MR FIBER OPTIC ECG GATING SYSTEM

• K Number: K031731
• Device Name: MR FIBER OPTIC ECG GATING SYSTEM
• Manufacturer: SA INSTRUMENTS, INC.
• Date Cleared: 2003-07-30 ( 56 days)
• Product Code: LNH
• Regulation Number: 892.1000

Intended Use

The MR Fiber Optic ECG Gating System is intended to be used when it is necessary to svnchronize the MR scanner's data acquisition with the patient's electrocardiogram.

Device Description

The MR Fiber Optic ECG Gating System measures and digitizes the patient's electrocardiogram, detects the presence of an R-wave and provides a trigger to the Signa MR system. The gating system provides for operator control of parameters used in the R-wave detection algorithms and control of gate delay. The electrocardiogram waveform is displayed along with the gate, heart rate and the measured R to R interval.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ECG signal processing and R-wave detection algorithms with operator control, not AI/ML.

Therapeutic

No
The device synchronizes MR scanner data acquisition with the patient's electrocardiogram but does not treat or cure a disease or condition.

Diagnostic

No

The device is an ECG gating system used to synchronize an MR scanner's data acquisition with a patient's electrocardiogram. It measures and digitizes the ECG, detects R-waves, and provides a trigger to the MR system. While it displays the ECG waveform and heart rate, its primary function is not to diagnose medical conditions but to facilitate cardiac-gated MR imaging.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system "measures and digitizes the patient's electrocardiogram," which implies the use of hardware components (sensors, digitizers) to acquire the physiological signal. It is not solely software processing data from another source.

IVD (In Vitro Diagnostic)

Based on the provided information, this device 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.
• Device Function: The MR Fiber Optic ECG Gating System measures and digitizes the patient's electrocardiogram (ECG) and uses this information to synchronize an MR scanner. It is directly interacting with the patient's physiological signals in vivo (within the living body).
• Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient.

Therefore, the device's function falls outside the scope of in vitro diagnostics. It is a medical device used for patient monitoring and synchronization during an imaging procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MR Fiber Optic ECG Gating System is intended to be used when it is necessary to synchronize the MR scanner's data acquisition with the patient's electrocardiogram.

Product codes (comma separated list FDA assigned to the subject device)

90 LNH

Device Description

The MR Fiber Optic ECG Gating System measures and digitizes the patient's electrocardiogram, detects the presence of an R-wave and provides a trigger to the Signa MR system. The gating system provides for operator control of parameters used in the R-wave detection algorithms and control of gate delay. The electrocardiogram waveform is displayed along with the gate, heart rate and the measured R to R interval.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Performance Testing:
The MR Fiber Optic ECG Gating System meets IEC 601-1-2, IEC 601-1-2, IEC 601-2-27, IEC 801-2. -3. 4. -5. CISPR 11. In addition, tests were performed to establish that the Gating system operated in the MRI environment substantially equivalent to the predicate device.

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.

Gating cable provided by General Electric for the 1.0 T and 1.5 T Signa MR systems

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

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.

Summary

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Ko 3 1731 510(k) Summary

JUL 3 0 2003

Summary of Safety and Effectiveness

Submitter:	SA Instruments, Inc.
Address:	65 Main Street
Stony Brook, NY, 11790
Telephone:	[phone]
Contact:	President
Prepared:	May 28, 2003
Proprietary Name:	MR Fiber Optic ECG Gating System
Common/Classification Name:	Gating system
Predicate Devices:	Gating cable provided by General Electric for the
1.0 T and 1.5 T Signa MR systems

New Device Description: ·

The MR Fiber Optic ECG Gating System measures and digitizes the patient's electrocardiogram, detects the presence of an R-wave and provides a trigger to the Signa MR system. The gating system provides for operator control of parameters used in the R-wave detection algorithms and control of gate delay. The electrocardiogram waveform is displayed along with the gate, heart rate and the measured R to R interval.

Intended Use:

The MR Fiber Optic ECG Gating System is intended to be used when it is necessary to svnchronize the MR scanner's data acquisition with the patient's electrocardiogram.

Performance Testing:

The MR Fiber Optic ECG Gating System meets IEC 601-1-2, IEC 601-1-2, IEC 601-2-27, IEC 801-2. -3. 4. -5. CISPR 11. In addition, tests were performed to establish that the Gating system operated in the MRI environment substantially equivalent to the predicate device.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The central symbol appears to be a stylized representation of an eagle or bird, with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2003

G. Ronald Morris, Ph.D. President SA Instruments, Inc. P.O. Box 740 STONY BROOK NY 11790 Re: K031731

Trade/Device Name: MR Fiber Optic ECG Gating System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: May 30, 2003

Received: June 4, 2003

Dear Dr. Morris:

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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This letter will allow you to begin marketing your device as described in your Section 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 the letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] 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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INDICATIONS FOR USE

510 (k) NUMBER (IF KNOWN) Ko 3 / 7 3 /

DEVICE NAME: MR Fiber Optic ECG Gating System

INDICATIONS FOR USE:

The MR Fiber Optic ECG Gating System would be used when it is necessary to synchronize the MR scanner's data acquisition with the patient's electrocardiogram.

David R. Lyon

productive, Abdominal,

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)