(129 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not indicate the use of AI/ML.
Yes
The device is intended for the temporary relief of pain and promotes relaxation, which are therapeutic effects.
No
The indications for use describe the device as providing temporary relief or management of pain and promoting relaxation, which are therapeutic functions, not diagnostic.
No
The device description and performance studies mention conformance with standards related to "Medical electrical equipment" and "nerve and muscle stimulators," which strongly suggests the device includes hardware components for electrical stimulation or light therapy, not just software.
Based on the provided information, the ComboCare 2000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as being used for the temporary relief of pain and promoting muscle relaxation. This is a therapeutic use, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reiterates the therapeutic uses.
- Lack of IVD-related information: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
The ComboCare 2000 appears to be a physical therapy or pain management device that applies some form of energy (likely electrical stimulation or light therapy based on the predicate devices) to the body.
N/A
Intended Use / Indications for Use
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
Product codes
GZJ, NHN, ISA
Device Description
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
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
Not Found
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
Nonclinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standards:
- EN 60601-1 "Medical electrical equipment Part 1: General requirements for safety". .
- EN 60601-1-2 "Medical electrical equipment -- Part 1-2: General requirements for safety Collateral ● Standard"
- EN 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve . and muscle stimulators"
Key Metrics
Not Found
Predicate Device(s)
K071445, K021755, K061650, K041530, K041565, K050668
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
510(k) Number: _ _ K081141
Date: _
Page: 1 of 3
510(k) Summary
Introduction
This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Applicant
Xanacare Technologies LLC 9185 East Kenyon Ave., Ste. 270 Denver, CO 80237 USA Tel: 720-554-9262 / Fax: 720-554-9264
510(k) Correspondent
Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors, Inc. 13605 West 7th Ave., Golden, CO 80401 USA Tel: 303-463-0900 / Fax: 303-558-3833
Date Prepared
August 19, 2008
Trade Name of Device
ComboCare 2000
Common Name of Device
Lamp, non-heating, for adjunctive use in pain therapy
Classification Name
Infrared Lamp
510(k) Classification
Class II
Device Description and Intended Use
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
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| 510(k) Number: | K081141 |
|---|---|
| Date: | |
| Page: 2 of 3 |
Predicate Devices
The ComboCare 2000 does not differ significantly from predicate devices in its technological characteristics, except that it combines modalities using Red LED light, infrared LED light, therapeutic vibratory massage and E-Stim or Micro-current TENS into a single package. Modalities are similarly combined in the TerraQuant device, except that the TerraQuant uses higher power laser IR diodes and does not include a vibrator. The ComboCare 2000 has technological characteristics similar to the following predicate device(s):
- K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS .
- K021755 Apex Medical Corp., Apex TS1211 .
- K061650 EMPI, EMPI Select TENS ●
- K041530 Excalibur Light Therapy System .
- . K041565 Lazr Pulsr 4x
- K050668 GRT LITE Model 8-A Light Therapy System .
Summary of Technological Characteristics Compared to Predicate Devices
| ComboCare 2000 | Predicate Device | |
|---|---|---|
| Electrical Power Source | Class II Wall-Mount Battery Charger Input | |
| 100-240 VAC 50-60 Hz, 0.6A Output: 9 VDC | ||
| at 2A | Equivalent to other predicate devices rated for | |
| international electrical use (i.e. 100-240 VAC | ||
| 50-60 Hz). | ||
| Battery Type | 4 rechargeable Size AA NiMH batteries | Equivalent to other predicate devices that use |
| rechargeable batteries for portability. | ||
| Infrared Light | Pulsed infrared light emitting diodes (IR | |
| LED). 24 IR LEDs @ 870 nm (standard pad), | ||
| 48 IR LEDs @ 870 nm (large pad). | Equivalent to other predicate devices cleared | |
| as non-heating lamps for adjunctive use in | ||
| pain therapy. | ||
| Red Light | Pulsed red light emitting diodes (RED LED). | |
| 32 RED LEDs @ 640 nm (standard pad), 64 | ||
| RED LEDs @ 640 nm (large pad). | Equivalent to other predicate devices cleared | |
| as non-heating lamps for adjunctive use in | ||
| pain therapy | ||
| Vibratory massage | Off + 3 levels | Equivalent to other predicate therapeutic |
| electrical massagers and vibrators. | ||
| E-Stim TENS mode | ||
| Maximum Output Current | Maximum peak output current (1 KΩ load) = | |
| 30 mA / Maximum peak output current (500 Ω | ||
| load) = 40 mA | K021755: 0-80 mA (500 Ω load) | |
| K061650: 0-60 mA, adjustable (500 Ω load) | ||
| Maximum Output Voltage | Maximum peak output voltage (1 KΩ load) = | |
| 30 V / Maximum peak output voltage (500 Ω | ||
| load) = 20 V | K021755: 40 V (500 Ω load) | |
| K061650: 0-60V (1K Ω load) | ||
| Pulse Frequency | 72 pps/Hz nominal | K021755: 2-150 pps/Hz |
| K061650: 2-150 pps/Hz | ||
| Pulse Width | 200 μs | K021755: 50-300 μs |
| K061650: 0-400 μs | ||
| Micro-Current TENS Mode | ||
| Maximum Output Current | Maximum peak output current (1 KΩ load) – | |
| 9.3 mA / Maximum peak output current (500 | ||
| Ω load) = 14.4 mA | K021755: 0-80 mA (500 Ω load) | |
| K061650: 0-60 mA, adjustable (500 Ω load | ||
| Maximum Output Voltage | Maximum peak output voltage (1 KΩ load) = | |
| 9.3v V / Maximum peak output voltage (500 | ||
| Ω load) = 7.2 V | K021755: 40 V (500 Ω load) | |
| K061650: 0-60V (1K Ω load) | ||
| Waveform | 8 Hz Asymmetrical biphasic square wave | K021755: Asymmetrical biphasic square wave |
| K061650: Asymmetrical biphasic square wave |
2
| 510(k) Number: | K081141 |
|---|---|
| Date: | |
| Page: 3 of 3 |
Clinical & Non-Clinical Testing
Xanacare did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standards:
- EN 60601-1 "Medical electrical equipment Part 1: General requirements for safety". .
- EN 60601-1-2 "Medical electrical equipment -- Part 1-2: General requirements for safety Collateral ● Standard"
- EN 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve . and muscle stimulators"
Risk Management
This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program according to standard ISO 14971.
Substantial Equivalence
Based on the above Xanacare Technologies LLC believes that the ComboCare 2000 is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate device(s).
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2008
Xanacare Technologies, LLC. % Medical Device Regulatory Advisors, Inc. Mr. Robert N. Clark President and Senior Consultant 13605 West 7th Avenue Golden, Colorado 80401
Re: K081141
Trade/Device Name: ComboCare 2000 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: Class II Product Code: GZJ, NHN, ISA Dated: August 19, 2008 Received: August 21, 2008
Dear Mr. Clark:
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
4
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Mark M. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K081141 ComboCare 2000 Device Name: _ Indications for Use: The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain. Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) .............................................................................................................................................................................. waluation (ODE) Concurrence of CDRH, Office of Device E (Division Sign-C Division and Neur 510(k) Number
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ComboCare 2000 K081141/S002 Page 8 of 29