(144 days)
Not Found
No
The description focuses on mechanical application of tension based on a pre-programmed logarithmic curve and continuous monitoring and adjustment based on measured tension, not on learning or adaptive algorithms.
Yes
The device is designed to treat various painful conditions of the spine by non-surgically decompressing the spine and intervertebral disc, indicating a therapeutic purpose.
No
The device description indicates it is a treatment device designed to apply distraction tensions to relieve pain caused by spinal conditions, not to diagnose them.
No
The device description clearly outlines a physical system including a table, harnesses, tensionometer, and handgrips, indicating it is a hardware device with integrated software for control and monitoring.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The VAX-D Genesis G2 is a physical therapy device designed to apply mechanical forces (distraction tensions) to the spine to relieve pain. It directly interacts with the patient's body.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The device's function is based on applying physical forces, not analyzing biological markers.
Therefore, the VAX-D Genesis G2 falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: The VAX-D Genesis G2 Dynamic Logarithmic Spinal Decompression System is designed to relieve pressure on structures that may be causing low back pain, sciatica and neck pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radio. This is achieved non- surgically through the application of logarithmic distraction tensions applied to the patient according to the VAX-D protocol.
Indications for Use: This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with spinal pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the spine that generate localized pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs as well as those with acute facet problems and sciatica.
Product codes (comma separated list FDA assigned to the subject device)
89 ITH
Device Description
The VAX-D Genesis G2 is designed to apply distraction tensions to the patient's lumbar and cervical spine in order to non-surgically decompress the spine and intervertebral disc. Disc decompression is defined as unloading due to distraction and positioning. For lumbar treatment the patient is fitted with pelvic harness and lies on the table; the upper body is positioned on the stationary partion of the table and is restrained by the patient holding on to adjustable handgrips, or by the vise of possive shoulder restraint. The table is a split table design, whereby distraction tensions are applied to the patient through a harness attached to a tensionometer and by the separation of the movable part of the movable The tensionometer can be programmed to move synchronously in a horizontal rand vertical plane in order to apply tension in a logarithmic time/force progression that is designed to follow the curvature of the spine.
The system is designed to apply tensions to the spine in a smooth logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system provides automated or variable e ined distraction-relaxation cycles. For safety the patient holds on to handgrips which can be released at any time to end the session and restore full relaxation. The patient may choose to use a passive shoulder restraint that utilizes a patient 'quick release' buckle, or they may use the handheld patient safety with to stop the treatment. For cervical treatment the tensionometer applies tension to the cervical spine through a cervical harness. Distraction tensions and rates are continuously monitored and measured hy the tensionometer, and the output is monitored by a computer system which continuously processes the data and adjusts the tension to produce a patented 'logarithmic' curve. The chart recording produced is 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 and cervical spine, intervertebral disc
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VAX-D therapy has been in clinical use since 1989 and has been the subject of multiple clinical studies examining its effectiveness and mechanisms of action. VAX-D therapy Medical Technologies maintains contact with the clinics administering the therapy, and over the past fourteen years, not a single MDR report of injury has been filed, which reflects 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 Genesis System K053503, VAX-D Therapeutic Table K951622, 3D Activetrac K001712, Henley Tru-Trac 401 K844385
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
VAXED GENESIS G2 510(k)
SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION 1.
VAX-D MEDICAL TECHNOLOGIES LLC. 310 Mears Blvd Oldsmar, FL 34677
0CT 5 * 2007
Telephone: (813) 343-5000 Facsimile: (813) 343-5005
2. SPONSOR ESTABLISHMENT REGISTRATION NUMBER(s): 1058809 Owner ID No. 9031244
-
- OFFICIAL CONTACT PERSON Dr. Lawrence A. Dyer Telephone:
(813) 343-5000 Facsimile: (813) 343-5005
- OFFICIAL CONTACT PERSON Dr. Lawrence A. Dyer Telephone:
-
DATE OF PREPARATION OF SUMMARY: April 30, 2007 4.
5. DEVICE INFORMATION
DEVICE PROPRIETORY NAME: VAX-D Genesis G2 - Dynamic A. Logarithmic Spinal Decompression System
- B. CLASS AND REFERENCE: Class II (21CFR Section 890.5900)
- C. PRODUCT CODE: 89 ITH
- D PANEL CODE: 87OR
| 6. | PREDICATE DEVICE(s): | VAX-D Genesis System | K053503 |
|---|---|---|---|
| VAX-D Therapeutic Table | K951622 | ||
| 3D Activetrac | K001712 | ||
| Henley Tru-Trac 401 | K844385 |
DEVICE DESCRIPTION .
The VAX-D Genesis G2 is designed to apply distraction tensions to the patient's lumbar and cervical spine in order to non-surgically decompress the spine and intervertebral disc. Disc decompression is defined as unloading due to distraction and positioning. For lumbar treatment the patient is fitted with pelvic harness and lies on the table; the upper body is positioned on the stationary partion of the table and is restrained by the patient holding on to adjustable handgrips, or by the vise of possive shoulder restraint. The table is a split table design, whereby distraction tensions are applied to the patient through a harness attached to a tensionometer and by the separation of the movable part of the movable The tensionometer can be programmed to move synchronously in a horizontal rand vertical plane in order to
1
apply tension in a logarithmic time/force progression that is designed to follow the curvature of the spine.
The system is designed to apply tensions to the spine in a smooth logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system provides automated or variable e ined distraction-relaxation cycles. For safety the patient holds on to handgrips which can be released at any time to end the session and restore full relaxation. The patient may choose to use a passive shoulder restraint that utilizes a patient 'quick release' buckle, or they may use the handheld patient safety witch to stop the treatment. For cervical treatment the tensionometer applies tension to the cervical spine through a cervical harness. Distraction tensions and rates are continuously monitored and measured hy the tensionometer, and the output is monitored by a computer system which continuously processes the data and adjusts the tension to produce a patented 'logarithmic' curve. The chart recording produced is a permanent record of the treatment parameters which becomes part of the patient's chart.
8. INTENDED USE
The VAX-D Genesis G2 Dynamic Logarithmic Spinal Decompression System is designed to relieve pressure on structures that may be causing low back pain, sciatica and neck pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radio. This is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the VAX-D protocol.
9. INDICATIONS FOR USE
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with spinal pain. It has been found to provide relief in a variety of sonditions involving anatomical dysfunctions of the spine that generate localized pain as well as veninheral radiation, including patients with protruding or herniated intervertebral disco as well as those with acute facet problems and sciatica.
10. TECHNOLOGICAL CHARACTERISTICS
The VAX-D Genesis G2 incorporates the various principles and working characteristics of the predicate devices, VAX-D Genesis System K053503, the VAX-D Therapeutic Table K951622, the aD Activetrac K001712 and the Henley Tru-Trac 401 K844385. VAX-D Medical Technologies has made some modifications to the appearance and components used in the VAX-D Genesis System which provides for a control arm instead of a control console; to provide for more accurate application of tension, and to provide for the storage of patient data. Each of these changes was evaluated by VA-D Medical Technologies and found not to impact the safety and effectiveness of this device. The Tru-Trac 401 has been in use for more than ten years for traction of the cervical spine and we have no evidence of an MDR report being filed by the manufacturer.
SUMMARY OF SAFETY AND EFFECTIVENESS 11.
The operating principles of the VAX-D Genesis G2 permit the application of accurately controlled distraction tensions to the lumbar and cervical spine in order to decompress the intervetebral
2
discs and spinal structures. Disc decompression is defined as unloading due to distraction and The important basic parameters contributing to the safety and effectiveness of the device positioning. include the smooth and gentle logarithmically applied distraction tensions, the smooth logarithmic 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 important safety factors are that patients can immediately release all tensions by simply releasing the handgrips, by using the quick release buckle on the passive shoulder restraint or through the patient handheld safety switch.
VAX-D therapy has been in clinical use since 1989 and has been the subject of multiple clinical studies examining its effectiveness and mechanisms of action. VAX-D therapy Medical Technologies maintains contact with the clinics administering the therapy, and over the past fourteen years, not a single MDR report of injury has been filed, which reflects the inherent safety of the device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vax-D Medical Technologies USA % Regulatory Technology Services Mr. Mark Job 1394 25th Street Buffalo, MN 55313
OCT 5 2007
Re: K071347
Trade/Device Name: VAX-D Genesis G2-Dynamic Logarithmic Spinal Decompression System Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: September 19, 2007 Received: September 21, 2007
Dear Mr. Job:
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.
4
Page 2 - Mr. Mark Job
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 (240) 276-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Yorbay Bneems
Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number : ______________________________________________________________________________________________________________________________________________________________
Device Name: VAX-D Genesis G2
Indications for Use:
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with spinal pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the spine that generate localized pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs as well as those with acute facet problems and sciatica.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Copeur ance of CDRH, Office of Device Evaluation (ODE)
Barbara Bucklin
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number K071344/52