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.

Device Description

The Intercept-Urethral Microcoil (IUMC) is an intracavitary specialty coil for use in MRI imaging of the anatomical regions surrounding the urethra. 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 imaging coil and the coaxial cable are completely sealed inside the insulating sleeve. This device is advanced into the subject's urethra and positioned in the region of interest. The balancing and decoupling circuit is located outside the body.

AI/ML Overview

The provided text is a 510(k) summary for the Intercept-Urethral Microcoil (IUMC). It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not contain specific acceptance criteria, numeric performance metrics (sensitivity, specificity, AUC), or a detailed study description with a test set, ground truth experts, or training set information as requested in the prompt.

The document states that the imaging performance was evaluated and that "The imaging performance was evaluated in the male and female urethra. These images are shown in Exhibit 7." However, Exhibit 7 is not provided in the given text, and therefore, no quantitative performance metrics for imaging performance are available to construct the acceptance criteria table.

Based on the provided text, I can extract the following information about the studies performed, but without the specific numerical acceptance criteria or performance results:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes the types of tests performed and their general outcomes ("no excess heating," "no possibility of increased susceptibility," "imaging performance was evaluated," "met performance specifications"), but it does not provide specific, quantifiable acceptance criteria or numerical performance results (e.g., a specific temperature threshold, a specific imaging quality score, or mechanical specifications). Therefore, this table is based on the qualitative outcomes described.

Acceptance Criteria Category	Reported Device Performance (Qualitative)
Excess RF Heating	No excess heating when IUMC is positioned in a phantom representative of worst-case clinical conditions. Change in temperature not significantly different than without the coil.
Peripheral Nerve Stimulation	No possibility of increased susceptibility of patients to peripheral nerve stimulation (based on current leakage calculations).
Imaging Performance	Evaluated in the male and female urethra (images shown in Exhibit 7, not provided).
Mechanical Testing	No safety issues found; all performance specifications (stiffness, tensile, tracking, torque, electrical testing) were met to satisfaction. Mechanical flexing resulted in insignificant changes in electrical properties.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for imaging performance. For RF heating, a "phantom that is representative of worst case clinical conditions" was used. For mechanical testing, individual components underwent testing.
Data Provenance: Not explicitly stated. The studies appear to be laboratory-based and phantom-based for heating and mechanical testing. Imaging performance evaluation was done on "male and female urethra," implying human subjects, but details are not provided. Origin (e.g., country) is not mentioned.
Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not specified. The document does not describe a ground truth establishment process involving experts for the tests mentioned. For imaging performance, it only states that images were evaluated and shown in an exhibit.

4. Adjudication Method for the Test Set

Not specified. No mention of an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document describes tests related to safety (heating, nerve stimulation, mechanical) and general imaging performance, not a comparison of human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable as the device described (Intercept-Urethral Microcoil) is an accessory to an MRI system designed to improve image quality, not an AI algorithm. Its "standalone" performance refers to its physical and electrical properties, not an algorithmic output.

7. Type of Ground Truth Used for the Test Set

For RF Heating and Nerve Stimulation: Calculated values and phantom measurements, comparing with and without the coil.
For Mechanical Testing: Performance specifications (presumably engineering standards and internal benchmarks).
For Imaging Performance: "Evaluated in the male and female urethra" - the specific ground truth (e.g., clinical diagnosis, pathology) is not described, nor is how the "evaluation" was performed (e.g., by experts, objectively).

8. Sample Size for the Training Set

Not applicable. The device is a physical medical device (a coil), not a software algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a physical device and not an AI algorithm.

Summary

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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

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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

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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

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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

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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)

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

Page III-1

Regulation Number and Section

§ 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.