(12 days)
Not Found
No
The description focuses on mechanical distraction and a patented logarithmic time/force curve, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive learning.
Yes
The device description and intended use clearly state that this therapy is for the management of pain and disability for patients suffering from various conditions involving the lumbar spine, specifically to decompress intervertebral discs. This directly addresses medical conditions and provides a therapeutic effect.
No
The device description clearly states its purpose is to "apply distraction tensions to the patient's lumbar spine in order to non-surgically decompress the intervertebral discs" and "provides a primary treatment modality." There is no mention of it being used to diagnose conditions; rather, it is a therapy device.
No
The device description clearly describes a physical table with mechanical components (split table design, tensionometer, handgrips, shoulder restraint) used to apply physical distraction tensions to the patient's spine. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapy for managing pain and disability related to low back pain and spinal injuries. This is a therapeutic intervention, not a diagnostic one.
- Device Description: The device description details a system designed to apply distraction tensions to the lumbar spine to decompress intervertebral discs. This is a physical treatment method.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is to apply a physical force for therapeutic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The VAX-D Genesis System is designed to relieve pressure on structures that may be causing low back pain and sciatica. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome, and radicular pain. The application of logarithmic distraction decompression is achieved non-surgically through the application of logarithmic distraction forces to the VAX-D protocol.
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with 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 as well as those with acute facet problems and sciatica.
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging discs, degenerative disc disease, posterior facet syndrome, and sciatica.
Product codes (comma separated list FDA assigned to the subject device)
ITH
Device Description
The VAX-D Genesis System is designed to apply distraction tensions to the patient's lumbar spine in order to hon-surgically decompress the intervertebral discs. The patient upper body is positioned on the stationary portion of the table and is restrained by the patient holding on to adjustable handgrips, or by the use of a passive shoulder restraint. The table is a split table design, whereby distraction tensions are applied to the patient first via a pelvic harness attached to a tensionometer and by the separation of the movable part of the table. The system is designed to apply tensions to the spinal structures in a managed logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system provides for timed 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 simply raise their arms to release. Distraction tensions and rates are continuously monitored and measured by the tensionometer and a computer system which continuously processes the input data and adjusts the tension to produce a patented logarithmic decompression 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 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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 Therapeutic Table (K951622)
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
OEC 2 8 2005
FDA 510(k) ___________________________________________________________________________________________________________________________________________________________________
VAX-D GENESIS SYSTEM
SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION 1.
VAX-D MEDICAL TECHNOLOGIES LLC. 310 Mears Blvd Oldsmar, FL 34677
Telephone: (813) 343-5000 (813) 343-5005 Facsimile:
SPONSOR ESTABLISHMENT REGISTRATION NUMBER(s): 2.
- 1058809 Owner ID No. 9031244
OFFICIAL CONTACT PERSON 3.
Dr. Lawrence A. Dyer Telephone: (813) 343-5000 Facsimile: (813) 343-5005
- DATE OF PREPARATION OF SUMMARY: October 21, 2005 4.
DEVICE INFORMATION 5.
- DEVICE PROPRIETORY NAME: A
- CLASS AND REFERENCE: B.
- PRODUCT CODE: ்.
- PANEL CODE: D
VAX-D Genesis System Class II (21CFR Section 890.5900) 89 ITH 87OR
- PREDICATE DEVICE: VAX-D Therapeutic Table (K951622) 6.
DEVICE DESCRIPTION 7.
The VAX-D Genesis System is designed to apply distraction tensions to the patient's lumbar The VAX-D Genesis System is designed to apine and intervertebral discs. The patient spine in order to hon-surgically decompress the upper body is positioned on the stationary portion of the table and is restrained by the patient holding on to adjustable stationary portion of the table and is restraint. The table is a split table design, handgrips, or by the use of a passive should for the patient first a pelvic harness attached to whereby distraction tensions are applied to the part of the table. The system is
a tensionometer and by the separation of the movebble part of the force curve that a tensionometer and by the separation of the moved logarithmic time/force curve that designed to apply tensions to the finited spins in a shown is a managed on variable a allows trunk and paraspinal muscles to relax. "The bytter." Pro no handgrips which can
timed distraction-relaxation cycles. For safety the patient holds on to handgrips whic
1
be released at any time to end the session and restore full relaxation. The patient may
ly buckle, or be released at any time to end the session and Testore rain rolexicon in and memor and rates, or
choose to use a passive shoulder restraint that utilizes a patient 'quick rel choose to use a passive shoulder restraint that thires and rates are continuously
they may simply raise their arms to release. Distraction tensions and rates are continuout i they may simply raise their arms to release. Disulation tensible list.
monitored and measured by the tension continues who belt, and adjusts the monitored and measured by the tensioneries in the politic data and adjusts the
monitored by a computer system which continuously procession curve. The chart recording monitored by a computer system which continued by the chart recording of the chart recording
tension to produce a patented logarithmic decompression curves part of the tension to produce a patented l'ogarithmic decompression our vol.
produced is a permanent record of the treatment parameters which becomes part of the patient's chart.
INTENDED USE 8.
The VAX-D Genesis System is designed to relieve pressure on structures that may be
r in the supportunity the significalisms the nein associated with herniated discs, The VAX-D Genesis System is designed to relieves the own associated with herniated discos,
causing low back pain and sciatica. It relieves the pain associated with hernial di causing low back pain and sciences the pain addoclutes and includes and included and degenerative disc disease, posterior racer synutionel paintent partication of logarithmic distraction
decompression is achieved non-surgically through the application of loga decompression is achieved non cargroum, to the VAX-D protocol.
INDICATIONS FOR USE 9.
This therapy provides a primary treatment modality for the management of pain and
ers in a disability for patients suffering with low beek pain. It has been found to provide relief in a
disability for patients suffering with micel dysfundings of the lumbar spine th disability for patients suffering with low back pain. " it' has been repine that generate
variety of conditions involving anatomical dysfunctions of the the generate with variety of conditions involving anatomical rysiuling patients with protruding or
localized low back pain as well as peripheral radiation, including patients with protruction localized low back pain as well as penpheral radiation, welcome problems and sciatica.
herniated intervertebral discs as well as those with acute facet problems and sciatica.
TECHNOLOGICAL CHARACTERISTICS 10.
The VAX-D Genesis System is essentially the same product as the predicate device, The VAX-D Genesis System is essentially the Sainc prochor do an and some
the VAX-D Therapeutic Table (K951622). VAX-D Medical Technologies has made some the VAX-D Therapeutic Table (K951622). VAX-D Medical Houlders (18) 10) Therapeutic Table to
modifications to the appearance and components used in the storage of patient data modifications to the appearance and components used in the storage of patient data.
provide more accurate application of tension, and to provide for the storage of patient no provide more accurate application of tellsion, and to provide for the compress.
Each of these changes was evaluated by VAX-D Medical Technologies and found not to
f finese ch Each of these onlanges was effectiveness of this device.
SUMMARY OF SAFETY AND EFFECTIVENESS 11.
The operating principles of the VAX-D Genesis System permit the application of
the operating principation in the durches anine in order to decompress the The operating principles of the VAX-D Senests syine in order to decompress the accurately controlled distraction tensions of the imperient basic parameters contributing to
intervertebral discs and spinal structures . The important pasic logarithmically intervertebral discs and spinal structures. The information of gentle logarithmically
the safety and effectiveness of the device include the smooth and relaxation the safety and effectiveness of the device include and of tensions and relaxation applied distraction tensions, the smoul rioganimite rensions of one-hundred pounds,
cycles, the cyclic periodicity, the upper in it on distraction tensions of tying the upper cycles, the cyclic periodicity, the upper ilini on unstractive of the upper body. An and in addition, the positioning of the patients on the mounts on the simply
important safety factor is that patients can immediately release all the passive shoulder important safety factor is that patients can inninediately follower shoulder releasing the hand-grips or by using the quick release backle in the pro
2
subject of multiple clinical studies examining its effectiveness and mechanisms of action.
The states of the United Transaccine maintains contact with the clinics administeri subject of multiple clinical studies examing its enimiss and incontribution the clinics and the VAX-D therapy Medical Technologies maintains contact with the binness of any and over the agent filed,
therapy, and over the past twelve years, not a single MDR report of inj therapy, and over the past the past they which reflects 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2005
VAD-D Medical Technology Services, LLC % Mark Job Responsible Third Party Regulatory Technology Services, LLC 1394 25th Street N. N. Buffalo, Minnesota 55313
Re: K053503
Trade/Device Name: VAX-D Genesis System Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: December 13, 2005 Received: December 16, 2005
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
This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket notification. The FDA finding of substantial equivalence of your device to a legally prerketed 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 its toll-free number (800) 638 2041 or (301) 443 6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Harbare BuiehuD
fr
Mark N. Melkerson Acting 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 (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VAX-D Genesis System
Indications for Use:
This therapy provides a primary treatment modality for the management of pain and disability for patients sumering will micapacitive injuries of the spine. It has
apply decompressive forces to compressive and degenerative injuries of the spire. It has apply decompressive forces to compressive with herniated discs, bulging or been found to provide relier of pain and symptoms association fromation of and submitted and sciatica.
AND/OR Prescription Use __ X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
charlare Buchu
Division of General, Restorative and Neurological Devices
Page 1 of 1 __
510(k) Number. K053503