(90 days)
The Lordex Power Traction Unit provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the Lordex Traction Unit, and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is unloading due to distraction and positioning.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a clearance letter from the FDA for a medical device called "Lordex Power Traction Unit," indicating that it has been deemed substantially equivalent to a predicate device.
The letter discusses:
- Trade Name: Lordex Power Traction Unit
- Regulation Number: 21 CFR 890.5900
- Regulation Name: Power traction equipment
- Regulatory Class: II
- Product Code: ITH
- Indications For Use: Relief from pain for patients suffering with low back pain, including pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs.
However, it does not include any of the following:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Information on experts used to establish ground truth or adjudication methods.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone algorithm performance study.
- The type of ground truth used in any study.
- Sample size for a training set or how its ground truth was established.
Therefore, I cannot fulfill your request for that specific information based on the text provided.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2003
Dr. John Boren President Lordex, Inc. 15915 Katy Freeway, Suite 645 Houston, Texas 77094
Re: K031227
Trade Name: Lordex Power Traction Unit Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: March 27, 2003 Received: May 6, 2003
Dear Dr. Boren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.'
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Dr. John Boren
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark A. Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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March 27, 2003
Lordex Inc.
Device Name: Lordex Power Traction Unit 510k Pre market notification number KO31227
Indications For Use:
Intended Use:
The Lordex Power Traction Unit provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the Lordex Traction Unit, and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is unloading due to distraction and positioning.
Concurrence of CDRH, Office of Device Evaluation
Division sign off
510k Number KO31227
Prescription Use し (Per 21 CFR 801.109)
OR
Over-The-Counter Use
to Monk N Millikan
(Division Sign-Off) Di ision of General, Restorative and Neurological Devices
510(k) Number K031227
§ 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).