(56 days)
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.
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.
The provided text describes the MR Fiber Optic ECG Gating System. However, it does not contain specific acceptance criteria or a detailed study description with performance metrics in the way you've outlined.
The document primarily focuses on regulatory approval (510(k) submission) and states that performance testing was conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on the available information, highlighting what is not present as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified beyond compliance with IEC standards and substantial equivalence) | 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. Tests were performed to establish that the Gating system operated in the MRI environment substantially equivalent to the predicate device. |
Missing Information:
- Specific numerical targets for performance metrics (e.g., accuracy of R-wave detection, latency, heart rate measurement accuracy, synchronization stability).
- Quantitative results from operating in the MRI environment.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No mention of an MRMC study. The comparison was to a predicate device (Gating cable provided by General Electric), not explicitly human readers.
- Effect size of human readers with vs. without AI assistance: Not applicable, as no MRMC or human-AI comparison is described.
6. Standalone Performance Study
- Was it done?: Yes, to some extent. The document states "tests were performed to establish that the Gating system operated in the MRI environment substantially equivalent to the predicate device." This implies a standalone evaluation of the device's function. However, detailed performance metrics are not provided.
7. Type of Ground Truth Used
- Given the nature of an ECG gating system, the ground truth would likely be established through:
- Reference ECG measurements: Gold standard ECG readings.
- Simulated physiological signals: Controlled inputs to test R-wave detection and timing.
- Comparison to predicate device's output: As mentioned, substantial equivalence to the predicate device was evaluated, implying the predicate's performance served as a benchmark for "ground truth" or acceptable performance in the MRI environment.
Missing Information: The specific method of ground truth establishment is not detailed.
8. Sample Size for the Training Set
- Sample Size: Not specified. The document does not mention any "training set" in the context of machine learning or AI. This device appears to be a hardware/firmware system for signal detection and gating, not an AI-driven image analysis tool that would typically involve a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as a training set for machine learning is not mentioned.
In summary: The provided document is a 510(k) summary, which is typically a high-level overview focused on regulatory compliance and substantial equivalence. It does not contain the detailed, quantitative performance study data or methodology that would be present in a scientific publication or a more comprehensive technical report. The "performance testing" mentioned is general and refers to compliance with international standards and substantial equivalence to a predicate device.
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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 StreetStony Brook, NY, 11790 |
| Telephone: | (631) 689-0408 |
| 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 the1.0 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 | (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" (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 (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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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)
§ 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.