MEDX HOME

K050022 · Medx Electronics, Inc. · ILY · May 5, 2005 · Physical Medicine

Device Facts

• Record ID: K050022
• Device Name: MEDX HOME
• Applicant: Medx Electronics, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: May 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedX HOME System Console System is an infrared lamp system, The Medx HOME System Console of Stations of Station of Call heating as per 21 CFR 890.5500. as per 21 CFR 090155001 Title temporary increase in local blood when neat is indicated "relief of minor muscle and joint aches, pains Circulation, temporary relier of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis".

Device Story

MedX HOME is an infrared lamp system consisting of a console and 1-2 MedX 601 SLD (superluminous diode) accessories. The device uses 633 nm and 870 nm diodes to generate 500 mW of therapeutic heat. The console features a membrane switch interface and LCD for user interaction. Clinicians use a programming key to set specific treatment parameters (time, pulsing 1-2000 Hz) for up to 5 pre-programmed treatments. Patients operate the device at home by plugging in the SLD accessory and selecting one of the pre-set treatments. The console automatically terminates treatment after the programmed duration. The device provides topical heating to increase local blood circulation and relieve minor muscle/joint pain, stiffness, and spasms. It is intended for use in home settings following clinician setup.

Clinical Evidence

No clinical research was conducted for this 510(k) submission. Evidence is based on bench testing of mechanical, electrical, controls, and thermal safety, as well as temperature control and irradiation distribution patterns. The device complies with UL 2601 standards.

Technological Characteristics

Infrared lamp system (21 CFR 890.5500). Emits 633 nm (visible red) and 870 nm (infrared) light via 49 SLDs (9 red, 40 IR). Radiant surface area: 19.4 cm². Power: 500 mW. Pulse frequency: 1-2000 Hz. Materials: ABS plastic enclosure, polycarbonate window. Connectivity: Standalone console with dual-purpose port for programming key or SLD accessories. Safety standards: UL 2601, ISO 9001, ISO 13485.

Indications for Use

Indicated for patients requiring topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains, and stiffness, relaxation of muscles, and relief of muscle spasms and minor pain/stiffness associated with arthritis.

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

• MedX 1000 Series Console & LED Accessories (K020017)

Submission Summary (Full Text)

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### DISCUSSION OF SAFETY AND EFFECTIVENESS 4.

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA A.

| Model No. /Names: | MedX HOME (Console and 1 - 2 SLD<br>Accessories - MedX 601) |
|-------------------|------------------------------------------------------------------------------------------------|
| Classification: | Lamp Infrared, Heating Category ILY<br>Physical Medicine Device, 21 CFR 890.5500<br>(Class II) |
| Predicate Device: | MedX 1000 Series Console & LED Accessories<br>(uses the MedX 600 LED Accessory) |

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

### Description of the Device

માટતાં:

MedX HOME console powers one to two SLD Accessories. It uses the MedX 600 accessory, called the MedX 601 SLD accessories for the HOME unit and a smaller console, based on the MedX 1100 Console.

The MedX HOME console powers one to two SLD accessories. The MedX HOME Console includes semiconductors and assembly, electronics, controls, liquid crystal display, front panel and labels. The front panel contains the membrane switch with command keys to enter data and select options.

The port on the right side of the console is dual purpose. First, with the use of a programming key, the clinician can access software to sets the specific treatment parameters for individual patients. Without this key plugged in the software is not visible.

MedX HOME 510 (k) Submission

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The second purpose of the port is for the patient to pluq in the SLD accessories. This only provides access to a limited area of the software, allowing the patient to select one of potentially 5 different treatment numbers associated with a pre-programmed treatment.

The left side of the console panel has the ON/OFF switch and the plug for the electrical outlet.

The liquid crystal display provides 4 lines of 15 characters each line for prompting, options, and selections.

The main label is located on the rear panel of the console.

The MedX HOME uses the MedX 600 SLD accessory, called the MedX 601 for this purpose, to generate therapeutic heating, to comply with the heating category, ILY requirements.

The SLD accessory use 633 nm and 870 nm superluminous diodes to produce the heat required for topical heating, resulting in the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis.

The SLD device generates 500 mW of power to produce therapeutic heat. The accessories are powered by the console and can be set to pulse from 1 – 2000 pulses per second. The console automatically turns itself off after the set treatment time has been delivered.

No national body has established safety or performance standards for infrared lamps in the US or Canada. The device is designed in accordance with UL 2601, and meets the requirements of this standard in Canada with field inspections completed by Entella on all equipment prior to shipping.

The products have been:

- Health Canada Medical Device Branch Therapeutic . Devices Directorate approved (Canada)
- . ISO 9001 and ISO 13485
- . QSR compliant

MedX HOME 510 (k) Submission

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### Technology Characteristics Summary

The technological characteristics are based on the predicate device -K020017.

MedX HOME has been tested in the areas of mechanical, electrical, controls, and thermal safety, environmental conditions and electromagnetic compatibility, temperature control and irradiation distribution patterns. The MedX HOME has been found to be safe in all of the above areas for the intended use referenced in this submission.

### Discussion of Non-Clinical and Clinical Data

Internal testing has demonstrated the ability of MedX HOME to warm the surface temperature to therapeutic heating. No clinical research was conducted for this specific 510(k) submission.

### Conclusions Demonstrating Safety, Effectiveness and Performance

The testing carried out for MedX HOME indicates that they meet design and performance functional requirements. Clinical practice and academic research demonstrate that therapeutic heating from an infrared lamp can be used successfully to provide topical heating for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles, for muscle spasms, minor pain and stiffness associated with arthritis. The proposed device meets the requirements of international and US medical electrical equipment standards for safety, and key performance and safety requirements.

MedX HOME 510 (k) Submission

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#### DEVICE SPECIFICATIONS B.

### The MedX HOME Console

The MedX HOME Console powers the SLD accessories that produce the therapeutic heating. The console supports the electronics, controls and labels. See Appendix 1(a) for the MedX HOME Main Board, 1 (b) the MedX HOME Daughter Board and 1 (c) the Block Diagram of the MedX HOME system.

The front panel contains the membrane switch with four buttons for Select/Start, menu, pause/clear and < and > keys. The liquid display window has 4 lines with 15 characters per line. The main label is located on the console rear panel. The ON/OFF switch is on the left side of the console with the electrical plug input. The right side of the console has a dual purpose port. When the clinician plugs in the set-up key, software is accessible to select specific treatment parameters, including treatment time and pulsing for up to 5 different treatments (A, B, C, D, and E) and number of days the unit will function prior to requiring re-setting by the clinician. When the SLD accessory is plugged into the port and the console is turned ON, only the pre-set treatments (A through E) appear on the LED display. (Figure 1 - MedX HOME Console Front View and SLD Accessories (Front and Back Views).

### The MedX HOME SLD Accessory

The MedX HOME powers and controls the MedX 601 SLD accessory, consisting of 9 - 633 nm visible red SLD and 40 - 870 nm infrared SLDs. The MedX HOME SLD accessory treatment area or radiant surface is 19.4 cm². The enclosure material is made of ABS plastic, with the radiant surface covered with a polycarbonate window. (Figure 1 - The MedX 601 Accessory Radiant Surface and Back Views are included.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2005

Ms. Anita Saltmarche RN, BScN, MHSc VP of Clinical and Scientific Affairs MedX Health, Incorporated 3350 Ridgeway Drive Unit 3 Mississauga Ontario, Canada L5L 5Z9

Re: K050022

Trade/Device Name: MedX Home Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: April 15, 2005 Received: April 20, 2005

Dear Ms.Saltmarche:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use cared in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de nees mat have been rocation of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diererere, mains of the Act include requirements for annual registration, listing of general obliavil profitering practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your devibe to such additional controls. Existing major regulations affecting your device n may of sayon to basis 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 i rease of advisod that i Dr renation that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I odetar statuate is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR 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.

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## Page 2 – Ms. Anita Saltmarche RN, BScN, MHSc

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and will be finding of substantial equivalence of your device to a legally premarket notification - 12 a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at rioliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Stupt Rurch

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510 (k) Number:

Device Names: MedX HOME

# INDICATION FOR USE

## Indication for Use

The MedX HOME System Console System is an infrared lamp system, The Medx HOME System Console of Stations of Station of Call heating as per 21 CFR 890.5500. as per 21 CFR 090155001 Title temporary increase in local blood when neat is indicated "relief of minor muscle and joint aches, pains Circulation, temporary relier of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis".

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × OR

Over-the-counter Use -(Optional Format 1-2-96)

(Division Sign-off)
Division of General Restorative Devices

510(k) Number:

Stypt Rhodes

(Division S Division of General, Restorative, and Neurological Devices

**510(k) Number** K050022

MedX HOME 510 (k) Submission

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