The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Device Description

The TerraQuant MQ2000 is a non-invasive pain therapy system, which utilizes heating lamps consisting of laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.

The TerraQuant MQ2000 system consists of a desktop control unit, a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The laser and light therapy releases radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.

AI/ML Overview

The provided text is a 510(k) Summary for the TerraQuant MQ2000 Laser Therapy Device, seeking substantial equivalence to a predicate device. It describes the device's intended use and technological characteristics but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, and ground truth based on the provided text.

The document indicates that the basis of approval was a "Predicate Device (PD)", implying substantial equivalence was established by comparing its technological characteristics and intended use to an already legally marketed device, not through new clinical trials or performance studies with specific acceptance criteria that would generate the kind of data requested.

Summary based on the provided text:

Acceptance Criteria and Reported Device Performance: Not provided in the document. The clearance is based on substantial equivalence to a predicate device, not on specific performance metrics or acceptance criteria from a study.
Sample size for the test set and data provenance: Not applicable. No test set or performance study data is described.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No ground truth was established for a test set described in this document.
Adjudication method for the test set: Not applicable. No test set is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document does not describe any MRMC study.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser therapy system, not an algorithm.
The type of ground truth used: Not applicable. No ground truth data is mentioned for this 510(k) submission.
The sample size for the training set: Not applicable. No training set is mentioned as this is a physical device, not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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JUL 2 5 2005 510(k) Summary for TerraQuant MQ2000 Laser Therapy Device

1. SPONSOR

Escada International, Inc. 27100 Richmond Road Solon, Ohio 44139

Contact Person: Max Kanarsky Telephone: 440-542 0762

Date Prepared: March 10, 2005

2. DEVICE NAME

Proprietary Name: TerraQuant MQ2000 Laser Therapy Device Common/Usual Name: heating lamp Classification Name: Infrared lamp

3. PREDICATE DEVICES

Quantum WARP 10 Light Delivery System -- K032229

4. DEVICE DESCRIPTION

. :

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KO4/3055

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5. INTENDED USE

The TerraQuant MQ2000 Laser Therapy Device is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 in indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The TerraQuant MQ2000 device and the predicate device are substantially equivalent in intended use in that they are both heating lamps intended for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated. The proposed device and predicate devices are intended to provide relief to various areas of the body depending on the site of pain.

The proposed TerraQuant MQ2000 Laser Therapy System and the predicate devices are also substantially equivalent in technological characteristics in that they all consist of hand-held, heating infrared lamps that deliver low level laser to various anatomic areas.

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Name of Manufacturer: Escada International, Inc. Laser Model Name and Number: Terraquant MQ2000

Laser Type: (Circle all that apply)

Alexandrite. Argon, CO2, Copper-Vapor, Diode, Dye, Nd:YAG, Erbium, Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other

Indications in this application:

The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The TerraQuant MQ2000 is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

FDA Document Control Number: K043055

FDA Product Code: 79GEX

Reviewer Computer Initials: CYH

Date of Clearance Letter: 07/18/05

Basis of Approval: (Circle all that apply)

Predicate Device (PD), Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other

Description of Laser: Operation Modes: (Circle all that apply) CW, Pulsed, Q-Switched, Mode Locked, Contact, Free Beam, Other

Wavelength in Nanometers: 900, 860-960, 600-700

Power/Energy Range (Watts/Joules): 60-90 mW

Pulse Width:

Repitition Rate:

Delivery System: hand held emitter Comments:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2005

Escada International, Inc. c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. . . 49 Plain Street North Attleboro, Massachusetts 02760

Re: K043055

Trade/Device Name: TerraQuant MQ2000 Laser Therapy Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 5, 2005 Received: July 6, 2005

Dear Ms. McNamara-Cullinane:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2- Mary McNamara-Cullinane, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and by John finding of substantial equivalence of your device to a legally predicated predicate device results in 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 contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

E.A.
Miriam C. Provost, Ph.D.

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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Indications for Use

KO43055

510(k) Number (if known):

Device Name: TerraQuant MQ2000 Laser Therapy Device

.. .

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eula A

Jon Sign-Off) vision of General, Restorative rd Neurological Devices

March 10, 2005

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.