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.

Device Description

The VAX-D Genesis System is designed to apply distraction tensions to the patient's lumbar spine in order to non-surgically decompress the intervertebral discs. The patient's 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 by a pelvic harness attached to a tensionometer and by the separation of the moveable part of the table. The system is designed to apply tensions to the lumbar spine in a patented logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system is managed on variable 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 in the pelvic belt, 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.

AI/ML Overview

This 510(k) submission (K053503) for the VAX-D Genesis System does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (VAX-D Therapeutic Table, K951622).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample size, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies as these types of studies are not presented.

The device's safety and effectiveness are supported by its substantial equivalence to the predicate device and the claim that the VAX-D therapy has been the "subject of multiple clinical studies examining its effectiveness and mechanisms of action." However, these studies are not described or included within this 510(k) document.

Here's what can be extracted based on the provided text, focusing on how substantial equivalence is argued:

1. A table of acceptance criteria and the reported device performance:
Not applicable. This 510(k) does not present specific acceptance criteria or performance metrics in a study. The argument is based on substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No new performance studies or test sets are described in this 510(k). The document mentions that the VAX-D therapy has been the "subject of multiple clinical studies," but these studies are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No ground truth establishment for a new test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No new test set or adjudication method is described.

5. 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 applicable. This device is not an AI-assisted diagnostic tool, and no MRMC studies are mentioned. It is a physical therapy device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical therapy system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for this 510(k) submission, as it does not detail new clinical studies with defined ground truth. The primary ground for approval is demonstrated prior use and regulatory clearance of a substantially equivalent predicate device. The "intended use" and "indications for use" are based on clinical outcomes associated with the VAX-D therapy, which are presumably supported by the unreferenced "multiple clinical studies."

8. The sample size for the training set:
Not applicable. This 510(k) does not describe an AI model or a training set.

9. How the ground truth for the training set was established:
Not applicable. This 510(k) does not describe an AI model or a training set.

Summary of the K053503 approach to demonstrating safety and effectiveness:

The VAX-D Genesis System's acceptance into the market is based entirely on its substantial equivalence to a previously cleared device, the VAX-D Therapeutic Table (K951622).

Basis for Equivalence:
- Technological Characteristics: The VAX-D Genesis System is described as "essentially the same product" as the predicate device.
- Modifications: VAX-D Medical Technologies "made some modifications to the appearance and components used in the storage of patient data to provide more accurate application of tension, and to provide for the storage of patient data."
- Evaluation of Changes: These changes were "evaluated by VAX-D Medical Technologies and found not to affect the safety or effectiveness of this device."
- Operating Principles: The operating principles (application of controlled distraction tensions to decompress intervertebral discs and spinal structures) are the same as the predicate.
- Safety Features: The "important safety factor is that patients can immediately release all the distraction tensions by simply releasing the hand-grips or by using the quick release buckle in the passive shoulder restraint." This feature is implied to be present and effective in both the predicate and the new device.
- Clinical History (of the therapy, not this specific device): The document states VAX-D therapy has been the "subject of multiple clinical studies examining its effectiveness and mechanisms of action" and that there have been no MDR (Medical Device Reporting) reports of injury over twelve years of contact with clinics administering the therapy. This broadly supports the safety of the underlying VAX-D therapeutic method, which the new device also executes.
Conclusion: Because the new device is fundamentally similar in design, operating principle, and intended use, and its minor modifications do not affect safety or effectiveness, it is deemed substantially equivalent to the predicate, thus meeting the FDA's requirements for 510(k) clearance without requiring a new clinical performance study.

Summary

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K053503

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

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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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).