1.5T SCANMED PV ARRAY

K022395 · Medic, Inc. · MOS · Aug 13, 2002 · Radiology

Device Facts

• Record ID: K022395
• Device Name: 1.5T SCANMED PV ARRAY
• Applicant: Medic, Inc.
• Product Code: MOS · Radiology
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Soft tissue and bone imaging of both lower extremities simultaneously as allowed by the MRI system. Magnetic resonance peripheral angiography.

Device Story

1.5T ScanMed PV Array is a receive-only MRI accessory coil designed for use with GE 1.5 Tesla Signa systems. Device collects peripheral vascular image data via three overlapping coil groups. Multi-channel design utilizes standard GE phased array coil inputs and configuration files. Coil geometry facilitates close coupling to patient anatomy; includes comfort pad set. Operated by MRI technicians/radiologists in clinical settings. Device acts as a passive antenna to receive RF signals; no energy is imparted to the patient. Output is raw image data processed by the host MRI system to generate diagnostic images for clinical decision-making regarding musculoskeletal and vascular conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Receive-only multi-channel MRI antenna (coil). Multi-element design with overlapping coil groups. Interfaces with GE 1.5T Signa systems using standard phased array inputs. Passive device; no energy imparted to patient. Form factor optimized for lower extremity anatomy.

Indications for Use

Indicated for soft tissue and bone imaging of both lower extremities simultaneously, including both knees and/or ankles, and for magnetic resonance peripheral angiography from the inguinal canal distally to the feet.

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

• Lower Extremity Quadrature Detection Array (K933659)

Submission Summary (Full Text)

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K02 23 95

Image /page/0/Picture/1 description: The image shows the logo for Scan Med of Medic, Inc. The logo features a stylized "S" with a symbol inside it. To the right of the logo is the date "AUG 1 3 2002".

"Reducing the cost of Health care through the manufacturing of Quality, Economical Products"

## 510(k) Summary

| 1. | Manufacturer name & address: | MEDIC Inc.<br>6912 N. 97th Circle, Suite C<br>Omaha, NE 68122 |
|----|--------------------------------------------------------------|---------------------------------------------------------------|
| | Establishment Registration No.: | 1932898 |
| | Applicant/Contact Person: | Randall Jones, Dr.Eng. |
| | Applicant Contact Info : | Ph : 402-571-3271 |
| | | Fax : [phone] |
| | | Email : |
| | Date Prepared : | 15 July 2002 |
| 2. | Device common name : | MRI Accessory\ Coil |
| | Specific Device Tradename : | 1.5T ScanMed PV Array |
| | Classification: | Class II/Radiology/LNH |
| 3. | Unmodified Device Tradename:<br>Array Coil Model # 100GE1500 | Lower Extremity Quadrature Detection |
| | Unmodified Device 510(k) No. | K933659. |

4. Device Description: The 1.5T PV Array, Catalog #155GE1501, interfaces with the G.E. 1.5 Tesla Signa® system. It has been designed and optimized to collect peripheral vascular image data in three overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inputs and utilizes standard coil configuration files available on the G.E. Signa® Plasma or Mouse-Driven Screen. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.

- ડ. Intended Use Statement:
Soft tissue and bone imaging of both lower extremities simultaneously as allowed by the MRI system.

Magnetic resonance peripheral angiography.

Note that the intended use is not susbstantively different than that of the unmodified device (below).

> Musculoskeletal: Soft tissue and bone imaging of both lower extremities: simultaneous imaging of both knees and/or ankles. Magnetic Resonance Angiography: Peripheral arterial studies from the inguinal canal distally to the feet.

6. The modified device has the same technological characteristics as the unmodified device with only minor changes to the size and physical orientation of the individual elements of the multi-element or multi-channel MRI antenna (coil). The materials, use, and safety features are equivalent. Both are receive-only MRI antennas so no energy is imparted to the patient.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Randall W. Jones, Dr. Eng. President MEDIC, Inc. 6912 North 97th Circle Suite C OMAHA NE 68122

## Re: K022395

Trade/Device Name: 1.5T ScanMed PV Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: July 15, 2002 Received: July 23, 2002

Dear Dr. Jones:

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 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.

AUG 13 2002

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Henry C. 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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## Appendix A

## Statement of Indications for Use

The new device labeled the 1.5T ScanMed PV Array will have no substantive change in the Indications for Use over the predicate (unmodified) device, Lower Extremity Quadrature Detection Array (k933659).

The intention of the new device is to expand the anatomical coverage provided by the device by modifying the patient-user interface in terms of altering the size and anatomical location of some of the array's individual resonators, as well as adding. resonators.

The Intended Use Statements remain virtually identical to those of the Unmodified device. These statements follow.

- Soft tissue and bone imaging of both lower extremities simultaneously as . allowed by the MRI system.
- Magnetic resonance peripheral angiography. .

*Prescription Use*

David A. Seymon

(Division Sian-Of Division of Reproductive and Radiological Devic 510(k) Number

102 2395