(90 days)
To emit energy in the infrared spectrum to provide topical temperature. Intended to use for the temporary relief of minor muscle and joint stiffness, temporary increase in local circulation where applied, and the relaxation of muscles.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Sacred Crane TDP Lamp". This type of document does not contain details about acceptance criteria, device performance studies, or clinical trial methodologies as typically found in a clinical study report or a premarket approval (PMA) application.
A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device, not on proving safety and effectiveness through extensive clinical trials for a new device type. Therefore, most of the information requested in your prompt is not available in this document.
Here's what can be extracted based on the information provided in the 510(k) letter:
1. A table of acceptance criteria and the reported device performance
- Not Available: This document does not specify acceptance criteria or report detailed device performance metrics. Its clearance is based on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: This document does not describe a clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available: This document does not describe a clinical study with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: This document does not describe a clinical study with an adjudication method.
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 is a physical device (TDP Lamp) and does not involve AI or human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical device (TDP Lamp) and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: This document does not describe a clinical study or the establishment of ground truth. The clearance is based on substantial equivalence.
8. The sample size for the training set
- Not Available: This document does not describe a training set as it's not an AI/algorithm-based device and doesn't detail clinical study specifics for training.
9. How the ground truth for the training set was established
- Not Available: This document does not describe a training set or how ground truth for such a set would be established.
In summary: The provided document is a regulatory approval letter based on substantial equivalence, not a detailed clinical study report. Therefore, it does not contain the specifics about clinical trial design, acceptance criteria, sample sizes, or ground truth establishment that you are looking for. Such information would typically be found in a separate 510(k) submission summary or a full study report, which is not part of this letter.
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Image /page/0/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 a stylized caduceus or a bird-like figure with three wavy lines beneath it, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 1999
Mr. Daniel Ye Hua, MBA President United Pacific Company, Ltd. 219 South Raymond Avenue Alhambra, California 91801
K991503 Re: Trade Name: Sacred Crane TDP Lamp Regulatory Class: II Product Code: ILY Dated: April 24, 1999 Received: April 29, 1999
Dear Mr. Ye Hua:
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 control provisions of the Act. The general control 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 (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 regulation may result in regulatory 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.
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Page 2 - Mr. Daniel Ye Hua, MBA
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Neil R.P. Ogden
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 8 of 32
510(k) Number (if known):_K991503
Device Name: SACRED CRANE TDP LAMP
Indications For Use:
To emit energy in the infrared spectrum to provide topical To emit energy in the infract bpood and the many temperature.
Intended to use for the temporary relief of minor muscle and joint stifthess, cemporary increase in local relief of minor strain spasm, cemporary increase a
circulation where applied, and the relaxation of muscles.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ARO
| Division Sign-Off | |
|---|---|
| Division of General Restorative Devices | K991503 |
| 510(k) Number |
Prescription Use_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.