(224 days)
The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV
Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.
The provided text is a 510(k) Summary for the "Irradiation Aesthetic Device (Model: HairPro)". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo clinical efficacy or safety through a separate performance study with acceptance criteria.
Therefore, the document does not report on a study that proves the device meets specific performance acceptance criteria in the way you've described (e.g., in terms of clinical accuracy, sensitivity, specificity, etc., for a diagnostic AI device). This is a marketing clearance for a device like an "Infrared Lamp" which generally relies on established safety and performance standards for similar devices already on the market.
Here's why the requested information cannot be fully provided from this document:
- Acceptance Criteria & Device Performance Table: The document provides "Comparison to Predicate Device" (Section 7) which lists various technical specifications and their values for the subject device and predicate devices. This is a comparison for substantial equivalence, not a list of acceptance criteria for a new performance study. The "Verdict" column indicates "SE" (Substantially Equivalent) rather than a pass/fail against a quantitative criterion.
- Sample Size and Data Provenance: This document describes bench testing against electrical safety, electromagnetic compatibility, laser safety, and biocompatibility standards (Section 6). It does not mention any clinical study involving patients or a "test set" of patient data for performance evaluation. The "Attachment 9" and "Attachment 10" are references to reports for these technical tests, not clinical data.
- Experts for Ground Truth/Adjudication Method: Since no clinical performance study involving an AI component or diagnostic capability is mentioned, there's no discussion of ground truth establishment or expert adjudication.
- MRMC Comparative Effectiveness Study: No such study is mentioned. The device is a "Irradiation Aesthetic Device" (likely a low-level laser therapy device for hair growth), not a diagnostic AI.
- Stand-alone Performance: Not applicable as it's not a diagnostic AI device.
- Type of Ground Truth: Not applicable, as no clinical performance study for an AI or diagnostic function is described. The ground truth refers to established standards for the material and electrical properties of the device.
- Training Set Sample Size and Ground Truth Establishment (for training set): Not applicable, as this is not an AI/machine learning device that requires a training set of data.
In summary, based solely on the provided 510(k) summary, the device is cleared based on its substantial equivalence to predicate devices, supported by bench testing conforming to relevant safety and performance standards, rather than a clinical study with new performance acceptance criteria.
The "acceptance criteria" for this clearance are implicitly met if the device demonstrates (through engineering specifications and bench testing) that it is as safe and effective as the predicate devices, and that any differences do not raise new questions of safety or effectiveness.
If this were an AI/ML medical device, the 510(k) summary would typically include a "Clinical Performance" section detailing studies with specific endpoints and criteria. This document does not contain such a section.
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January 30, 2018
Chongqing Peninsula Medical Technology Co., Ltd. % Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion No.121 Science Road, Guangzhou Science Park Guangzhou, 51006 China
Re: K171835
Trade/Device Name: Irradiation Aesthetic Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: October 29, 2017 Received: November 6, 2017
Dear Ms. Lee:
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, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer R. Stevenson -S3
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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Indications for Use
510(k) Number (if known) K171835
Device Name Irradiation Aesthetic Device
Indications for Use (Describe)
The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV
| 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
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 890.5500.
Submitter Information 1.
Sponsor Name: Chongqing Peninsula Medical Technology Co., Ltd. Address: No.2-4, 2F Block I, Biological and Biochemical Park, 70-1&70-2# Ke Yuan 4th Road, Jiulongpo District, Chongqing, China Contact name: Zhang Sudi (RA) Tel: +86-150 1257 8550 Fax: 023-6861 1963 E-mail: zsd@peninsulalaser.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com
Subject Device Information 2.
| Type of 510(k): | Traditional |
|---|---|
| Trade Name: | Irradiation Aesthetic Device |
| Classification Name: | Infrared Lamp |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OAP |
| Regulation Number: | 890.5500 |
| Regulation Class: | 2 |
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Sponsor: Chongqing Peninsula Medical Technology Co., Ltd Subject Device: Irradiation Aesthetic Device, Model: HairPro File No.: 510(k) submission report (V1.0), Chapter 23
Predicate Device Information 3.
Sponsor: Capillus LLC Classification Name: Infrared Lamp Trade Name: Capillus272, Capillus202, Capillus82 510(K) Number: K153618, K160285, K163170 Review Panel: General & Plastic Surgery Product Code: OAP Requlation Number: 890.5500 Regulation Class: 2
4. Device Description
Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.
5. Intended Use
The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila – V and for both. Fitzpatrick Classification of Skin Phototypes I to IV.
6. Test Summary
Irradiation Aesthetic Device (Model: HairPro) has been evaluated the safety and performance by lab bench testing according to the following standards:
| Standards No. | Standard Title | Version | Date | Detail |
|---|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for Safety | 2005+A1:2012 | 01/14/2014 | Attachment 10 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential | 2007 | 06/27/2016 | Attachment 10 |
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Chongqing Peninsula Medical Technology Co., Ltd Sponsor: Subject Device: Irradiation Aesthetic Device, Model: HairPro
| performance - Collateralstandard: ElectromagneticcompatibilityRequirements and tests | ||||
|---|---|---|---|---|
| IEC 60825-1 | Safety of laser products –Part 1:Equipment classificationand requirements | Secondedition:03/2007 | 03/2007 | Attachment10 |
| IEC60601-1-11 | Medical ElectricalEquipment - Part 1-11:General Requirements forBasic Safety and EssentialPerformance - CollateralStandard: Requirementsfor Medical ElectricalEquipment and MedicalElectrical Systems Used | 2010 | 03/1/2011 | Attachment10 |
| ISO10993-5(Cytotoxicity) | Biological evaluation ofmedical devices - Part 5:Tests for In Vitrocytotoxicity | 2009 | 05/05/2010 | Attachment9 |
| ISO 10993-10(SensitizationandIrritation) | Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization | 2010 | 03/16/2010 | Attachment9 |
File No.: 510(k) submission report (V1.0), Chapter 23
Comparison to Predicate Device 7.
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Verdict | ||
|---|---|---|---|---|---|
| Company | Chongqing PeninsulaMedical Technology Co.,Ltd. | Capillus LLC | -- | ||
| Trade Name | HairPro | Capillus82 | Capillus272 | Capillus202 | -- |
| ClassificationName | Infrared Lamp | Infrared Lamp | SE | ||
| 510(k) Number | K171835 | K163170 | K160285 | K153618 | -- |
| Product Code | OAP | OAP | SE | ||
| Intended Use /Indications forUse | The Irradiation AestheticDevice (Model: HairPro) isindicated to promote hairgrowth in females withandrogenetic alopecia whohave Ludwig-SavinClassifications of I - II andmales with androgenetic | TheCapilluslaserdomes 82,202, 272Pro, 272OfficePro,302, 312, | TheCapillus272Pro,Capillus272OfficePro,Capillus82andCapillus202 | TheCapillus202is indicatedto promotehair growthin femaleswithAndrogenet | SE |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | ||
| alopecia who haveNorwood-HamiltonClassifications of IIa - V andfor both, FitzpatrickClassification of SkinPhototypes I to IV. | 352, areintended totreatAndrogenetic Alopeciaandpromotehair growthin maleswho haveNorwoodHamiltonClassifications of Ila toV patternsof hair lossand to treatAndrogenetic Alopeciaandpromotehair growthin femaleswho haveLudwig(Savin)Scale I-1 tol-4, II-1, II-2, or frontal;both withFitzpatrickSkin Typesl to IV. | areintended totreat thepromotehair growthin femaleswithAndrogenetic Alopeciawho haveLudwig(Savin)Scale I-II,and inmales withandrogenicalopeciawho haveNorwoodHamiltonClassifications lia-V;and bothgendershavingFitzpatrickClassifications of SkinPrototypes Ito IV.ic Alopeciawho haveLudwig-SavinClassifications of I-II,and withFitzpatrickSkin Typesl to IV. | |||
| Waveform | Visible red laser | Visible red laser | SE | ||
| Wavelength | 650nm±5nm | 650nm | SE | ||
| Amounts of LaserLamp | 81 | Capillus272 Pro: 272Capillus202: 202Capillus82: 82 | SENote 1 | ||
| Energy of perLaser Lamp | 5mW ±10% | <5mW | SENote 1 | ||
| Classificationaccording toIEC60825-1 | Class 3R | Class 3R | SE | ||
| Treatment Time | Each Treatment: 30 minTotal Treatment: 3 times per | Each Treatment: 30 minTotal Treatment: every other day, for 17 | SENote 1 |
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Sponsor: Subject Device:
Chongqing Peninsula Medical Technology Co., Ltd Irradiation Aesthetic Device, Model: HairPro File No.: 510(k) submission report (V1.0), Chapter 23
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Sponsor: Chongqing Peninsula Medical Technology Co., Ltd Subject Device: Irradiation Aesthetic Device, Model: HairPro File No.: 510(k) submission report (V1.0), Chapter 23
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| week | weeks. | ||
| Treatment Area | 202.3 cm²Mathematically Max. derived | Capillus272: 495.37 cm²Capillus202: 449.51 cm²Capillus82: 194.42 cm²Mathematically Max. derived | SENote 1 |
| Irradiance (powerper area) | 2.2022 mW/cm²Mathematically Max. derived | Capillus272: 2.7454 mW/cm²Capillus202: 2.2469 mW/cm²Capillus82: 2.1088 mW/cm²Mathematically Max. derived | SENote 1 |
| Fluence | 3.9639 J/cm²Mathematically Max. derived | Capillus272: 4.9417 J/cm²Capillus202: 4.044 J/cm²Capillus82: 3.7920 J/cm²Mathematically Max. derived | SENote 1 |
| Dimension | 199mm179mm88mm (L xW x H) | -- | SENote 2 |
| Life Expectancy | 5 years | -- | SE |
| Weight | 1000g | -- | SE |
| Environment forOperation | Temperature: 5°C~30°CHumidity: ≤ 80%Atmosphere range: 700hPa-1060hPa | -- | SENote 2 |
| Environment forStorage | Temperature: 0°C~50°CHumidity: ≤ 85%Atmosphere range: 50kPa-110kPa | -- | SENote 2 |
| Safety Feature | Complied with IEC 60601-1and IEC 60601-1-2 | Complied with IEC 60601-1 and IEC60601-1-2 | SE |
| BiocompatibilityFeature | All patient contactingmaterials are complied withISO 10993-5, ISO 10993-10 | All patient contacting materials arecomplied with ISO 10993-5, ISO 10993-10 | SE |
Comparison in Detail(s):
Note 1:
Although "Amounts of Laser Lamp", "Treatment Area", "Irradiance (power per area)" and "Fluence" of the subject device are different from the predicate devices, however, the energy and power parameters' range of subject device can be covered by predicate device's several models' range; they are very similar. So these parameters' differences will not raise any safety or effectiveness issue.
Note 2:
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Sponsor: Chongqing Peninsula Medical Technology Co., Ltd Subject Device: Irradiation Aesthetic Device, Model: HairPro File No.: 510(k) submission report (V1.0), Chapter 23
"Dimension", "Weight", "Environment for Operation" and "Environment for Storage" of subject device are different from the predicate device, it will not affect the main function and the intended use of the device as they all also comply with IEC 60601-1 requirements. Besides, the subtle changes of the physical characteristics will not affect the critical functions or the normal use.
8. Conclusion
The subject device Irradiation Aesthetic Device (Model: HairPro) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.
9. Summary Prepared Date 26 January 2018
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.