The Integrity Spinal Care System 3.0 provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Device Description

AI/ML Overview

The Integrity Spinal Care System 3.0 is a spinal decompression device. The provided text indicates that no clinical data was required for its 510(k) clearance, as non-clinical comparisons to its predicate device, the DRX9000 True Non Surgical Decompression System (K060735), demonstrated substantial equivalence. Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is limited to non-clinical testing.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device	Substantial equivalence in principles, characteristics, size, shape, function.	"incorporates the same principles and working characteristics of the predicate devices," and "is same in size, shape and function." "substantially equivalent in form, fit, function and configuration." "essentially the same product as the predicate device."
Component Equivalence to Predicate Device	Similar/same components for treatment and measurement.	"has the same components to the DRX9000 True Non Surgical Decompression System."
Performance in Applying Controlled Tensions	Accurately controlled tensions, smooth and gentle logarithmically applied distraction, smooth logarithmic release rate, cyclic periodicity, upper limits on distractions.	"delivers accurately controlled tensions in the same manner as its predicate device." "smooth and gentle logarithmically applied distraction tensions, the smooth logarithmic release rate of tensions and relaxation cycles, the cyclic periodicity, the upper limits on distractions."
Safety Features	Inclusion of a patient safety switch.	"patients hold a patient safety switch to allow at anytime the pausing of any tensile forces." "patients can stop the treatment by pressing the patient hand held safety switch."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	"The device is in compliance with the following safety standards: ... IEC 60601-1-2:2001 Medical Electrical Equipment Part 1 2: General requirements for ● Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests."
Electrical Safety	Compliance with IEC 60601-1.	"The device is in compliance with the following safety standards: ... IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988: Amendment 1, 1991-11, Amendment 2, 1995."
Risk Management	Application of risk management to medical devices (ISO 14971).	"The Integrity Spinal Care System has been reviewed for risk management utilizing ISO 14971:2007, Application of risk management to medical devices ensuring all aspects of the device are reviewed for potential hazards."
Tension Measurement Accuracy	Displayed tension readings comparable to calibrated dynamometer and predicate devices.	"Measurements of tension demonstrate that the tension readings displayed and noted from the calibrated dynamometer are comparable to predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of clinical data for this 510(k). The non-clinical testing involved a "calibrated dynamometer" to stimulate a patient, implying a hardware-based test rather than a patient dataset. The sample size for this non-clinical test is not specified, but it refers to a device-to-device comparison and standard compliance tests.
Data Provenance: Not applicable for clinical data. For non-clinical tests, the data was generated internally by the applicant (Integrity Life Sciences) and/or by an "independent party" for evaluation of modifications to appearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as no clinical ground truth was established for the 510(k) clearance. The determination of substantial equivalence was based on non-clinical engineering and performance comparisons.

4. Adjudication Method for the Test Set

Not applicable as no clinical ground truth was established.

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 a physical traction system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical traction system, not an algorithm, and its performance is inherently "standalone" in the sense that its mechanical operation is evaluated independently of a human interpreter.

7. The Type of Ground Truth Used

For functional and performance characteristics, the "ground truth" was established by comparison to the predicate device (DRX9000 True Non Surgical Decompression System) and compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 14971). The accuracy of tension display was verified against a calibrated dynamometer.

8. The Sample Size for the Training Set

Not applicable as no machine learning algorithm was involved, and thus no training set was used.

9. How the Ground Truth for the Training Set was Established

Not applicable as no machine learning algorithm was involved.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Integrity Life Sciences. The word "INTEGRITY" is in bold, block letters, with a plus sign above the "I" and a plus sign replacing the dot on the "I". To the right of the word is a black cross with a spine superimposed on it, and below the word is the phrase "LIFE SCIENCES" in smaller, block letters.

K130249 510(k) Summary As required by section 807.92(c)

Device Description:

Device Trade Name: Model Number Common Name: Classification Name: Classification Panel: Class and Reference Product Code:

Integrity Spinal Care System 3.0 ICSC 3.0 Traction Equipment Power Traction Equipment Physical Medicine Class II (21 CFR Section 890.5900) 89 ITH

Applicant/Official Contact Person:

James J. Gibson, Jr. Integrity Life Sciences Tel. (813) 935-5500 / Fax (935) 5505

Submitter /Manufacturer:

(This is the only manufacturing site.)

Integrity Life Sciences 2189 West Busch Blvd Tampa, Florida 33612 Tel. (813) 935-5500 / Fax (935) 5505

Prepared on

December 30th 2013

Conforming Standards:

EMC: IEC 60601-1 2nd Edition: 1988 IEC 60601-1-2 2nd Edition: 2001 ISO 14971 : 2007

Predicate Devices:

Integrity Life Sciences is making the claim that Integrity Spinal Care System is substantially equivalent to the predicate devices listed below:

Legally MarketedPredicate Device	ManufactureName	Regulatory Classand Product Code	510(K)RegistrationNumber
DRX9000 True NonSurgicalDecompressionSystem	Axiom Worldwide,LLC.	Class II/ITH	K060735

FEB - 6 2014

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Technological Characteristics

The Integrity Spinal Care System 3.0 incorporates the same principles and working characteristics of the predicate devices, the DRX9000 True Non Surgical Decompression System (K060735) and is same in size, shape and function. The components of The Integrity Spinal Care System 3.0 are substantially equivalent in form, fit, function and configuration to its predicate device the DRX9000 True Non Surgical Decompression System (K060735).There are similar key design technical characteristics; multi-function table designed to applied distraction forces and controlled by a computer console, same/similar components for treatment and measurement; similar size, power source, and performance. The Integrity Spinal Care System 3.0 is essentially the same product as the predicate device the DRX9000 True Non Surgical Decompression System (K060735), however, Integrity Life Sciences has made some modifications to the appearance. Those changes were evaluated by an independent party, through testing, and found not to impact the safety and effectiveness of this device. The Integrity Spinal Care System 3.0 has the same components to the DRX9000 True Non Surgical Decompression System (K060735) and has proven to be safe through testing.

The Integrity Spinal Care System 3.0 delivers accurately controlled tensions in the same manner as its predicate device the DRX9000 True Non Surgical Decompression System (K060735) designed to relax paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. Integral to effective spinal decompression and included in the Integrity Spinal Care System 3.0 and its predicate device the DRX9000 True Non Surgical Decompression System (K060735) are continuous load-cell tensile feedback into the treatment computer, dedicated and matched servoamplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating lower body mattress. An important safety feature designed into The Integrity Spinal Care System 3.0 and its predicate the DRX9000 True Non Surgical Decompression System (K060735) is patients hold a patient safety switch to allow at anytime the pausing of any tensile forces.

Summary of Safety and Effectiveness

The operating principles of the Integrity Spinal Care System 3.0 is similar/same the DRX9000 True Non Surgical Decompression System (K060735) which permit the application of accurately controlled distraction to the lumbar spine in order to decompress the intervertebral discs and spinal structures. Disc decompression is defined as unloading due to distraction and positioning. The important basic parameters contributing to the safety and effectiveness of the device 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 distractions, and in additions, the positioning of the patient and the means of fixing the upper body. The important safety factor is patients can

stop the treatment by pressing the patient hand held safety switch.

Proposed Intended Use

The INTEGRITY CARE SYSTEM 3.0 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 INTEGRITY CARE SYSTEM 3.0 and is designed to provide static,

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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.

Indications for use

The INTEGRITY CARE SYSTEM 3.0 provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Non-clinical Tests:

The Integrity Spinal Care System 3.0 is as safe and effective as the predicate device demonstrating compliance to FDA recognized Consensus Standards. A calibrated dynamometer was placed between the tower and bed to stimulate a patient. Measurements of tension demonstrate that the tension readings displayed and noted from the calibrated dynamometer are comparable to predicate devices.

The device is in compliance with the following safety standards:

IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988: Amendment 1, 1991-11, Amendment 2, 1995
IEC 60601-1-2:2001 Medical Electrical Equipment Part 1 2: General requirements for ● Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests
. The Integrity Spinal Care System has been reviewed for risk management utilizing ISO 14971:2007, Application of risk management to medical devices ensuring all aspects of the device are reviewed for potential hazards

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Conclusion:

The non clinical comparisons of the Integrity Spinal Care System 3.0 to its predicate device the DRX9000 True Non Surgical Decompression System (K060735) demonstrates that the proposed device is substantially equivalent in the areas technical characteristics, general function, application, intended use, indications for use, and performance testing data. No clinical data was required for this 510(k) clearance. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2014

Integrity Life Sciences James J. Gibson, Jr., Ph.D 2189 W Busch Blvd. Tampa, FL 33612

Re: K130249

Trade/Device Name: Integrity Spinal Care System 3.0 Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II Product Code: ITH Dated: December 30, 2013 Received: January 2, 2014

Dear Dr. 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2 - James J. Gibson, Jr., Ph.D

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carlos LíPeňa -S

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130249

Device Name: .. . Integrity Spinal Care System 3.0

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Carlos L. Penä¬SA

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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).