(68 days)
Not Found
No
The description focuses on the physical design and function of the MR coils for improved signal acquisition, with no mention of AI/ML for image processing, analysis, or other functions.
No
The device is used for improved image quality in MRI scans, not for treatment or mitigation of a disease or condition.
No.
The device is an internal MR coil used to improve image quality during MRI scans, it does not interpret or diagnose conditions, but rather aids in obtaining better images which a healthcare professional, not the device itself, would then use for diagnosis.
No
The device description explicitly states it is a physical coil with a coaxial cable and polymeric housing, designed for insertion into body orifices. This indicates a hardware component, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Intercept™ Internal MR Coils are devices designed to be inserted into the body (esophagus, urethra, blood vessels) during an MRI scan. Their purpose is to improve the quality of the MRI images by being closer to the anatomical structures being imaged.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a tool used in vivo (within the living body) to enhance an imaging procedure.
Therefore, the function and intended use of the Intercept™ Internal MR Coils clearly fall outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intercept™ Internal MR Coils are recommended for high-resolution Magnetic Resonance Imaging of internal anatomical structures. The single use, disposable coils were designed to be inserted into body orifices of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the coil. The unique coil shapes facilitate orientation of the coils to the anatomy. These products are to be used with a 1.5T MRI machine.
The Intercept™ Esophageal Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the human esophagus. The single use, disposable coil is designed for insertion into 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 Siemens 1.5T MRI systems.
The Intercept™ Urethral Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of a patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra and including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy. This product is to be used with Siemens 1.5T MRI systems. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The coil and cable are completely sealed inside the insulating layer.
The Intercept™ Vascular Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the peripheral vasculature. The single use, disposable coil is designed for insertion into an artery or vein of a patient during MRI scans in order to obtain improved image quality in the peripheral vasculature. The flexible coil facilitates placement of the coil in the peripheral vascular anatomy. The coil would most commonly be used through femoral artery access similar to .035" guidewires currently in use. The handling characteristics of this device are familiar to vascular interventionalists thereby facilitating integration into their practices.
This product is to be used with Siemens 1.5T MRI systems.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Intercept™ Internal MR Coils are intracavitary specialty coils for use in MR imaging of the anatomical regions surrounding a body cavity. The signals picked up by the coil are conducted through a small coaxial cable and interfacing network to a connection with the standard surface coil connector for MRI systems. The coil is insulated with polymeric housing that protects is from contact from body fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Esophagus, male and female urethra and surrounding tissue, prostate (males), peripheral vasculature, internal anatomical structures, body orifices, artery, vein.
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)
Testing
Surgi-Vision carried out testing and/or analysis of the Intercept™ Esophageal Internal MR Coil that addressed the following issues:
- Possibility of excess RF heating
- Possibility of increased susceptibility of patients to peripheral nerve stimulation
- Imaging performance
- Mechanical Testing
Possibility of Excess RF Heating
The primary safety issue for the Intercept™ Esophageal Internal MR Coil is the potential for excess heating of tissue near the coil by MRI system's RF Surgi-Vision carried out a phantom study showing localized power. temperature changes caused by the coil are within an acceptable temperature range.
The results of the heating experiments demonstrate that there is no excess heating when the coil is positioned in a phantom that is representative of clinical conditions. The change in temperature observed during use of the coil is within an acceptable range (
§ 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
APR 2 3 2002
510(k) Summary
Intercept™ Esophageal, Urethral and Vascular Internal MR Coils Siemens 1.5T Compatible
Common/Classification Name: Accessory to Magnetic Resonance Diagnostic Device, 21 CFR 892, 1000
Surgi-Vision, Inc. 20 Firstfield Road, Suite 200 Gaithersburg, MD 20878
Contact: Nancy E. Taylor, Prepared: April 04, 2002
LEGALLY MARKETED PREDICATE DEVICES A.
The Intercept ™ Esophageal Internal MR Coil is substantially equivalent to the Surgi-Vision Esophageal Stylet Coil, which was cleared for marketing on March 14, 2000, in premarket notifications K994436. The Intercept™ Urethral Microcoil, is substantially equivalent to the Intercept Urethral Microcoil, which was cleared for marketing on August 31, 2001 in premarket notification K011781. The Intercept™ Vascular Internal MR Coil is substantially equivalent to the Surgi-Vision Guidewire Coil, and cleared for marketing on February 2, 2001 in premarket notification K003436. This submission also represents notification of the change from SV coils to Intercept Coils. The predicate devices are compatible with the GE 1.5T system and the current submission requests clearance on the identical product, with a Siemens compatible connector.
DEVICE DESCRIPTION B.
The Intercept™ Internal MR Coils are intracavitary specialty coils for use in MR imaging of the anatomical regions surrounding a body cavity. The signals picked up by the coil are conducted through a small coaxial cable and interfacing network to a connection with the standard surface coil connector for MRI systems. The coil is insulated with polymeric housing that protects is from contact from body fluids.
INTENDED USE C.
The Intercept™ Internal MR Coils are recommended for high-resolution Magnetic Resonance Imaging of internal anatomical structures. The single use, disposable coils were designed to be inserted into body orifices of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the coil. The unique coil shapes facilitate
Surgi-Vision, Inc. Intercept™ Internal MR Coils February 12, 2001
1
orientation of the coils to the anatomy. These products are to be used with a 1.5T MRI machine.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Intercept™ Internal MR Coils have identical, indications for use as the legally marketed predicate devices.
The Intercept™ Internal MR Coils have the same technological characteristics as the predicate devices. 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 the scanner systems that make it desirable to provide performance data to assure substantial equivalence. Such performance data are available and do demonstrate substantial equivalence.
ய் TECHNOLOGICAL CHARACTERISTICS
See Section D. above.
F. TESTING
Surgi-Vision carried out testing and/or analysis of the Intercept™ Esophageal Internal MR Coil that addressed the following issues:
-
- Possibility of excess RF heating
-
- Possibility of increased susceptibility of patients to peripheral nerve stimulation
-
- Imaging performance
-
- Mechanical Testing
POSSIBILITY OF EXCESS RF HEATING
The primary safety issue for the Intercept™ Esophageal Internal MR Coil is the potential for excess heating of tissue near the coil by MRI system's RF Surgi-Vision carried out a phantom study showing localized power. temperature changes caused by the coil are within an acceptable temperature range.
The results of the heating experiments demonstrate that there is no excess heating when the coil is positioned in a phantom that is representative of clinical conditions. The change in temperature observed during use of the
2
coil is within an acceptable range (