(170 days)
Not Found
No
The summary describes a mechanical traction device and does not mention any AI or ML capabilities.
Yes
The device is intended to provide "relief from pain for those patients suffering with low back pain" and "relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica." These are therapeutic claims.
No
The device is described as providing "a program of treatments for relief from pain" and "is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain." It is explicitly a treatment device.
No
The device description explicitly states "DRX3000 Traction Equipment" and refers to a "treatment period on the DRX3000," indicating a physical piece of equipment is involved in delivering the treatment. The predicate devices are also described as traction equipment and a therapeutic table, further supporting that this is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- DRX3000 Function: The DRX3000 is a traction device that applies physical forces (distraction) to the patient's low back. It is used on the patient's body to provide therapy and relieve pain.
- Lack of Specimen Analysis: The provided information does not mention the DRX3000 analyzing any biological specimens. Its function is purely mechanical and therapeutic.
- Classification: The device is classified as "Power traction equipment" (21 CFR Section 890.5900), which falls under the category of physical medicine devices, not IVDs.
Therefore, based on the intended use, device description, and classification, the DRX3000 is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
ITH
Device Description
Device Trade Name: DRX3000 Traction Equipment
Common Name: Power Traction Equipment
Classification Name: Class II (21 CFR Section 890.5900)
Class and Reference Product Code: 89 ITH
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
low back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician prescribed treatment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical trials carried out by VAX-D endorse the principle of decompression and similar studies using similar technology have reported the same results.
Key Metrics
Not Found
Predicate Device(s)
K010292 DRX 2000 - Axiom WorldWide, K844385 Tru-Trac 401 Traction, K951622 VAX-D® Therapeutic Table - Vat-Tech, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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).
1
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.
2
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
3
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)
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