(181 days)
Not Found
No
The summary describes a programmable control unit and manual interface, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is intended to provide topical heating for the temporary relief of muscle and joint pain, stiffness, arthritis pain, or muscle spasm, and to promote relaxation of muscle, which are therapeutic claims.
No
The "Intended Use" section describes the device as providing "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." This indicates a therapeutic, not a diagnostic, function.
No
The device description explicitly mentions a "control unit," "manual interface," "display," and "applicator instrument attached to the main unit," all of which are hardware components. The performance studies also discuss hardware verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide topical heating for therapeutic purposes (pain relief, increased circulation, muscle relaxation). This is a direct treatment applied to the body.
- Device Description: The description details a device with a control unit, manual interface, display, and an applicator instrument. This aligns with a physical therapy or medical device used for external application.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
A complete device specification is included in attachment 11 and in the Operator's Manual located in attachment 13 of this submission.
Complete labeling is located in attachment 13
Use principles are provided in the Device Description located in attachment 13
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 (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
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 | |
| HILT Family Laser | New Device | |
| Hilthera 4.0 | ||
| 510(k) Number | K051537 | Not assigned |
| Intended Use | To provide topical heating for | |
| the purpose of elevating tissue | ||
| temperature for temporary relief | ||
| of muscle & joint pain & | ||
| stiffness, arthritis pain or muscle | ||
| spasm; the temporary increase in | ||
| local blood circulation and/or | ||
| promoting relaxation of muscle. | To provide topical heating for | |
| the purpose of elevating tissue | ||
| temperature for temporary relief | ||
| of muscle & joint pain & | ||
| stiffness, arthritis pain or muscle | ||
| spasm; the temporary increase | ||
| in local blood circulation and/or | ||
| 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 | |
| HILT Family Laser | New Device | |
| Hilthera 4.0 | ||
| Wave length | 1064nm | 1064nm |
| Power Source | 230 VAC, 15A, 50/60 Hz | 230 VAC, 50/60 Hz |
| Power/Energy | ||
| 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 | |
| 0.2 cm2 | Ø 5mm | |
| 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.