The Le'pen is a battery-powered cordless unit designed for curing VLC materials whose initiator systems are sensitive to light in the 385-480 nm wavelength range of the visible spectrum. The unit is based on violet and blue LED (light emitting diode) technology for light generation in the desired wavelength and Li-Ion rechargeable batteries.

The Le'pen includes:

A cordless rechargeable handpiece with a focusing light emitted from a multi LED package tip and controlled by built-in control electronics
A base unit that plugs into main power as the handpiece stand and charger
A cap at probe tip to block light scattering
Disposable disinfectant barrier sleeves on the tip probe
User manual

AI/ML Overview

The provided text is a 510(k) summary for the Le'pen dental curing light. It describes the device, its intended use, and arguments for its substantial equivalence to a predicate device (Ultradent Valo Cordless K110582).

However, the document does not contain the kind of detailed information about acceptance criteria, a study proving device performance against those criteria, or clinical study specifics (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) that would be expected for a medical device cleared based on AI/ML or complex diagnostic capabilities.

The Le'pen is a dental curing light, a physical device used to cure photo-activated dental materials. Its clearance relies on benchtop testing demonstrating equivalent performance specifications (like radiometric power, wavelength range, depth of cure, thermal generation) and safety (electrical safety, EMC, software validation) compared to a predicate device, rather than on a study with human readers or AI-driven performance metrics.

Therefore, many of the requested items (e.g., related to AI/ML performance, ground truth establishment for test/training sets, expert adjudication, MRMC studies, effect size of human reader improvement) are not applicable to the information provided in this 510(k) summary.

Here's how to interpret the available information relative to your request:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format as you might see for an AI-based diagnostic. Instead, it describes various non-clinical tests conducted and confirms that the Le'pen's performance is either "similar to or greater" than the predicate device or meets relevant standards.

Test Performed	Acceptance Criterion (Implicit)	Reported Device Performance
Radiometric Power Testing	Similar to or greater radiometric power compared to the predicate device, Valo Cordless, supporting similar functionality.	"Testing concluded that the Le'pen provided similar to or greater radiometric power compared to the predicate device, Valo Cordless. These results, in conjunction with 'Depth of Cure' testing, supports a designation of substantial equivalence as similar functionality is provided by the Le'pen and Valo Cordless."
Spectral Irradiance Testing	Spectrum emitted matches intended specifications and is nearly identical to the predicate device for curing dental materials.	"Testing verified the spectrum emitted from the Le'pen matches the intended specifications. Comparing the spectrum results between the Le'pen and Valo Cordless supports a substantial equivalent designation as both curing lights emit nearly identical wavelength spectrums for curing dental materials."
LED Lifetime	Device longevity over a three-year period.	"Testing verified device longevity through simulating LED use over a three year period. This test supports product efficacy and longevity."
Depth of Cure	Satisfactory depth of cure for various dental composite resins and shades, in line with ISO 4049:2009.	"Testing was performed in-line with the ISO 4049:2009 standard... Results confirm that satisfactory depth of cure was achieved for several dental composite resins and shades. Results support device efficacy as well as substantial equivalence as compliance with the ISO 4049:2009 standard was observed." Also, for "soft start mode" differences: "...confirmed that the Le'pen provides satisfactory depth of cure results..."
Thermal Generation	Device does not reach unsafe temperatures during typical and worst-case use.	"Testing verified that the device does not reach unsafe temperatures during typical use and simulated worst-case scenarios. Results support device safety as well as substantial equivalence as the predicate device exhibits thermal safety during routine use."
Software Validation	Device software functions properly.	"Testing confirmed the device's software is functioning properly. This test supports product efficacy and safety."
Electrical Safety and EMC	Compliance with IEC 60601-1 and IEC 60601-1-2 standards.	"Testing confirmed that the device is safety [sic] and in compliance with relevant electrical safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2)."

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

Sample Size: Not explicitly stated as "sample size" in the context of a clinical study or data set. The document refers to "testing" on the device itself, materials, or simulated scenarios. For example, "several dental composite resins and shades" were used for Depth of Cure testing, but the exact number isn't quantified.
Data Provenance: The tests are benchtop, non-clinical tests performed on the physical device and related materials. No specific country of origin for test data is mentioned; it's likely from the manufacturer's testing facilities or contract labs. The tests are prospective in nature as they evaluate the specific Le'pen device.

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

This is not applicable. The ground truth for this device's performance is established by objective physical measurements and compliance with engineering standards (e.g., ISO 4049:2009 for depth of cure, IEC 60601-1 for electrical safety), not by expert consensus on medical images or diagnoses.

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

This is not applicable. No human adjudication or consensus process is mentioned for these non-clinical, objective benchtop tests.

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:

This is not applicable. No MRMC study was done as this is a dental curing light, not an AI-assisted diagnostic tool requiring human reader studies.

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

This is not applicable. There is no algorithm performance being evaluated in this context.

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

The "ground truth" for this device's performance is based on objective physical measurements (e.g., light output readings, temperature measurements, material cure depth, electrical parameters) and adherence to specified industry standards (e.g., ISO 4049:2009, IEC 60601-1).

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of an AI/ML model for this device. The device's design is based on established engineering principles for dental curing lights.

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

This is not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one. The device's functionality is proven through direct physical testing against established performance metrics and industry standards. The "existing literature on LED-based dental curing lights" also contributes to the understanding of safety and efficacy.

Summary

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

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

KMIHH Ltd Or Ramot 9 Hamovil Str., Kfar-Saba, 4442411 ISRAEL April 1, 2019

Re: K181597

Trade/Device Name: Le'Pen Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: January 16, 2019 Received: January 22, 2019

Dear Or Ramot:

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/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.

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

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

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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.04.01
14:01:11 -04'00'

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K181597

Device Name Le'pen

Indications for Use (Describe)

Source of illumination for curing photo-activated dental restorative materials and adhesives.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| 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."

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

Image /page/3/Picture/0 description: The image shows the logo for Kii.am. The "Kii." part of the logo is in a dark blue color, while the "am" part is in a teal color. A green leaf with a circuit board pattern is placed above the "a" in "am."

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92(a).

807.92(a)(1) Submitter Information KMIHH LTD (kii.am) 9 HaMovil Str., Kfar-Sava 4442411, Israel Contact Person: Or Ramot Telephone: +972-3-3030-163 Date of writing: 2017-11-02

Name & Classification 807.92(a)(2)

Trade name: Le'pen

Common Name: Dental Curing Light

Classification Name(s): Ultraviolet Activator for Polymerization - 872.6070

Classification Number: EBZ

807.92(a)(3) Predicate device

Ultradent Valo Cordless K110582 Common Name: Dental Curing Light Classification Name(s): Ultraviolet Activator for Polymerization - 872.6070 Classification Number: EBZ

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

Image /page/4/Picture/0 description: The image shows the logo for Kii.am. The "Kii" is in a dark blue color, and the ".am" is in green and teal. There is a green leaf above the "a" in ".am".

807.92(a)(4) Device Description

The Le'pen includes:

A cordless rechargeable handpiece with a focusing light emitted from a multi LED package tip and controlled by built-in control electronics
A base unit that plugs into main power as the handpiece stand and charger
A cap at probe tip to block light scattering
Disposable disinfectant barrier sleeves on the tip probe
User manual

807.92(a)(5) Intended Use(s)

Aka Indication For Use

Source of illumination for curing photo-activated dental restorative materials and adhesives.

Technological Characteristics and Substantial Equivalence 807.92(a)(6)

The Le'pen is substantially equivalent to K110582 in intended use, operation, wavelength range, and light source.

We believe the similarity of the Le'pen to the legally marketed predicate devices and the performance data provided support the claim for equivalence of the Le'pen to the Valo Cordless.

	Predicate Device	Le'pen
	Valo Cordless (Ultradent)	(KMIHH LTD)
510(k) Number	K110582	K181597 (pending)
Common Name	Activator, ultraviolet forpolymerization	Activator, ultraviolet forpolymerization
Product Code	EBZ	EBZ
CFR	872.6070	872.6070
Indications for Use	Source of illumination forcuring photo-activated dentalrestorative materials andadhesives.	Source of illumination forcuring photo-activated dentalrestorative materials andadhesives.
Where Used	Dental offices	Dental offices
Target Population	Health care professionals	Health care professionals
Anatomical Site	Oral cavity	Oral cavity

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

Image /page/5/Picture/0 description: The image shows the logo for Kii.am. The "Kii." part of the logo is in a dark blue color, while the "am" part is in green and teal. There is a green leaf above the "a" in "am."

Light source	4 broad blue LEDs forphotoinitiated curing ofdental materials	4 broad blue LEDs forphotoinitiated curing of dentalmaterials4 white light LEDs forgeneral illumination
Wavelength Range[nm]	385-490	385-490
Power [watts/cm²]	1200	1200
Cooling System	Convection cooled	Convection cooled
Materials	Aluminum body, glass lens	Aluminum body, glass lens
Battery Type	Lithium orLithium-Ferrite-Polymer	Lithium-Manganese
Sterility	Non-sterile	Non-sterile
Weight	150g	150g
Rotating Tip	No	No
Built in Meter	No	No
Replaceable Bulb orTip	No	No
Multiple CuringModes / Durations	Yes	Yes

Similarities between the Le'pen and Valo Cordless:

The Le'pen has identical indications for use as the predicate device, the Valo Cordless.
. The Le pen has the same mode of action as the predicate device, the Valo Cordless (i.e. photo-polymerization of monomers and oligomers to polymers via activation of photoinitiators).
. The Le'pen has equivalent performance characteristics as the predicate device (Valo Cordless) as both products use the same light source (LED).
The Le'pen has equivalent performance characteristics as the predicate device (Valo Cordless) as both products provide the user with various curing durations / settings.
The Le'pen and the Valo provide a nearly equivalent wavelength spectrum range.
. The Le'pen is substantially equivalent to the predicate device (Valo Cordless) as both devices shown compliance with IEC 60601-1 and ADA 48 (i.e. ISO 10650-1).
The Le'pen and the Valo Cordless are both equivalent in their design; both medical devices are Li-ion battery operated cordless devices with an aluminum body construction.
The Le'pen and the Valo Cordless have identical mass.

Difference between the Le'pen and Valo Cordless:

. The Le'pen uses an LED package containing 8 LEDs, while the predicate device (Valo Cordless) utilizes an LED package containing 4 LEDs.
- This does not raise any substantial equivalence concerns as the total energy emitted

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

is very similar between the devices, as shown during benchtop testing. Additionally, benchtop testing confirmed adequate depth of cure, radiometric power, and spectral distribution of the subject device and confirmed substantial equivalence to the predicate device.

Therefore, the Le'pen remains substantially equivalent to the Valo Cordless. O
The Le'pen contains a white light mode, whereas the Valo Cordless does not.
- This does not raise any substantial equivalence concerns as the white light is O classified as a class I medical device (CRF 872.4630, dental operating light).
- o It should be noted that other 510(k) cleared dental curing lights contain a white light mode: K152936 - Sirius Max Diode Curing Light and K170101 - Valiant Curing Light. These device are mentioned for reference purpose only.
- O Therefore, the Le'pen remains substantially equivalent to the Valo Cordless.
The Le'pen contains a Violet mode, whereas the Valo Cordless does not.
- o Many photopolymerizable dental materials contain lower wavelength photoinitiators (between 385nm and 410nm). Therefore, this violet mode is simply another curing mode and does not introduce any additional safety or efficacy concerns and does not make the subject device not substantially equivalent.
- O Therefore, the Le'pen remains substantially equivalent to the Valo Cordless.
. Slight variations in "radiometric power" and "light duration" exist between the Le ben and Valo Cordless.
- о Functionality testing (e.g. Depth of Cure testing) confirmed that the Le'pen provides satisfactory depth of cure results for various dental composite resins. Therefore, any slight differences in "radiometric power" and "light duration" do not yield any efficacy or safety concern as the Le'pen cures composite effectively. Therefore, the Le'pen remains substantially equivalent to the Valo Cordless.
The Le'pen has a "soft start mode", whereas the Valo Cordless does not.
- O Functionality testing (e.g. Depth of Cure testing) confirmed that the Le'pen provides satisfactory depth of cure results for various dental composite resins on all Le'pen settings. Therefore, the "soft start mode" does not yield any efficacy or safety concern as the Le'pen cures composite effectively. Therefore, the Le'pen remains substantially equivalent to the Valo Cordless.
- It should be noted that other 510(k) cleared dental curing lights contain a "soft start" o or "ramp" mode: K152936 - Sirius Max Diode Curing Light and K170101 - Valiant Curing Light. These device are mentioned for reference purpose only.

The Le'pen and Valo Cordless share similar intended uses, technical characteristics, specifications, and features. Kiiam concludes that the Le'pen is substantially equivalent to the Valo Cordless, and that any of the discussed differences between the two devices do not raise any additional safety or efficacy concerns that would necessitate further testing.

807.92(b)(1-3) Brief Discussion of the Nonclinical & Clinical Testing

The following nonclinical tests were performed to evaluate device safety and efficacy as well as offer

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Kii.am. The "Kii." part of the logo is in a dark blue color, while the "am" part is in a light green color. There is a leaf above the "a" in "am".

a comparison to the predicate device.

1. Radiometric Power Testing
- a. Testing concluded that the Le'pen provided similar to or greater radiometric power compared to the predicate device, Valo Cordless. These results, in conjunction with "Depth of Cure" testing, supports a designation of substantial equivalence as similar functionality is provided by the Le'pen and Valo Cordless.
1. Spectral Irradiance Testing
- a. Testing verified the spectrum emitted from the Le'pen matches the intended specifications. Comparing the spectrum results between the Le'pen and Valo Cordless supports a substantial equivalent designation as both curing lights emit nearly identical wavelength spectrums for curing dental materials.
1. LED Lifetime
- a. Testing verified device longevity through simulating LED use over a three year period. This test supports product efficacy and longevity.
1. Depth of Cure
- a. Testing was performed in-line with the ISO 4049:2009 standard which is commensurate with depth of cure testing described in the FDA Curing Light Guidance. Results confirm that satisfactory depth of cure was achieved for several dental composite resins and shades. Results support device efficacy as well as substantial equivalence as compliance with the ISO 4049:2009 standard was observed.
1. Thermal Generation
- a. Testing verified that the device does not reach unsafe temperatures during typical use and simulated worst-case scenarios. Results support device safety as well as substantial equivalence as the predicate device exhibits thermal safety during routine use.
1. Software Validation
- a. Testing confirmed the device's software is functioning properly. This test supports product efficacy and safety.
1. Electrical Safety and Electromagnetic Compatibility
- a. Testing confirmed that the device is safety and in compliance with relevant electrical safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2).

Based on the longstanding history of dental curing lights, significant published literature confirming safety and efficacy of LED-based dental curing lights, and satisfactory benchtop testing, Kiiam concludes that clinical testing is not deemed necessary.

Conclusion

The Le'pen is substantially equivalent to the Valo Cordless (K110582) in intended use and operation; both medical devices use LEDs as the source of light for curing dental materials. Benchtop testing, and existing literature on LED-based dental curing lights, supports substantial equivalence of the

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Kii.am. The "Kii." part of the logo is in a dark blue color, while the "am" part of the logo is in a light green color. There is a leaf above the "a" in "am".

KMIHH LTD ● 9 Hamovil Str., Kfar-Saba 4442411, Israel ● † +972-3-3030168 ● info@kii.am

Le'pen to the Valo Cordless.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.