(369 days)
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No
The summary describes a calibrated pressure device for measuring pain response and finger strength, with no mention of AI or ML terms or functionalities.
No
The device measures pain tolerance, pain threshold, trigger point tenderness, and finger strength, which are diagnostic or assessment functions, not therapeutic ones.
Yes
The device measures pain tolerance, pain threshold, and trigger point tenderness, which are diagnostic indicators of a patient's condition.
No
The device is described as a "calibrated pressure or force stimulus device" and measures "response for pain tolerance, pain tolerance, pain threshold and trigger point tenderness." This description strongly implies a physical device that applies pressure or force, not solely software.
Based on the provided information, the JTECH Commander Algometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- JTECH Commander Algometer Function: The description states the device is a "calibrated pressure or force stimulus device" that measures "response for pain tolerance, pain tolerance, pain threshold and trigger point tenderness" and "screens for finger strength." This involves applying pressure to the body and measuring the patient's response, not analyzing a sample taken from the body.
Therefore, the JTECH Commander Algometer is a physical measurement device used for assessing pain sensitivity and strength, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The JTECH Commander Algometer is a calibrated pressure or force stimulus device. It measures the tissue conninential response for pain tolerance, pain tolerance, pain threshold and trigger point tenderness. It is also used to screen for finger strength.
Product codes
HRW
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.1250 Nonpowered dynamometer.
(a)
Identification. A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 20 1330
Mr. Tracy Livingston Senior Vice President JTech Medical Industries 357 West 910 South Heber City, Utah 84032
Re: K971407 JTECH Commander and Algometer Trade Name: Regulatory Class: II Product Code: HRW Dated: January 12, 1998 Received: January 20, 1998
Dear Mr. Livingston:
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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.
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Page 2 - Mr. Livingston
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) 594-4595. 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
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Page 1 of 1
510(k) Number (if known): K971407
Device Name: JTECH Commander™ Algometer
Classification Panel: BSI
Indications for Use:
The JTECH Commander Algometer is a calibrated pressure or force stimulus device. It measures I he 51 LC1 Conninential response for pain tolerance, pain tolerance, pain threshold and trigger point tenderness. It is also used to screen for finger strength.
(Please DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| or | Over-The-Counter Use |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K971407 |
|---|---|
| --------------- | --------- |
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