(21 days)
The NeoCoil 3.0T 6-Channel Carotid Array Coil is a receive only phased array RF coil used to produce diagnostic images of the carotid arteries that can be interpreted by a trained physician. The coil provides coverage of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging systems. The NeoCoil 3.0T 6-Channel Carotid Array Coil is designed for use with the HD series (3.0Tesla) MRI scanners manufactured by General Electric Healthcare (GEHC). Anatomic Regions: Head and neck vasculature. Nuclei Excited: Hydrogen.
The indications for use are the same as for standard imaging:
The GE scanner 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 vasculature of the head and neck regions specifically the carotid arteries and associated soft tissue. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The NeoCoil 3.0T 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout.
The submitted device consists of a dual set of foam covered "paddles", consisting of three antennas each. The three antennas in each paddle are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas. Pre-amplifier decoupling reduces any remaining decoupling between the antennas.
The paddles are held in place over the imaging area via a headband. A system interface cable connects to the coil at the top of the headband. The foam paddles connect to the headband using a ball and socket joint that enable proper positioning of the paddles over the imaging area.
To ensure safety, each antenna is equipped with two transmit decoupling circuits; one active and the other passive. Active decoupling is achieved by PIN diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. These passive switched detune the antennas further during RF transmit.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices. | Concluded to be substantially equivalent to predicate devices. |
| Satisfy design objectives (e.g., SNR, image uniformity). | SNR and image uniformity testing performed, supporting this conclusion. |
| No new potential hazards or alteration of MRI scanner safety. | Concluded to not result in new hazards or alter safety. |
| Coil coverage: Superior/Inferior 15 cm | 15 cm |
| Coil coverage: Anterior/Posterior 15 cm | 15 cm |
| Coil coverage: Right/Left 24 mm | 24 mm |
| Primary applications: High-quality imaging of carotid arteries. | Designed and tested to provide high-quality imaging of carotid arteries. |
| Complete coverage of head and neck vasculature from sternal notch through internal carotid arteries at C1. | Offers complete coverage from sternal notch through internal carotid arteries at C1. |
| Sub-millimeter resolution of carotid lumen, vessel walls, and atherosclerotic plaques. | Allows for sub-millimeter resolution of the carotids lumen, vessel walls, and atherosclerotic plaques. |
Explanation of Implied Acceptance Criteria: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the primary "acceptance criteria" are not explicitly stated as numerical targets but are inferred from the claims of equivalence and the summary of studies. The "Summary of Studies" explicitly mentions "SNR and image uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives," suggesting these were key performance metrics evaluated for substantial equivalence. The "Preliminary Product Data Sheet" provides specific "Coil Coverage (FOV)" and imaging capabilities, which are de facto performance specifications that the device is expected to meet.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for any human subjects or patient data used in testing. The summary of studies mentions "SNR and image uniformity testing," which typically involves phantom studies or a limited number of healthy volunteers, but no specific numbers are given.
- Data Provenance: The document does not specify the country of origin for any data or whether the data was retrospective or prospective. Given the nature of performance testing for an MRI coil, most testing would likely involve phantom studies and possibly prospective imaging of volunteers/patients within a clinical setting (though not explicitly stated).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document does not mention the use of experts to establish ground truth for a test set. This type of testing (SNR, image uniformity) for an MRI coil primarily relies on quantitative physics measurements and visual assessment by qualified MR physicists or engineers.
- Qualifications of Experts: Not applicable, as expert review for ground truth is not indicated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The summary of studies refers to technical performance metrics (SNR, image uniformity) rather than diagnostic performance requiring expert adjudication of clinical findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. The document does not mention a multi-reader, multi-case comparative effectiveness study. This type of study is more common for AI-powered diagnostic tools where human interpretation is directly assisted or compared. This device is an MRI coil, a hardware component.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done? Yes, in a way. The "SNR and image uniformity testing" would be considered standalone performance of the coil (hardware). It measures the intrinsic capabilities of the device without human interpretation being directly part of the performance metric. However, it's not an "algorithm" in the typical software sense.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "SNR and image uniformity testing," the ground truth would be based on quantitative physics measurements from phantoms and potentially measurements from human images. For image uniformity, it would also involve visual assessment against predefined quality standards. It is not clinical pathology, expert consensus on disease, or outcomes data.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware component (an MRI coil), not an AI algorithm that requires a training set of data. Its design and validation rely on engineering principles, physics, and performance testing rather than machine learning training.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for a hardware device.
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510(k) Summary of Safety and Effectiveness
| Device Name: | NeoCoil 3.0T 6-Channel Carotid Array Coil |
|---|---|
| Proprietary Name: | NeoCoil 3.0T 6-Channel Carotid Array Coil |
| APR 11 2007 | |
| Common/Usual Name: | Magnetic Resonance Specialty Coil |
| Classification Name: | Magnetic Resonance Specialty Coil |
| Classification Number: | 892.1000 |
| Classification Panel: | Radiology Device Panel |
| CDRH Product Code: | MOS |
| Regulatory Class: | II |
| Reason for 510(k): | New device |
| Applicant: | Brian BrownExecutive DirectorNeoCoilN27 W23910A Paul RdPewaukee, WI 53072262-347-1250 x 12 (office)261-347-1251 (fax)brian.brown@neocoil.com |
| Preparation date: | 12/12/2006 |
| Est. Registration No: | |
| Intended Use: | The NeoCoil 3.0T 6-Channel Carotid Array Coil is a receive only phased array RF coil used to produce diagnostic images of the carotid arteries that can be interpreted by a trained physician. The coil provides coverage of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging systems. The NeoCoil 3.0T 6-Channel Carotid Array Coil is designed for use with the HD series (3.0Tesla) MRI scanners manufactured by General Electric Healthcare (GEHC). Anatomic Regions: Head and neck vasculature. Nuclei Excited: Hydrogen. |
| The indications for use are the same as for standard imaging:The GE scanner 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 vasculature of the head and neck regions specifically the carotid arteries and associated soft tissue. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. | |
| Standards:Performance: | No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act. |
| Device Description: | The NeoCoil 3.0T 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout. |
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| The submitted device consists of a dual set of foam covered "paddles",consisting of three antennas each. The three antennas in each paddle areuniquely positioned with the appropriate overlap to cancel out mutual couplingeffects from adjacent antennas. Pre-amplifier decoupling reduces any remainingdecoupling between the antennas. | |
|---|---|
| The paddles are held in place over the imaging area via a headband. A systeminterface cable connects to the coil at the top of the headband. The foampaddles connect to the headband using a ball and socket joint that enable properpositioning of the paddles over the imaging area. | |
| To ensure safety, each antenna is equipped with two transmit decouplingcircuits; one active and the other passive. Active decoupling is achieved by PINdiodes that receive signals from the scanner to turn the coil to a high impedancestate during system RF transmit. Crossed diodes are installed on each antennaacting as passive switches. These passive switched detune the antennas furtherduring RF transmit. | |
| Predicate Devices: | Machnet Carotids Coil Array Assembly (K012491)USAI 3T HD Breast Array (K052585)USAI Millennium III 3T-8-Channel Neurovascular Coil (K042342) |
| Comparison to Predicate: | It is our opinion that the NeoCoil 3.0T 6-Channel Carotid Array Coil in thissubmission is substantially equivalent to the previously cleared Machnet CarotidsCoil Array Assembly (K012491), the USAI 3T HD Breast Array (K052585), andthe USAI Millennium III 3T-8-Channel Neurovascular Coil (K042342). Remainingdifferences do not impact indications for use or have an impact on safety. |
| Summary of Studies: | In all material respects, the NeoCoil 3.0T 6-Channel Carotid Array is substantiallyequivalent to the Machnet Carotids coil Assembly. SNR and image uniformitytesting was performed which support the conclusion that the submitted devicesatisfies design objectives. |
| Conclusion: | The NeoCoil 3.0T 6-Channel Carotid Array is substantially equivalent to thepredicate device. Use of the NeoCoil 3.0T 6-Channel Carotid Array does notresult in any new potential hazards and does not alter the safety of the MRIscanner. |
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Appendix F: Preliminary Product Data Sheet
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Image /page/3/Picture/0 description: The image is a dense collection of text, arranged in a vertical format. The text appears to be of a small font size, making it difficult to read individual words or sentences without closer inspection. The overall impression is that of a document or page filled with a large amount of written information.
- Neocoll
3.0T 6-Channel Carotid Array Coll
The 3.0T &Channel Carolld Array Cost enables by Isteral diagnoctic maging of the caroed arrary bifurcation using a QE Signa® 3.0T EXCITE® HD series MR system.
Primary Applications
The 3.0T 6-Channel Carolid Array Coll has been designed and tested to provide high quality imaging of the carond arteries. The unique array configuration offers complete coverage head and neck vasculature from the sternal notch through the internal carolid arteries at the level of cervical vertebrae C1. The coll allows for sub-millimeter resolution of the carolids lumen, vessel walls, and atheroscierolic plaques,
Image /page/3/Picture/6 description: The image shows a pair of headphones with a white rectangular device attached to the headband. The headphones are dark in color, and the white device appears to be some sort of control or interface. A cable extends from the headphones, ending in a white connector. The headphones and cable are resting on a textured surface.
Technical Features
This phased-array coll has 6 elements. The element configuration is optimized to provide daep penetrabon SNR and improved Sil coverage.
The unique headband and positioning system facilitate patient seeip and fit, providing greater patient confort and imaging periormance.
The coll is companible with ASSET® parallel imaging iechniques
NeoCoil, LLC N27 W23810A Paul Rd. Penaukee, WI 53072 @ 2006 NeoColl All Rights Reserved
Coil Coverage (FOV) Supence inferor 15om Anterior / Posterior 15 cm Right | Lett 24 mm
| Coil Dimensions | ||
|---|---|---|
| Length | 17.5 cm | 6.9 in |
| Width | 28.0 cm | 11.0 in |
| Height | 48.0 cm | 18.9 in |
| Weight | 1.5 kg | 3.4 lbs |
Image /page/3/Picture/14 description: This is a black and white image of a medical scan. The scan appears to be of the neck and upper chest area, showing the blood vessels. The vessels are highlighted in white against the dark background, allowing for a clear view of their structure and potential abnormalities.
System Requirements and Ordering Requires a GE 3.0T Signa EXCITE HD zeries MR system. Compatible with all such models. Offered by GE through catalog MTBD. or NeoCoil catalog number NC001
Warranty
The published Company warranty in effect on the date of shipment shall apply. The Company reserves the right to make changes
Manufactured by NecCoil, LLC.
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Third Party Review Quality Assessment
Section 1 - Submission Information
| 510(k) No.: | K070778 |
|---|---|
| Third Party Organization: | Intertek Testing Services NA, Inc. |
Third Party's Primary Reviewer(s): Daniel Lehtonen
ODE/OIVD Division: DRARD Branch/Team: Radiological Devices Branch
Section 2 - 510(k) Decision
Third party recommendation: SE √ ____ NSE _______ Other (specify): ___________________________________________________________________________________________________________
ODE/OIVD final decision: SE _ V___ NSE _____ Other (specify): _________________________________________________________________________________________________________________________________________
Section 3 -- Assessment of Third Party Review
| Review Element | Rating (check one) | ||
|---|---|---|---|
| Adequate | Minor Issue(s) | Major Issue(s) | |
| a. Determination of device eligibility for third party review | √ | ||
| b. Extent of pre-submission consultation with ODE/OIVD division | |||
| c. Organization and format of review documentation | √ | ||
| d. Determination of 510(k) administrative completeness (screening review) | √ | ||
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | √ | ||
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | √ | ||
| g. Rationale for conclusions and recommendation | √ | ||
| h. Use of guidance documents and standards | √ | ||
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | |||
| j. Scope of reviewer expertise and use of consulting reviewers | |||
| k. Other (specify): |
Comments (explanation of ratings/issues): The performance of the coil did not match the labeling, IFU and 510(k) summary. This was corrected by the Sponsor after I requested additional information.
Section 4 - ODE/OIVD Assessor Information
Sunder Rajan - Date: April 5, 2007 Tel. No.: 240 276 3968 Assessed by:
Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k). DMC -- Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 2007
c/o Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices and Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K070778
NeoCoil
Trade/Device Name: NeoCoil 3.OT 6-Channel Carotid Array Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 20, 2007 Received: March 21, 2007
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivelon (for the indiver 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 device 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 the evideral manufacturing practice, labeling, and prohibitions against misbranding and adultersting.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/5/Picture/9 description: The image shows the FDA Centennial logo, which is a circular emblem with the letters "FDA" in the center. The logo also includes the years "1906-2006" at the top and the word "Centennial" below the letters. Below the logo is the text "Protecting and Promoting Public Health" in a decorative font.
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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 (OS) 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 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" (21 CFR 807.97). 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 (301) 443-6597 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
长070778 510(k) Number (if known):
Device Name: NeoCoil 3.0T 6-Channel Carotid Array Coil
Indications For Use:
The NeoCoil 3.0T 6-Channel Carotid Array Coil is a receive only phased array RF coil used to produce diagnostic images of the carotid arteries that can be interpreted by a trained physician. The coil provides coverage of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging systems. The NeoCoil 3.0T 6-Channel Carotid Array Coil is designed for use with the HD series (3.0Testa) MRI scanners manufactured by General Electric Healthcare (GEHC). Anatomic Regions: Head and neck vasculature. Nuclei Excited: Hydrogen.
The indications for use are the same as for standard imaging:
The GE scanner 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 vasculature of the head and neck regions specifically the carotid arteries and associated soft tissue. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
David A. Seymour
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Page
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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.