MACHNET CAROTIDS COIL ARRAY ASSEMBLY

K012491 · Machnet BV · MOS · Oct 24, 2001 · Radiology

Device Facts

• Record ID: K012491
• Device Name: MACHNET CAROTIDS COIL ARRAY ASSEMBLY
• Applicant: Machnet BV
• Product Code: MOS · Radiology
• Decision Date: Oct 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. Anatomic Regions: Head and Neck Vasculature.

Device Story

Receive-only phased array RF coil assembly; used with MRI scanners (e.g., GE Signa series) to capture hydrogen proton signals from head and neck vasculature. Device consists of four overlapping coils connected to a quick-disconnect interface; utilizes PIN diodes for active decoupling during transmit phase and fast-switching crossed diodes for passive detuning to ensure safety. Includes 'bazooka baluns' on transmission lines to minimize outer braiding currents. Coil geometry optimized for sensitivity within 35mm of surface with sharp cutoff beyond 40mm to reduce noise from outside regions of interest. Operated by MRI technicians/radiologists in clinical imaging settings; output is raw MR signal data processed by the scanner into diagnostic images for physician interpretation. Facilitates visualization of carotid anatomy to assist in clinical diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Four-element phased array receive-only RF coil. Features PIN diode active decoupling, crossed-diode passive detuning, and bazooka baluns for coaxial cable current suppression. Designed for 1.0T and 1.5T MRI systems. Non-invasive, passive hardware component.

Indications for Use

Indicated for use with Magnetic Resonance Imaging (MRI) systems to produce diagnostic images of carotid arteries and associated vasculature (aortic arch through Circle-of-Willis) in patients requiring head and neck vascular imaging. For use by trained physicians.

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

• USA Instruments Hi-Res 9000 Phased Array Carotid Coil (K001210)

Submission Summary (Full Text)

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K012491

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OCT 2 4 2001

#### EXHIBIT 2

MACHNET BV PO BOX 85444 NL-3508 AK UTRECHT THE NETHERLANDS

## AMERSFOORTSEWEG 24 A NL-3951 LB MAARN

# PHONE [phone] FAX [phone] Contact: Abe van der Werf, President August 1, 2001 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: "Machnet Carotids Coil Array Assembly." (Catalog # PACC-GSXX) Classification Name: 90 MOS Common/Usual Name: Carotids Coil Array Assembly
- Equivalent legally marketed device: This device is similar in design and identical 2. in function to the USA Instruments Hi-Res 9000 Phased Array Carotid Coil K001210.
- 3. Indications for Use (intended use): To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. Anatomic Regions: Head and Neck Vasculature
- 4. Description of the device: The Carotids Coil Array Assembly is a receive only coil array which consists of a dual set of coils electrically connected to a quick disconnect box which interfaces the assembly to the MR scanner. Each half of the coil assembly consists of two overlapping coils to buck out the mutual inductance between the coils. Active decoupling is achieved by PIN diodes which turn the coils to a high impedance state at transmit time. A pair of fast switching crossed diodes is installed in each coil segment acting as passive switches detuning the coils to further improve the safety of the Carotids Coil Array Assembly. Each transmission line has so called "bazooka baluns" installed to minimize the outer braiding currents on the coaxial cables. Coil diameter have been chosen to optimize sensitivity at distances to about 35 mm from the coil surface while a sharp cutoff beyond 40 mm from the surface minimizes the noise from volumes

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K012491
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outside the region of interest. This ensures maximum signal ratio from the region of the carotids arteries.

Image /page/1/Picture/2 description: The image is a dark, grainy photo of a product. The product appears to be made of a dark material, and it has a strap or handle attached to it. The background of the image is blurry and indistinct. The title of the image is "Photo of Product".

- 5. Safety and Effectiveness, comparison to predicate device:
---

| Comparison Areas | USA Instruments Hi-Res<br>9000 Phased Array Carotid<br>Coil K001210. | "Machnet Carotids Coil<br>Array Assembly." (Catalog<br># PACC-GSXX) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Indications for use | The Hi-Res 9000 Phased Array<br>Carotid Coil is a receive-only<br>phased array RF coil used for<br>obtaining diagnostic images of the<br>carotid arteries and associated<br>vasculature from the Aortic arch<br>through the Circle-of-Willis in<br>Magnetic Resonance Imaging<br>systems. The indications for use<br>are the same as for standard MR<br>Imaging. | SAME |
| Use with MRI Model | The Hi-Res 9000 Phased Array<br>Carotid Coil is designed for use<br>with the SignaTM (1.5Tesla) MRI<br>scanner manufactured by GE<br>Medical Systems, Inc. | SAME, Signa Advantage 1.5T<br>and 1.0T.<br>Signa Horizon LX 1.5T and 1.0T. |
| Description | The Hi-Res 9000 Phased Array<br>Carotid Coil is an eight-element<br>phased array receive only coil.<br>The elements and associated<br>circuitry are enclosed in housing<br>made of plastic materials, which<br>are fire rated and have high<br>impact and tensile strength. | SAME except four element. |
| Function | Receive only | SAME |

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KC12491
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#### 6. Testing information and Conclusion

In all material respects, the "Machnet Carotids Coil Array Assembly." (Catalog # PACC-GSXX) is substantially equivalent to USA Instruments Hi-Res 9000 Phased Array Carotid Coil (K001210). Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

Machnet BV % Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K012491

Trade/Device Name: Machnet Carotids Coil Array Assembly Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 MOS Dated: August 1, 2001 Received: August 3, 2001

Dear Mr. Kamm:

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.

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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,

Nancy 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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## j) Indications for Use

#### Kol2491 510(k) Number

"Machnet Carotids Coil Array Assembly." (Catalog # PACC-GSXX) To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. mages of Carotid Straction and igned to provide coverage of the carotid arteries and I he Machiner Survice from the aortic arch through the Circle-of-Willis. assoonaton Regions: Head and Neck Vasculature. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Signa system is indicated for use as an NMR device that produces images that: The OL Signa system is manufon of protons exhibiting NMR signal, (2) depend upon (1) correspond to the disationsity, spin lattice relaxation time Tl, spin-spin relaxation Nivil parameters (process consessed ture of the head and neck regions specifically the thire 12) and (3) and (3) and (2) tissue. When interpreted by a trained physician, these carone arteries and association can be useful in the determination of a diagnosis.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use |

Over the Counter Use (Per 21 CFR 801.109)

Nancy C. Broadon

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012491

OR