(112 days)
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Not Found
No
The summary describes a paraffin warmer for pain relief, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes.
The device is intended for the temporary symptomatic relief of minor pain due to arthritis and bursitis, muscle relaxation, and stimulation of circulation, which are therapeutic claims.
No
The device is used for temporary symptomatic relief of pain and muscle relaxation, not for identifying or diagnosing a condition.
No
The device description explicitly states "Paramed Paraffin Warmer," which is a hardware device used for heating paraffin wax for therapeutic purposes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing temporary symptomatic relief of pain and relaxing muscles. This is a therapeutic or physical therapy application, not a diagnostic one.
- Device Description: The device is described as a "Paramed Paraffin Warmer." Paraffin warmers are used to heat paraffin wax for therapeutic purposes (like heat therapy for pain relief), not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Paramed Paraffin Warmer, as described, falls under the category of a physical therapy or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in temporary symptomatic relief of minor pain due to medically diagnosed arthritis and bursitis. Relaxes muscles, aids in the relief of stiff muscles, muscle spasms; helps to stimulate circulation.
Product codes
IMC
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.)
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.
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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.
Not Found
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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§ 890.5110 Paraffin bath.
(a)
Identification. A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.(b)
Classification. Class II (special controls). The device 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 Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1:3 1999
Mr. Mike Vidal President Divi International Co. 12188 SW 128th Street Miami, Florida 33186
Re: K991427
Trade Name: Paramed Paraffin Warmer Regulatory Class: II Product Code: IMC Dated: June 14, 1999 Received: June 21, 1999
Dear Mr. Vidal:
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 (OS) 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.
1
Page 2 - Mr. Mike Vidal
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,
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
510(k)Number (if known): K991427
Device Name: Paramed Paraffin Warmer
Indications For Use:
For use in temporary symptomatic relief of minor pain due to medically diagnosed arthritis and bursitis.
Relaxes muscles, aids in the relief of stiff muscles, muscle spasms; helps to stimulate circulation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991427 |
| Prescription Use
| (Per 21 CFR 801.109) | OR Over-The-Counter Use X |
|---|---|
| ------------------------------------------ | ----------------------------- |