(21 days)
Soft tissue and bone imaging of both lower extremities simultaneously as allowed by the MRI system. Magnetic resonance peripheral angiography.
The 1.5T PV Array, Catalog #155GE1501, interfaces with the G.E. 1.5 Tesla Signa® system. It has been designed and optimized to collect peripheral vascular image data in three overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inputs and utilizes standard coil configuration files available on the G.E. Signa® Plasma or Mouse-Driven Screen. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.
This document is a 510(k) premarket notification for a medical device, specifically an MRI accessory coil. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove the device meets them, especially in the context of AI/algorithm performance, is not available in this type of submission.
Here's a breakdown of the available information based on your request, along with explanations for the missing elements:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. For MRI coils, acceptance criteria typically relate to performance metrics like signal-to-noise ratio (SNR), image uniformity, and artifact levels, often compared directly to the predicate device or established standards. However, these specific metrics and their performance results are not detailed in this summary, which focuses on the regulatory submission.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. 510(k) summaries for devices like MRI coils generally do not detail "test sets" or "data provenance" in the way an AI/algorithm study would. Instead, performance is often demonstrated through engineering testing, phantom studies, and possibly limited human subject imaging (but not typically a large-scale clinical trial with detailed sample information for proving performance against set criteria).
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)
This is not applicable and not provided. Establishing ground truth by experts is a concept relevant to diagnostic algorithms or AI systems where human interpretation is the benchmark. For an MRI coil, performance is assessed through technical measurements and image quality evaluations, not by expert consensus on diagnostic outcomes based on a "test set" in the traditional sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are used in studies involving human readers or interpretations, primarily in clinical trials or studies evaluating diagnostic accuracy, which is not the primary focus of this 510(k) submission for an MRI coil.
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
This is not applicable and not provided. This document describes an MRI accessory coil, not an AI or algorithm-driven diagnostic system. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. This document describes an MRI accessory coil, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable and not provided. As explained above, the concept of "ground truth" as used in diagnostic studies (e.g., from pathology or outcomes) is not relevant to the technical performance evaluation of an MRI coil in a 510(k) submission. Performance is typically a comparison of physical specifications and imaging characteristics to a predicate device.
8. The sample size for the training set
This is not applicable and not provided. Training sets are used for machine learning algorithms, which are not described in this 510(k) submission for an MRI coil.
9. How the ground truth for the training set was established
This is not applicable and not provided. As explained above, training sets and their ground truth are concepts relevant to AI/ML development, which is outside the scope of this particular medical device submission.
Summary of what the document does provide:
- Device Description: The 1.5T PV Array, Catalog #155GE1501, interfaces with the G.E. 1.5 Tesla Signa® system. It's designed to collect peripheral vascular image data in three overlapping coil groups, utilizing G.E. Phased Array Coil inputs. It has a coil form geometry for close coupling to the anatomy and includes a comfort pad set.
- Intended Use: Soft tissue and bone imaging of both lower extremities simultaneously, and magnetic resonance peripheral angiography.
- Substantial Equivalence: The document asserts that the modified device has the same technological characteristics as the unmodified device, with only minor changes to the size and physical orientation of individual elements. Materials, use, and safety features are equivalent. Both are receive-only MRI antennas.
- Predicate Device: Unmodified Device Tradename: Array Coil Model # 100GE1500 (Lower Extremity Quadrature Detection), 510(k) No. K933659.
- Regulatory Classification: Class II/Radiology/LNH, Product Code 90 MOS.
Conclusion:
The provided text is a 510(k) summary for an MRI accessory coil. Its purpose is to demonstrate substantial equivalence to a predicate device for regulatory clearance, not to present a detailed study on meeting specific diagnostic acceptance criteria with a rigorous clinical trial or AI performance evaluation. Therefore, most of the questions regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (especially in the context of AI) are not addressed in this type of document.
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K02 23 95
Image /page/0/Picture/1 description: The image shows the logo for Scan Med of Medic, Inc. The logo features a stylized "S" with a symbol inside it. To the right of the logo is the date "AUG 1 3 2002".
"Reducing the cost of Health care through the manufacturing of Quality, Economical Products"
510(k) Summary
| 1. | Manufacturer name & address: | MEDIC Inc.6912 N. 97th Circle, Suite COmaha, NE 68122 |
|---|---|---|
| Establishment Registration No.: | 1932898 | |
| Applicant/Contact Person: | Randall Jones, Dr.Eng. | |
| Applicant Contact Info : | Ph : 402-571-3271 | |
| Fax : 402-571-3340 | ||
| Email : | ||
| Date Prepared : | 15 July 2002 | |
| 2. | Device common name : | MRI Accessory\ Coil |
| Specific Device Tradename : | 1.5T ScanMed PV Array | |
| Classification: | Class II/Radiology/LNH | |
| 3. | Unmodified Device Tradename:Array Coil Model # 100GE1500 | Lower Extremity Quadrature Detection |
| Unmodified Device 510(k) No. | K933659. |
- Device Description: The 1.5T PV Array, Catalog #155GE1501, interfaces with the G.E. 1.5 Tesla Signa® system. It has been designed and optimized to collect peripheral vascular image data in three overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inputs and utilizes standard coil configuration files available on the G.E. Signa® Plasma or Mouse-Driven Screen. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.
- ડ. Intended Use Statement:
Soft tissue and bone imaging of both lower extremities simultaneously as allowed by the MRI system.
Magnetic resonance peripheral angiography.
Note that the intended use is not susbstantively different than that of the unmodified device (below).
Musculoskeletal: Soft tissue and bone imaging of both lower extremities: simultaneous imaging of both knees and/or ankles. Magnetic Resonance Angiography: Peripheral arterial studies from the inguinal canal distally to the feet.
- The modified device has the same technological characteristics as the unmodified device with only minor changes to the size and physical orientation of the individual elements of the multi-element or multi-channel MRI antenna (coil). The materials, use, and safety features are equivalent. Both are receive-only MRI antennas so no energy is imparted to the patient.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Randall W. Jones, Dr. Eng. President MEDIC, Inc. 6912 North 97th Circle Suite C OMAHA NE 68122
Re: K022395
Trade/Device Name: 1.5T ScanMed PV Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: July 15, 2002 Received: July 23, 2002
Dear Dr. Jones:
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.
AUG 13 2002
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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,
Henry 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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Appendix A
Statement of Indications for Use
The new device labeled the 1.5T ScanMed PV Array will have no substantive change in the Indications for Use over the predicate (unmodified) device, Lower Extremity Quadrature Detection Array (K933659).
The intention of the new device is to expand the anatomical coverage provided by the device by modifying the patient-user interface in terms of altering the size and anatomical location of some of the array's individual resonators, as well as adding. resonators.
The Intended Use Statements remain virtually identical to those of the Unmodified device. These statements follow.
- Soft tissue and bone imaging of both lower extremities simultaneously as . allowed by the MRI system.
- Magnetic resonance peripheral angiography. .
Prescription Use
David A. Seymon
(Division Sian-Of Division of Reproductive and Radiological Devic 510(k) Number
102 2395
§ 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.