(170 days)
The DRX3000 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 DRX3000 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.
Device Trade Name: DRX3000 Traction Equipment
Common Name: Power Traction Equipment
Classification Name: Power traction equipment
Class and Reference Product Code: Class II (21 CFR Section 890.5900) 89 ITH
The provided text does not contain information about acceptance criteria or a study proving that the DRX3000 meets such criteria. The document is a 510(k) summary for the DRX3000 Traction Equipment, outlining its description, predicate devices, and intended use for relief from low back pain. It states that the device is substantially equivalent to legally marketed predicate devices and mentions that "clinical trials carried out by VAX-D endorse the principle of decompression and similar studies using similar technology have reported the same results." However, it does not provide details about these studies, their methodologies, sample sizes, acceptance criteria, or specific performance metrics of the DRX3000 device itself.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented for the DRX3000.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant to this device, which is a traction equipment, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than on detailed clinical performance studies of the DRX3000 itself with specific acceptance criteria.
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Axiom USA DRX3000TM - 510(k) Notification Submission
KO22602
SECTION VIII
JAN 2 3 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Description:
Device Trade Name: Common Name: Classification Name: Class and Reference Product Code:
DRX3000 Traction Equipment Power Traction Equipment Class II (21 CFR Section 890.5900) 89 ITH
Predicate Devices:
K010292 DRX 2000 - Axiom WorldWide K844385 Tru-Trac 401 Traction K951622 VAX-D® Therapeutic Table - Vat-Tech, Inc.
Proposed Intended Use
The DRX3000 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 DRX3000 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.
Technological and Clinical Application Characteristics
The DRX3000 incorporates various principles and working characteristics of the predicate devices, the DRX 2000 Axiom's proprietary predicate device (K010292), the Tru-Trac 401 Traction Device (K844385) and the VAX-D Therapeutic Table (K951622). The incorporating of the traction device and a flat surface type powered bed, whilst giving a new overall appearance to the apparatus, has not impacted on or changed the safety of effectiveness of the devices. The Tru-Trac 401 has been in use in this country for more than ten years and we have no evidence of a MDR report being filed by the manufacturer nor have we been made aware of any events or conditions effecting the operation of this equipment. Clinical trials carried out by VAX-D endorse the principle of decompression and similar studies using similar technology have reported the same results. (Please see the Appendices).
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2003
Axiom USA. Inc. 3830 Gunn Highway Tampa, Florida 33624
Mr. James J. Gibson, Jr.
President & CEO
Re: K022602
Trade/Device Name: DRX3000TM Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II Product Code: ITH Dated: November 12, 2002 Received: November 13, 2002
Dear Mr. Gibson:
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 - Mr. James J. Gibson, Jr.
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" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 N Milkin
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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Axiom USA, Inc. DRX3000TM - 510(k) Notification Submission
510(k) Number (if known): K 022602
Page 1 of 1
Device Name: DRX3000
Indications For Use:
Intended Use
The DRX3000 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 DRX3000 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | OROver-The-Counter Use |
|---|---|
| inn Simm Off) | |
| 890 18000000.510(K) Name |
§ 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).