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 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 a 1.5T Philips MRI system.

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.

AI/ML Overview

This 510(k) summary describes a device that is essentially an accessory to an MRI system (internal MR coils). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on demonstrating that the new device (Philips compatible version of existing coils) is substantially equivalent to legally marketed predicate devices, particularly regarding safety and compatibility with the new MRI system.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Type
Possibility of excess RF heating: No excess heating, temperature change within acceptable range (< 2 degrees C in the trunk).	Change in temperature within the same range with the coil in place as without it in a phantom. Not significantly different than without the coil.	Phantom Study
Possibility of increased susceptibility of patients to peripheral nerve stimulation: No possibility of increased susceptibility to peripheral nerve stimulation.	Experiments done previously to determine current leakage by the MRI pulsed gradient field demonstrate no possibility of increased susceptibility. Remains true despite change from GE to Philips system.	Previous Experiment (referenced)
Imaging Performance: Enhanced resolution (specifically for aortic regions visualized from the esophagus). Functions like any other specialty MRI coil for general diagnostic imaging.	Imaging performance demonstrates enhanced resolution of aortic regions visualized from the esophagus. Images taken using the coil in a volunteer illustrating its use in the esophagus on the Philips 1.5T MRI system.	Volunteer Imaging Study
Mechanical Testing: Bonds between connector/coaxial connector and connector/introducer sleeve display strengths in excess of 1 lb/f.	Results on the Esophageal Coil showed strengths in excess of required 1lb/f. (Stated as identical to predicate, so previous results apply).	Mechanical Testing

Study Details

Sample size used for the test set and the data provenance:
- RF Heating Study: A "phantom" was used. The specific type or number of phantoms is not detailed.
- Peripheral Nerve Stimulation: No specific test set described for this submission; it references "experiments done previously" and asserts that the findings remain true for the Philips system.
- Imaging Performance: "a volunteer" was used. No further details on the volunteer or data provenance (e.g., country of origin, retrospective/prospective).
- Mechanical Testing: Not explicitly stated for this particular submission, but references "the Esophageal Coil" and states it's identical to the "original Surgi-Vision Esophageal Stylet Coil," implying prior mechanical testing. No specific sample size or provenance for this re-affirmation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission focuses on engineering and compatibility testing, not diagnostic accuracy requiring expert interpretation for ground truth.
- For imaging performance, the enhanced resolution is an objective observation, not dependent on establishing a "ground truth" through expert consensus in the same way a diagnostic AI algorithm would be. No experts are mentioned for ground truth establishment.
Adjudication method for the test set: Not applicable for this type of technical and compatibility assessment.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI diagnostic device, nor is it a study comparing human readers with and without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (MRI coil), not an algorithm.
The type of ground truth used:
- RF Heating: Direct temperature measurements in a phantom, compared to baseline (without the coil). This is an objective physical measurement.
- Peripheral Nerve Stimulation: Current leakage measurements from previous experiments are the basis. This is an objective physical measurement.
- Imaging Performance: Visual assessment of image resolution (e.g., "enhanced resolution of aortic regions"). While qualitative, it's based on visual clarity and detail. This is an objective physical measurement (image quality metrics), not clinical "ground truth" derived from patient outcomes or pathology.
- Mechanical Testing: Force/load tests. This is an objective physical measurement.
The sample size for the training set: Not applicable. This device does not use machine learning or AI models with training sets.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

Summary

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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

C. INTENDED USE

Surgi-Vision, Inc. Intercept™ Internal MR Coils March 11, 2002

Exhibit I-8

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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

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Coil if the instructions for use are followed and the change in temperature observed during use of the coil is within an acceptable range (< 2 degrees C in the trunk).

POSSIBILITY OF INCREASED SUSCEPTIBILITY TO NERVE STIMULATION

The experiments done previously to determine current leakage by the MRI pulsed gradient field demonstrate that there is no possibility of increased susceptibility of patients to peripheral nerve stimulation. This remains true despite a change from the GE to the Philips system. A copy of this report is included in this 510k.

IMAGING PERFORMANCE

The Surgi-Vision coil functions like any other specialty MRI coil and it is indicated for general diagnostic imaging. Therefore, a series of images were taken using the coil in a volunteer illustrating its use in the esophagus on the Philips 1.5T MRI system.

MECHANICAL TESTING

The Surgi-Vision coils have undergone mechanical testing and the results on the Esophageal Coil were provided. Since the coils are identical to the original Surgi-Vision Esophageal Stylet Coil, the same results are presented. The bonds between the connector/coaxial connector and connector/Introducer sleeve have displayed strengths in excess of the required 1lb/f.

CONCLUSIONS G.

This pre-market submission has demonstrated Substantial Equivalence as defined 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™ Internal MR Coils March 11, 2002

Exhibit I-10

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line. The words are black against a white background.

od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K020790

Ms. Nancy E. Taylor CEO/President Surgi-Vision, Inc. 20 Firstfield Road, Suite 200 GAITHERSBURG MD 20878

Trade/Device Name: Intercept Esophageal Internal MR Coil Intercept Urethral Internal MR Coil Intercept Vascular Internal MR Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: March 11, 2002 Received: March 11, 2002

Dear Ms. Taylor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 prior 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) that do not require approval of a premarket approval application (PMA). 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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 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

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(K) Number (if known):

Device name: Intercept™ Urethral Internal MR Coil

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Surgi-Vision, Inc. Intercept™ Internal MR Coils

March 11, 2002

Prescription Use (Per 21 CFR 801.109) Exhibit III-

Daniel A. Seamon

f Reproductive. Abdomin

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STATEMENT OF INDICATIONS FOR USE

510(K) Number (if known): Ko26790

Device name: Intercept™ Vascular Internal MR Coil

Indications for Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Surgi-Vision, Inc. Intercept™ Internal MR Coils March 11, 2002

Prescription Use
(Per 21 CFR 801.109)

Exhibit III-

3 1 3

David A. Symon

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.