(14 days)
The NeoCoil 3.0T 32-Channel Torso Array Coil is a receive only phased array RF coil used to produce diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging systems that can be interpreted by a trained physician. The NeoCoil 3.0T 32-Channel Torso Array Coil is designed for use with the 3.0T HD Series MR System manufactured by General Electric Healthcare (GEHC).
The NeoCoil 3.0T 32-Channel Torso Array Coil is intended to be used in the abdomen, pelvis, and chest regions for 2D and 3D magnetic resonance imaging and parallel body imaging for use on 3.0T GE HD series Magnetic Resonance scanners.
The NeoCoil 3.0T 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE 3.0T HD Series MR System (K052293)
This 510(k) summary for the NeoCoil 3.0T 32-Channel Torso Array Coil does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for AI/ML or diagnostic devices.
The document describes a magnetic resonance specialty coil, which is a hardware component used in MR imaging systems. It is not an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC against a ground truth.
Therefore, the requested information cannot be extracted for this specific submission because it's not relevant to the type of device being reviewed.
However, I can describe what type of information is present, which relates to validating hardware performance, rather than AI algorithm performance.
Here's a breakdown of what is and isn't available based on your request and the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable for AI/ML metrics. The document states: "Testing was performed to demonstrate that the design of the NeoCoil 3.0T Summary of Studies: 32-Channel Torso Array Coil met predetermined acceptance criteria." However, it does not explicitly list the acceptance criteria or the specific results of these tests. For a medical device like an MRI coil, acceptance criteria would typically involve engineering specifications related to safety (e.g., heating, electromagnetic compatibility), image quality (e.g., signal-to-noise ratio, uniformity), and compatibility with the MR system.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This device is a hardware component. Its performance is evaluated through engineering tests, not on a dataset of patient images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. There is no "ground truth" in the diagnostic sense for a hardware coil. The "interpretation by a trained physician" mentioned in the Intended Use refers to the subsequent use of images produced by the coil, not a validation of the coil itself.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is a hardware device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what is present:
The submission focuses on demonstrating substantial equivalence to predicate devices (GE 3.0T Torso Phased Array Coil and GE 1.5T 8 Channel Torso Coil) based on:
- Device description: Multi-element phased array receive-only coil with 34 elements (17 anterior, 17 posterior) for 3.0T GE HD Series MR Systems.
- Intended Use/Indications for Use: To produce diagnostic images of chest, abdomen, and pelvic areas for 2D and 3D MRI and parallel body imaging.
- Performance Testing (implied): "Testing was performed to demonstrate that the design of the NeoCoil 3.0T 32-Channel Torso Array Coil met predetermined acceptance criteria." This implies engineering and performance tests relevant to MR coils (e.g., electrical characteristics, image quality parameters, safety aspects like SAR, specific absorption rate), but the details are not provided in this summary.
- Safety: "Use of the NeoCoil 3.0T 32-Channel Torso Array Coil does not result in any new potential hazards and does not alter the safety of the MRI scanner."
In conclusion, for this specific 510(k) for an MRI coil, the requested AI/ML specific criteria (ground truth, sample sizes, reader studies) are not applicable as the device is not an AI/ML diagnostic software. The "acceptance criteria" likely refer to technical performance and safety specifications for the hardware.
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510(k) Summary
| Proprietary Name: | NeoCoil 3.0T 32-Channel Torso Array Coil |
|---|---|
| Common Device Name: | Magnetic Resonance Specialty Coil |
| Regulation Number: | 892.1000 |
| Review Panel: | Radiology Device Panel |
| CDRH Product Code: | MOS |
| Device Class: | II |
| Reason for 510(k): | New device |
| Applicant: | NeoCoilN27 W23910A Paul RdPewaukee, WI 53072 |
| Contact | Brian BrownExecutive Director262-347-1250 x 12 (office)261-347-1251 (fax)brian.brown@neocoil.com |
| Preparation date: | 04/02/2007 |
| Est. Registration No: |
NOV 3 0 2007
| Intended Use: | The NeoCoil 3.0T 32-Channel Torso Array Coil is a receive only phased array RF coil used to produce diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging systems that can be interpreted by a trained physician. The NeoCoil 3.0T 32-Channel Torso Array Coil is designed for use with the 3.0T HD Series MR System manufactured by General Electric Healthcare (GEHC). |
|---|---|
| Indications for Use | The NeoCoil 3.0T 32-Channel Torso Array Coil is intended to be used in the abdomen, pelvis, and chest regions for 2D and 3D magnetic resonance imaging and parallel body imaging for use on 3.0T GE HD series Magnetic Resonance scanners. |
| Performance Standards: | No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act. |
| Device Description: | The NeoCoil 3.0T 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE 3.0T HD Series MR System (K052293) |
| Predicate Devices: | GE 3.0T Torso Phased Array Coil (K030495) GE 1.5T 8 Channel Torso Coil (K031209) |
| Comparison to Predicate: | The NeoCoil 3.0T 32-Channel Torso Array Coil is most similar to the GE 1.5T 8 Channel Torso Coil (K031209) with the main differences being the number of elements and the field strength. The NeoCoil Torso Coil uses 34 |
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elements compared to 12. It also operates at 3.0T like the GE 3.0T Torso Phased Array Coil (K030495) instead of 1.5T. Testing was performed to demonstrate to that the design of the NeoCoil 3.0T Summary of Studies: 32-Channel Torso Array Coil met predetermined acceptance criteria. It is the opinion of NeoCoil that the NeoCoil 3.0T 32-Channel Torso Array Conclusion:
Coil is substantially equivalent to the predicate devices. Use of the NeoCoil 3.0T 32-Channel Torso Array Coil does not result in any new potential hazards and does not alter the safety of the MRI scanner.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2007
NeoCoil % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K073236
Trade/Device Name: NeoCoil 3.0T 32-Channel Torso Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 15, 2007 Received: November 16, 2007
Dear Mr. Lehtonen
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 ean 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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
K073236 510(k) Number (if known): __
Device Name: NeoCoil 3.0T 32-Channel Torso Array Coil
Indications For Use:
The NeoCoil 3.0T 32-Channel Torso Array Coil is intended to be used in the abdomen, pelvis, and chest regions for 2D and 3D magnetic resonance imaging and parallel body imaging for use on 3.0T GE HD series Magnetic Resonance scanners.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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lomikhing
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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§ 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.