The Robin's Egg is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-I to I-4, II-I, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Device Description

The Telebrands' Robin's Egg is a non-invasive, helmet-style photobiomodulation device indicated to treat androgenetic alopecia in both men and women. It is operated using a single button at the front of the helmet to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. The Robin's Egg is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board containing 126 LEDs, as compared to 119 within the predicate device REVIAN RED. The Robin's Egg is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled by means of a single button and illuminated control display at the front of the helmet. Emitting red light energy within the 625 - 660 nm at 2.376 mW/cm² for a treatment time of 10 minutes, the Robin's Egg provides a well-established photobiomodulation effect upon the scalp to stimulate hair growth.

AI/ML Overview

This document is not a study that proves the device (Robin's Egg) meets acceptance criteria for efficacy. Instead, it is a 510(k) Premarket Notification from the FDA, confirming that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (REVIAN RED K173729) for its stated indications for use.

Crucially, no clinical trial data for the Robin's Egg was submitted for this 510(k). The clearance is based on the substantial equivalence of the device's technical characteristics and non-clinical performance to the predicate device. Therefore, a direct study proving the Robin's Egg meets specific efficacy acceptance criteria, as one might find in a clinical trial report, is not present here.

Given the information provided, I cannot fill out the requested table for "acceptance criteria and the reported device performance" as it pertains to efficacy, nor can I provide details on sample sizes, expert ground truth establishment, or MRMC studies for this specific device's efficacy. The regulatory review focused on equivalence, not a new demonstration of efficacy.

However, I can extract information regarding the basis for regulatory clearance and what non-clinical testing was performed:

Summary of Information from the 510(k) Document:

1. Table of (Non-Clinical) Acceptance Criteria and Reported Device Performance:

Since no clinical efficacy data for the Robin's Egg was submitted, the "acceptance criteria" here refer to non-clinical performance and substantial equivalence to the predicate.

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Electrical Safety: Conformance to IEC 60601-1 (Edition 3.2 2020-08) and ANSI/AAMI 60601-1-11:2015.	Performance testing confirmed conformance.
Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2:2014.	Performance testing confirmed conformance.
Photobiological Safety: Conformance to IEC 60601-2-57 (Edition 1.0) and IEC 62471 (Edition 1.0).	Performance testing confirmed conformance.
Biocompatibility: Conformance to ISO 10993-1:2018 (cytotoxicity, skin irritation, skin sensitization).	Biocompatibility testing of the Cap confirmed no effects related to cytotoxicity, skin irritation, or skin sensitization for the applied parts.
Software: (Implicitly, software validation and verification)	Testing performed. (Specific details not provided beyond "software performance testing").
Human Factors/Usability: Conformance to ANSI/AAMI/IEC 62366-1:2015 and 60601-1-6 (Edition 3.2 2020-07).	Human factors evaluation was performed following current versions of the standards. The process involved observational user research, formative, and summative user testing to evaluate representative users under expected conditions during simulated and actual use. (Results implicitly indicate compliance as it was cleared).
Equivalence of Spectral & Irradiance Parameters: Robin's Egg parameters equivalent to predicate device.	The device emits red light energy within 625 - 660 nm at 2.376 mW/cm² for a 10-minute daily treatment. The device has 126 LEDs compared to 119 in the predicate. The wavelength range (625-660 nm) is very similar to the predicate (620-660 nm). Performance verification and validation testing demonstrated that the Robin's Egg's spectral and irradiance parameters are equivalent to the predicate device.
User Needs & Design Inputs: Device meets these requirements for intended use.	Performance verification and validation testing demonstrate that the Robin's Egg meets user needs and design inputs and met requirements for its intended use. (Implicitly passed, as clearance was granted).

2. Sample Size Used for the Test Set and Data Provenance:

For clinical efficacy: No test set (clinical data) was used or submitted for the Robin's Egg as part of this 510(k). The clearance is based on substantial equivalence to a predicate device, not on new clinical efficacy data for the Robin's Egg itself.
For non-clinical testing (Electrical, EMC, Biocompatibility, etc.): The sample sizes for these engineering and lab tests are not specified in the document. The data provenance would be internal laboratory testing conducted by or for Telebrands Corporation. The FDA letter is dated September 17, 2024, and the submission was received on August 16, 2024.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

For clinical efficacy: Not applicable, as no clinical efficacy test set for the Robin's Egg was submitted.
For non-clinical testing: The document does not specify the number or qualifications of experts involved in establishing "ground truth" for the non-clinical tests (e.g., electrical safety, EMC). These tests typically rely on standardized methods and equipment calibration rather than expert consensus on a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical efficacy test set for the Robin's Egg was submitted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done or submitted for the Robin's Egg. This type of study is typically used to demonstrate the impact of AI algorithms on human reader performance, which is not relevant for this device's type of regulatory submission (substantial equivalence for a physical light therapy device).

6. Standalone (Algorithm Only) Performance Study:

No, this is not applicable. The Robin's Egg is a physical light therapy device, not an AI algorithm.

7. Type of Ground Truth Used:

For clinical efficacy: Not applicable, as no clinical efficacy data for the Robin's Egg was submitted.
For non-clinical testing: The "ground truth" was based on adherence to recognized national and international standards (e.g., IEC, ANSI/AAMI, ISO) for electrical safety, electromagnetic compatibility, biocompatibility, photobiological safety, and human factors. This is a technical ground truth based on compliance with established engineering and safety testing protocols.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 17, 2024

Telebrands Corporation Shepard Bentley Regulatory Affairs Consultant One Telebrands Plaza Fairfield. New Jersey 07004

Re: K240689

Trade/Device Name: Robin's Egg Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: August 16, 2024 Received: August 16, 2024

Dear Shepard Bentley:

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.

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"

{1}------------------------------------------------

(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 (QS) 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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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 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).

{2}------------------------------------------------

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-devices/deviceadvice-comprehensive-regulatory-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,

Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.09.17
15:39:24 -04'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K240689

Device Name Robin's Egg

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 201 Subpart D)
	Over-The-Counter Use (21 CFR 201 Subpart C)

|_ | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image is the logo for TeleBrands. The word "TELE" is in white letters inside of a red box with rounded corners. The word "Brands" is in blue letters and is partially behind the red box.

Image /page/4/Picture/1 description: The image contains two distinct elements: a logo and a text phrase. The logo features a yellow silhouette of a head with a lightbulb above it, set against a black background, with the word "BulbHead" written below. To the right of the logo, the text "Robin's Egg" is displayed in a bold, serif typeface, creating a contrast with the logo's modern design.

510(k) Summary # K240689

This summary of 510(k) safety and effectiveness information in being submitted in accordance with the requirements of SMDA and 21 CFR §890.5500.

1.1 Submitter Information:

Sponsor:	Telebrands CorporationOne Telebrands Plaza,Fairfield, NJ 07004
Contact Person:	Shepard G. Bentley, RACRegulatory Affairs ConsultantPhone: (949) 374 – 9187Email: sbentley@bentleybiomed.com
Preparation Date:	16 September 2024

1.2 Subject Device Information

Trade/Proprietary Name:	Robin's Egg
Regulations Name:	Infrared Lamp per 21 CFR §890.5500
Product Code:	OAP (laser, comb, hair)
Regulation Number:	21 CFR §890.5500
Regulatory Class:	Class 2

1.3 Predicate Device Information

Predicate Device: REVIAN RED K173729 PhotonMD, Inc.

1.4 Device Description

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for TeleBrands. The word "TELE" is in white letters inside a red rectangle with rounded corners. The word "Brands" is in blue letters and is partially overlapping the red rectangle. There is a registered trademark symbol in the lower right corner of the word "Brands".

Image /page/5/Picture/1 description: The image shows the logo for Robin's Egg. The logo includes a yellow image of a head with a lightbulb on top, and the word "BulbHead" written below. To the right of the logo, the words "Robin's Egg" are written in a large, bold font.

and is controlled by means of a single button and illuminated control display at the front of the helmet. Emitting red light energy within the 625 - 660 nm at 2.376 mW/cm² for a treatment time of 10 minutes, the Robin's Egg provides a well-established photobiomodulation effect upon the scalp to stimulate hair growth.

1.5 Indications for Use

The Robin's Egg device is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

1.6 Performance Test Summary

No clinical trial data for the Robin's Egg was submitted for this 510(k). Non-clinical performance testing to demonstrate substantial equivalence to the predicate device included evaluation to current versions of IEC 60601-1 (Edition 3.2 2020-08) and 60601-1-2:2014 to confirm the device's electrical safety and electromagnetic compatibility, and conformance with ANSI/AAMI 60601-1-11:2015, IEC 60601-2-57 (Edition 1.0), and IEC 62471 (Edition 1.0). Biocompatibility testing of the Cap per ISO 10993-1:2018 confirmed no effects of the applied parts with particular attention to cytotoxicity, skin irritation or skin sensitization.

In addition, performance verification and validation testing demonstrate that the Robin's Egg meets user needs and design inputs and met requirements for its intended use and spectral and irradiance parameters of the subject are equivalent to the similar parameters of the predicate device.

Studies Related to Human Factors Evaluation

Human factors evaluation of the Robin's Egg was performed following the current versions of ANSI/AAMI/IEC 62366-1:2015 and 60601-1-6 (Edition 3.2 2020-07) standards. The study protocol was designed to evaluate representative users of the device under expected conditions during simulated and actual use of the device. The Human Factors Engineering and Usability Engineering process involved several methodologies, including observational user research, formative and summative user testing.

1.7 Comparison to Predicate Device

Robin's Egg has similar technological characteristics as the REVIAN RED (K173729). including wavelength, light energy delivery method, timers and intended use.

		Table 1 - Summary of Predicate Device Comparison

10. Summer and many and the comments of the comments of the country of the country of the country of the county of the country of the county of the county of the county of th	Comments of the county of the first of the may of the may be any
510/12ران جي القرار الملوب المنتدى المنتدى المنتدى المنتدى المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل	K240689	TT 1 HO HOO111/ JIL

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for TeleBrands. The logo is split into two parts, with the first part being the word "TELE" in white letters on a red background. The second part of the logo is the word "Brands" in blue letters.

Image /page/6/Picture/1 description: The image shows the words "Robin's Egg" next to the BulbHead logo. The BulbHead logo is a yellow head with a lightbulb on top of it. The words "Robin's Egg" are in a bold, serif font.

Device	Robin's Egg	REVIAN RED
Company	Telebrands Corp.	PhotonMD, Inc.
Product Code	OAP	OAP
Rx/OTC	OTC	OTC
Intended Use/Indicationsfor Use	The Robin's Egg device isindicated to treatAndrogenetic Alopecia andto Promote Hair Growth inmales who have Norwood-Hamilton Classifications ofIIa - V patterns of hair lossand to treat AndrogeneticAlopecia and Promote HairGrowth in females whohave Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontalpatterns of hair loss; bothwith Fitzpatrick Skin TypesI-IV.	The Robin's Egg device isindicated to treatAndrogenetic Alopecia andto Promote Hair Growth inmales who have Norwood-Hamilton Classifications ofIIa - V patterns of hair lossand to treat AndrogeneticAlopecia and Promote HairGrowth in females whohave Ludwig-Savin ScaleI-1 to I-4, II -1, II-2 orfrontal patterns of hair loss;both with Fitzpatrick SkinTypes I - IV.
Wearable Mounting			Textile Cap	Textile Cap
Wavelengths			625 - 660 nm	620 - 660 nm
Visible Light source			126 Red LEDs	119 Red LEDs
Battery			Lithium Polymer	Lithium Polymer
Treatment Time			Every day 10 minutes	Every day 10 minutes
Restrictions of DailyIrradiance			Yes, daily limit fortreatments	Yes, daily limit fortreatments

1.8 Conclusion

This notification contains all information required by 21 CFR 807.87. Performance testing including electrical, electromagnetic compatibility, biocompatibility, software, and human factors demonstrates Robin's Egg meets the requirements for its intended use and does not raise any new types of safety or effectiveness questions when compared to the predicate device.

End 510(k) Summary

Regulation Number and Section

§ 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.