(85 days)
Not Found
No
The summary describes a physical medical device (an MRI coil) designed to improve image quality. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical properties and imaging performance, not algorithmic performance.
No.
The document clearly states that the device is "recommended for high-resolution Magnetic Resonance Imaging" and is used "to obtain improved image quality." Its purpose is diagnostic imaging, not treatment.
No
Explanation: The device is an imaging coil designed to gather improved image quality during an MRI scan. It is a tool used in the diagnostic imaging process, but it does not perform the diagnosis itself.
No
The device is a physical coil designed for insertion into the urethra during MRI scans. It is a hardware component used to improve image quality and is not solely software.
Based on the provided information, the Intercept-Urethral Microcoil 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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The Intercept-Urethral Microcoil is a medical device used during an MRI scan. Its purpose is to improve the quality of the images obtained from the urethra and surrounding tissues within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue." This is an imaging procedure, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of a medical imaging accessory rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Intercept-Urethral Microcoil 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 the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra 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 GE Signa MRI machine. 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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Intercept-Urethral Microcoil (IUMC) is an intracavitary specialty MR imaging coil for use in MR imaging of the anatomical regions surrounding the urethra. The coiled portion of the coil is advanced into the subject's urethra and positioned in the region of interest. The signals picked up by the coil are conducted through a urethral interfacing network to a connection with the standard surface coil connector for MRI systems. The imaging coil and the coaxial cable are completely sealed inside the insulating sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
male and female urethra and surrounding tissue, including the prostate in males.
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-Urethral Microcoil that addressed the following issues:
- Possibility of excess RF heating; The results of the heating experiments demonstrate that there is no excess heating when IUMC is positioned in a phantom that is representative of worst case clinical conditions. The change in temperature observed during use of the IUMC is not significantly different then that observed without the coil.
- Possibility of increased susceptibility of patients to peripheral nerve stimulation; The calculations 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; The imaging performance was evaluated in the male and female urethra. These images are shown in Exhibit 7.
- Mechanical testing. Mechanical test results demonstrated that there are no safety issues and that all of the performance specifications were met. Stiffness, tensile, tracking, torque, and electrical testing were all completed to the satisfaction of the specifications. Mechanical flexing resulted in insignificant changes in the electrical properties of the coils. These results are described in Exhibit 8.
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
Kol
510(k) Summary
Intercept-Urethral Microcoil
Common/Classification Name: Accessory to Magnetic Resonance Diagnostic Device, 21 CFR 892.1000
Surgi-Vision, Inc. 20 Firstfield Road, Suite 200 Gaithersburg, MD 20878
Prepared: June 7, 2001 Contact: Nancy E. Taylor,
LEGALLY MARKETED DEVICE A.
The Intercept-Urethral Microcoil was cleared for marketing as the The Intercept-Orchhar Microcon November 28, 2000 in prospect Surgi-Vision, Inc. submits the present notification K0022916. notification Koozzo For Suignifications for use for use for the Surgipremarket notheation of dadinoner of the Intercept-Urethral Microcoil.
DEVICE DESCRIPTION B.
The Intercept-Urethral Microcoil (IUMC) is an intracavitary specialty The Intercept of ordinal Micros the anatomical regions surrounding the coll for use in NH muging or he coil are conducted through a urethia. The orghale pronterfacing network to a connection with the standard surface coil connector for MRI systems.
The imaging coil and the coaxial cable are completely sealed inside the The imaging our and the coil from direct contact with any insulating slevvo. This lociated ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . is advanced into the subject's urethra and positioned in the region of ls auvanced into the babjoor atching and decoupling circuit is located interest: "The balan, values outside the body.
INTENDED USE C.
The Intercept-Urethral Microcoil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and
Surgi-Vision, Inc. Intercept-Urethral Microcoil June 7, 2001
Exhibit 1-Page 1
1
surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra 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 GE Signa MRI machine. 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.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
This premarket notification concerns only additional intended uses for the IUMC. Concurrently, the name will be changed from the Surgi-Vision Prostate Coil to the Intercept Urethral Microcoil.
In all other aspects, the IUMC is the device that was cleared for marketing by FDA on November 28, 2000, in premarket notification K002916.
TECHNOLOGICAL CHARACTERISTICS E.
See Section D, above.
E. TESTING
Surgi-Vision carried out testing and/or analysis of the Intercept-Urethral Microcoil that addressed the following issues:
- Possibility of excess RF heating; (1)
- Possibility of increased susceptibility of patients to peripheral (2) nerve stimulation;
- (3) Imaging performance; and
- (4) Mechanical testing.
The results of the heating experiments demonstrate that there is no Surgi-Vision, Inc. Exhibit 1-Page 2 Intercept-Urethral Microcoil June 7, 2001
2
excess heating when IUMC is positioned in a phantom that is representative of worst case clinical conditions. The change in temperature observed during use of the IUMC is not significantly different then that observed without the coil.
The calculations 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.
The imaging performance was evaluated in the male and female urethra. These images are shown in Exhibit 7.
Mechanical test results demonstrated that there are no safety issues and that all of the performance specifications were met. Stiffness, tensile, tracking, torque, and electrical testing were all completed to the satisfaction of the specifications. Mechanical flexing resulted in insignificant changes in the electrical properties of the coils. These results are described in Exhibit 8.
G. CONCLUSIONS
This pre-market submission has demonstrated the IUMC is safe and effective for the additional indications as required 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. Intercept-Urethral Microcoil June 7, 2001
Exhibit 1-Page 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2001
Ms. Nancy E. Taylor CEO/President Surgi-Vision Inc. 20 Firstfield Road, Suite 200 GAITHERSBURG MD 20878 Re: K011781
Intercept Urethral Microcoil (MRI specialty coil) Dated: June 7, 2001 Received: June 7, 2001 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 is w marked for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate substance prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in econdance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to ate general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 decemination assumes compliance with the Current Good Manufacturing Practice requirements, 000 to 09:51 Pater Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic as so rolling 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 rotation 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
(301) 594-4591 8xx.1xxx (301) 594-4616 876.2xxx, 3xxx, 4xxx, 5xxx (301) 594-4616 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx (301) 594-4654 892.2xxx, 3xxx, 4,xxx, 5xxx (301) 594-4692 Other
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, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
STATEMENT OF INDICATIONS FOR USE
510(K) Number (if known): _ Ko | 1781
Device name: Intercept-Urethral Microcoil
Indications for Use:
The Intercept-Urethral Microcoil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and magnetis is tissue. The single use, disposable coil was designed to be inserted in the urethra of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra 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 GE Signa MRI machine. 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.
(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
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
Surgi-Vision, Inc.
Intercept-Urethral Microcoil
June 7, 2001
and Radiological Devices
510(k) Number
K011781
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