(187 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description and intended use are purely focused on infrared lamp technology for pain relief.
Yes
The Intended Use/Indications for Use section explicitly states that the device is for "temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm" and "promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion," which are therapeutic claims.
No
Explanation: The device description states its purpose is to provide temporary relief of pain and stiffness, and promote relaxation and improved range of motion, not to diagnose medical conditions.
No
The device description explicitly states "Skylark Infrared Lamp, Models SD-956IR and SD-100IR," indicating a physical hardware device that emits infrared energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a therapeutic device that applies infrared energy to the body for pain relief and improved circulation. This is a physical therapy or pain management application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an "Infrared Lamp," which is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
Therefore, the Skylark Infrared Lamp, Models SD-956IR and SD-100IR, is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To provide infrared lamp energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion.
Product codes
ILY
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Public Health Service
JUN 6 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Betty Chien Skylark Device & Systems Co., Ltd 4F, Number 34, Section 3 Chung Shan North Road Taipei, Taiwan. R.O.C.
Re: K043306
Trade/Device Name: Skylark Infrared Lamp, Models SD-956IR and SD-100IR Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: May 16, 2005 Received: May 17, 2005
Dear Ms. Chien:
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.
1
Page 2 -Ms. Betty Chien
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Skylark Infrared Lamp, Models, SD -956IR and SD-100IR
Indications for Use:
To provide infrared lamp energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion.
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
X
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | -------- | ----------------------------------------------------- |
|---|
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of (Division Sign-Off Evaluation (ODE) | |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices Page ___ of ___ | |
| (Posted November 13, 2003) | |
| 510(k) Number | K043306 |