic tool for "human readers." The document describes a usability and label comprehension study for a direct treatment device, not a diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device described is a direct treatment device (Intense Pulsed Light System), not an algorithm or AI system. Its performance inherently involves human interaction for operation as a home-use device. The "standalone" performance here refers to its physical operation and energy output, which was subject to "Bench testing for performance verification."
7. The type of ground truth used
- For the label comprehension test: "Ground truth" was established by pre-defined correct answers/interpretations of the Instructions For Use (IFU) and safety warnings.
- For the usability test: "Ground truth" was established by pre-defined safe and appropriate operational steps and procedures for using the device.
8. The sample size for the training set
- This information is not provided. The document describes a usability and label comprehension study, which are typically evaluation studies, not "training set" development for machine learning models. The device's underlying technology (Intense Pulsed Light) relies on established principles of photothermolysis, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable as there is no "training set" in the context of this device and study. The device's operation is based on physical principles, not a machine learning model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
Shaser Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs 10 Maguire Road Lexington, Massachusetts 02421
Re: K142924
Trade/Device Name: Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family 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: December 4, 2014 Received: December 5, 2014
Dear Mr. Burns:
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 (reporting of medical
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device-related 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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 -ഗ
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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ATTACHMENT 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142924
Device Name
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family
Indications for Use (Describe)
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosecea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
510(K) Summary K142924
| Submitter: | Shaser, Inc.10 Maguire RoadLexington, MA 02421 |
|---|---|
| Contact: | Anthony BurnsSenior Director of Regulatory Affairs |
| Date Summary Prepared: | October 6, 2014 |
| Device Trade Name: | Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light System Family |
| Common Name: | Intense Pulsed Light Therapy System |
| Classification Name: | Powered Light Based Non-Laser Surgical Instrument with ThermalEffect79-ONF, 21 CFR 878.4810 |
| Equivalent Devices: | Sciton Profile Multi-Platform System (K070833)Shaser Skin Beauty Intense Pulsed Light System Family (K141583) |
| Device Description: | Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light System Familydevices are prescription home use, light-based skin care systems. Thefamily includes an AC mains powered and battery powered version ofthe same device.The Principle of Operation is selective photothermolysis and theMechanism of Action is to lighten or resolve lesions using light forpreferentially heating.Emission activation is by finger switch. Device includes a limited lifetreatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz,single phase. |
| Intended Use: | Treatment of benign pigmented lesions and benign cutaneous vascularlesions. |
| Indications For Use: | The Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light SystemFamily is a prescription home use device intended to providephototherapeutic light to the body. It is specifically intended for:The treatment of benign pigmented lesions including dyschromia,hyperpigmentation, melisma, ephelides (freckles);The treatment of benign cutaneous vascular lesions, including portwine stains, hemangiomas, facial, truncal and leg telangiectasias,rosacea, erythema of rosacea, angiomas and spider angiomas,poikiloderma of Civatte, leg veins and venous malformations. |
| Comparison: | The Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light SystemFamily has the identical 'Indications For Use', the identical'Fundamental Science', and the same performance specifications as the(IPL platform of the) Sciton Profile Multi-Platform System. |
| Exhibit E (1 of 2)The Shaser Skin Beauty SkinREJUV TM Intense Pulsed Light System |
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Family has the identical ‘Fundamental Science’, identical performance specifications, the same design, materials, and funtions as the Shaser Skin Beauty Intense Pulsed Light System Family.
| Nonclinical Performance Data: | Bench testing for performance verification and electrical safety testing. |
|---|---|
| Clinical Performance Data: | Label comprehension and usability test of consumers' ability to understand the instructions for use and to evaluate their ability to use the device safely in a simulated home-use environment. |
| 150 study subjects were tested for label comprehension and 123 study subjects tested for usability. Both test populations included low literacy subjects. | |
| The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device. | |
| Conclusion: | The results of the nonclinical and clinical performance data conclusively demonstrates that the proposed device is at least as safe and effective as the Sciton Profile Multi-Platform System and is a safe and effective device for the intended uses. |
| Additional Information: | None |
§ 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.