(65 days)
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Not Found
No
The summary describes a pneumatic traction device with no mention of AI, ML, or any related technologies.
Yes
The device is expressly used to perform traction and mobilization of cervical muscles and vertebrae, and is intended for clinical use by prescription of a licensed physician, indicating a therapeutic purpose.
No
Explanation: The device is described as a "pulling-traction device expressly used to perform traction and mobilization." It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "pneumatic pulling-traction device," which implies a physical hardware component for applying traction.
Based on the provided information, the CTD Mark I is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use of the CTD Mark I is to perform traction and mobilization on the cervical muscles and vertebrae directly on the patient. It does not involve analyzing samples like blood, urine, or tissue.
- The description focuses on a physical therapy/rehabilitation function. The device applies physical force (pneumatic pulling-traction) to the body. This is characteristic of therapeutic or physical medicine devices, not diagnostic devices that analyze biological samples.
Therefore, the CTD Mark I falls under the category of a physical medicine or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CTD Mark I is a mobile, cervical, pneumatic pulling-traction device expressly used to perform traction and mobilization of the cervical muscles and vertebrae. It provides intermittent or continuous traction modes. The CTD Mark I when used as a cervical traction device is for clinical use only by prescription of a licensed physician.
Product codes
ITH
Device Description
CTD MARK I TRACTION DEVICE
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
cervical muscles and vertebrae
Indicated Patient Age Range
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Intended User / Care Setting
clinical use only by prescription of a licensed physician
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Mr. Earnie S. Philpot President Therasys, Incorporated 2295 North Moraine Drive Moraine, Ohio 45439
Re: K991931 Trade Name: CTD Mark I Traction Device Regulatory Class: II Product Code: ITH Dated: June 3, 1999 Received: June 8, 1999
Dear Mr. Philpot:
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 (OS) 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. Earnie S. Philpot
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
IC99/93//A
Food and Drug Administration
June 22, 1999
DUPLICATE
510K Number: K991931
Device Name: CTD MARK I TRACTION DEVICE
INDICATIONS FOR USE:
The CTD Mark I is a mobile, cervical, pneumatic pulling-traction device expressly used to perform traction and mobilization of the cervical muscles and vertebrae. It provides intermittent or continuous traction modes. The CTD Mark I when used as a cervical traction device is for clinical use only by prescription of a licensed physician.
P. O'Dell
(Division Sign Off) Division of General Restorative Devices 510(k) Number
2007
Prescription Use
(Per 21 CFR 801.109)