(73 days)
The intended use of the Panorama 0.6T SSA coil is to be used in MR imaging of the spine. The Panorama 0.6T system is a whole body scanner and is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2) and (3) display the internal structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The SSA coil is indicated for use in the following anatomic regions and with the designated nuclei:
Thoracic and Lumbar or spine and sternum Anatomic Regions:
Nuclei Excited: Hydrogen
The SSA coil is an optional accessory to the Panorama 0.6T MR system. This receiveonly coil is designed for use when large imaging volume is required or when the patient is large or when easy usage is essential.
This 510(k) summary describes a new MRI coil, the Synergy Spine Array (SSA) coil, for the Panorama 0.6T MRI system. The primary goal of the submission is to demonstrate that the SSA coil is substantially equivalent to a predicate device, the Integrated Spine Array (ISA) coil for the Philips Infinion 1.5T system, in terms of safety and effectiveness.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets. Instead, the document relies on demonstrating "substantial equivalence" to the predicate device. The performance is assessed by confirming that key safety and performance parameters are "unaffected" by the new coil and that technological differences "do not raise new questions pertaining to safety and effectiveness."
| Parameter Category | Acceptance Criteria (Implied) | Reported Device Performance (SSA Coil) |
|---|---|---|
| Safety Parameters | Substantially equivalent to predicate, unaffected by SSA coil | Unaffected by the SSA coil |
| Static Field | (Implicitly: within established limits of Panorama 0.6T system) | Unaffected by the SSA coil |
| dB/dt | (Implicitly: within established limits of Panorama 0.6T system) | Unaffected by the SSA coil |
| SAR | (Implicitly: within established limits of Panorama 0.6T system) | Unaffected by the SSA coil |
| Acoustic Noise | (Implicitly: within established limits of Panorama 0.6T system) | Unaffected by the SSA coil |
| Performance Parameters | Substantially equivalent to predicate, unaffected by SSA coil | Unaffected by the SSA coil |
| SNR | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
| Image Uniformity | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
| Geometric Distortion | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
| Slice Thickness & Spacing | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
| Spatial Resolution | (Implicitly: comparable to existing Body & Spine coils and predicate) | Unaffected by the SSA coil |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Phantom and clinical studies were performed to support the claim of substantial equivalence," but it does not specify the sample size for either the phantom or clinical studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The "Intended Use" section mentions "When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis," which implies a physician reviews the images, but this is a general statement about clinical use, not a specific detail about the validation study.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluation focuses on equivalence of the device itself rather than human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an accessory device (MRI coil), not an algorithm or AI. Therefore, the concept of a "standalone (algorithm only)" performance study does not apply to this submission. The evaluation is of the hardware's imaging capabilities.
7. The Type of Ground Truth Used
For the phantom studies, the ground truth would be precise, known physical properties and measurements within the phantom.
For the clinical studies, the document does not explicitly state the type of ground truth used. It's broadly implied that the images produced by the SSA coil are evaluated to determine if they provide "information that can be useful in the determination of a diagnosis." This suggests a comparison against a clinical "gold standard" or expert interpretation from other imaging modalities, but this is not detailed. Expert consensus or clinical diagnosis would be the most likely type of ground truth for human-interpreted clinical images, but it's not explicitly stated.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is expected as the submission is for an MRI coil, which is a hardware device, not a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As this is a hardware device and not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it does not apply.
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Ko 33662
FEB - 2 2004
510(k) Summary
(As required by 21CFR 807.92)
I General Information
| Classification: | Class IIClassification Number 90 MOSMagnetic Resonance Imaging (MRI) Accessory |
|---|---|
| Common/usual name: | Magnetic Resonance Imaging (MRI) Coil |
| Proprietary Name: | Synergy Spine Array coil (SSA) |
| Predicate device(s): | Integrated Spine Array (ISA) coil for Philips Infinion 1.5T system |
| Establishment Registration: | Manufacturer:Philips Medical Systems MR Technologies Finland, Inc.Äyritie 4FI-01510 Vantaa, FinlandPhone: +358 9 2535 9300Fax: +358 9 2535 9600FDA Facility Registration #9680194FDA Owner #1217116United States Contact:Philips Medical Systems (Cleveland), Inc.595 Miner RoadHighland Heights, Ohio 44143Contact: Duane C. PraschanPhone: (440) 483-3000FDA Registration #1525965 |
| Performance Standards: | No applicable performance standards have been issued under section 514of the Food, Drug and Cosmetic Act. |
Safety and Effectiveness Information Supporting Substantial Equivalence 【】
Intended use o
The intended use of the Panorama 0.6T SSA coil is to be used in MR imaging of the spine. The Panorama 0.6T system is a whole body scanner and is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2) and (3) display the internal structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination
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Koszalin
1 sie 2012
of a diagnosis.
The SSA coil is indicated for use in the following anatomic regions and with the designated nuclei:
Thoracic and Lumbar or spine and sternum Anatomic Regions:
Nuclei Excited: Hydrogen
Device Description
The SSA coil is an optional accessory to the Panorama 0.6T MR system. This receiveonly coil is designed for use when large imaging volume is required or when the patient is large or when easy usage is essential.
Relevant Technological Characteristics ം
The technological characteristics of the SSA coil are similar to the predicate ISA coil. The potential benefits associated with the SSA coil include improved patient handling and possibilities to image larger patients than with the Body & Spine coils in the Panorama 0.6T system.
Safety & Effectivness
The SSA coil is substantially equivalent to the Philips ISA Coil in safety and effectiveness. The safety parameters (Static Field, dB/dt, SAR and Acoustic Noise) and the performance parameters (SNR, Image Uniformity, Geometric Distortion, Slice Thickness & Spacing, and Spatial Resolution) for the Panorama 0.6T MR system are unaffected with the SSA coil.
Substantial Equivalence o
Phantom and clinical studies were performed to support the claim of substantial equivalence and to show that the technological differences do not raise new questions pertaining to safety and effectiveness.
. Conclusion
It is the opinion of Philips Medical Systems that the SSA coil of the Panorama 0.6T system is substantially equivalent to the predicate ISA coil of the Philips Infinion 1.5T system.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 emblem featuring three curved lines that resemble a bird in flight or a symbolic representation of human services. The emblem is positioned diagonally within the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2004
Mr. Duane C. Praschan Manager, Regulatory Affairs Philips Medical Systems (Cleveland), Inc. 595 Miner Road HIGHLAND HEIGHTS OH 44143
Re: K033662
Trade/Device Name: Synergy Spine Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 18, 2003 Received: November 21, 2003
Dear Mr. Praschan:
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 such 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. Bryden
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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510(k) Number (if known): __ Ko 3 3 ما جاء 2
SYNERGY SPINE ARRAY COIL Device Name:
Indications for Use:
Intended Use
The Synergy Spine Array Coil does not change the existing indications as defined below.
The Panorama 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Indications for Use
The Synergy Spine Array Coil is indicated for use in the following anatomic regions and with designated nuclei:
| Anatomic Regions: | Thoracic and lumbar |
|---|---|
| Nuclei Excited: | Hydrogen |
(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) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K033462 |
§ 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.