(217 days)
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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 is for a simple far-infrared lamp.
Yes
The device is intended to temporarily relieve minor muscle and joint aches and pains, which is a therapeutic effect.
No
The "Intended Use" states that the device "temporarily increases local blood circulation... and temporarily relieves minor muscle and joint aches and pains." This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly states "Sanidad Far-Infrared Mini Lamp, FI-3646," which indicates a physical hardware device (a lamp).
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 effect (increasing blood circulation, relieving aches and pains) applied directly to the body. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to diagnose or monitor conditions.
- Device Description: The description "Sanidad Far-Infrared Mini Lamp" suggests a physical device that emits far-infrared light, which is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical components or processes associated with IVDs.
Therefore, the Sanidad Far-Infrared Mini Lamp, FI-3646, as described, is a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
Product codes
ILY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2002
Rolor Electronics Corporation c/o Ke-Min Jen, Ph.D. Roc Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin-Chu City China (Taiwan)
Re: K020464
Trade/Device Name: Sanidad Far-Infrared Mini Lamp, FI-3646 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: IL Y Dated: July 26, 2002 Received: August 2, 2002
Dear Dr. Jen:
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 - Ke-Min Jen, Ph.D.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html .
Sincerely yours,
R. Merle Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ROLOR ELECTRONICS CORPORATION SANIDAD HEALTH INDUSTRIES, INC.
No. 274, Nanking E. Road, Sec. 5, Taipei, Taiwan, R.O.C. P.O. Box 46-379 TEL: 886-2-27682174-5, FAX: 886-2-27605922 Email: webmaster@rolor.com, http://www.rolor.com
Indications for Use Statement
Ver/ 3-4/24/96
Applicant: ROLOR ELECTRONICS CORPORATION
510(k) Number ( if known):
Device Name: Sanidad Far-Infrared Mini Lamp, FI-3646
Indications For Use :
Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
| Concurrence of CDRH, Office of Device Evaluation (ODE | |
|---|---|
| ------------------------------------------------------- | -- |
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K020464 |
|---|---|
| (Per 21 CFR 801.109) | |
| (Optional Format 1-2-96) |