HAMMERSMITH ENDOCAVITARY COILS

K981410 · Philips Medical Systems (Cleveland), Inc. · LNH · Jun 30, 1998 · Radiology

Device Facts

• Record ID: K981410
• Device Name: HAMMERSMITH ENDOCAVITARY COILS
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Hammersmith Endocavitary Coils do not change the intended use of the Picker MR system with which they are used. Picker MR systems are intended for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR. (2) devend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis. The Hammersmith Endocavitary Coils are indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: The Anus or Prostate by insertion into the rectum, and the Cervix by insertion into the vagina Nuclei Excited: Hydrogen

Device Story

Hammersmith Endocavitary Coils are receive-only MRI accessory coils designed for high-resolution imaging of the anus, prostate, and cervix. Unlike predicate devices using inflatable latex balloons, these are rigid, reusable probes shaped like ultrasound transducers. The device is inserted into the rectum or vagina by a clinician. It functions as an antenna to capture hydrogen proton signals during MRI scanning, which are then processed by the host Picker MR system to produce soft tissue images. The rigid design allows for fixed tuning and matching, eliminating the need for patient-specific tuning and reducing susceptibility artifacts caused by air. The device is used in a clinical MRI environment; output is interpreted by a physician to assist in diagnosis. Benefits include reusability, improved image quality due to reduced artifacts, and simplified setup.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Receive-only MRI coil; rigid Acrylonitrile resin enclosure; linear antenna configuration; fixed factory-set tuning and impedance matching; active diode decoupling; single receive channel; reusable; compatible with Picker Edge, Vista, Asset, Eclipse, Polaris, and Apollo MRI systems.

Indications for Use

Indicated for imaging the anus, prostate (via rectal insertion), or cervix (via vaginal insertion) in patients undergoing MRI. Contraindicated for any patient excluded from a normal digital examination.

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

• Philips Endo-Cavitary MRI Coil (K930193)

Submission Summary (Full Text)

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K98 14/10

JUN 3 0 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

#### 1. General Information

Class II Classification: Magnetic Resonance Imaging (MRI) Accessory Common/Usual Name: Magnetic Resonance Imaging (MRI) Coil Hammersmith Endocavitary Coils Proprietary Name: Establishment Registration: Picker International, Inc. World Headquarters 595 Miner Road Highland Heights. Ohio 44143 FDA Owner Number: #1580240 FDA Registration Number: #1525965 Performance Standards: Not Applicable

Intended Uses

2.

The Hammersmith Endocavitary Coils do not change the intended use of the Picker MR system with which they are used.

Picker MR systems are intended for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR. (2) devend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.

The Hammersmith Endocavitary Coils are indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: The Anus or Prostate by insertion into the rectum, and the Cervix by insertion into the vagina Nuclei Excited: Hydrogen

PICKER INTERNATIONAL, INC.

(ENDOCAV)

3/31/98

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#### Device Description 3.

These three separate receive-only coils are for imaging the anus, prostate and cervix. The coils are designed to be inserted in either the rectum or vagina before imaging. The Hammersmith Endocavitary Coils are similar to the Philips Endo-Cavitary Coil in that they are reusable. However, unlike the Philips Endo-cavitary MRI Coil, they are rigid structures that do not contain an inflatable latex balloon. This difference in the design eliminates the need for limiting the number of times the Hammersmith Coils can be used, allows for fixed tuning and matching, and reduces the image artifacts due to susceptibility effects from air. Instead, the shape and dimensions of the Hammersmith Endocavitary Coils are similar to ultrasound probes used in endocavitary applications.

### Safety and Effectiveness 4.

The Picker Hammersmith Endocavitary Coils are substantially equivalent in safety and effectiveness to the Philips Endo-Cavitary MRJ Coil. The following chart has been compiled to demonstrate the substantial equivalence of these devices.

| Parameter | Hammersmith Endocavitary<br>Coils | Predicate Device: Philips Endo-<br>Cavitary MRI Coil (K930193) |
|-------------------------------|------------------------------------------------------------|----------------------------------------------------------------------|
| Compatible MRI<br>Systems | Picker Edge, Vista, Asset, Eclipse,<br>Polaris and Apollo. | Philips Gyroscan ACS Series II<br>and Gyroscan T5 series II systems. |
| Mode of Operation | Receive-Only. | Receive-Only. |
| Antenna<br>Configuration | Linear. | Linear. |
| Tuning/Impedance<br>Matching | Fixed tuning and matching. Factory<br>set. | Tuned for each patient. |
| Method of<br>Decoupling | Active diode decoupling. | Decoupling diode switch |
| Coil Enclosure | Rigid Acrylonitrile resin. | Flexible coil loop inside a non-<br>permeable latex balloon. |
| Coil Stabilization | External immobilization positioning<br>device. | Inflate balloon on coil with luer-<br>lock syringe. |
| Number of Receive<br>Channels | One. | One. |

PICKER INTERNATIONAL, INC.

(ENDOCAV)

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| Parameter | Hammersmith Endocavitary<br>Coils | Predicate Device: Philips Endo-<br>Cavitary MRI Coil (K930193) |
|-------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cleaning and<br>Disinfection Method | Cleaning: MetriZyme detergent.<br>Disinfectant: Cidex Dip.<br>Covered with sheath. | Cleaning: Detergent.<br>Disinfectant: Cidex Dip<br>Covered with sheath. |
| Use Limits | None. | Used up to 50 times within one<br>year of manufacturing. |
| Indications for use | Anus or Prostate by insertion into<br>the rectum and Cervix by insertion<br>into the vagina. | Prostate or Uterus by insertion<br>into the rectum. |
| Contraindications | Any exclusion for a normal digital<br>examination. | Severe hemorrhoids, recent<br>surgery in the area of the rectum,<br>inflammatory bowel disease,<br>Crohn's disease and any exclusion<br>for normal endorectal<br>examinations. |

.

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3/3 1/98

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 3 0 1998

Elaine K. Keeler, Ph.D. Manager, MR Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143 Re:

K981410 Hammersmith Endocavitary Coils Dated: April 17, 1998 Received: April 20, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS/90 LNH

Dear Dr. Keeler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1198 1410 510(k) Number (if known):

Device Name: Hammersmith Endocavitary Coils

### Indications for Use:

The Hammersmith Endocavitary Coils do not change the intended use of the Picker MR system with which they are used.

Picker MR systems are intended for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Hammersmith Endocavitary Coils are indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions:

The Anus or Prostate by insertion into the rectum, and the Cervix by insertion into the vagina

Nuclei Excited:

Hydrogen

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Javid A. Segrin
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devi

Radiological Devices
510(k) Number K981410

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)