JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031

K982761 · Chamco, Inc. · LNH · Oct 22, 1998 · Radiology

Device Facts

• Record ID: K982761
• Device Name: JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031
• Applicant: Chamco, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Joint Motion Devices are an accessory to MRI diagnostic devices, including the Hitachi AIRIS™, Siemens Magnatom™, Toshiba OPART™ Picker Outlook™, Fonar, and GE Medical Systems Open MRI systems. In addition, the devices may be used in any MRI system where the physical limits of the bore size is not a constraint. The devices are built from plastics and nonferromagnetic materials, and hold patients securely during MRI imaging sequences. The devices also constrain joint motion to one of several user-designated planes of rotation, dependant upon the joint to be imaged, and emulate the natural motion of the joint. The Joint Motion Devices increase the clinical utility of MRI systems to provide high quality, repeatable imaging and constraint for the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies to enable fixed position imaging, and kinematic (incremental stepped) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, and dynamic (continuous) motion of the knee, cervical spine, ankle, wrist , lumbar spine, hip and shoulder joint anatomies. The devices will enable the physician to evaluate the anatomy of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, in a static mode as well as to evaluate the dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such functional interaction may be useful in diagnosis. The intended patients are primarily drawn from a pool of those subjects undergoing diagnostic evaluation by physicians who are skilled in diagnosis and treatment of the disease process(es) under consideration.

Device Story

Joint Motion Devices are non-ferromagnetic, plastic accessories for MRI systems; designed to hold patients securely during imaging. Devices provide constraint for knee, cervical spine, ankle, wrist, lumbar spine, hip, and shoulder; enabling fixed-position, kinematic (incremental), or dynamic (continuous) motion during scans. Operated manually by clinicians in MRI suites; no motors or active components. By emulating natural joint motion, devices allow physicians to evaluate dynamic tissue interactions (ligaments, cartilage, bone, muscle, fat) in addition to static anatomy. Output is high-quality, repeatable MRI imagery used to inform clinical diagnosis of joint-related disease processes.

Clinical Evidence

Bench testing only. Testing confirmed form, fit, function, and that the devices do not adversely affect the magnetic field for imaging.

Technological Characteristics

Manually operated, non-ferromagnetic plastic joint positioning accessories. No active components (motors) or ferromagnetic materials. Designed for use with open MRI systems and high-tesla magnets where bore size permits. Standalone mechanical devices.

Indications for Use

Indicated for patients undergoing MRI diagnostic evaluation of the knee, cervical spine, ankle, wrist, lumbar spine, hip, or shoulder. Used to provide fixed-position, kinematic (stepped), or dynamic (continuous) imaging of joint tissues (ligaments, cartilage, bone, muscle, fat) to assist physicians in diagnosing functional interactions. No specific age or gender contraindications stated.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Hitachi Medical Systems America, Inc. (K953918)

Submission Summary (Full Text)

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OCT 22 1998

. . . . . . . .

Image /page/0/Picture/1 description: The image shows the word "CHAMCO" in a bold, serif font, with a five-pointed star above the letters "HA". To the right of the word "CHAMCO" is the abbreviation "INC.", which is smaller than the main word. The star is black and solid, and the letters are also black. The overall design is simple and corporate.

American Made Medical Products

# 510(k) Summary

长982761

# 1. Submitter Information

CHAMCO, Inc. 1.1 Submitter: 798 Clearlake Road Cocoa, Fl 32922 Owner/operator number: 9034336 David P Salvadorini 1.2 Contact: PH: 407-774-4488 FX: 407-774-0599 email: [e-mail]

- August 4, 1998 1.3 Date:
# 2.0 Device Name

| 2.1 | Classification Panel: | Radiology |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 2.2 | Classification Number: | 892.100 Magnetic Resonance Diagnostic Device |
| 2.3 | Product Number: | 90LNH |
| 2.4 | Product Nomenclature: | System, Nuclear Magnetic Resonance Imaging, Accessory |
| 2.5 | Device Classification: | II |
| 2.6 | Performance Standards: | None established under section 514 of the Food, Drug and Cosmetic Act |
| 2.7 | Trade Name: | Joint Motion Devices |
| | 2.7.2 Knee/Cervical Joint Motion Device<br>2.7.3 Lumbar Joint Motion Device<br>2.7.4 Wrist Joint Motion Device<br>2.7.5 Ankle Joint Motion Device<br>2.7.6 Shoulder Joint Motion Device | P/N 1026<br>P/N 1027<br>P/N 1028<br>P/N 1029<br>P/N 1030 |

798 Clearlake Road • Cocoa, Florida 32922 • Phone [phone] • Fax [phone]

E -

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| 2.7.7 Hip Joint Motion Device | P/N 1031 |
|------------------------------------|----------|
| 2.7.8 Joint Motion Device Package* | P/N 1032 |
| 2.7.9 Storage Cabinet | P/N 1033 |

*Includes all devices plus the storage cabinet

#### 3.0 Predicate Device

3.2

- 3.1 K953918
Hitachi Medical Systems America, Inc. Manufactured by CHAMCO. Inc.

- 3.3 Sept. 12, 1995
- 3.4 Regulatory Class II
- 3.5 21 CFR 892.1000/Procode: 90LNH

Joint Motion Devices

- These devices are identical to the predicate device. CHAMCO and Hitachi 3.6 Medical Systems America, developed these devices together. CHAMCO has been the only manufacturer of these devices. CHAMCO intends to market these devices under its own name, and has adequate information demonstrating its legal right to distribute these devices.
#### 4.0 Device Description

- 4.1 Function
The Joint Motion Devices provide constraint for the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies to enable fixed position imaging, and kinematic (incremental stepped) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, and dynamic (continuous) motion of the knee, cervical spine, ankle, wrist , lumbar spine, hip and shoulder joint anatomies. Form, fit and function, as well as a determination that the devices do not adversely affect the magnetic field for imaging has been tested.

The Joint Motion Devices add clinical utility to all known open MRI diagnostic devices, including the Hitachi AIRISTM, Siemens Magnatom™, Toshiba OPART™, and Picker, Fonar, Phillips and GE Medical Systems Open MRI systems. In addition, several of the devices have use in higher tesla magnets where bore size is not a constraint.

- 4.2 Scientific Concepts
Identical to the predicate device

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### 4.3 Physical and Performance Characteristics

Identical to the predicate device

#### 5.0 Device Intended Use

Identical to the predicate devices will enable the physician to evaluate the anatomy of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, in a static mode as well as to evaluate the dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such functional interaction may be useful in diagnosis.

### 6.0 Technological Characteristics

Identical to the predicate device. The devices are manually operated by the user. No active components (i.e. motors) are used and there are no ferromagnetic materials that could affect the scan field.

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Image /page/3/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and healing. The caduceus is composed of three human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 1998

David P. Salvadorini Director of Marketing Chamco. Inc. 798 Clearlake Road Cocoa, FL 32714

Re:

K982761 Joint Motion Devices Package for MRI Dated: August 4, 1998 Received: August 6, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Salvadorini:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for-use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device; please contact the Office of Compliance at [phone]. Also, please mote the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html",

Sincerely yours,

William Yip

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Ver/3- 4/24/96 | Indications for Use Statement | |
|-----------------|------------------------------------|----------|
| Applicant: | CHAMCO, Inc. | |
| | 798 Clearlake Road | |
| | Cocoa, Fl 32922 | |
| | Owner/operator number: 9034336 | |
| | David P Salvadorini | |
| | PH: 407-774-4488 | |
| | FX: 407-774-0599 | |
| | email: [e-mail] | |
| 510 (k) Number: | K982761 | |
| Device Name: | Joint Motion Device | |
| | Knee/Cervical Joint Motion Device | P/N 1026 |
| | Lumbar Joint Motion Device | P/N 1027 |
| | Wrist Joint Motion Device | P/N 1028 |
| | Ankle Joint Motion Device | P/N 1029 |
| | Shoulder Joint Motion Device | P/N 1030 |
| | Hip Joint Motion Device | P/N 1031 |
| | Joint Motion Device Package* | P/N 1032 |
| | Storage Cabinet | P/N 1033 |

*Includes all devices plus the storage cabinet

Indications for Use:

The Joint Motion Devices are an accessory to MRI diagnostic devices, including the Hitachi AIRIS™, Siemens Magnatom™, Toshiba OPART™ Picker Outlook™, Fonar, and GE Medical Systems Open MRI systems. In addition, the devices may be used in any MRI system where the physical limits of the bore size is not a constraint.

The devices are built from plastics and nonferromagnetic materials, and hold patients securely during MRI imaging sequences. The devices also constrain joint motion to one of several user-designated planes of rotation, dependant upon the joint to be imaged, and emulate the natural motion of the joint.

The Joint Motion Devices increase the clinical utility of MRI systems to provide high quality, repeatable imaging and constraint for the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies to enable fixed position imaging, and kinematic (incremental stepped) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, and

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dynamic (continuous) motion of the knee, cervical spine, ankle, wrist , lumbar spine, hip and shoulder joint anatomies.

The devices will enable the physician to evaluate the anatomy of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, in a static mode as well as to evaluate the dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such functional interaction may be useful in diagnosis.

The intended patients are primarily drawn from a pool of those subjects undergoing diagnostic evaluation by physicians who are skilled in diagnosis and treatment of the disease process(es) under consideration.

David C. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

Concurrence of CDRH, Office of Device Evaluation, (ODE)

Prescription use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

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