(104 days)
The CLARIMEDIX device is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 blood circulation where applied.
The system is a self-contained unit with four treatment areas.
- . Popliteal treatment zone
- Calf treatment zone .
- Foot treatment zone .
- . Heel treatment zone
The provided 510(k) summary for the CLARIMEDIX Model 2200 System does not contain the information requested to describe acceptance criteria and a study proving the device meets those criteria.
This document is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices, rather than demonstrating clinical efficacy through performance studies against pre-defined acceptance criteria. The summary focuses on comparing the new device's intended use and technological characteristics to existing devices to show it is "substantially equivalent."
Therefore, I cannot populate the table or provide answers to the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present within the provided text.
The closest relevant information is contained in the "Comparison with Predicate Devices" section:
- Intended Use: The device is indicated for use for the treatment of chronic pain by emitting energy in the IR spectrum 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 applied.
- Technological Characteristics: Key characteristics like temperature at the skin surface (Less than 95° F), energy source (Multidiodes), and safety features (Remains cool to touch) are listed for the subject device.
However, these are descriptive characteristics and intended uses, not quantified acceptance criteria with reported performance from a study designed to validate those criteria.
In summary, the provided document does not include the requested information about acceptance criteria and a study that proves the device meets those criteria.
{0}------------------------------------------------
:
510(k) Summary Prepared August 5, 2006
| Submitted by: | CLARIMEDIX, Inc.1035 Pearl Street, Suite 400Boulder, Colorado 80302 | ||
|---|---|---|---|
| Contact Person: | John DunningPresidentTelephone:FAX:e-mail: | (303) 905 6163(303) 625 1030jdunning@clarimedix.com | DEC 1 9 2006 |
| Product Name: | Model 2200 System | ||
| Common Name: | Infrared lamp | ||
| Classification: | ILY; Class II; CFR 21 890.5500 |
Predicate Devices:
| Device Name | Manufacturer | K Number |
|---|---|---|
| Warp 10 | Quantum Devices | K032229 |
| Spectropad(a.k.a.RestorativeProducts, Inc.) | SMI (A.k.a. AnodyneTherapy System) | K931261 |
{1}------------------------------------------------
Description of Device:
The device is indicated for use for the treatment of chronic pain by emitting energy in the IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffiess; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied
The system is a self-contained unit with four treatment areas.
- . Popliteal treatment zone
- Calf treatment zone .
- Foot treatment zone .
- . Heel treatment zone
Intended Use:
The device is indicated for use for the treatment of chronic pain by emitting energy in the IR spectrum 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 applied
Comparison with Predicate Devices:
The submission device and the predicate devices have substantially equivalent intended use and technological specifications as shown in the tables below. The device is compliant with the standards for electrical safety and EMC, IEC 60601-1 IEC 60601-1-2 respectively.
{2}------------------------------------------------
| Predicate Devices | Subject Device | ||
|---|---|---|---|
| Quantum Warp 10K032229 | SMI SpectropadK931261(a.k.a. Anodyne TherapySystem) | CLARIMEDIX Model 2200 | |
| FDAclassification | 21 CFR 890.5500 InfraredLamp (ILY)a) Identification. An infraredlamp is a device intended formedical purposes that emitsenergy at infrared frequencies(approximately 700 nanometersto 50,000 nanometers) toprovide topical heatingb) classification Class II | 21 CFR 890.5500 InfraredLamp (ILY)a) Identification. An infraredlamp is a device intended formedical purposes that emitsenergy at infrared frequencies(approximately 700nanometers to 50,000nanometers) to provide topicalheatingb) classification Class II | 21 CFR 890.5500 InfraredLamp (ILY)a) The CLARIMEDIX deviceis indicated for use to emitenergy in the infraredspectrum to provide topicalheating for the purpose ofelevating tissue temperature;for the temporary relief ofminor muscle and joint pain,arthritis and muscle spasm;relieving stiffness; promotingrelaxation of muscle tissue;and to temporarily increaseblood circulation whereapplied.b) classification Class II |
| Intended Use | Indicated for use for thetreatment of chronic pain byemitting energy in the Near-IRspectrum for the temporaryrelief of minor muscle and jointpain, arthritis and musclespasm; relieving stiffness;promoting relaxation of muscletissue; and to temporarilyincrease local blood circulationwhere applied | Intended for relief of minormuscle and joint pain andimprovement of superficialcirculation 1 | indicated for use for thetreatment of chronic pain byemitting energy in the IRspectrum for the temporaryrelief of minor muscle andjoint pain, arthritis and musclespasm; relieving stiffness;promoting relaxation of muscletissue; and to temporarilyincrease local blood circulationwhere applied |
| IntendedUsers | Physical medicine health careprofessionals | Physical medicine health careprofessionals | Physical medicine health careprofessionals |
| Intended Siteof Use | Medical health care facilities | Medical health care facilities | Medical health care facilities |
Table 1 Comparison of Indications for Use
{3}------------------------------------------------
| Predicate Devices | Predicate Devices | Subject Device | |
|---|---|---|---|
| Quantum Warp 10K032229 | SMI SpectropadK931261(a.k.a. Anodyne TherapySystem) | CLARIMEDIX Model 2200 | |
| Method ofadministration | Topical | Topical | Topical |
| Treatment areas | 10cm2 | Leg, foot, arm, neck | Lower leg, foot, adjustablelocation |
| Number ofzones | Not specified in productlabeling | 4-8 therapy pads | Four zones |
| Temperature atthe skin surface | Not specified in labeling | Not specified in labeling | Less than 95° F |
| Energy source | Multidiodes dispersed overtreatment zones | 60 Infrared diodes per array | Multidiodes |
| Waveform | Constant | Not specified in labeling | Modulating |
| Power supply | 8 each 1.5 AA batteriesprovides 50 doses | Not specified in labeling | 24V |
| Safety features | Remains cool to the touch | Not specified in labeling | Remains cool to touch |
| Biocompatibility | Not specified in labeling | Not specified in labeling; | Biocompatible draperecommended |
| Configuration | Handheld | 4-8 pads applied | 4 zones applied |
| Length andwidth | 5.55in x 2.65 in | Not specified in labeling | 25.1 in. x 10.0 in. |
| Portable | Yes | Yes | Yes |
| Electrical safety | Not specified in labeling | Not specified in labeling | Compliant with IEC 60601-1 |
| Firmwarecontrol | Yes | Yes | Yes |
·
:
Table 2 Comparison of Technological Characteristics
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CLARIMEDEX, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25TH Street, Northwest Buffalo, Minnesota 55313
DEC 1 9 2006
Re: K062635
Trade/Device Name: Model 2200 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 6, 2006 Received: December 7, 2006
Dear Mr. Job:
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.
{5}------------------------------------------------
Page 2 - Mr. Mark Job
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For Pablo
Mark N. Melkerson
DEP D.R.SECTOR
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
510(k) Number (if known):
Device Name: Model 2200
Indications For Use:
The CLARIMEDIX device is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 blood circulation where applied.
X Prescription Use (Per 21CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Of CDRH, Office Of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
(K) Number 2062635
§ 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.