FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL

K020601 · Odin Medical Technologies , Ltd. · MOS · Apr 24, 2002 · Radiology

Device Facts

• Record ID: K020601
• Device Name: FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
• Applicant: Odin Medical Technologies , Ltd.
• Product Code: MOS · Radiology
• Decision Date: Apr 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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. The FlexiCoil - malleable receive-only surface coil expands the capability of the PoleStar N-10 MR Imaging System (K002242). It improves imaging of selected sections of the head and extremities.

Device Story

FlexiCoil is a malleable, receive-only surface coil designed for intraoperative MR imaging of head and extremities. Device consists of copper straps enclosed in closed-cell polyethylene foam tape with an electronic tuning box. Malleable structure allows manual adjustment of shape/size via plastic holders to ensure close contact with patient anatomy. Used with PoleStar N-10 MR Imaging System; improves signal-to-noise ratio (SNR) and image uniformity by positioning coil closer to signal-emitting tissue. Operated by clinical staff in surgical or imaging environments. Single-use, non-sterile device. Benefits include enhanced image quality for specific anatomical regions and reduced patient discomfort during positioning.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by performance data and sample images demonstrating equivalent SNR and image uniformity compared to predicate devices.

Technological Characteristics

Receive-only surface coil; copper straps; closed-cell polyethylene enclosure; active PIN diode decoupling; non-sterile; single-use; malleable form factor; connects to PoleStar N-10 MR Imaging System.

Indications for Use

Indicated for imaging of selected sections of the head and extremities in patients undergoing MR diagnostic procedures.

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

• NORMA 10 surface coil (K991243)
• Phased Array Musculo-Skeletal Flex Coil Package (K003366)

Reference Devices

• PoleStar N-10 MR Imaging System (K002242)

Submission Summary (Full Text)

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APR 2 4 2002

Image /page/0/Picture/1 description: The image shows the logo for Odin Medical Technologies. The logo features the word "odin" in bold, sans-serif font, with the words "Medical Technologies" in a smaller font size underneath. A stylized graphic of a circle with an orbital path around it is positioned to the right of the word "odin", adding a modern and technological feel to the logo.

### K020601

# 510(k) Summary of Safety and Effectiveness

The following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).

### 807.92(a)(1) - Submitter Details:

| Submitter name: | Adi Ickowicz - Corporate Director of Regulatory Affairs, IP and Quality |
|-----------------|-------------------------------------------------------------------------|
| Address: | P.O. Box 548, Yokneam Elit 20692, Israel |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Contact Person: | Adi Ickowicz - Corporate Director of Regulatory Affairs, IP and Quality |
| Date: | February 11, 2002 |

#### 807.92(a)(2) - Device Details:

| Trade Name and Common Name: | FlexiCoil - malleable receive-only surface coil |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | 21 CFR 892.1000 Magnetic Resonance Diagnostic Device. |
| Class: | II |
| | MRDD were reclassified by FDA from |
| | Class III to Class II effective July 28, 1998. |
| Product Code: | MOS - Magnetic Resonance Specialty Coil |
| Performance Standards: | No applicable performance standards have been issued for this product code under section 514 of the Food and Drug and Cosmetic Act. |

#### 807.92(a)(3) - Predicate Devices:

The FlexiCoil - malleable receive-only surface coil is substantially equivalent to the following legally marketed medical devices:

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Image /page/1/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "ODIN" is in large, bold, black letters. Below the word "ODIN" is the phrase "Medical Technologies" in a smaller font. A curved line starts above the "N" in "ODIN" and wraps around the right side of the word, ending near the bottom of the "N".

| Medical Device Name | Applicant Name | 510(k)<br>Number | Product Code |
|------------------------------------------------------|-----------------------------------|------------------|--------------|
| NORMA 10 surface coil | Odin Medical<br>Technologies Ltd. | K991243 | LNH |
| Phased Array Musculo -<br>Skeletal Flex Coil Package | IGC-Medical<br>Advances, Inc. | K003366 | MOS |

Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.

### 807.92(a)(4) - Device Description:

The FlexiCoil is a malleable receive-only surface coil intended to facilitate intraoperative MR imaging of selected sections of the head and extremities. This component is a malleable circular enclosed coil that consists of copper straps covered with Medical Foam Tape and an electronic tuning box, which can be placed around the anatomy of interest for MR imaging. The malleable structure of the coil allows adjustment of size and shape by pulling/releasing the plastic holders on both sides of the coil, providing the highest possible contact between the coil and the area to be imaged.

Due to its malleability the FlexiCoil can cover a wider area than the presently used coils (K991243) resulting in better image uniformity and a better overall SNR when imaging structures near the surface of the patient's head or extremity. The improved SNR is a result of the coil being closer to the signal-emitting anatomy, and being fully tuned and matched to the signal and receive channel. In addition the coil can be easily placed near the anatomy to be imaged with little or no patient post procedure discomfort. The FlexiCoil is for single use only and is supplied non-sterile.

#### 807.92(a)(5) - Device Intended Use:

The FlexiCoil - malleable receive-only surface coil expands the capability of the PoleStar N-10 MR Imaging System (K002242). It improves imaging of selected sections of the head and extremities.

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Image /page/2/Picture/0 description: The image shows the logo for Odin Medical Technologies. The logo features the word "odin" in bold, sans-serif font, with "Medical Technologies" written in a smaller font size below it. A stylized graphic resembling an orbit or a curved path with a dot at the top right of the word "odin" adds a modern touch to the logo.

# 807.92(a)(6) – Substantial Equivalence Comparison Table:

| | Candidate Device | Predicate Devices | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Parameter | FlexiCoil | NORMA 10 surface<br>coil | Phased Array<br>Musculo -Skeletal<br>Flex Coil Package |
| Coil enclosure<br>material | Closed-cell<br>polyethylene | Polyolefin | Cotton fabric |
| Coil design | Receive-Only Surface<br>Coil | Receive-Only Surface<br>Coil | Receive-Only or<br>Transmit and Receive<br>Coil |
| Decoupling | Active PIN diode<br>decoupling | Active PIN diode<br>decoupling | Active PIN diode<br>decoupling |
| Formation of<br>Resonant<br>Loops | Surface Coil | Surface Coil | Phased Array Coil |
| Potential for RF<br>burns | SAR substantially<br>below the permissible<br>limit | SAR substantially<br>below the permissible<br>limit | Not Available |
| RF absorption | Does not transmit RF<br>power | Does not transmit RF<br>power | Not Available |
| Intended use | General diagnostic use<br>to present images<br>which reflect the spatial<br>distribution and/or<br>magnetic resonance<br>spectra, which reflect<br>frequency and<br>distribution of nuclei<br>exhibiting nuclear<br>magnetic resonance | General diagnostic use<br>to present images<br>which reflect the spatial<br>distribution and/or<br>magnetic resonance<br>spectra, which reflect<br>frequency and<br>distribution of nuclei<br>exhibiting nuclear<br>magnetic resonance | 2D, 3D imaging, proton<br>density, Ti and T2<br>weighted imaging. 2D,<br>3D time of flight, phase<br>contrast imaging |
| Indications for<br>use | Selected sections of<br>the head and<br>extremities | Selected sections of<br>the head and<br>extremities | Cranial structures,<br>musculoskeletal<br>structures, peripheral<br>nerves and pediatric<br>applications |

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Image /page/3/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in bold, sans-serif font, with the "o" being capitalized. Below "odin" is the phrase "Medical Technologies" in a smaller, sans-serif font. Above and to the right of the word "odin" is a curved line that resembles an orbit, with a solid circle at the top of the curve.

#### Performance Data:

Substantial equivalence was based on performance data. Sample images were provided in attachment 4 of the 510(k) submission.

#### Conclusions:

The PoleStar N-10 operated with the FlexiCoil - malleable receive-only surface coil adressed in this premarket notification, has the same intended use and technological characteristics as the same system operated with the legally marketed coil cleared in K991243 and does not affect the PoleStar N-10 system safety parameter specification. The FlexiCoil also has the the same intended use and technological characteristics as the other OEM predicate coil.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Adi Ickowicz Corporate Director of Regulatory Affairs, IP and Quality Odin Medical Technologies Ltd. P.O. Box 248 Yokneam Elit 20692 ISRAEL

## APR 2 4 2002

Re: K020601

Trade/Device Name; FlexiCoil-Malleable receive-only surface coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 MOS Dated: February 20, 2002 Received: February 22, 2002

Dear Mr. Ickowicz:

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 (OS) 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 11 you 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 of receive to promation of 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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510(k) Number (if known): 020601

Device Name:

FlexiCoil - malleable receive-only surface coil

Indication For Use:

A magnetic resonance diagnostic device is intended for general diagnostic use A magnetic resonalloo alagheet the spatial distribution and/or magnetic to present infages, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance.

The FlexiCoil - malleable receive-only surface coil expands the capability of the The Flexioon - mancubio roome imaging of selected sections of the head and extremities.

(PLEASE DO NOT WRITE BELOW THE LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Nancy C. Brogdon
(Division Sign-Off)

Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020601