BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.

Device Description

The LumiWave 1X4 Infrared Therapy Device is an over-the-counter, infrared-therapy device, designed to emit energy at infrared frequencies to provide topical heating. The LumiWave 1X4 Infrared Therapy Device provides infrared therapy through the use of an efficient and easy to use set of 4 small pods that delivers infrared light for the purpose of elevating tissue temperature to treat living tissue in the body. Infrared light is delivered to the tissue through 49 Gallium Aluminum Arsenide (GaAlAs) Light Emitting Diodes (LEDs) (per pod) distributed under the each pod cover of the LumiWave 1X4 Infrared Therapy Device. The LEDs used in the LumiWave 1X4 Infrared Therapy Device have average wavelengths of between 880 nm and 893 nm depending on temperature.

AI/ML Overview

The provided text is a 510(k) summary for the LumiWave 1X4 Infrared Therapy Device, which is an infrared therapy device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as one would expect for a novel device undergoing a rigorous performance study.

Instead, this 510(k) summary is focused on demonstrating substantial equivalence to a previously cleared predicate device (BioCare System's PremIR 818, K042532). The performance data cited is primarily technical specifications of the device itself, rather than clinical performance data against specific acceptance criteria.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

The document does not specify general "acceptance criteria" for clinical performance. Instead, it details technical specifications and compares them to the predicate device to establish substantial equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (LumiWave 1X4)
Indications for Use	Equivalent to Predicate Device (PremIR 818)	Same as Predicate Device
Wavelength (Central)	Similar to Predicate Device	HIGH Mode: 900 nm; LOW Mode: 899 nm
Wavelength (Mean)	Similar to Predicate Device	HIGH Mode: 893 nm; LOW Mode: 890 nm
Wavelength (Min)	Similar to Predicate Device	HIGH Mode: 824 nm; LOW Mode: 822 nm
Wavelength (Max)	Similar to Predicate Device	HIGH Mode: 941 nm; LOW Mode: 934 nm
Delivered Energy	Similar to Predicate Device	12 – 56 mW/cm²
Thermal Control	Skin temperature regulation	Between 40-43°C (HIGH Mode) and 38-41°C (LOW Mode)
Electromagnetic Compatibility	Compliant with EN 60601-1-2	Complies with EN 60601-1-2
General Electrical Safety	Compliant with EN 60601-1	Complies with EN 60601-1

2. Sample size used for the test set and the data provenance

Sample size: Not applicable. No clinical test set data is provided in this 510(k) summary for performance evaluation against acceptance criteria. The document focuses on technical specifications.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set data is provided.

4. Adjudication method for the test set

Not applicable. No clinical test set data is provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an infrared therapy device, not an AI-based diagnostic tool. No MRMC study was conducted or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an infrared therapy device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical performance study is detailed with a "ground truth" for patient outcomes. The ground truth for this submission is substantial equivalence to the predicate device based on technical and safety specifications.

8. The sample size for the training set

Not applicable. The device is a physical infrared therapy device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K05/8/6

9. 510(k) Summary

510(k) SUMMARY BIOCARE SYSTEMS, INC - LumiWave 1X4 Infrared Therapy Device

SUBMITTER INFORMATION

Company name / address:	Regiera LLC518 17th StreetSuite 1350Denver, CO 80202
510(k) contact name / numbers:	Clay AnselmoPhone: 800-341-4255 or 303.223.4303Fax: 303-832-6700anselmoc@reglera.com
Date summary prepared:	6/9/05
DEVICE IDENTIFICATION
Trade names:	LumiWave 1X4 Infrared Therapy Device
Common name:	LumiWave 1X4 Infrared Therapy Device

Infrared Lamp Classification name:

MODIFIED FROM DEVICE:

Trade name: BioCare System's PremIR 818 510(k) number: K042532

DEVICE DESCRIPTION

INDICATIONS FOR USE

BioCare System's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended

{1}------------------------------------------------

to provide a temporary increase in local blood circulation and provide temporary relief of muscle
r and the started in the same in the deville attrains anrains or strains to provide a temporary increase in local blood ordailer and provided with arthritis, sprains or strains.
spasms and minor sub-acute or chronic pain associated with arthritis,

TECHNOLOGICAL CHARACTERISTICS COMPARISON

The following primary characteristics of the LumiWave 1X4 Infrared Therapy Device are THC following quivalent to the BioCare PremIR 818.

Indications for Use ●
Wavelength of the diode utilized .
Waveform .
Power supply and specifications .
Energy source .
Device type .
Delivered energy per unit area .

PERFORMANCE DATA

12 – 56 mW/cm² Delivered Energy:

	HIGH Mode	LOW Mode
Central Wavelength:	900 nm	899 nm
Mean Wavelength:	893 nm	890 nm
Minimum Wavelength:	824 nm	822 nm
Maximum Wavelength:	941 nm	934 nm

Note: maximum and minimum wavelengths were calculated using the area under the distribution which contains 99.7% of the population (+/- 3 sigma)

Complies with EN 60601-1-2, Electromagnetic Compatibility Complies with EN 60601-1, General Electrical Safety

The Thermal control circuit in each pod provide for regulation of skin temperatures to between 40 The Themial Control Circuit in Cach pour provide in Togalation of C in LOW Mode).

CONCLUSION

The LumiWave 1X4 Infrared Therapy Device is substantially equivalent to the device it was modified from, the PremIR 818.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Public Health Service

AUG 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioCare Systems, Inc. c/o Mr. Clay Anselmo Reglera LLC 518 17th Street, Suite 1350 Denver, Colorado 80202

Re: K051816

R051010
Trade/Device Name: LumiWave 1X4 Infrared Therapy Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 16, 2005 Received: August 17, 2005

Dear Mr. Anselmo:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your becaon 910(x) premier is substantially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the enclosure) to tegans annent date of the Medical Device Amendments, or to commerce proc to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require app o the general controls provisions of the Act. The Y ou may, merciole, market the device, ich include requirements for annual registration, listing of general controls provisions of the free 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 If your device is classified (soc aboro) xils. Existing major regulations affecting your device can may be subject to such additional controller L. Ribbing of Parts 800 to 898. In addition, FDA may oe found in the Oous neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc advised that I Dri s issualite of our device complies with other requirements of the Act that I Dri has made a acterimisations administered by other Federal agencies. You must of any recetal statures and regalations and and limited to: registration and listing (21 comply with an the Not 8 requirements) 01); good manufacturing practice requirements as set CFR in 1 or 7, adoling (21 OFR Part 820); and if applicable, the electronic ford in the quality bystello (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin nakemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of sybstantial end this permits vour premarket notification. The PDA Inding of substantial organity of the succession for your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rst led If you desire specific advice for your de vice of tour its . Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note contact the Office of Compliance at (240) 276 - 1 - 1 - (217) Part 807.97). You may obtain
"Misbranding by reference to premarket notification the Oxycision of Small "Misbranding by reference to premarks notified.com the Act from the Division of Small
other general information on your responsibilities under the Act first number (800) 638other general information on your responsionities and areas and areas and or (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-idemanain html Manufacturers, International and Consumer Heelswafdagov/cdrh/dsma/dsmamain.html

Sincerely yours,

Signature

Mark N. Melkerson S 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: LumiWave 1X4 Infrared Therapy Device_____________________________________________________________________________________________________________________________

Indications for Use:

BioCare system's infrared therapy products emit energy in the infrared spectrum for the BloCare system's imfarca therapy products chappersy relief / reduction of minor
purposes of elevating tissue temperature; for temporary relief / reductiff ass purposes of elevating tissue tomperature, roin and minor joint pain and stiffiess.
muscular pain, minor muscular back pain and minor joint pain and stiffiness. muscular pain, minor muscular vack pain and miner 3 semporary increase in local blood
Additionally, these products are intent as a sense miner sub acute or Additionally, these products are mirelief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use xxx (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE

	Page ___ of ___
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(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

(Posted November 13, 2003)

LumiWave 1X4 Infrared Therapy Device 510(k)	510(k) Number K051816
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	Page 7-1
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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.