To provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Description

The devices have a control unit that can be programmed utilized for the patient parameters. In addition, they are equipped with manual interface, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. During operation the devices have an applicator instrument attached to the main unit.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the Hilthera 4.0 Therapeutical Laser System. It seeks to establish substantial equivalence to a predicate device, the El En HILT Family Laser (K051537).

Based on the provided document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics for the Hilthera 4.0 Therapeutical Laser System in comparison to detailed criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through non-clinical testing focused on safety and functional specifications, rather than clinical efficacy against defined acceptance thresholds for a specific medical outcome.

The closest comparison of "performance" is in the Comparison of Technological Characteristics (Table 5A), which compares specifications:

Characteristic	Acceptance Criteria (from Predicate Device - El En HILT Family Laser, K051537)	Reported Device Performance (Hilthera 4.0)
Intended Use	To provide topical heating for temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation, and/or promoting relaxation of muscle.	Same
Energy Source	ND:YAG laser	ND:YAG laser
Laser mode	Pulsed(PW)	Pulsed(PW)
Wave length	1064nm	1064nm
Power Source	230 VAC, 15A, 50/60 Hz	230 VAC, 50/60 Hz
Maximum Power	10W	10W
Fluence	0.15~0.45 J/cm²	0.15~1.2 J/cm²
Pulse width	60-150µs	100-150µs
Repetition rate	10-40 Hz	10-30 Hz
Spot size	Ø 5mm (0.2 cm²)	Ø 5mm (0.2 cm²)
Delivery System	Contact and Non-contact hand pieces via 600µm diameter fiber optic cable	Contact hand pieces via 1000µm diameter fiber optic cable
Aiming Beam	Diode 655nm (Red) 1mW	Diode 655nm (Red) 1mW
Weight	40 kG	80 kG
Dimensions	30 cm x 70 cm x 78 cm	40 cm x 92.1 cm x 128.2 cm

Note on Acceptance Criteria: For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering, electrical, and performance testing, rather than direct clinical outcome comparisons with predefined thresholds for efficacy in a novel clinical trial.

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

Test Set Sample Size: Not applicable in the context of clinical patient data. The non-clinical performance data involved testing of the device hardware and software. The document refers to "test plans" for software and "all testing" for electrical and safety, implying comprehensive unit and integration testing.
Data Provenance: The testing was carried out by the manufacturer, Jeisys Medical, Inc. The document does not specify the country of origin for the non-clinical testing data beyond the manufacturer's location (Seoul, Korea). The testing is retrospective in the sense that it evaluates the manufactured device against pre-established specifications and standards.

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

Not applicable for this type of submission. The ground truth for the non-clinical tests (hardware, software, electrical safety, EMC) is adherence to engineering specifications, national/international standards, and FDA guidelines. This generally involves standard engineering verification and validation processes and compliance checks, not expert adjudication of medical images or diagnostic outcomes.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple experts where ground truth is subjective or requires consensus (e.g., radiology diagnoses). For this device, verification and validation testing against technical specifications serve as the "ground truth establishment."

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

Not applicable. This device is a laser system for therapeutic purposes (topical heating), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is a physical therapeutic device, not an algorithm. Its performance is inherent in its hardware, software, and physical properties.

7. The type of ground truth used

The ground truth used for the non-clinical performance data (hardware and software testing, electrical safety, EMC) was engineering specifications, established software design specifications, Device Hazard analysis, and national/international voluntary standards (e.g., for Electromagnetic Compatibility and Safety). The device performed as intended based on these specified acceptance criteria.

8. The sample size for the training set

Not applicable. This is a hardware therapeutic device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model in this submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 7, 2015

Jeisys Medical Incorporated % Ms. Priscilla Chung LK Consulting Group USA Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831

Re: K141861

Trade/Device Name: Hilthera 4.0 Therapeutical Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: July 3, 2014 Received: July 10, 2014

Dear Ms. Chung:

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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K141861

Device Name

Hilthera 4.0 Therapeutical Laser System

Indications for Use (Describe)

To provide topical heating for the purpose of elevating tissue temperary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

1. Submission Sponsor

Jeisys Medical, Inc. 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu, Seoul 153-775 Korea Phone: (82) 2.2603.6417 Fax: (82) 2.2603.6447 Contact: kyung won- Hwang, RA Manager

2. Submission Correspondent

Priscilla Chung LK Consulting Group USA Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 Email: juhee.c@lkconsultinggroup.com

3. Date Prepared

November 18th, 2014

4. Device Identification

Trade/Proprietary Name: Hilthera 4.0 Therapeutical Laser System Common/Usual Name: ND:YAG Laser Classification Regulation: 890.5500 ILY Product Code: Device Class: Class II Classification Panel: Infrared Lamp

5. Predicate Devices

El En SpA – El En HILT Family Laser, K051537

6. Device Description

- Device Specification

A complete device specification is included in attachment 11 and in the Operator's Manual located in attachment 13 of this submission.

- Labeling / instructions for use

Complete labeling is located in attachment 13

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- Use principles

Use principles are provided in the Device Description located in attachment 13

7. Intended Use

8. Comparison of Technological Characteristics

The Hilthera 4.0 device shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices. The Hilthera 4.0 device is similar in design and function to the predicate devices for the modes of operation and use.

9. Substantial Equivalence Discussion

The following table compares the Hilthera 4.0 device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	El En SpA	Jeisys Medical, Inc.
Trade Name	PredicateHILT Family Laser	New DeviceHilthera 4.0
510(k) Number	K051537	Not assigned
Intended Use	To provide topical heating forthe purpose of elevating tissuetemperature for temporary reliefof muscle & joint pain &stiffness, arthritis pain or musclespasm; the temporary increase inlocal blood circulation and/orpromoting relaxation of muscle.	To provide topical heating forthe purpose of elevating tissuetemperature for temporary reliefof muscle & joint pain &stiffness, arthritis pain or musclespasm; the temporary increasein local blood circulation and/orpromoting relaxation of muscle.
Energy Source	ND:YAG laser	ND:YAG laser
Laser mode	Pulsed(PW)	Pulsed(PW)

Table 5A - Comparison of Characteristics

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Manufacturer	El En SpA	Jeisys Medical, Inc.
Trade Name	PredicateHILT Family Laser	New DeviceHilthera 4.0
Wave length	1064nm	1064nm
Power Source	230 VAC, 15A, 50/60 Hz	230 VAC, 50/60 Hz
Power/EnergyRange	Maximum 10W	Maximum 10W
Fluence	0.15~0.45 J/cm2	0.15~1.2 J/cm2
Pulse width	60-150us	100-150us
Repetition rate	10-40 Hz	10-30 Hz
Spot size	Ø 5mm0.2 cm2	Ø 5mm0.2 cm2
Delivery System	Contact and Non-contact hand pieces connected to the system via a 600 um diameter fiber optic cable	Contact hand pieces connected to the system via a 1000 um diameter fiber optic cable
Aiming Beam	Diode 655nm (Red) 1mW	Diode 655nm (Red) 1mW
Weight	40 kG	80 kG
Dimensions	30 cm x 70 cm x 78 cm	40 cm x 92.1 cm x 128.2 cm

10. Non-Clinical Performance Data

The device's hardware and software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing result supports that all the hardware specifications and software specifications have met the acceptance criteria of each module and interaction of processes. The Hilthera 4.0 device passed all testing and supports the claims of substantial equivalence and safe operation.

The Hilthera 4.0 device complies with the applicable voluntary standards for Electromagnetic Compatibility and Safety. The device passed all the electrical and safety testing according to national and international standards.

11. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. The verification and validation testing of the device software and electrical safety and EMC testing of the device was found to acceptable and supports the claims of substantial equivalence.

12. Statement of Substantial Equivalence

It has been shown in this 510(k) submission that the difference between the Hilthera 4.0

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device and the predicate device do not raise any questions regarding its safety and effectiveness. The Hilthera 4.0 device, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

13. Conclusion

The Hilthera 4.0 device has similar intended use and technological characteristics as the predicate devices.

The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.

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.