The Surgi-Vision Esophageal Stylet Coil is recommended for highresolution Magnetic Resonance Imaging of the human esophagus. The single use, disposable 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 Description

The Surgi-Vision Esophageal Stylet 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 systems. The coil and cable are completely sealed inside the insulating layer.

AI/ML Overview

The provided document is a 510(k) summary for the Surgi-Vision Esophageal Stylet Coil, indicating that it is a medical device submission to the FDA. The information focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study proving the device meets specific acceptance criteria in the way AI/ML devices typically would.

Therefore, much of the requested information (e.g., sample sizes for training/test sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or cannot be extracted from this type of regulatory document.

However, I can organize the available information into the requested format where possible.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
Safety - RF Heating	No excess heating when positioned in a phantom representative of clinical conditions.	The results of heating experiments demonstrate there is no excess heating. The change in temperature observed during use is not significantly different than that observed without the coil.
Safety - Nerve Stimulation	No increased susceptibility of patients to peripheral nerve stimulation.	Experiments on current leakage by the MRI pulsed gradient field demonstrate there is no possibility of increased susceptibility of patients to nerve stimulation.
Performance - Imaging Quality	Enhanced resolution of aortic regions visualized from the esophagus.	Imaging performance demonstrates enhanced resolution of aortic regions visualized from the esophagus.
Compliance - Instructions for Use	Safe for imaging a patient if instructions for use are followed.	The results of testing demonstrate no safety problems if instructions for use are followed.
Compliance - SAR Limit	Safe for imaging a patient if the whole-body average SAR is no more than the present recommended limit of 4 W/kg.	The results of testing demonstrate no safety problems if the whole-body average SAR is no more than the present recommended limit of 4 W/kg.
Substantial Equivalence	Identical indications for use as the predicate device. Same technological characteristics as the predicate device (matching circuit, coaxial cable, RF coil).	The device has identical indications for use as the legally marketed predicate device (Surgi-Vision Endo-Esophageal MRI Coil, K992193). The device has the same technological characteristics (electronic matching circuit, connecting coaxial cable, inter-cavitary probe with radiofrequency receiving coil).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes phantom testing for safety and performance, not a clinical test set with human subject data. Therefore, concepts like "sample size for the test set" and "data provenance" (country/retrospective/prospective) are not applicable in their usual clinical study context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The safety and performance testing involved physical measurements (heating, current leakage) and imaging performance in a phantom. There is no mention of expert consensus for ground truth on a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no human-read test set data is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for improved MRI imaging quality, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a passive MRI coil, not an algorithm. The "standalone" performance here refers to the coil's physical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For safety criteria (RF heating, nerve stimulation), the ground truth was based on physical measurements and established scientific thresholds/limits (e.g., 4 W/kg SAR limit).
For imaging performance, the ground truth for "enhanced resolution" would likely be based on objective image quality metrics in the phantom, possibly compared to images acquired without the device, though the document does not specify these metrics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device requiring a training set.

Summary

{0}------------------------------------------------

MAR 1 4 2000

510(k) Summary

Surqi-Vision Esophageal Stylet 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: December 30, 1999

LEGALLY MARKETED PREDICATE DEVICES A.

The Surgi-Vision Esophageal Stylet Coil is substantially equivalent to the Surgi-Vision Endo-Esophageal MRI Coil, which was cleared for marketing on September 3, 1999, in premarket notification K992193.

B. DEVICE DESCRIPTION

C. INTENDED USE

The Surgi-Vision Esophageal Stylet Coil is recommended for highresolution Magnet Resonance Imaging of the human esophagus. The single use, disposable Stylet 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.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The Surgi-Vision Esophageal Stylet Coil has identical indications for use as the legally marketed predicate device.

Surgi-Vision, Inc. Esophageal Stylet Coil December 30, 1999

Page 1-1

{1}------------------------------------------------

The Surgi-Vision Esophageal Stylet 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 inter-cavitary 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.

E. TECHNOLOGICAL CHARACTERISTICS

See Section D. above.

F. TESTING

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

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

The results of the heating experiments demonstrate that there is no excess heating when SVESC is positioned in a phantom that is representative of clinical conditions. The change in temperature observed during use of the SVESC is not significantly different then that observed without the coil. The experiments done to determine 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 esophaqus. The results of the testing demonstrate that there are no safety problems for imaging of a patient using the Surgi-Vision Esophageal Stylet 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.

G. CONCLUSIONS

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and

Surgi-Vision, Inc. Esophageal Stylet Coil December 30, 1999

{2}------------------------------------------------

various guidance documents issued by the Center for Devices and Radiological Health.

Surgi-Vision, Inc. Esophageal Stylet Coil
December 30, 1999

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2000

Nancy E. Taylor CEO/President Surgi-Vision, Inc. 9250 Rumsey Rd., Suite 100 Columbia, MD 21045

Re:

K994436 Esophageal Sylet Coil Dated: December 30, 1999 Received: December 30, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Ms. Taylor:

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 pror 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Aproval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 Reculation (QS) for Medical Devices: General requiration (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 conceming your device in the Federal Register. Please note: this response to your premarket notfication submission you might have under sections 531 through 542 of the Act for devices under 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) 594-4591. Additionally, for questions and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entititled, "Misbranding by reference to premarket notification" (21CFR 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

David C. Schuller, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

510(K) Number (if known):

Device name: Surgi-Vision Esophageal Stylet Coil

Indications for Use:

(PLEASE 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

(Division Sign-Off)
Division Reproductive, Abdominal, ENT,
and Radiological Devices
J9944310

510(k) Number

Surgi-Vision, Inc. Esophageal Stylet Coil December 30, 1999

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.