SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING

K103274 · Sentinelle Medical, Inc. · MOS · Aug 18, 2011 · Radiology

Device Facts

• Record ID: K103274
• Device Name: SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
• Applicant: Sentinelle Medical, Inc.
• Product Code: MOS · Radiology
• Decision Date: Aug 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Endo Coil Array is a receive-only MRI coil array for imaging (including spectroscopy) in the prostate, cervix and colon and surrounding pelvic tissues in adult populations with clinically present anus and rectum or vagina. The Endo Coil Array can be used with many commercial MRI scanners. This device is for exclusive use by a qualified medical professional under the order of a physician. For use with GE, Toshiba and Siemens 1.5T MR systems.

Device Story

Reusable, rigid transrectal or transvaginal receive-only MRI coil array; cylindrical housing similar to ultrasound probes. Held by articulating stabilization arm attached to patient support (transporter or tabletop versions). Used in clinical MRI settings with GE, Toshiba, or Siemens 1.5T systems. Operated by qualified medical professionals. Device captures magnetic resonance signals from pelvic tissues; signals processed by external MRI scanner to produce diagnostic images and spectroscopy data. Output used by physicians for clinical assessment of prostate, cervix, and colon. Benefits include high-resolution pelvic imaging for diagnostic purposes.

Clinical Evidence

Bench testing only. Performance evaluated via non-clinical testing including SNR comparison, spectroscopy, and image uniformity per NEMA 9:2008 standards. No clinical data provided.

Technological Characteristics

Reusable, rigid transrectal/transvaginal receive-only MRI coil array. Cylindrical form factor. Compatible with GE, Toshiba, and Siemens 1.5T MR systems. High-level disinfection required. No internal software or active electronic processing; passive receive-only coil technology.

Indications for Use

Indicated for adult patients with clinically present anus, rectum, or vagina requiring MRI imaging or spectroscopy of the prostate, cervix, colon, and surrounding pelvic tissues. Must be used by qualified medical professionals. Contraindicated for patients without the specified anatomy.

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

• MEDRAD 1.5T Pelvic Imaging System Interface Device (K053042)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of lines and curves, and it resembles a stylized flower or star. The word "sentinelle" is in a smaller font than the word "MEDICAL".

AUG 18 2011

555 Richmond Street West
Suite 800, P.O. Box 301
oronto, Ontario, Canada, M5V 3B1

phone - 416-366-4994
fax - 416-594-9696
sentinellemedical.com

# 510(k) Summary

| Submitter: | Sentinelle Medical Inc. |
|----------------------|------------------------------------------------------------------------------------------------|
| Address: | 555 Richmond Street West, Suite 800<br>Toronto, Ontario, M5V 3B1<br>Canada |
| Contact: | Cameron Piron |
| Telephone: | 647-258-3601 |
| Date: | August 17th, 2011 |
| Trade Names: | Sentinelle Endo Coil Array for Pelvic Imaging |
| Common Names: | Sentinelle Pelvic Solution, eArray, Prostate Coil Array, Female Pelvic Coil Array |
| Classification Name: | Accessory to Magnetic Resonance Diagnostic Device,<br>Class II as described in 21 CFR 892.1000 |
| Product Code: | MOS |
| Predicate Devices: | K053042 - MEDRAD 1.5T Pelvic Imaging System Interface Device |

## Device Description:

The Endo Coil Array is a reusable, rigid transrectal or transvaginal receive-only MRI coil array similar to other products. The Coil Array housing has a cylindrical shape similar to transrectal and transvaginal ultrasound probes.

The Coil Array is held by an articulating Stabilization Arm that is attached to a Patient Support. The Patient Support is available in both Transporter and Tabletop versions, which dock to the scanner or are placed on top of the scanner's existing couch respectively.

## Intended Use:

The Endo Coil Array is a receive-only MRI coil array for imaging (including spectroscopy) in the prostate, cervix and colon and surrounding pelvic tissues in adult populations with clinically present anus and rectum or vagina. The Endo Coil Array can be used with many commercial MRI scanners. This device is for exclusive use by a qualified medical professional under the order of a physician. For use with GE, Toshiba and Siemens 1.5T MR systems.

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Image /page/1/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of lines that form a symmetrical design. The word "sentinelle" is in a larger font than the word "MEDICAL".

555 Richmond Street West
Suite 800, P.O. Box 301
Toronto, Ontario, Canada, M5V 3B1

phone - 416-366-4994
fax - 416-594-9696
sentinellemedical.com

### Indications for Use:

The Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems.

#### Substantial Equivalence Summary:

| Proposed Device | Predicate Device | Substantially Equivalent Aspect |
|-----------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endo Coil Array | MEDRAD Interface<br>Device | • Transrectal receive-only MRI coils for<br>imaging.<br>• Regions of interest: Prostate, Colon,<br>Cervix and surrounding tissue.<br>• For use exclusively by trained medical<br>professionals. |

#### Performance Testing:

Non-clinical performance testing was done to ensure the device performed equivalently to predicates in the areas of SNR comparison, spectroscopy, and image uniformity per NEMA 9:2008 with no additional concerns of safety or effectiveness.

#### Comparison to Predicate:

In the opinion of Sentinelle, the intended use and technological characteristics of the Sentinelle Endo Coil Array are substantially equivalent to those of the predicate devices and do not pose any issues for its safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Sentinelle Medical. Inc. c/o Casev Conrv Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747

AUG 1 8 2011

Re: K103274

> Trade Name: Sentinelle Endo Coil Array for Pelvic Imaging Regulation Number: 21 CFR. 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 25, 2011 Received: July 26, 2011

Dear Mr. Conry:

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 class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Mary S Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K103274

Device Name: Sentinelle Endo Coil Array for Pelvic Imaging

Indications for Use:

The Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Petty

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103274

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