(682 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, deep neural networks (DNN), image processing, or any other terms typically associated with AI/ML in medical devices. The device description is simply "DYNA T-2000 Physical Therapy System," which does not inherently suggest AI/ML technology.
Yes
The device is described as a "Physical Therapy System," which falls under the category of therapeutic devices as it implies treatment or rehabilitation.
No
The device description "DYNA T-2000 Physical Therapy System" indicates it is a device used for physical therapy, which is generally a treatment modality rather than a diagnostic one. There is no information in the provided text that suggests it is used for diagnosing conditions or diseases.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device's nature and components. Without a device description that clarifies whether it's purely software or includes hardware, it's impossible to determine if it's a software-only medical device.
Based on the provided information, there is no indication that the DYNA T-2000 Physical Therapy System is an IVD (In Vitro Diagnostic) device.
Here's why:
- No mention of IVD: The provided text does not contain any terms or descriptions related to in vitro diagnostics, such as analyzing biological samples (blood, urine, tissue), diagnostic tests, or laboratory procedures.
- Device Description: The description "Physical Therapy System" strongly suggests a device used for physical rehabilitation or treatment, which is distinct from diagnostic testing.
- Lack of Relevant Information: The absence of information about intended use for diagnosis, anatomical sites for sample collection, or performance metrics related to diagnostic accuracy further supports the conclusion that it's not an IVD.
Therefore, based solely on the provided text, the DYNA T-2000 Physical Therapy System is not an IVD.
N/A
Intended Use / Indications for Use
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Product codes
IMB, IRO
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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§ 890.5250 Moist steam cabinet.
(a)
Identification. A moist steam cabinet is a device intended for medical purposes that delivers a flow of heated, moisturized air to a patient in an enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.(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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven J. Daffer ·President Thermia, Inc. 9220 James Avenue South Bloomington, Minnesota 55431
NOV - 3 1997
Re: K955808 DYNA T-2000 Physical Therapy System Requlatory Class: II Product Codes: IMB and IRO Dated: August 6, 1997 Received: August 7, 1997
Dear Mr. Daffer:
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 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 aqainst 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 Requlations, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 requlations.
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Page 2 - Mr. Steven J. Daffer
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 markets preams, 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,
to colle
C. Colin M. Witton, Ph.D. M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health