(46 days)
No
The device description focuses on physical modifications (magnets, increased light strength) and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as providing "temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain," which are all therapeutic claims.
No
The device description and intended use indicate that the ComboCare 2000 is for therapeutic purposes (pain relief, muscle relaxation, increased blood circulation, etc.) rather than for diagnosing conditions. It focuses on treatment and management of symptoms, not on identifying or characterizing diseases.
No
The device description explicitly states the addition of permanent magnets and increased Infrared light strength to the flexible pads, indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the ComboCare 2000 is for the temporary relief of pain, muscle relaxation, and increased blood circulation. These are therapeutic applications, not diagnostic ones.
- Device Description: The device uses electrical stimulation, infrared light, and static magnets. These are physical modalities applied to the body, not used to examine specimens from the body.
- Lack of IVD Indicators: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
In summary, the ComboCare 2000 is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
Product codes
GZJ, ILY, ISA
Device Description
This device, modified from the ComboCare 2000 device previously cleared under 510(k) K081141, includes the addition of permanent magnets to the flexible pads to create a static magnetic field and increased Infrared light strength for therapeutic heating.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081141 Xanacare Technologies LLC ComboCare 2000, K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS
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).
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DEC 1 5 2008
ro8320元
Page 1 of 2
510(k) Number:
Page 1 of 2
Date: .
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
October 24, 2008
Trade Name of Device
ComboCare 2000
Classification Name
Transcutaneous electrical nerve stimulator for pain relief
510(k) Classification
Class II
Predicate Devices
The ComboCare 2000 has technological characteristics similar to the following predicate device(s):
- K081141 Xanacare Technologies LLC ComboCare 2000 .
- K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS .
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Date:
Page 2 of 2
Device Description and Intended Use
This device, modified from the ComboCare 2000 device previously cleared under 510(k) K081141, includes the addition of permanent magnets to the flexible pads to create a static magnetic field and increased Infrared light strength for therapeutic heating.
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of postsurgical or post-traumatic acute pain.
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).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2008
Xanacare Technologies, LLC. % Medical Device Regulatory Advisors, Inc Mr. Robert Clark 13605 West 7th Avenue Golden, Colorado 80401
Re: K083202
Trade Name: ComboCare 2000 Regulation Number: 21 CFR 882.5890 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, ILY, ISA Dated: November 21, 2008 Received: November 25, 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 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.
3
Page 2 -- Mr. Robert Clark
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 Biometric's (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 toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
083202
510(k) Number (if known):
Device Name:
ComboCare 2000
Indications for Use:
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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
510(k) Number K083202
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