ACCESS BREAST COIL 4/SMS

K060547 · Confirma, Inc. · MOS · Mar 29, 2006 · Radiology

Device Facts

• Record ID: K060547
• Device Name: ACCESS BREAST COIL 4/SMS
• Applicant: Confirma, Inc.
• Product Code: MOS · Radiology
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) to produce diagnostic and interventional images of the breast, chest wall and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in acquiring diagnostic breast MRI studies and interventional breast MRI studies for localization of lesions, biopsies and other interventional procedures.

Device Story

Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil for Siemens 1.5T MRI systems. Device captures RF signals from breast, chest wall, and axillary tissues; transforms signals into diagnostic/interventional images via MRI scanner. Features open design with two insulating coil chambers; integrated lighting for interventional procedures; positioning accessories (headrest, armrest, torso pad) for patient comfort. Used in clinical settings by physicians/technicians. Output viewed by physician on MRI workstation to guide lesion localization and biopsies. Benefits include enhanced interventional access (lateral, medial, cranial-caudal) and improved patient ergonomics.

Clinical Evidence

Bench testing only. No clinical data presented. Substantial equivalence supported by design verification, risk analysis, and comparison of imaging capabilities to predicate device.

Technological Characteristics

4-channel phased array receive-only RF coil. Materials: rigid plastic housing (fire-rated, high impact/tensile strength). Connectivity: compatible with Siemens 1.5T MRI systems. Features: integrated lighting, ergonomic positioning accessories. Non-software device.

Indications for Use

Indicated for patients requiring diagnostic or interventional MRI imaging of the breast, chest wall, and axillary tissues. Used by trained physicians for lesion localization, biopsies, and other interventional 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

• Model OBC-63 Breast Array Coil (K022488)

Submission Summary (Full Text)

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Kobo547

MAR 2 9 2006

# 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted as part of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart E and Section 807.92.

#### 1. Identification of Submitter:

| Submitter: | Confirma, Inc. |
|------------|-------------------------------------------|
| Address: | 821 Kirkland Avenue<br>Kirkland, WA 98033 |
| Phone: | 425-576-1226 |
| Fax: | 425-576-9295 |

| Contact: | Patricia A. Milbank, JD |
|----------------|-------------------------------------------------------------|
| Title: | Vice President, Regulatory Affairs and<br>Quality Assurance |
| Phone: | 425-894-9733 |
| Fax: | 425-822-3648 |
| Date Prepared: | February 23, 2006 |

#### 2. Identification of Product:

| Trade Name: | Access Breast Coil 4/SMS |
|--------------------|-------------------------------------------------------------|
| Regulatory Number: | 21 CFR 892.1000 |
| Regulation Name: | Magnetic Resonance Diagnostic Device |
| Common Name: | Coil, Magnetic Resonance Specialty |
| Regulatory Class: | Class II |
| Product Code: | 90 MOS |
| Manufacturer: | Confirma, Inc.<br>821 Kirkland Avenue<br>Kirkland, WA 98033 |

#### 3. Indications for Use

The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) to produce diagnostic and interventional images of the breast, chest wall and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in acquiring diagnostic breast MRI studies and interventional breast MRI studies for localization of lesions, biopsies and other interventional procedures.

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## 4. Device Description:

Access Breast Coil 4/SMS is a 4-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast, and axillary tissue. This device is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access.

The design of the Access Breast Coil 4/SMS focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of diagnostic and interventional breast MR1 studies.

The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength.

The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in localization of lesions during interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

## Features of the Access Breast Coil 4/SMS:

## Imaging

.

- 4-channel phased array design uses multiple elements that . surround the breast tissue
- Optimized for parallel imaging applications .
- Supports both unilateral and bilateral imaging exams +
- Compatible with Siemens 1.5T MRI systems .
- Extensive coverage of chest wall and axilla .
- . High SNR

## Ergonomics

- Large apertures to accommodate a major percentage of patient . population
- . Ergonomically designed for patient comfort to minimize motion artifact
- . Positioning accessories include a flexible, adjustable headrest, arm rest and torso pad
- . Cushioned head rest
- . Padded arm rests

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#### Interventional Access

- Coil design allows lateral, medial and cranial-caudal interventional . access
- Lighting is integrated into the coil for interventional procedures . that demand a well-lit area

### 5. Comparison with Legally Marketed Devices

The Access Breast Coil 4/SMS is substantially equivalent to the following legally marketed device:

| Model: | Model OBC-63 Breast Array Coil |
|----------------|--------------------------------|
| Manufacturer: | MRI Devices Corporation |
| 510(k) Number: | K022488 |

Both breast coils are designed as receive-only RF coils, intended for use in conjunction with a magnetic resonance scanner to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

The predicate device is designed for use with the Siemens 1.5 MR scanners. The Access Breast Coil 4/SMS also is designed for use with the Siemens 1.5T MR scanners.

The Access Breast Coil 4/SMS and the predicate device are 4-channel, phased array coils that allow bilateral and unilateral imaging of the breast. Both of these breast coils have an open coil design to optimize imaging of breasts of various sizes.

The predicate device allows lateral access to the breast for biopsy and interventional procedures, while the Access Breast Coil 4/SMS is designed to allow for lateral, medial and cranial-caudal access to the breast.

#### 6. Conclusions

The Access Breast Coil 4/SMS is substantially equivalent to the identified legally marketed devices. The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes. The Access Breast Coil 4/SMS provides images comparable to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2006

Ms. Patricia A. Milbank Vice President, Regulatory Affairs and Quality Assurance Confirma, Inc. 821 Kirkland Avenue KIRKLAND WA 98033

Re: K060547

Trade/Device Name: Access Breast Coil 4/SMS Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 28, 2006 Received: March 2, 2006

Dear Ms. Mildbank:

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 (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 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) lateling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality of 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 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 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 807.97). 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/industrv/support/index.html.

Sincerely vours.

Nancy C. Bugdon

Nancv (). Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication(s) for Use Statement

510(k) Number:

Kobo 547 To be assigned by FDA

Device Name:

Access Breast Coil 4/SMS

Indications for Use:

The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) to produce diagnostic and interventional images of the breast, chest wall and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in acquiring diagnostic breast MRI studies and interventional breast MRI studies for localization of lesions, bionsies and other interventional procedures.

Prescription Use 1 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Padslogical Devices
510(k) Number K060 547