(237 days)
The Philips Gyroscan NT systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
The GYROSCAN T5-NT (0.5T), GYROSCAN T10-NT (1.0T), GYROSCAN ACS-NT (1.5T) Release 5 series are designed and manufactured to comply with the relevant safety standards. Adequate safety precautions include RF-limit protection, rate of gradient change, and selection/decoupling circuitry for the applicable coils. The systems, as their predecessors, are indicated for use as diagnostic devices producing transverse, sagittal, coronal, and oblique cross-sectional images and displaying the internal structure of the head, body, or extremities. These images, when interpreted by a trained physician, yield information useful in the determination of diagnosis. MR Imaging utilizes mature technology to visualize images with which the industry and users have many years of experience. A Comprehensive Operator's Manual contains adequate instructions and provides sufficient cautions and warnings to ensure safe operation. The software used in Release 5 is equivalent to the software used in the predicate device. The hardware used in Release 5 is identical to the predicte device.
Based on the provided text, the Philips GYROSCAN NT systems (T5-NT, T10-NT, and ACS-NT Release 5 series) are Magnetic Resonance (MR) Imaging devices. The information provided is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device, rather than detailed performance criteria and a specific study proving those criteria were met in the way a clinical trial for a new therapeutic would.
Here's an attempt to extract and interpret the information based on the typical requirements for such a request, acknowledging the limitations of a 510(k) summary for this type of detailed performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative "acceptance criteria" for diagnostic accuracy (e.g., sensitivity, specificity, accuracy percentages) for the GYROSCAN NT systems, nor does it provide a specific study that reports these metrics. Instead, the "acceptance criteria" implied by a 510(k) submission are related to:
- Safety Standards Compliance: The device is designed and manufactured to comply with relevant safety standards.
- Equivalence to Predicate Device: The device performs as well as or similarly to a legally marketed predicate device.
- Expected Diagnostic Utility: The images produced, when interpreted by a trained physician, yield information useful in diagnosis, similar to MR imaging devices already on the market.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety Compliance | "The GYROSCAN T5-NT (0.5T), GYROSCAN T10-NT (1.0T), GYROSCAN ACS-NT (1.5T) Release 5 series are designed and manufactured to comply with the relevant safety standards. Adequate safety precautions include RF-limit protection, rate of gradient change, and selection/decoupling circuitry for the applicable coils." |
| Indication for Use / Diagnostic Utility (Equivalence to Predicate) | "The systems, as their predecessors, are indicated for use as diagnostic devices producing transverse, sagittal, coronal, and oblique cross-sectional images and displaying the internal structure of the head, body, or extremities. These images, when interpreted by a trained physician, yield information useful in the determination of diagnosis." This is further supported by the statement: "The software used in Release 5 is equivalent to the software used in the predicate device. The hardware used in Release 5 is identical to the predicate device." The FDA's letter states: "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." |
| Usability / Operator Instructions | "A Comprehensive Operator's Manual contains adequate instructions and provides sufficient cautions and warnings to ensure safe operation." |
| Image Quality / Visualization (Implied by equivalence) | "MR Imaging utilizes mature technology to visualize images with which the industry and users have many years of experience." The substantial equivalence claim implies that the image quality is comparable to existing devices used for similar diagnostic purposes. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe a specific "test set" of patient data or images used to evaluate the device's diagnostic performance in a clinical study. Substantial equivalence for devices like MR systems often relies on technical comparisons to predicate devices, adherence to standards, and sometimes phantom testing or limited clinical scanning to confirm expected performance, rather than a large-scale diagnostic accuracy study on a patient cohort that would have a "test set" in the context of AI product development.
- Sample Size: Not applicable/Not mentioned for a diagnostic performance test set.
- Data Provenance: Not applicable/Not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since a specific test set for diagnostic accuracy was not detailed, information about experts for ground truth establishment is not provided. The general statement, "These images, when interpreted by a trained physician, yield information useful in the determination of diagnosis," implies the expected use case, but not a formal ground truth process for a study.
- Number of Experts: Not applicable/Not mentioned.
- Qualifications of Experts: Not applicable/Not mentioned.
4. Adjudication Method for the Test Set
As there is no detailed test set described for diagnostic performance, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study comparing human readers with and without AI assistance is mentioned. This is an MR Imaging device itself, not an AI-assisted diagnostic tool built upon MR images.
- MRMC Study Done: No.
- Effect Size of Human Improvement with AI: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is an MR imaging device, not a standalone AI algorithm. It produces images for human interpretation. Therefore, a standalone algorithm performance study as typically understood for AI is not applicable.
- Standalone Study Done: No.
7. Type of Ground Truth Used
Given that a specific clinical diagnostic accuracy study evaluating the device's output against a defined ground truth is not detailed in the summary, "ground truth" in the clinical diagnostic sense is not explicitly described for the purpose of validating the device's diagnostic performance. The ground truth for MR imaging is ultimately established by clinical diagnosis, pathology, or outcomes, but the 510(k) focuses on the device's ability to produce images from which a physician can make such diagnoses.
- Type of Ground Truth: Not explicitly detailed as this type of study was not presented. The fundamental "ground truth" for MR imaging's utility is the ability of trained physicians to interpret the images for clinical diagnosis, pathology correlation, or patient outcomes.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI models. This 510(k) submission is for a conventional medical imaging device (an MRI scanner). Therefore, there is no "training set" in the context of an algorithm learning from data.
- Sample Size: Not applicable.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this question is not applicable.
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Summary of Safety and Effectiveness
MAY 2 9 1997
Philips GYROSCAN NT Systems
8963990
-
- The GYROSCAN T5-NT (0.5T), GYROSCAN T10-NT (1.0T), GYROSCAN ACS-NT (1.5T) Release 5 series are designed and manufactured to comply with the relevant safety standards. Adequate safety precautions include RF-limit protection, rate of gradient change, and selection/decoupling circuitry for the applicable coils.
- The systems, as their predecessors, are indicated for use as diagnostic devices 2. producing transverse, sagittal, coronal, and oblique cross-sectional images and displaying the internal structure of the head, body, or extremities. These images, when interpreted by a trained physician, vield information useful in the determination of diagnosis.
- MR Imaging utilizes mature technology to visualize images with which the industry 3. and users have many years of experience. A Comprehensive Operator's Manual contains adequate instructions and provides sufficient cautions and warnings to ensure safe operation.
-
- The software used in Release 5 is equivalent to the software used in the predicate device. The hardware used in Release 5 is identical to the predicte device.
Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines extending from its back, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avonue .... P.O. Box 860 Shelton, Connecticut 06484-0917 Re: K963990 GYROSCAN T5-NT, T10-NT and ACS-NT Release 5 Series Dated: March 6, 1997 Received: March 7, 1997 Regulatory class: II ... 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Altman:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactnent date of the Medical Device Amendances or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, ind Cosmetic Act (Act). 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 III (Prematce 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 determination assumes compliance with the Good Manufacturing Pracice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, 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 note: this response to your premarket notification does not affect any obligation you might have under sections 51 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 predication 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please postaal the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premacted notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Frien Petr 1 in
510(k) Number (if known): __ Unknown
Philips Gyroscan T5-NT, T10-NT, and ACS NT Device Name :
Indications For Use :
The Philips Gyroscan NT systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number
Prescription Use ( Per 21 CFR 801.109 OR
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.