The Kiierr Family of Devices, the 272 and 148 Laser Devices are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.

Device Description

The Kiierr Family of Devices, the 272 and 148 Lasers each contain the listed number of diodes lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The Kiierr Family of Devices, the 272 and 148 Lasers are powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical.

AI/ML Overview

The provided document is a 510(k) summary for the Kiierr Family of Devices, Model 272 Premier & Model 148 Pro Laser Hair Growth Caps. It details the device's substantial equivalence to predicate devices rather than proving its performance through a new clinical study. Therefore, an "acceptance criteria" table as typically seen for AI/ML device performance studies, and information related to MRMC studies, standalone performance, training sets, and ground truth establishment cannot be fully provided as this information is not present in the given text.

The document focuses on demonstrating that the Kiierr devices are identical to already cleared predicate devices and, as such, do not require new clinical performance data. However, it does include an "Over-The-Counter Testing Program" which serves as a form of human factors or usability study, rather than a clinical efficacy trial.

Here's a breakdown of the information that can be extracted or deduced from the provided text, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance:

The document does not present acceptance criteria or reported performance for the efficacy of promoting hair growth for the Kiierr devices themselves, because it relies on the predicate devices' established performance. The only "performance data" mentioned is for an Over-The-Counter (OTC) Testing Program related to usability and comprehension, not clinical effectiveness.

Over-The-Counter (OTC) Testing Program Acceptance Criteria and Reported Performance:

Acceptance Criteria (for usability/comprehension)	Reported Device Performance (Compliance with Criteria)
80% success rate (32 out of 40 subjects) correctly answer all 26 questions related to:	Overall 90% pass rate for the subject group of 40 male and female participants. The testing demonstrated that "age, education, socioeconomic group, race or medical hair loss status are not variants that prevent proper self-selection, usability and comprehension of hazards and maintenance procedures for the average consumer to successfully navigate the purchasing and use process." The sponsor concludes the devices met requirements for OTC sale.
- Correct Self-Selection (making the correct decision to purchase the product or not based on intended use and manual).
- Correct assembly and use of the product.
- Comprehension of hazards and maintenance procedures for the device.
Note: This OTC testing focuses on user comprehension and safe usage for an over-the-counter device, not on the clinical effectiveness of hair growth itself. The clinical effectiveness is deferred to the predicate device.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: 40 subjects for the Over-The-Counter Testing Program.
Data Provenance: The document does not specify the country of origin for the data for the OTC testing. It also doesn't explicitly state whether it was retrospective or prospective, but the description of "asking twenty-six questions, after being provided a standard retail package and a full owner's manual" strongly suggests a prospective usability study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the traditional sense for clinical ground truth. The "ground truth" for the OTC testing was based on the correctness of answers to 26 questions related to understanding the product packaging, manual, and safe/correct use. The document doesn't mention external experts to establish this "ground truth" beyond the implicit judgment of the device manufacturer or the study design in determining the correct answers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

None specified. The "interviewer then conducted the interview and filled in the responses from the subjects." The assessment appears to be a direct comparison of subject responses against predetermined correct answers (P for PASS, F for FAIL). No multi-reviewer adjudication process is described for evaluating subject responses.

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 MRMC comparative effectiveness study was done. This document is for a laser hair growth device, not an AI/ML-driven diagnostic or imaging analysis tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, not an AI algorithm. Its direct "performance" is based on the physical properties of the laser and its equivalence to predicate devices, not on a standalone AI algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the OTC testing: The "ground truth" was the pre-defined correct answers to questions assessing user comprehension of labeling, instructions for use, hazards, and maintenance. It's akin to a knowledge check or usability assessment standard, rather than medical ground truth from patient outcomes, pathology, or expert consensus on clinical findings.
For the device's clinical efficacy: The document explicitly states: "No clinical performance data was produced for this submission because the Kiierr Family of Devices...are the same devices as the predicate... All proposed devices and predicate devices are IDENTICAL". Therefore, the "ground truth" for clinical efficacy of hair growth relies on the established performance and clearance of the predicate devices, not on new data for the Kiierr devices.

8. The sample size for the training set:

Not applicable. There is no AI/ML model for which a training set would be used for this submission.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set was used.

Summary

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September 5, 2018

Kiierr International, LLC % Raymond Blanche Consultant NST Consultants, Inc 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928

Re: K181878

Trade/Device Name: Kiierr Family of Devices, Model 272 Premier & Model 148 Pro Laser Hair Growth Caps Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: May 9, 2018 Received: July 13, 2018

Dear Raymond Blanche:

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/cfpmr/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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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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 Stevenso 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) K181878

Device Name

Kiierr Family of Devices, 272 and 148 Laser

Indications for Use (Describe)

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

August 15, 2018 Revised

Kiierr International, LLC

Submitter's Contact Information

Name:	Raymond R. Blanche
Address	NST Consultants, Inc.641 Shunpike Road, Suite 311Chatham, NJ 07928
Telephone:	(973) 539-7444
Facsimile:	(973) 539-7445

Name of Device and Name/Address of Sponsor

Trade Name:	Kiierr Family of Devices, the 272 and 148 Laser
Sponsor ContactInformation:	Michael AndersonKiierr International, LLC863 East Downington AvenueSalt Lake City, Utah 84105-3211Telephone: 435-840-8199
Common or Usual Name:	Lamp, non-heating, for promotion of hair growth
Classification Name:	Infrared lamp per 21 CFR 890.5500
Classification Code:	OAP (Laser, comb, hair)

Predicate Devices:

Device Trade Name	Manufacturer
Diode Laser Cap K173678	Cosmo Far East Technology Limited

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Reference Devices:

None

Date Prepared: May 9, 2018

Intended Use / Indications for Use

The Kiierr Family of Devices, the 272 and 148 Lasers are indicated to promote hair growth in females who have Ludwig-Savin Classifications of I – II males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V, and for both, Fitzpatrick Skin Phototypes I to IV.

Technological Characteristics

Performance Data:

No clinical performance data was produced for this submission because the Kiierr Family of Devices, the 272 and 148 Lasers are the same devices as the predicate, the Diode Laser, cleared under K173678. All proposed devices and predicate devices are IDENTICAL and the same devices offered for PRIVATE LABEL by the manufacturer. They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime. It is essential to understand that this class of device is manufactured by many different manufacturers, all using the same parts supplied by the same OEM suppliers. Hence, there are virtually no differences between the devices.

Substantial Equivalence

Both the Kiierr Family of Devices, the 272 and 148 Lasers and the Diode laser 272 use red light diode lasers, classified as class IIIa/3R laser systems by the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same. The sponsor believes that there is no difference in the physical appearance or in the method of delivering the radiant energy of the systems and therefore, there are no variations in the therapeutic value or safety profile.

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For these reasons, the Kiierr Family of Devices, the 272 and 148 Lasers overwhelmingly satisfies the FDA's substantial equivalence with respect to intended use, technological and design characteristics.

The Kiierr Family of Devices, the 272 and 148 Lasers are prospective devices that will be manufactured by the ISO 13485 compliant contract manufacturer, on the same platform as the Diode Laser, predicate devices. There are no safety concerns raised by this process of manufacturing because the model 272 and 148 are the same devices the predicate manufacturer sells under its proprietary label and name.

Treatment Protocol

The Kiierr Family of Devices, the 272 and 148 Lasers and the identified predicates, possess the same treatment regime of 30 minutes, every other day, on non-consecutive days, for the initial treatment regime of 16 weeks.

The following Comparison Chart in support of substantial equivalence is provided:

The Kiierr Family of Devices, the 272 and 148 Lasers		Diode Laser 272	Diode Laser 148
LLLT Device Type	Laser diode	Laser Diode	Laser Diode
Use Application	OTC	OTC	OTC
Intended Use - Androgenetic Alopecia	Yes	Yes	Yes
Contain Laser Diodes-Class 3R,	Yes 272 & 148	Yes 272	Yes 148
Optical Output – 5mW or less	Yes	Yes	Yes
Helmet Design	Yes	Yes	Yes
650+/-5 nm.	Yes	Yes	Yes
Marketing Clearance -Females & Males, OTC	Yes	Yes	Yes
Passive Use-Hands Free	Yes	Yes	Yes
OAP Classification	Yes	Yes	Yes
Classification Name -Infrared Lamp	Yes	Yes	Yes
Common Usage Name - Lamp, Non-Heating	Yes	Yes	Yes
General & Plastic Surgery Committee	Yes	Yes	Yes
Skin Phototypes - I- IV	Yes	Yes	Yes
Hamilton-Norwood IIa-V Hair Loss Classification	Yes	Yes	Yes
Ludwig-Savin I – II Hair Loss Classification	Yes	Yes	Yes
Treatment- 16 weeks, for 30 minute treatment times three times a weekon alternate days.	Yes	Yes	Yes
Device Class II	Yes	Yes	Yes

The data presented in the Comparison Chart, demonstrates that all Kiierr models 272 and 148 devices are identical and equivalent, PRIVATE LABEL devices from the same manufacturer. The Models 272 and 148 will be manufactured on the same platform by the same manufacturer as the 272 and 148 Diode Lasers, by Cosmo Far East Technology, Ltd.

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Based on this comparison and determination, the sponsor requests the FDA to clear the device via the 510(k) notice.

Over – The – Counter Testing Program

To test volunteer subjects for the suitability of the The Kierr Family of Devices, the 272 and 148 Lasers 40 subjects were asked twenty-six questions, after being provided a standard retail package and a full owner's manual. The test subjects were given as long as they required to read and understand the product packaging and manual. No assistance was provided to them and they were not permitted to ask any questions of the interviewer. The interviewer then conducted the interview and filled in the responses from the subjects. The subjects were required to answer all questions correctly to be counted as PASS for the correct Self Selection or, to have made the correct decision to purchase the product or not; to assemble and use the product correctly and comprehend the hazards and maintenance procedures for the device. These decisions would be based upon their understanding of the Intended Use of the product and the manual.

If the questions were answered correctly, they were given a P for PASS. If any questions were answered incorrectly, they were given an F for FAIL. The number of subjects required to answer all questions correctly is 32 out of 40, for an 80% success rate.

The results of the Over-the-Counter testing demonstrate that the Kiierr Family of Devices, the 272 and 148 Lasers comply with the requirements the FDA determined to be applicable. The test revealed an overall 90% pass rate for the subject group of 40 male and female participants. The testing further demonstrates that age, education, socioeconomic group, race or medical hair loss status are not variants that prevent proper self-selection, usability and comprehension of hazards and maintenance procedures for the average consumer to successfully navigate the purchasing and use process of the The Kijerr Family of Devices, the 272 and 148 Lasers.

Based on this data, the sponsor believes that the The Kiierr Family of Devices, the 272 and 148 Lasers, for female and male users have met the requirements for OTC sale.

Electrical Safety and Electromagnetic Compatibility Testing Performance

The The Kiierr Family of Devices, the 272 and 148 Lasers were evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:

1. IEC 60825-1 Edition 2.0 2007-03 Safety of Laser Products Part 1: Equipment Classification and Requirements.
1. IEC 60601-1-2 Edition 3.0 2007-03 Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Part 1: Requirements and Tests.

Conclusion

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Based on the technical comparisons between the The Kiierr Family of Devices, the 272 and 148 Lasers and the identified predicates it can be concluded that the Kiierr models are identical to the predicate devices in technical specifications. Since the Kiierr models are built using the identical platform with no difference between models, it can be concluded that all of the Kiierr models are equally safe. Therefore, it can be determined that the The Kiierr Family of Devices, the 272 and 148 Lasers are Substantially Equivalent to the identified predicates.

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.