(75 days)
Not Found
No
The summary describes a physical device (an MRI coil) designed to improve image quality, with no mention of software, algorithms, or data processing that would typically involve AI/ML.
No
The device is used for improved imaging quality during MRI scans and does not claim to treat or diagnose any condition.
No
The device is used to obtain improved image quality for MRI scans of the esophagus and surrounding anatomical regions, not to diagnose a condition directly.
No
The device is a physical coil and cable designed to be inserted into the esophagus for MRI imaging. It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Surgi-Vision Esophageal Stylet Coil is an accessory used during an MRI scan. It is inserted into the esophagus to improve the quality of the MRI images of the surrounding anatomical regions. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it is for "high-resolution Magnetic Resonance Imaging of the human esophagus" and to "obtain improved image quality." This is an imaging aid, not a diagnostic test performed on a sample.
Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Esophagus and anatomical regions surrounding the esophagus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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; 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.
- Possibility of increased susceptibility of patients to peripheral nerve (2) stimulation: 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.
- (3) Imaging performance. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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.
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:
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.
(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