(71 days)
Not Found
No
The summary describes a physical medical device (MR coils) and its intended use and performance characteristics. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is described as an internal MR coil used to improve image quality during MRI scans, which is a diagnostic function, not a therapeutic one.
No.
The device is an MR coil used to obtain improved image quality during MRI scans, which is a tool for imaging rather than directly diagnosing.
No
The device description explicitly states it is a physical coil with a coaxial cable and interfacing network, designed for insertion into body cavities to improve image quality during MRI scans. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Intercept™ Internal MR Coils are used during an MRI scan to improve image quality of internal anatomical structures. They are inserted into body orifices or vessels and interact with the MRI system to enhance the signal received from the targeted area.
- No Specimen Examination: The device does not collect, prepare, or examine any specimens from the body. It is a tool used in conjunction with an imaging modality (MRI) to acquire better images in vivo.
Therefore, the function and intended use of the Intercept™ Internal MR Coils clearly fall outside the scope of In Vitro Diagnostics. They are considered medical devices used for imaging purposes.
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 Philips MRI system.
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 a 1.5T Philips MRI system. 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 voilly 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 a 1.5T Philips MRI system.
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
internal anatomical structures, body orifices, male and female urethra, surrounding tissue of urethra, prostate (males), peripheral vasculature, artery or 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)
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
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 power. Surgi-Vision carried out a study in a phantom that shows that the change in temperature is within the same range with the coil in place as without it. 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 not significantly different then that observed without the coil. 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 Intercept™ Esophageal Internal MR Coil if the instructions for use are followed and 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
510(k) Summary
Intercept™ Esophageal, Urethral and Vascular Internal MR Coils Philips 1.5T Compatible
K020790
Page 1 of 3
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: March 11, 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 Philips compatible connector.
B. 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.
C. INTENDED 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 Philips MRI system.
Surgi-Vision, Inc. Intercept™ Internal MR Coils March 11, 2002
Exhibit I-8
1
SUBSTANTIAL EQUIVALENCE SUMMARY D.
K020790
Page 2 of 3
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 Both proposed and predicate devices have an as the predicate devices. 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 Such performance data are available and do substantial equivalence. demonstrate substantial equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
See Section D, above.
ட் 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 1.
- Possibility of increased susceptibility of patients to peripheral nerve 2. stimulation
- Imaging performance 3.
- র্বা 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 power. Surgi-Vision carried out a study in a phantom that shows that the change in temperature is within the same range with the coil in place as without it.
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 not significantly different then that observed without the coil. 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 Intercept™ Esophageal Internal MR
Surgi-Vision, Inc. Intercept™ Internal MR Coils March 11, 2002
Exhibit 1-9
2
Coil if the instructions for use are followed and the change in temperature observed during use of the coil is within an acceptable range (