(488 days)
Not Found
No
The description focuses on mechanical distraction and monitoring of tension, with no mention of AI or ML algorithms for diagnosis, treatment planning, or control.
Yes
The device is designed to treat low back pain and various associated conditions through decompression of intervertebral discs, which is a therapeutic action aimed at alleviating symptoms and improving patient well-being.
No
The device is described as a therapeutic table designed to relieve pain through decompression of intervertebral discs. It provides treatment, not diagnosis. This is confirmed by the "Intended Use / Indications for Use" section stating it provides a "primary treatment modality."
No
The device description clearly details a physical table with mechanical components (split-table design, tensionometer, hand grips) used to apply physical distraction to the patient's lumbar spine. While it mentions optional connection to a computer terminal for data capture, the core functionality and mechanism of action are hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- VAX-D® Therapeutic Table Function: The description clearly states that the VAX-D® Therapeutic Table is a physical therapy device designed to apply mechanical forces (distraction tensions) to the lumbar spine to relieve pain. It works externally on the patient's body.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
Therefore, based on the provided information, the VAX-D® Therapeutic Table falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VAX-D® Therapeutic Table is designed to relieve pressure on structures that may be causing low back pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. It achieves these effects through decompression of intervertebral discs, that is, unloading, due to distraction and positioning.
This therapy provides a primary treatment modality for the management of pain and disability for patients presenting with incapacitating low back pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the lumbar spine that generate localized low back pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs, degenerative discs as well as those with acute facet problems.
Product codes
89ITH
Device Description
The VAX-D® Therapeutic Table is designed to apply distraction tensions to the patient's lumbar spine. The patient lies on the table in a prone position; the upper body is on the stationary portion of the table and is restrained by the patient holding on to adjustable hand grips. The table is a split-table design, whereby distraction tensions are applied to the patient through a pelvic harness attached to a tensionometer and by the separation of the movable part of the table. The VAX-D® Therapeutic Table provides automated or varied timed distraction cycles. For safety, the patient holds on to the handgrip which can be released at any time to end the session and restore full relaxation. Distraction tensions and rates are continuously monitored and measured by the tensionometer attached to the pelvic belt, and the output is shown on a digital gauge and captured on a pen-writer printout, or optionally through direct connection to a computer terminal. The chart recording forms a permanent record of the treatment parameters, which becomes part of the patient's chart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The operating principles of the VAX-D® Therapeutic Table permit application of effective distraction tensions to the lumbar spine. The important basic parameters contributing to the safety and effectiveness of the device include the use of air pressure as the energy source, the ramp characteristics employed in applying distraction tensions, the release rate of tensions and relaxation cycles, the cyclic periodicity, the upper limits on distraction tensions and, in addition, the positioning of the patient and the means of fixing the upper body. The fact that the patient can, at will, release all tensions completely and immediately through releasing the hand grips, is an important safety factor. The VAX-D® Therapeutic Table has been in clinical use since 1989. VAT-TECH maintains contact with the clinics administering the therapy, and our professional staff provides ongoing advisory services to these clinics. We would, therefore, be aware of events and conditions affecting the operation of this equipment and, in the past seven years, have not filed a single MDR report, which reflects on the inherent safety of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
VAX-D® (or "VAX-T® ") Therapeutic Table (K894435)
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.
Not Found
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).
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
Image /page/0/Picture/0 description: The image shows a logo for VAX-D. The logo is in black and white and features a stylized font. The letters are bold and have a unique design. The logo is likely for a company or product named VAX-D.
JUL - 2 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. SPONSOR IDENTIFICATION
x 95 16 93
| 瑞隆
Allan Dyer, Pharm.B., BSc., Ph.D., M.D. President VAT-TECH, INC. 38549 U.S. Highway 19 North Palm Harbor, FL 34684 Telephone: (800) 558- 8293 FAX: (813) 943-9899
SPONSOR ESTABLISHMENT REGISTRATION NUMBER: 2. 8022271
3. OFFICIAL CONTACT PERSON
Norman F. Estrin, Ph.D., RAC President ESTRIN CONSULTING GROUP, INC. 9109 Copenhaver Drive Potomac, MD 20854 Telephone: (301) 279-2899 FAX: (301) 294-0126
4. DATE OF PREPARATION OF SUMMARY: June 11, 1996
DEVICE INFORMATION પં
- DEVICE PROPRIETARY NAME: A.
- B. COMMON NAME:
- C. CLASSIFICATION NAME:
- D. CLASS AND REFERENCE:
- E. PRODUCT CODE:
- F. PANEL CODE:
VAX-D® Therapeutic Table Traction Equipment, Powered Equipment, Traction, Powered Class II (21 CFR Section 890.5900) 89ITH 870R
:
Connell Square. 38549 U.S. Highway 19 North, Palm Harbor, Florida 34684
1
VAX-D® (or "VAX-T® ") Therapeutic Table (K894435) PREDICATE DEVICE: 6.
7. DEVICE DESCRIPTION
The VAX-D® Therapeutic Table is designed to apply distraction tensions to the patient's lumbar spine. The patient lies on the table in a prone position; the upper body is on the stationary portion of the table and is restrained by the patient holding on to adjustable hand grips. The table is a split-table design, whereby distraction tensions are applied to the patient through a pelvic harness attached to a tensionometer and by the separation of the movable part of the table. The VAX-D® Therapeutic Table provides automated or varied timed distraction cycles. For safety, the patient holds on to the handgrip which can be released at any time to end the session and restore full relaxation. Distraction tensions and rates are continuously monitored and measured by the tensionometer attached to the pelvic belt, and the output is shown on a digital gauge and captured on a pen-writer printout, or optionally through direct connection to a computer terminal. The chart recording forms a permanent record of the treatment parameters, which becomes part of the patient's chart.
INTENDED USE 8.
The VAX-D® Therapeutic Table is designed to relieve pressure on structures that may be causing low back pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. It achieves these effects through decompression of intervertebral discs, that is, unloading, due to distraction and positioning.
g. INDICATIONS FOR USE
This therapy provides a primary treatment modality for the management of pain and disability for patients presenting with incapacitating low back pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the lumbar spine that generate localized low back pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs, degenerative discs as well as those with acute facet problems.
10. TECHNOLOGICAL CHARACTERISTICS
The VAX-D® Therapeutic Table is essentially the same product as the predicate device, VAX-T® Therapeutic Table (K894435). VAT-TECH, INC. has made some minor modifications in the appearance and components used in The VAX-D® Therapeutic Table since its introduction in 1989. Each of these changes was evaluated by VAT-TECH and found not to impact the safety or effectiveness of this device. The changes include changes in appearance, replacement of timers and replacement of cycle counters.
2
11. SUMMARY OF SAFETY AND EFFECTIVENESS
The operating principles of the VAX-D® Therapeutic Table permit application of effective distraction tensions to the lumbar spine. The important basic parameters contributing to the safety and effectiveness of the device include the use of air pressure as the energy source, the ramp characteristics employed in applying distraction tensions, the release rate of tensions and relaxation cycles, the cyclic periodicity, the upper limits on distraction tensions and, in addition, the positioning of the patient and the means of fixing the upper body. The fact that the patient can, at will, release all tensions completely and immediately through releasing the hand grips, is an important safety factor. The VAX-D® Therapeutic Table has been in clinical use since 1989. VAT-TECH maintains contact with the clinics administering the therapy, and our professional staff provides ongoing advisory services to these clinics. We would, therefore, be aware of events and conditions affecting the operation of this equipment and, in the past seven years, have not filed a single MDR report, which reflects on the inherent safety of the device.