HILTHERA 4.0

K141861 · Jeisys Medical, Inc. · ILY · Jan 7, 2015 · Physical Medicine

Device Facts

• Record ID: K141861
• Device Name: HILTHERA 4.0
• Applicant: Jeisys Medical, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Jan 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Hilthera 4.0 is an ND:YAG laser system providing topical heating for pain relief and muscle relaxation. Device consists of a main control unit with a display and a contact handpiece connected via a 1000 um fiber optic cable. Operator programs therapy parameters via the control unit interface; system delivers pulsed 1064nm laser energy to target tissue. Aiming beam (655nm diode) assists in positioning. Used in clinical settings by trained operators. Output is thermal energy; clinical benefit is temporary relief of musculoskeletal pain and stiffness through increased local circulation and muscle relaxation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, and electrical safety and electromagnetic compatibility (EMC) testing.

Technological Characteristics

ND:YAG laser system; 1064nm wavelength; pulsed mode (100-150us pulse width, 10-30 Hz repetition rate); 10W max power; 0.15-1.2 J/cm2 fluence; 5mm spot size; 1000 um fiber optic delivery; 655nm diode aiming beam. Power: 230 VAC, 50/60 Hz. Dimensions: 40cm x 92.1cm x 128.2cm; Weight: 80kg. Complies with electrical safety and EMC standards.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of muscle and joint pain, stiffness, arthritis pain, muscle spasm, increased local blood circulation, and muscle relaxation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• El En HILT Family Laser (K051537)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing. The logo is black and white.

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

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

# 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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

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

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}------------------------------------------------

# 510(k) Summary

# 1. Submission Sponsor

Jeisys Medical, Inc. 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu, Seoul 153-775 Korea Phone: [phone] Fax: [phone] 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: [e-mail]

#### 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

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

#### - Use principles

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

## 7. Intended Use

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.

#### 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.

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.

## 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 | Predicate<br>HILT Family Laser | New Device<br>Hilthera 4.0 |
| 510(k) Number | K051537 | Not assigned |
| Intended Use | To provide topical heating for<br>the purpose of elevating tissue<br>temperature for temporary relief<br>of muscle & joint pain &<br>stiffness, arthritis pain or muscle<br>spasm; the temporary increase in<br>local blood circulation and/or<br>promoting relaxation of muscle. | To provide topical heating for<br>the purpose of elevating tissue<br>temperature for temporary relief<br>of muscle & joint pain &<br>stiffness, arthritis pain or muscle<br>spasm; the temporary increase<br>in local blood circulation and/or<br>promoting relaxation of muscle. |
| Energy Source | ND:YAG laser | ND:YAG laser |
| Laser mode | Pulsed(PW) | Pulsed(PW) |

Table 5A - Comparison of Characteristics

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

| Manufacturer | El En SpA | Jeisys Medical, Inc. |
|-----------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Trade Name | Predicate<br>HILT Family Laser | New Device<br>Hilthera 4.0 |
| Wave length | 1064nm | 1064nm |
| Power Source | 230 VAC, 15A, 50/60 Hz | 230 VAC, 50/60 Hz |
| Power/Energy<br>Range | 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 5mm<br>0.2 cm2 | Ø 5mm<br>0.2 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

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

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.