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 esophaqus. 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.

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

The provided document is a 510(k) summary for the Intercept™ Esophageal, Urethral, and Vascular Internal MR Coils. It focuses on demonstrating substantial equivalence to previously cleared predicate devices for use with Siemens 1.5T MRI systems. This type of submission generally emphasizes safety and functional equivalence rather than extensive clinical comparative effectiveness studies found in other regulatory pathways.

Therefore, the information typically requested in your prompt regarding acceptance criteria for clinical performance, sample sizes for test/training sets, expert qualifications, and MRMC studies is not extensively detailed. The performance data presented primarily addresses safety and a qualitative assessment of imaging performance.

Here's an attempt to extract and describe the information based on the provided text:

Acceptance Criteria and Device Performance

Criteria (Issue Addressed)	Acceptance Criteria (Stated or Implied)	Reported Device Performance and Study Findings
1. Excess RF Heating (Safety)	Localized temperature changes caused by the coil are within an acceptable temperature range (< 2 degrees C in the trunk).	A phantom study showed localized temperature changes caused by the coil are within an acceptable range, specifically < 2 degrees C in the trunk. The results demonstrate no excess heating.
2. Increased Susceptibility to Peripheral Nerve Stimulation (Safety)	No possibility of increased susceptibility to peripheral nerve stimulation.	Experiments done previously (for the predicate device) demonstrated no current leakage by the MRI pulsed gradient field, confirming no increased susceptibility to PNS. This remains true despite changing to a Siemens system.
3. Imaging Performance (Efficacy/Functionality)	Enhanced resolution of anatomical regions when using the coil.	A series of images taken using the Esophageal coil in a volunteer illustrated its use in the esophagus on the Siemens 1.5T MRI system, demonstrating enhanced resolution of aortic regions visualized from the esophagus.
4. Mechanical Testing (Safety/Durability)	Bonds between connector/coaxial connector and connector/Introducer sleeve display strengths in excess of 1 lb/f.	The Esophageal Coil displayed bond strengths in excess of the required 1 lb/f. (Stated as identical to original Surgi-Vision Esophageal Stylet Coil).

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size:
- RF Heating and Nerve Stimulation: Not explicitly stated as a number of 'cases' but rather as "a phantom study" and "experiments done previously."
- Imaging Performance: "a volunteer" for the Esophageal coil. So, n=1 for the qualitative imaging performance demonstration for the esophageal coil.
- Mechanical Testing: Not explicitly stated as a number of units, but "the Esophageal Coil" was tested, implying at least one.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal testing conducted by Surgi-Vision, Inc. These were retrospective analyses of existing data (for nerve stimulation and mechanical testing of the predicate, and newly conducted phantom/volunteer tests for the Siemens compatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The studies described are primarily engineering/phantom tests and qualitative imaging assessments, not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable/not provided. The studies were not designed for diagnostic adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence in terms of safety and basic imaging capability, not comparative diagnostic performance with or without AI assistance (as AI is not part of this device).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is an MR coil, not an algorithm or AI system. Its performance is intrinsically tied to its use with an MRI machine and a human operator/interpreter.

7. The type of ground truth used:

RF Heating: Measured temperature changes in a phantom, compared against physical safety limits.
Nerve Stimulation: Measurements from previous experiments on current leakage, compared against safety thresholds.
Imaging Performance: Qualitative assessment of "enhanced resolution" of aortic regions visualized from the esophagus. This is a subjective assessment, likely by internal personnel, rather than a formally established "ground truth" for a diagnostic task.
Mechanical Testing: Measured bond strengths compared against a defined mechanical requirement (1 lb/f).

8. The sample size for the training set:

This question is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

This question is not applicable as the device is not an AI/ML algorithm.

Summary

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K020495

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.

INTENDED USE C.

Surgi-Vision, Inc. Intercept™ Internal MR Coils February 12, 2001

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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:

1. Possibility of excess RF heating
1. Possibility of increased susceptibility of patients to peripheral nerve stimulation
1. Imaging performance
1. 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

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coil is within an acceptable range (< 2 degrees C in the trunk). 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.

INCREASED SUSCEPTIBILITY TO NERVE POSSIBILITY OF 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 Siemens 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 Siemens 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. between the connector/coaxial connector and The bonds connector/Introducer sleeve have displaved strengths in excess of the required 11b/f.

G. CONCLUSIONS

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various quidance documents issued by the Center for Devices and Radiological Health.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be part of a document or sign.

9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2002

Re: K020495

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

Trade/Device Name: Intercept™ Esophageal, Urethral and Vascular Internal MR Coils Siemens 1.5T Compatible Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: 90 MOS Dated: February 12, 2002 Received: February 14, 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 (OS) 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): _ Ko 2 . 495

Device name: Intercept™ Esophageal 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)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

David A. Ingram

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0204

Surgi-Vision, Inc. Intercept™ Internal MR Coils February 12, 2001

Exhibit III - 1

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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)

David A. Bergman

(Division Sign Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020495

Prescription Use (Per 21 CFR 801.109)

Exhibit III - 2

Surgi-Vision, Inc. Intercept™ Internal MR Coils February 12, 2001

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STATEMENT OF INDICATIONS FOR USE

510(K) Number (if known): K o 2 o 49 S

Device name: Intercept™ Vascular Internal MR Coil

Indications for Use:

This product is to be used with Siemens 1.5T MRI systems.

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

Prescription Use
(Per 21 CFR 801.109)

David A. deym
(Division Sign-Off)

Surgi-Vision, Inc. Intercept™ Internal MR Coils February 12, 2001

Exhibit III - 3

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.