(66 days)
The Surgi-Vision Endo-Esophageal MRI Coil is recommended for high-resolution 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.
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 systems. The coil and cable are completely sealed inside a standard nasogastric tube.
Here's an analysis of the provided text regarding the Surgi-Vision Endo-Esophageal MRI Coil, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Testing Conducted | Reported Device Performance |
|---|---|---|
| Safety - Heating | Possibility of excess RF heating (demonstrated no excess heating in phantom) | "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." |
| Safety - Nerve Stimulation | Possibility of increased susceptibility of patients to peripheral nerve stimulation (demonstrated no increased susceptibility) | "The calculations and 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." |
| Imaging Performance | Imaging performance (demonstrated enhanced resolution) | "the imaging performance demonstrates enhanced resolution of aortic regions visualized from the esophagus." |
| Overall Safety | No safety problems if instructions for use are followed and SAR is within limits | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for the test set. It mentions "experiments" for heating and "calculations and experiments" for nerve stimulation, and "imaging performance," but no details on the number of subjects (human or phantom) or cases used.
The data provenance is also not explicitly stated as retrospective or prospective, nor does it mention the country of origin. The testing likely occurred in a controlled lab or internal facility given the nature of premarket submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on direct measurements and observations during testing (e.g., temperature changes, current leakage, visual assessment of image resolution).
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1, none) is mentioned, as the study does not describe a scenario where multiple readers or assessors would be making subjective evaluations that require adjudication. The testing seems to be based on objective physical measurements and direct observation of imaging output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on the device's technical performance and safety compared to the predicate device's function, not on comparing human reader performance with and without AI assistance. The device itself is a passive imaging coil, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This question is not applicable in the context of this device. The Surgi-Vision Endo-Esophageal MRI Coil is a hardware accessory for an MRI machine, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not conducted or relevant. The "performance" described refers to the coil's ability to produce clear images.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance appears to be based on:
- Direct Physical Measurements (quantitative): For heating (temperature change) and nerve stimulation (current leakage calculations and experiments).
- Direct Visual Assessment (qualitative/semi-quantitative): For imaging performance, where "enhanced resolution of aortic regions visualized from the esophagus" implies a visual comparison of image quality.
It does not utilize expert consensus, pathology, or outcomes data as "ground truth" in the way an AI diagnostic tool would.
8. The Sample Size for the Training Set
This device does not involve a training set. As a hardware device, it is not "trained" in the manner of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this hardware device.
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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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§ 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.