(16 days)
The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MRI system manufactured by GE Medical Systems.
The Pelvic Array Coil is designed to provide Magnetic Resonance Images of the pelvis, including the hips. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MR scanner.
The indications for use are the same as for standard imaging:
The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, 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.
The Pelvic Array Coil is a receive-only, quadrature phased array RF coil, used for obtaining diagnostic MR images of the pelvis, including the hips. The elements and associated circuitry are enclosed in a semi-flexible housing that is fire rated and has a high impact and tensile strength.
The provided document is a 510(k) summary for a Magnetic Resonance Imaging Accessory (Pelvic Array Coil), dated December 17, 2003. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/software-based device.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.
This document describes a physical medical device (an MRI coil) and its intended use, rather than a diagnostic algorithm or AI product. The safety and effectiveness are established through comparison to a predicate device based on material, design, and function, not through clinical performance metrics against specific diagnostic criteria.
Key areas from your request that are NOT present in the provided document:
- A table of acceptance criteria and the reported device performance: This document does not establish specific performance metrics or acceptance criteria like sensitivity, specificity, accuracy, or image quality scores that would be typical for an AI/software device. Its acceptance is based on substantial equivalence.
- Sample size used for the test set and the data provenance: There is no mention of a test set, human subjects study, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no test set or ground truth in the context of an AI/software evaluation.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical MRI coil, not an AI system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding safety and effectiveness:
The document establishes safety and effectiveness by demonstrating "substantial equivalence" to a legally marketed predicate device (Insight Plus 9000 Torso and Pelvis Coil manufactured by USA Instruments, Inc. - K001209).
The comparison focuses on:
- Intended Use: Similar for imaging of the pelvis, including hips.
- Indications for Use: Identical to routine MRI imaging.
- Coil Enclosure Material: Similar materials (Delrin Acetal, Flame Retardant PVC, Flame Retardant Polyurethane, Vinyl Coated EVA Foam).
- Coil Design: Receive-only quadrature phased array coil, similar to the predicate.
- Decoupling: Switching diode decoupling, similar to the predicate.
- Prevention of RF Burns: Does not transmit RF power, decoupling isolates elements, and uses a non-conductive housing. These features are similar to the predicate.
- Radio Frequency Absorption: It's a receive-only coil and does not transmit RF power, consistent with the predicate.
- Formation of Resonant Loop: Decoupling isolates elements and the cable design prevents looping, similar to the predicate.
In essence, the "study" demonstrating the device meets acceptance criteria is a technical and functional comparison study against a predicate device, focusing on design, materials, and operational principles to show that it is as safe and effective as the already-cleared device. There are no performance metrics in the sense of diagnostic accuracy or reader improvement for this type of device.
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033753
DEC 1 7 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Pelvic Array Coil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc.,1515 Danner DriveAurora, Ohio 44202, USATelephone: 330-995-8572; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Pelvic Array Coil is a receive only phasedarray RF coil used for obtaining diagnostic imagesof the pelvis, including the hips, in magneticresonance imaging systems. The Pelvic Array Coilis designed for use with the GE Signa 1.5T MRIsystem manufactured by GE Medical Systems. |
| 8. Device Description: | The Pelvic Array Coil is a receive-only, quadraturephased array RF coil, used for obtaining diagnosticMR images of the pelvis, including the hips. Theelements and associated circuitry are enclosed in asemi-flexible housing that is fire rated and has a highimpact and tensile strength. |
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9. Safety and Effectiveness
| Insightec Pelvic Array Coil productfeatures | Comparison to predicate device or other 510(k)cleared products |
|---|---|
| Intended Use: Imaging of the pelvis,including the hips | -Similar to the Insight Plus 9000 Torso and PelvisCoil manufactured by USA Instruments, Inc.(K001209) |
| Indications for Use: Identical to routineMRI imaging | -Similar to the Insight Plus 9000 Torso and PelvisCoil manufactured by USA Instruments, Inc.(K001209) |
| Coil Enclosure Material:Delrin Acetal,Flame Retardant PVC,Flame Retardant PolyurethaneVinyl Coated EVA Foam | -Similar to the Insight Plus 9000 Torso and PelvisCoil manufactured by USA Instruments, Inc.(K001209)-Similar to the Mark 5000 Quadrature Shoulder Coilmanufactured by USA Instruments, Inc. (K013854) |
| Coil Design: Receive-only quadraturephased array coil | -Similar to the Insight Plus 9000 Torso and PelvisCoil manufactured by USA Instruments, Inc.(K001209) |
| Decoupling: Switching diode decoupling | -Similar to the Insight Plus 9000 Torso and PelvisCoil manufactured by USA Instruments, Inc.(K001209) |
| Prevention of RF Burns: Does nottransmit RF power; decoupling isolatesthe coil elements from RF fields duringRF transmission; coil elements andcircuitry are enclosed in a non-conductivehousing. | -Similar to the Insight Plus 9000 Torso and PelvisCoil manufactured by USA Instruments, Inc.(K001209) |
| Radio Frequency Absorption: Coil is areceive only coil and does not transmitRF power | -Similar to the Insight Plus 9000 Torso and PelvisCoil manufactured by USA Instruments, Inc.(K001209) |
| Formation of Resonant Loop:Decoupling isolates the coil elementsfrom RF fields during RF transmission;length of cable and stiffness does notpermit looping | -Similar to the Insight Plus 9000 Torso and PelvisCoil manufactured by USA Instruments, Inc.(K001209) |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2003
Ms. Christie Shumaker Manager. OA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K033753
Trade/Device Name: Pelvic Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS
Dated: November 26, 2003 Received: December 1, 2003
Dear Ms. Shumaker:
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Pelvic Array Coil
Indications for Use: The Pelvic Array Coil is designed to provide Magnetic Resonance Images of the pelvis, including the hips. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MR scanner.
Anatomic Regions: pelvis, including the hips Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, 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.
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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)
Rancy Borden
(Division Sign Division of Reproductive, and Radiological Devices 510(k) Number
§ 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.