CHOY COMPRESSION FRAME

K070968 · Choy Medical Technologies, Inc. · LNH · Nov 15, 2007 · Radiology

Device Facts

• Record ID: K070968
• Device Name: CHOY COMPRESSION FRAME
• Applicant: Choy Medical Technologies, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Choy Compression Frame is indicated as an accessory for axial compression of the lumbar spine in CT and MR diagnostic imaging.

Device Story

The Choy Compression Frame is an accessory for CT and MR imaging systems. It consists of a fabric shoulder harness with straps and an MRI-compatible aluminum frame assembly connected to a pneumatic pump. During imaging, the device is used to apply axial compression to the patient's lumbar spine, which increases intradiscal pressure. This mechanical loading is intended to improve the sensitivity of MR diagnoses by better correlating presenting symptoms with imaging findings. The device is operated in a clinical imaging environment. It does not cause image distortion during MRI procedures.

Clinical Evidence

Clinical testing demonstrated the device's effectiveness in increasing the sensitivity of MR diagnoses by matching presenting symptoms with MR findings. Testing confirmed no MRI image distortion occurred due to device materials.

Technological Characteristics

Fabric shoulder harness with straps; MRI-compatible aluminum frame assembly; pneumatic pump for force application. Operates via mechanical axial compression to increase intradiscal pressure. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring axial compression of the lumbar spine during CT or MR diagnostic imaging to increase intradiscal pressure.

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

• DynaWell axial compression frame (K992120)

Submission Summary (Full Text)

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K070968
Page 1 of 2

## 510(k) SUMMARY

Choy Medical Technologies, Inc. Choy Compression Frame

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Choy Medical Technologies 66 East 80th Street New York, NY 10012

Phone: [phone] Facsimile: 212-517-372

NOV 1 5 2007

Contact Person: Daniel S. J. Choy, M.D.

Date Prepared: April 5, 2007

## Regulatory Counsel

Jonathan S. Kahan. Esq. 555 Thirteenth Street, NW Washington, D.C. 20004

Phone: [phone] Facsimile: 202-637-5910

## Name of Device and Name/Address of Sponsor

Choy Compression Frame

## Common or Usual Name

Axial compression frame

## Classification Name

Accessory to Magnetic Resonance Imaging

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KC70862
Page 1 of 2

#### Predicate Devices

DynaMed AB's DynaWell axial compression frame (K992120)

#### Intended Use / Indications for Use

The Choy Compression Frame is indicated as an accessory for axial compression of the lumbar spine in CT and MR diagnostic imaging.

#### Technological Characteristics

The Choy Compression Frame consists of a fabric shoulder harness with straps and an MRI-compatible aluminum frame assembly with pneumatic pump. The pneumatic pump operates to apply a force to the patient and thus raise the patient's intradiscal pressure.

## Performance Data

Clinical testing demonstrated the effectiveness of the Choy Compression Frame in increasing the sensitivity of MR diagnoses in matching presenting symptoms with MR findings without resulting in MRI image distortion from the device material.

#### Substantial Equivalence

The Choy Compression Frame is as safe and effective as the DynaWell compression device. The Choy Compression Frame has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. Minor technological differences between the device and its predicate raise no new issues of safety or effectiveness. Performance testing demonstrates the effectiveness of the device in increasing the sensitivity of MR diagnoses without producing distortion in the MRI images. Thus, the Choy Compression Frame is as safe and effective as the predicate and thus, substantially equivalent.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 a stylized symbol featuring three abstract shapes that resemble human figures or waves, arranged in a vertical stack.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 5 2007

Choy Medical Technologies, Inc. % Mr. Jonathan S. Kahan Official Correspondent Hogan & Hartson LLP Columbia Square 555 Thirteenth Street, NW WASHINGTON DC. 20004

Re: K070968

Trade/Device Name: Choy Compression Frame Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 18, 2007 Received: October 18, 2007

#### Dear Mr. Kahan:

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.

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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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

长070968 510(k) Number (if known):_

Device Name: Choy Compression Frame

Indications for Use:

The Choy Compression Frame is indicated as an accessory for axial compression of the lumbar spine in CT and MR diagnostic imaging.

Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lozn Nn Vha

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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