(275 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is described as temporarily increasing local blood circulation and temporarily relieving minor muscle and joint aches and pains, which are therapeutic claims.
No
The "Intended Use / Indications for Use" states that the device temporarily increases blood circulation and relieves minor aches and pains, which are therapeutic functions, not diagnostic.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that is applied to the body to temporarily increase local blood circulation and relieve muscle/joint pain. This is a therapeutic or physical medicine application, not a diagnostic one.
- Lack of Diagnostic Information: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Missing Information: The absence of information about image processing, AI/ML, imaging modality, anatomical site, patient age, user/setting, and performance studies further supports that this is not a diagnostic device. These elements are often present in IVD submissions, especially those involving imaging or AI.
In summary, the intended use clearly places this device outside the realm of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The INFRAREX temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
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)
Not Found
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
Public Health Service
Image /page/0/Picture/2 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 a stylized caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 1999
Mr. George K. C. Chen President and CEO Skylark Device Company Limited 12 Floor, Section 3 34 Chung Shan North Road Taipei, Taiwan
к990233 Re: Trade Name:ST-302 Infrarex Requlatory Class: II Product Code: ILY Dated: July 30, 1999 Received: August 2, 1999
Dear Mr. Chen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. George K. C. Chen
This letter will allow you to begin marketing your device as Inis letter will area your your more to a lease described in your 510(k) prematice of your device to a legally finding of substancial equivalinos on a classitication for your marketed predicate device rocared in the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 crk rate sontact the Office of vitro draghostic devices// productionally, for questions on Compilance at (501) 331 is not device, please contact the promotion and advertising or job4-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97) . . . . . . . . . . . premarket notification - (2) circles under the Act may be information on your responsiblic and Manufacturers Assistance ontained from the Division of Small Harrastadol (433–659) or all at ICS Coll-free number (000)-05-08-08-08 10:00 pm
its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
ನ್ Page
(210 (k) NUMBER (IF KNOWN) : 1890233 ST-302 INFRAREX DEVICE NAME:
INDICATIONS FOR USE:
carions FOR USE:
The INFRAREX temporarily increases local blood circulation where The INFRAREX temporarily increases local been and joint aches
applied, and temporarily relieves minor muscle and joint aches
and temporarily relieves minor muscle and joint and pains.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (SAGE FOR FREE PAGE ( IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Prescripció CFR 801 109)
ﺎﺩ .
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign Off)
Division of General Restorative Device 510(k) Number .