(69 days)
The Indications for Use for the Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil expands the imaging performance of the Signa Profile System. The Quadrature Thoracic / Lumbar spine Phased Array coil can also be used to image the following regions of anatomy: Thoracic Spine, Lumbar Spine, Chest, Abdomen, Pelvis, Hips.
The Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil is a receive only coil and can receive the quadrature signal. It is designed for use with a vertical magnetic field MR imaging system.
The provided text is a 510(k) summary for a medical device (Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil). It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for specific performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not explicitly present in the given document. The document primarily states that the device was evaluated to appropriate NEMA performance standards and International safety standards (IEC 601-1 and IEC 601-2-33) and performed to stated specifications. However, it does not elaborate on what those specific performance criteria were or how the device's performance measured against them.
Here's a breakdown of what can be extracted, and what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NEMA performance standards | Evaluated to appropriate NEMA performance standards. Performed to stated specifications. |
| IEC 601-1 safety standards | Evaluated to IEC 601-1. Performed to stated specifications. |
| IEC 601-2-33 safety standards | Evaluated to IEC 601-2-33. Performed to stated specifications. |
| Substantial Equivalence to Signa Profile Body Flexible Coil | The coil does not result in any new potential hazards. Substantially equivalent to the presently marketed Signa Profile Body Flexible Coil. |
Missing Information: The document does not provide specific numerical or qualitative performance metrics against which the device was evaluated for NEMA or IEC standards. It only states that the device "performed to stated specifications" without detailing those specifications.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The study appears to be a technical evaluation of the coil's performance against standards, not a clinical study with patient samples.
- Data Provenance: Not applicable in the context of a technical performance evaluation described. The evaluation was likely performed in a lab setting by the manufacturer (GE Yokogawa Medical Systems, Ltd. in Tokyo, Japan).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. The "ground truth" here would be the adherence to technical standards and specifications, not clinical diagnoses requiring expert consensus.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified. Standard compliance is typically verified through testing against defined protocols, not through expert adjudication in this context.
5. 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
- MRMC Study: No, this was not an MRMC study. This device is an MR coil, not an AI-assisted diagnostic tool for interpretation by human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a hardware component (an MR coil), not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" implicitly referred to here are the technical specifications and performance requirements outlined in the NEMA and IEC standards. The device's performance was measured against these predefined engineering and safety benchmarks.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular border. There are small, teardrop-shaped elements positioned around the outer edge of the circle, adding a decorative touch to the design.
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
- ் This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, July 31, 1998
- o Identification of the Product Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil
| Manufacturer Address: | GE Yokogawa Medical Systems, Ltd. |
|---|---|
| 4-7-127, Asahigaoka, Hino-Shi | |
| Tokyo, 191 Japan |
o Marketed Devices
The Signa Profile MR System with the Quadrature Thoracic/Lumbar Spine Phased Array Coil is substantially equivalent to the currently marketed Signa Profile Body Flexible Coil.
் Device Description
The Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil is a receive only coil and can receive the quadrature signal . It is designed for use with a vertical magnetic field MR imaging system.
o Indications for Use
The Indications for Use for the Quadrature Thoracic/Lumbar Spine Phased Array Coil expands the capability of the Signa Profile System. It can be used to image the thoracic spine, lumbar spine, chest, abdomen, pelvis and hips.
- 0 Comparison with Predicate
The Quadrature Thoracic/Lumbar Spine Phased Array Coil is similar Signa Profile Body Flexible Coil except that the Thoracic/Lumbar Spine Phased Array Coil has a larger circumference and uses phased array technology.
o Summary of Studies
The Quadrature Thoracic/Lumbar Spine Phased Array Coil was evaluated to the appropriate NEMA performance standards. The coil was evaluated to the International safety standards IEC 601-1 and IEC 601-2-33 and performed to stated specifications.
- ে Conclusions
It is the opinion of GE that the Signa Profile System with the Quadrature Thoracic/Lumbar Spine Phased Array Coil is substantially equivalent to the presently marketed Signa Profile Body Flexible Coil. This coil does not result in any new potential hazards.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1998
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 , W-709 Milwaukee, WI 53201
Re:
Signa Profile Ouadrature Thoracic/Lumbar Spine Phased Array Coil Dated: July 31, 1998 Received: August 7, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Dr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enolosure) to 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). 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 (Premarket 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 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 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 and additionally 809.10 for in vitn diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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/odrh/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_ K982772
Device Name: Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil Indications For Use:
The Indications for Use for the Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil expands the imaging performance of the Signa Profile System.
The Quadrature Thoracic / Lumbar spine Phased Array coil can also be used to image the following regions of anatomy:
- Thoracic Spine ●
- Lumbar Spine .
- Chest ●
- Abdomen ●
- Pelvis .
- Hips.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982772
Prescription Use ✓ OR Over-The-Counter Use__
(Per 21 CFR 801.109)
§ 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.