(15 days)
Not Found
No
The description focuses on the physical components and intended use of an infrared heat lamp, with no mention of AI or ML capabilities.
Yes
The device is described as providing "temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm," and promoting "relaxation of the muscle tissue," which are therapeutic claims.
No
The device description and intended use indicate it is an infrared heat lamp for pain relief and tissue relaxation, not for identifying or diagnosing a medical condition.
No
The device description clearly states it consists of hardware components including infrared diodes (LEDs), a battery, an operating system contained within a handheld device, and a charging cradle with a wall power supply.
Based on the provided information, the Painacea Model XR8 infrared heat lamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the body for pain relief and muscle relaxation. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a device that emits infrared light for heating. There is no mention of analyzing biological samples (like blood, urine, or tissue) or performing any diagnostic tests.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Painacea Model XR8 does not perform any of these functions.
The device is a therapeutic device intended for over-the-counter use to alleviate pain and stiffness through heat.
N/A
Intended Use / Indications for Use
The Painacea Model XR8 infrared heat lamp is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Product codes
ILY
Device Description
The Painacea Model XR8 consists of a collection of near and infrared diodes [LEDs], packaged in a compact handheld device. The system emits light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. The battery and operating system is contained within the handheld device. The device has a cradle with wall power supply to recharge the battery.
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)
Testing of the Painacea Model XR8 included functional performance testing and electrical safety testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY 1 0 2005
1021046
510(k) Submission, Painacea Model # XR8 Atlantis Luminescent Products, LLC, Lafayette, LA 70503
Summary
Date: April 11, 2005
This summary of 510(K)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Painacea Model XR8 Infrared Heat Lamp.
Company making the submission:
| This summary is submitted by: | |
|---|---|
| Name: | Atlantis Luminescent |
| Products, LLC | |
| Address: | 1405 W. Pinhook Road, |
| Ste. 205 | |
| Lafayette, LA 70503 | |
| Telephone: | 318-894-9490 |
| Fax: | 318-894-9505 |
| Contact: | Jim Cobb |
| President | |
| E-mail: | Jim@wnonline.net |
1. Device Name:
Trade/Proprietary Name: Common/Usual Name: Classification Name:
Painacea Model XR8 Infrared Heat Lamp. infrared heat lamp. Infrared lamp, 21 CFR § 890.5500
2. Predicate Device:
The Painacea Model XR8 Infrared Heat Lamp is substantially equivalent to other infrared lamps on the market, such as the Light Wave (K024027) and Warp 10 (K032229).
3. Intended use of the Device:
The Painacea Model XR8 infrared heat lamp is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Summary Rev B
DCG
510(k) Page #
1
3. Description of the Device:
The Painacea Model XR8 consists of a collection of near and infrared diodes [LEDs], packaged in a compact handheld device. The system emits light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. The battery and operating system is contained within the handheld device. The device has a cradle with wall power supply to recharge the battery.
Summary of the technological characteristics of the device 4. Compared to predicate devices:
The Painacea Model XR8 and the above referenced predicate devices are infrared lamps as defined in 21 CFR § 890.5500. These devices utilize infrared diodes [LEDs], to provide topical heating for the temporary relief of muscle and/or joint pain. The temperatures achieved by these devices are the same, using a similar number of diodes [LEDs], over a similar coverage area. The devices are handheld, and intended to be placed directly on the skin or held just over the skin to provide the heating.
5. Testing:
Testing of the Painacea Model XR8 included functional performance testing and electrical safety testing.
-
- Rx or OTC:
The Painacea Model XR8 is an Over the Counter (OTC), device. The fabeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. Both predicate devices are OTC. Predicate device labeling has been provided.
- Rx or OTC:
-
- Conclusions:
Based upon the testing and comparison to the predicate devices, the Painacea Model XR8 has the same intended uses, with similar technological characteristics as the predicate devices. The system performs as intended and does not raise any new safety or effectiveness issues.
- Conclusions:
510(k) Page #
ર્વ તા
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized lines or stripes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2005
Atlantis Luminescent Products, LLC c/o Daniel W. Lehtonen Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01779
Re: K051046
.
Trade/Device Name: Painacea Model XR8 Infrared Heat Lamp Regulation Numbers: 21 CFR 890.5500 ﻴ Regulation Names: Infrared Lamp Regulatory Class: II Product Code: IL Y Dated: April 11, 2005 Received: April 25, 2005
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to they 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices mat have ocen require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelove, manies of the Act include requirements for annual registration, listing of general controls pro resuring 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 IT your device is classified (600 world). Existing major regulations affecting your device can thay be subject to sach additions, 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 i lease oc actised that I Dr over device complies with other requirements of the Act that I Dri has made a astern regulations administered by other Federal agencies. You must or any it cachards and registments, including, but not limited to: registration and listing (21 Comply with an the Fee 81 cFR Part 801); good manufacturing practice requirements as set CFR I art 607), adoling (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Daniel Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the pe premarket notification. The PDA inding of backantal equate 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
rs the regulation of the 1100 - All and and on a note the regulation entitl If you desire specific advice for your dovice of can associety of the regulation entitled,
contact the Office of Compliance at (240) 276-0120 . . (207 07) . Voy may obtain contact the Office of Comphalice at (240) 276 - 1240) Part 807.97). You may obtain "Misbranding by reference to premainer noutheadon (c) the Act from the Division of Small other general information on your responsion in the mumber (800) 638-2041 or Manufacturers, Internet address .
(301) 443-6597 or at its Internet address