← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K992193

# ENDO-ESOPHAGEAL MR COIL (K992193)

_Surgi-Vision, Inc. · MOS · Sep 3, 1999 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K992193

## Device Facts

- **Applicant:** Surgi-Vision, Inc.
- **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md)
- **Decision Date:** Sep 3, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Intended Use

The Surgi-Vision Endo-Esophageal MRI Coils are recommended for high-resolution Magnet Resonance Imaging of the human esophagus. The one-time use, disposable Endo-Esophageal Coil has been designed to be inserted in the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with a 1.5T MRI machine.

## Device Story

Specialty endo-esophageal MRI coil; designed for high-resolution imaging of anatomical regions surrounding the esophagus. Device consists of a radiofrequency receiving coil, electronic matching circuit, and coaxial cable, all sealed within a nasogastric tube. Input: MRI signals from anatomical regions surrounding the esophagus. Output: Enhanced MRI image quality. Used in clinical MRI settings; operated by trained medical personnel. Coil inserted into patient esophagus during 1.5T MRI scans. Facilitates improved visualization of aortic regions. Benefits patient through higher resolution imaging compared to standard surface coils.

## Clinical Evidence

Bench testing only. Evaluated RF heating in phantoms (no excess heating observed; temperature change equivalent to control); assessed current leakage from pulsed gradient fields (no increased susceptibility to nerve stimulation); demonstrated enhanced imaging resolution of aortic regions. Safety confirmed for whole-body average SAR up to 4 W/kg.

## Technological Characteristics

Intercavitary probe with RF receiving coil, electronic matching circuit, and coaxial cable. Encased in PVC tube. Designed for 1.5T MRI systems. Disposable, single-use. No software or active electronic processing components described.

## Regulatory 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 MRInnervu Endorectal Coils ([K952232](/device/K952232.md))
- Medrad MRInnervu Endorectal Coils ([K952235](/device/K952235.md))

## Reference Devices

- Mallinkrodt Infant Feeding Tube

## Submission Summary (Full Text)

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>
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K992193

SEP 3 1999

# 510(k) Summary

# Surqi-Vision Endo-Esophageal MRI Coil

Common/Classification Name: Accessory to Magnetic Resonance Diagnostic Device, 21 CFR 892.1000

> Surgi-Vision, Inc. 9250 Rumsey Road, Suite 100 Columbia, MD 21045

Contact: Nancy E. Taylor, Prepared: June 18, 1999

### LEGALLY MARKETED PREDICATE DEVICES A.

The Surgi-Vision Endo-Esophageal MRI Coil is substantially equivalent to the Medrad MRInnervu Endorectal Coils, which were cleared for marketing on June 26, 1995, in premarket notifications K952232 and K952235. The Surgi-Vision device is also substantially equivalent in regard to the characteristics of its PVC encasing tube to the Mallinkrodt Infant Feeding Tube.

#### DEVICE DESCRIPTION B.

The Surgi-Vision Endo-Esophageal MRI Coil is a specialty coil for use in MRI imaging of the anatomical regions surrounding the esophagus. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for GE MRI The coil and cable are completely sealed inside a standard systems. nasogastric tube.

#### C. INTENDED USE

The Surgi-Vision Endo-Esophageal MRI Coils are recommended for high-resolution Magnet Resonance Imaging of the human esophagus. The one-time use, disposable Endo-Esophageal Coil has been designed to be inserted in the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions The unique coil shape facilitates surrounding the esophagus.

Surgi-Vision, Inc. Endo-Esophageal MRI Coil June 28, 1999

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orientation of the coil to the anatomy. This product is to be used with a 1.5T MRI machine.

# D. SUBSTANTIAL EQUIVALENCE SUMMARY

The Surgi-Vision Endo-Esophageal MRI Coil has similar, but not identical, indications for use as the legally marketed predicate device. However, the intended use, providing endocavitary reception of MRI signals for the purpose of creating an MRI image of nearby anatomy, is the same.

The Surgi-Vision Endo-Esophageal MRI Coil has the same technological characteristics as the predicate device. Both proposed and predicate devices have an electronic matching circuit, a connecting coaxial cable, and an intercavitary probe with a radiofrequency receiving coil. However, there are differences in construction and design that make it necessary to provide performance data to assure substantial equivalence. Such performance data are available and do demonstrate substantial equivalence.

## TECHNOLOGICAL CHARACTERISTICS E.

See Section D. above.

### F. TESTING

Surgi-Vision carried out testing and/or analysis of the Surgi-Vision Endo-Esophageal MRI Coil that addressed the following issues:

- (1) Possibility of excess RF heating;
- (2) Possibility of increased susceptibility of patients to peripheral nerve stimulation; and
- (3) Imaging performance.

The results of the heating experiments demonstrate that there is no excess heating when EEMRI coil is positioned in a phantom that is representative of clinical conditions. The change in temperature observed during use of the EEMRI coil is the same as that observed without the coil. The calculations and experiments done to determine

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current leakage by the MRI pulsed gradient field demonstrate that there is no possibility of increased susceptibility of patients to nerve stimulation. Finally the imaging performance demonstrates enhanced resolution of aortic regions visualized from the esophagus. The results of the testing demonstrate that there are no safety problems for imaging of a patient using the Surgi-Vision Endo-Esophageal MRI Coil if the instructions for use are followed and if the whole-body average SAR is no more than the present recommended limit of 4 W/kg.

## CONCLUSIONS G.

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

Surgi-Vision, Inc. Endo-Esophageal MRI Coil June 28, 1999

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SFP 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nancy E. Taylor CEO/President Surai-Vision. Inc. 9250 Rumsey Road Suite 100 Columbia, MD 21045

Dear Ms. Taylor:

K992193 Re: Surgi-Vision Endo-Esophageal MRI Coil Dated: June 28, 1999 Received: June 29, 1999 Regulatory Class: Il (two) Product Code: 90 MOS 21 CFR 892.1000

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 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 redassified 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. Jisting 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requirion (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 531 through 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

510(K) Number (if known):

Device name: Surqi-Vision Endo-Esophageal MRI Coil

Indications for Use:

The Surgi-Vision Endo-Esophageal MRI Coil is recommended for highresolution Magnetic Resonance Imaging of the human esophagus. The one-time use, disposable Endo-Esophageal MRI Coil has been designed to be inserted in the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with a 1.5T MRI machine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

Surgi-Vision, Inc.
Endo-Esophageal MRI Coil
June 28, 1999

510(k) Number. 1992193

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K992193](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K992193)

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