3D-SPINE

K962377 · Skill Technologies, Inc. · KQX · Sep 3, 1996 · Orthopedic

Device Facts

• Record ID: K962377
• Device Name: 3D-SPINE
• Applicant: Skill Technologies, Inc.
• Product Code: KQX · Orthopedic
• Decision Date: Sep 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1500
• Device Class: Class 1

Intended Use

3D-SPINE has the same intended use as a predicate device called the CA-6000 Spine Motion Analyzer. 3D-SPINE however, uses a different technological methodology to achieve the same results as the CA-6000. The technology used in the 3D-SPINE is the same as that used in a second predicate device called the CP-2000 Compu-Plotter, a 3D contour plotting and data gathering device. 3D-SPINE combines and produces the desired indications of the CA-6000 by using the superior features of the electromagnetic tracking principle used in the CP-2000.

Device Story

3D-SPINE is a real-time 3D motion analysis system for measuring spinal range-of-motion (ROM). It utilizes a transmitter to generate a low-frequency electromagnetic field and passive 6-degree-of-freedom (6DOF) receivers attached to the patient's head and spine via adhesive tape or straps. The system detects field orientation and strength to calculate x, y, z coordinates and pitch, yaw, and roll angles at 60 samples per second. Data is processed by a PC to generate 3D models, graphs, and tables comparing patient motion to AMA guidelines. Used in clinical settings to document spinal movement during extension/flexion, lateral bending, and rotation. Healthcare providers use the output to assess spinal impairment and monitor patient progress. The system replaces mechanical linkage-based analyzers with non-contact electromagnetic tracking.

Clinical Evidence

Bench testing only. Validation confirmed the system produces reliable and accurate measurements of head orientation during three cervical spine tests. Testing followed AMA guidelines (Version 4.0). Software was verified at unit, integration, and operational levels. No clinical patient trials were reported.

Technological Characteristics

Electromagnetic tracking system; consists of transmitter, passive 6DOF receivers, and PC. Operates via low-frequency electromagnetic field (5-foot radius). Connectivity: PC-based (Pentium 100MHz). Standards: UL, ACGIH, AAMI, NFPA. No sterilization required.

Indications for Use

Indicated for patients requiring dynamic range-of-motion (ROM) testing of the cervical, thoracic, thoracolumbar, and lumbar spine. Contraindicated for patients with metal fittings, plates, braces, or pins (cutaneous or subcutaneous) due to potential interference with electromagnetic measurements.

Regulatory Classification

Identification

A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.

Special Controls

*Classification.* (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of: (i) The performance standard under part 898 of this chapter, and (ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.

Predicate Devices

• CA-6000 Spine Motion Analyzer (K962377)
• CP-2000 Compu-Plotter (K962377)

Submission Summary (Full Text)

{0}

SEP 3 1996
K962377

# SKILL TECHNOLOGIES, INC.
## Innovative Biomechanics & Motion Capture Systems
1202 E. Maryland Ave., Suite 1G Phoenix, Arizona 85014 USA Telephone [phone] & Fax: [phone]

10 June, 1996

This is a summary of safety and effectiveness information included in the 510(k) Premarket Notification for the 3D-SPINE.

**REGULATORY AUTHORITY:** Safe Medical Devices Act of 1990, 21 CFR 807.92

**COMPANY NAME:** Skill Technologies,Inc.
1202 E. Maryland Ave., Suite 1G
Phoenix, Arizona 85014 USA
Telephone [phone] & Fax: [phone]

**COMPANY CONTACT:** Stephen Cheetham
Sales and Marketing Manager

**ESTABLISHMENT REGISTRATION NUMBER:** [00000000]

**DEVICE NAME:** 3D-SPINE A REAL-TIME 3D MOTION ANALYSIS SYSTEM FOR THE Spine

**TRADE NAME:** 3D-SPINE

**COMMON NAME:** Motion Analysis System (3D Dynamic Range-Of-Motion, ROM)

**CLASSIFICATION NAME:** Spine Motion Analyzer. (Medical Device, Medical Examination, AC Powered)

**CLASSIFICATION CODE:** 80KZF $7 K.G.X

**SUBSTANTIALLY EQUIVALENT DEVICES:**
1. Orthopedic Systems Inc.’s CA-6000 Spine Motion Analyzer
2. Heustis Machine Inc.’s CP-2000 Compu-Plotter

**DESCRIPTION OF DEVICE:**

3D-SPINE™ has been developed by Skill Technologies, Inc. as a motion measuring device. 3D-SPINE™ is a real-time three-dimensional motion analysis system that tracks, quantifies, displays and documents the motion of the spine, dynamically, accurately, instantaneously and in three-dimensions. The dynamic tests performed are; extension/flexion, lateral bending and rotation, of the cervical, thoracic, thoracolumbar and lumbar spine.

It has been designed to measure and monitor the three-dimensional angular movement of the human spine. It uses a transmitter to set up a low frequency electromagnetic field, up to a radius of 5 feet from the transmitter. Passive receivers, when brought into range of the transmitter will detect the orientation of the field and the field strength. The receivers will then report x, y and z coordinates, and pitch, yaw and roll angles at a rate of 60 samples per second to a PC computer. The computer then displays the information in the form of 3D models of the head and spine and the angular data in the form of graphs

8-2

{1}

and tables.

CONTRAINDICATIONS AND CAUTIONS. The patient being tested should have no metal fittings, plate, braces or pins, whether cutaneous or subcutaneous. These could affect the measurements. Additional warnings can be found in the Users Manual and the MCU Label attached to the top of the MCU.

## INTENDED USE OF DEVICE:

3D-SPINE has the same intended use as a predicate device called the CA-6000 Spine Motion Analyzer. 3D-SPINE however, uses a different technological methodology to achieve the same results as the CA-6000. The technology used in the 3D-SPINE is the same as that used in a second predicate device called the CP-2000 Compu-Plotter, a 3D contour plotting and data gathering device. 3D-SPINE combines and produces the desired indications of the CA-6000 by using the superior features of the electromagnetic tracking principle used in the CP-2000.

## SYSTEM ELEMENTS:

3D-SPINE (2 Sensor) Hardware Module Includes; Motion Capture Unit Includes; One Transmitter, One Passive 6DOF Receiver/Sensor, Additional Passive 6DOF Sensor, Adjustable Transmitter Support Stand, Adhesive Tape - Packet (Sensor Unit Attachment Tape), Head Sensor Support Strap, User's Manual, PC Computer - Pentium, 100MHz. (Minimum.), Isolation Transformer -- Medical Grade, and Color Ink Jet Printer.

The following items need assembly; The Transmitter Support Stand, the MCU transmitter must be attached to the Transmitter Support Stand, the sensors must be attached to the MCU and the MCU must be attached to the PC computer. Both the PC computer and the MCU must be plugged in to the Isolation transformer. These assembly steps plus diagrams are listed in the Users Manual. The Adhesive Tape and the Head Sensor Support Strap must be attached to the patient when testing.

## INSTRUMENTATION:

There are no system specific special or standard industry instruments necessary for proper use of this device

## PACKAGING:

Each 3D-SPINE system will be shipped in 6 boxes;

| BOX | ITEM | PACKAGING |
| --- | --- | --- |
| 1 | PC computer | Original Manufacturers Box |
| 2 | Monitor | Original Manufacturers Box |
| 3 | MCU (including the transmitter and sensors) | Original Manufacturers Box |
| 4 | Color Ink Jet Printer | Original Manufacturers Box |
| 5 | Transmitter Stand poles | Skill Technologies, Inc.
Custom Tube |
| 6 | Transmitter Support Stand base and transmitter plate and Users Manual | Skill Technologies, Inc.
Custom Box |

The items shipped in the original boxes follow the industry standard of shipping computer items. The 3D-SPINE custom tube and box provide sufficient size and packing to prevent damage during shipping.

## STERILIZATION/RE-STERILIZATION:

{2}

There is no sterilization or re-sterilization necessary for this device.

## TESTING:

All software was tested at unit levels, incremental integration levels and operational levels. The design of the 3D-SPINE is to test the dynamic range of motion of the Cervical, Lumbar, Thoracic and Thoracolumbar spine. Test procedures and requirements were defined using the AMA guidelines as outlined in the American Medical Association -- Guides to the Evaluation of Permanent Impairment, Version 4.0 guide. The document, "Validation of the 3D-SPINE Motion Analysis System for the Spine" confirmed that the system produces reliable and accurate measurements of the orientation of the head during three cervical spine tests. The calculation methodologies used in the 3D-SPINE system are provided and verified.

## EQUIVALENCE:

Skill Technologies, Inc's 3D-SPINE System is a combination of two currently marketed predicate devices:

1. CA-6000 Spine Motion Analyzer with EMG -- Computerized Anatometry Series

The following table summarizes the 3D-SPINE system compared to the CA-6000 Spine Motion Analyzer.

| PARAMETERS | 3D-SPINE | CA-6000 | SUBSTANTIAL EQUIV. |
| --- | --- | --- | --- |
| 6 Degrees of freedom of testing for the spine. | Yes | Yes | Yes |
| Provides Real-time data acquisition | Yes | Yes | Yes |
| Range of Motion (ROM) tests (Cervical, Lumbar, and Thoracic). | Yes | Yes | Yes |
| Real time display of motion as it occurs. | Yes | Yes | Yes |
| Provides progressive testing data for patients. | Yes | Yes | Yes |
| Compares test results to the AMA ROM Guidelines. | Yes | Yes | Yes |
| Data stored in ASCII format for ease of export. | Yes | Yes | Yes |
| Software driven. | Yes | Yes | Yes |
| Custom reports containing text, tables and graphs. | Yes | No | Yes |
| Standard reports containing text, tables and graphs. | Yes | Yes | Yes |
| Calculates acceleration | No | Yes | N/A |
| Calculates velocity | No | Yes | N/A |
| Provides EMG tracking during testing | No | Yes | N/A |
| Follows AMA Range-of-Motion Standards | Yes | Yes | Yes |

The OSI CA-6000 Spine Motion Analyzer is constructed of two interconnected mechanical linkages, joined together at a vertex. The CA-6000 uses head and body harnesses to attach the ends of each of the two mechanical linkages to the head and spine, respectively. Located at the vertex is an electro-mechanical potentiometer. When the subject wearing the device moves the potentiometer detects the physical change in the angle between the two rigid arms and converts it into an electric current. The amount of current generated by the potentiometer determines the angular change that has taken place.

The 3D-SPINE requires that a small passive receiver/sensor be attached to the forehead, using a neoprene head strap, and a second sensor attached at other specified spinal locations, using double-sided adhesive tape. The relative motion of the two sensors, as detected by the change in the field strength and orientation of the magnetic field lines, is compared and the resulting angular changes recorded.

{3}

8-6

adhered to throughout the entire phase of development. These procedure helped to assure that the 3D-SPINE is as safe and effective and substantially equivalent to the CA-6000 Spine Motion Analyzer and the CP-2000 Compu-Plotter. Quality assurance procedures will be continued and maintained with the distribution of the 3D-SPINE.

The 3D-SPINE meets the following standards; UL, ACGIH, AAMI, NFPA.

Stephen Cheetham
Sales and Marketing Manager

Date: 14, June 1996