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.

Device Description

AI/ML Overview

The provided 510(k) summary for the ComboCare 2000 does not describe a study that establishes acceptance criteria through clinical evidence or performance metrics like accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and conformance to voluntary design standards.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The submission is for a device based on "non-heating lamps for adjunctive use in pain therapy" and TENS technology, which typically relies on established safety and performance profiles of equivalent predicate devices rather than novel performance criteria requiring a new clinical study with specific acceptance metrics.

The document discusses "design requirements" and "conformance with voluntary design standards" instead of measurable performance acceptance criteria for diagnostic or treatment effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable/Not provided. No clinical or performance test set (in terms of patient data) is mentioned.
Data Provenance: Not applicable/Not provided. The submission explicitly states: "Xanacare did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Non-clinical testing for safety and design validation was performed.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Number of Experts: Not applicable/Not provided. Since no clinical performance study was conducted on patient data, there was no need for experts to establish ground truth for a test set.

4. Adjudication Method

Adjudication Method: Not applicable/Not provided. No clinical performance study on patient data, hence no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. The document explicitly states: "Xanacare did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, no MRMC study, and no effect size for human readers with and without AI assistance (as this is not an AI device).

6. If a Standalone (Algorithm Only) Performance Study Was Done

Standalone Performance Study: No. This is not an algorithm-only device. The submission relies on substantial equivalence to predicate devices based on technological characteristics and safety standards.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable/Not provided in the context of clinical performance. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and safety features are equivalent to legally marketed predicate devices and conform to relevant electrical safety and medical device standards.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not provided. This is not an AI/machine learning device that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable/Not provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary indicates that the ComboCare 2000's acceptance for market clearance is not based on a clinical study demonstrating specific performance criteria (like accuracy or effectiveness compared to a ground truth) directly for its intended use.

Instead, the "study" that proves the device meets the criteria for market clearance (i.e., substantial equivalence) is:

Non-clinical testing: Performed to "validate the design against the company's specified design requirements."
Conformance to voluntary design standards: EN 60601-1 (General safety), EN 60601-1-2 (Electromagnetic compatibility), and EN 60601-2-10 (Nerve and muscle stimulators safety).
Risk Management Program: Application of ISO 14971 to eliminate or mitigate known health hazards.
Comparison of Technical Characteristics: A detailed comparison table (provided in the document) demonstrates that the ComboCare 2000's electrical power source, battery type, light characteristics (IR and Red LED), vibratory massage, and E-Stim/Micro-Current TENS parameters (max output current/voltage, pulse frequency/width, waveform) are either equivalent to or within the ranges of legally marketed predicate devices.

The FDA's decision to clear the device is based on this demonstration of substantial equivalence to existing predicate devices already on the market, rather than a de novo clinical trial proving efficacy or specific performance metrics. The underlying assumption is that if the new device is technologically similar and meets the same safety standards as cleared predicate devices, it is equally safe and effective for its stated indications for use.

Summary

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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

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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 Input100-240 VAC 50-60 Hz, 0.6A Output: 9 VDCat 2A	Equivalent to other predicate devices rated forinternational electrical use (i.e. 100-240 VAC50-60 Hz).
Battery Type	4 rechargeable Size AA NiMH batteries	Equivalent to other predicate devices that userechargeable batteries for portability.
Infrared Light	Pulsed infrared light emitting diodes (IRLED). 24 IR LEDs @ 870 nm (standard pad),48 IR LEDs @ 870 nm (large pad).	Equivalent to other predicate devices clearedas non-heating lamps for adjunctive use inpain therapy.
Red Light	Pulsed red light emitting diodes (RED LED).32 RED LEDs @ 640 nm (standard pad), 64RED LEDs @ 640 nm (large pad).	Equivalent to other predicate devices clearedas non-heating lamps for adjunctive use inpain therapy
Vibratory massage	Off + 3 levels	Equivalent to other predicate therapeuticelectrical massagers and vibrators.
	E-Stim TENS mode
Maximum Output Current	Maximum peak output current (1 KΩ load) =30 mA / Maximum peak output current (500 Ωload) = 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 Ωload) = 20 V	K021755: 40 V (500 Ω load)K061650: 0-60V (1K Ω load)
Pulse Frequency	72 pps/Hz nominal	K021755: 2-150 pps/HzK061650: 2-150 pps/Hz
Pulse Width	200 μs	K021755: 50-300 μsK061650: 0-400 μs
	Micro-Current TENS Mode
Maximum Output Current	Maximum peak output current (1 KΩ load) –9.3 mA / Maximum peak output current (500Ω 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 (500Ω 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 waveK061650: Asymmetrical biphasic square wave

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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

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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

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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

Regulation Number and Section

§ 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).