(82 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. Anatomic Regions: Head and Neck Vasculature. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Signa 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 the density, spin lattice relaxation time Tl, spin-spin relaxation time T2) and (3) and (2) tissue. When interpreted by a trained physician, these images of the head and neck regions specifically the carotid arteries and association can be useful in the determination of a diagnosis.
The Carotids Coil Array Assembly is a receive only coil array which consists of a dual set of coils electrically connected to a quick disconnect box which interfaces the assembly to the MR scanner. Each half of the coil assembly consists of two overlapping coils to buck out the mutual inductance between the coils. Active decoupling is achieved by PIN diodes which turn the coils to a high impedance state at transmit time. A pair of fast switching crossed diodes is installed in each coil segment acting as passive switches detuning the coils to further improve the safety of the Carotids Coil Array Assembly. Each transmission line has so called "bazooka baluns" installed to minimize the outer braiding currents on the coaxial cables. Coil diameter have been chosen to optimize sensitivity at distances to about 35 mm from the coil surface while a sharp cutoff beyond 40 mm from the surface minimizes the noise from volumes outside the region of interest. This ensures maximum signal ratio from the region of the carotids arteries.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safe and effective operation | Testing performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent. The device is substantially equivalent to the predicate device. |
| Compatible with MRI scanners | Compatible with SignaTM (1.5Tesla) MRI scanner manufactured by GE Medical Systems, Inc., specifically Signa Advantage 1.5T and 1.0T, and Signa Horizon LX 1.5T and 1.0T. |
| Provides diagnostic images of carotid structures | The device produces diagnostic images of carotid structures that can be interpreted by a trained physician, covering carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. |
| Minimizes noise from outside region of interest | Coil diameter chosen to optimize sensitivity at distances to about 35 mm from the coil surface while a sharp cutoff beyond 40 mm from the surface minimizes the noise from volumes outside the region of interest. This ensures maximum signal ratio from the region of the carotid arteries. |
2. Sample size used for the test set and the data provenance:
The provided document (K012491 510(k) Summary) does not explicitly detail the sample size or provenance of data used for testing. It generally states that "Testing was performed according to internal company procedures" and that "Test results support the conclusion that actual device performance satisfies the design intent." This suggests that the testing was likely conducted in-house by Machnet BV. Given the submission date of 2001, it is highly probable that the testing, if it involved patient data, was retrospective, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The document mentions that images "can be interpreted by a trained physician," implying the eventual use by medical professionals, but it does not describe who established the ground truth for validating the device's performance during testing.
4. Adjudication method for the test set:
This information is not provided in the document.
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:
No. This document describes a medical device (a coil array for MRI) and its substantial equivalence to a predicate device, not an AI or algorithm-driven diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This document concerns a physical medical device (an MRI coil), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for testing. Given the nature of an MRI coil, "ground truth" would likely relate to image quality parameters such as signal-to-noise ratio, spatial resolution, and artifact levels, assessed against established benchmarks or comparative images from the predicate device. However, specifics are not provided beyond "Test results support the conclusion that actual device performance satisfies the design intent."
8. The sample size for the training set:
Not applicable. As this is a physical medical device (an MRI coil) and not an AI or machine learning algorithm, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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Page 1 of 3
OCT 2 4 2001
EXHIBIT 2
MACHNET BV PO BOX 85444 NL-3508 AK UTRECHT THE NETHERLANDS
AMERSFOORTSEWEG 24 A NL-3951 LB MAARN
PHONE +31(0)343 444 355 FAX +31(0)343 444 934 Contact: Abe van der Werf, President August 1, 2001 510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: "Machnet Carotids Coil Array Assembly." (Catalog # PACC-GSXX) Classification Name: 90 MOS Common/Usual Name: Carotids Coil Array Assembly
- Equivalent legally marketed device: This device is similar in design and identical 2. in function to the USA Instruments Hi-Res 9000 Phased Array Carotid Coil K001210.
-
- Indications for Use (intended use): To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. Anatomic Regions: Head and Neck Vasculature
-
- Description of the device: The Carotids Coil Array Assembly is a receive only coil array which consists of a dual set of coils electrically connected to a quick disconnect box which interfaces the assembly to the MR scanner. Each half of the coil assembly consists of two overlapping coils to buck out the mutual inductance between the coils. Active decoupling is achieved by PIN diodes which turn the coils to a high impedance state at transmit time. A pair of fast switching crossed diodes is installed in each coil segment acting as passive switches detuning the coils to further improve the safety of the Carotids Coil Array Assembly. Each transmission line has so called "bazooka baluns" installed to minimize the outer braiding currents on the coaxial cables. Coil diameter have been chosen to optimize sensitivity at distances to about 35 mm from the coil surface while a sharp cutoff beyond 40 mm from the surface minimizes the noise from volumes
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K012491
Page 2 of 3
outside the region of interest. This ensures maximum signal ratio from the region of the carotids arteries.
Image /page/1/Picture/2 description: The image is a dark, grainy photo of a product. The product appears to be made of a dark material, and it has a strap or handle attached to it. The background of the image is blurry and indistinct. The title of the image is "Photo of Product".
-
- Safety and Effectiveness, comparison to predicate device:
| Comparison Areas | USA Instruments Hi-Res9000 Phased Array CarotidCoil K001210. | "Machnet Carotids CoilArray Assembly." (Catalog# PACC-GSXX) |
|---|---|---|
| Indications for use | The Hi-Res 9000 Phased ArrayCarotid Coil is a receive-onlyphased array RF coil used forobtaining diagnostic images of thecarotid arteries and associatedvasculature from the Aortic archthrough the Circle-of-Willis inMagnetic Resonance Imagingsystems. The indications for useare the same as for standard MRImaging. | SAME |
| Use with MRI Model | The Hi-Res 9000 Phased ArrayCarotid Coil is designed for usewith the SignaTM (1.5Tesla) MRIscanner manufactured by GEMedical Systems, Inc. | SAME, Signa Advantage 1.5Tand 1.0T.Signa Horizon LX 1.5T and 1.0T. |
| Description | The Hi-Res 9000 Phased ArrayCarotid Coil is an eight-elementphased array receive only coil.The elements and associatedcircuitry are enclosed in housingmade of plastic materials, whichare fire rated and have highimpact and tensile strength. | SAME except four element. |
| Function | Receive only | SAME |
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KC12491
Page 3 of 3
6. Testing information and Conclusion
In all material respects, the "Machnet Carotids Coil Array Assembly." (Catalog # PACC-GSXX) is substantially equivalent to USA Instruments Hi-Res 9000 Phased Array Carotid Coil (K001210). Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2001
Machnet BV % Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K012491
Trade/Device Name: Machnet Carotids Coil Array Assembly Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: August 1, 2001 Received: August 3, 2001
Dear Mr. Kamm:
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 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 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:
| 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" (21 CFR Part 807.97). 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
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j) Indications for Use
Kol2491 510(k) Number
"Machnet Carotids Coil Array Assembly." (Catalog # PACC-GSXX) To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. mages of Carotid Straction and igned to provide coverage of the carotid arteries and I he Machiner Survice from the aortic arch through the Circle-of-Willis. assoonaton Regions: Head and Neck Vasculature. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Signa system is indicated for use as an NMR device that produces images that: The OL Signa system is manufon of protons exhibiting NMR signal, (2) depend upon (1) correspond to the disationsity, spin lattice relaxation time Tl, spin-spin relaxation Nivil parameters (process consessed ture of the head and neck regions specifically the thire 12) and (3) and (3) and (2) tissue. When interpreted by a trained physician, these carone arteries and association can be useful in the determination of a diagnosis.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use |
Over the Counter Use (Per 21 CFR 801.109)
Nancy C. Broadon
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012491
OR
§ 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.