(70 days)
The coil is indicated for use on the order of a physician, in conjunction with GE 1.5T MR scanners as an accessory to produce images of the wrist and hand regions, as an aid to diagnosis.
The design of the 1.5T 16-channel Hand-Wrist Coil is based on design features of the predicate device. · 1.5T 8-Channel Hand-Wrist Coil. The 16-Channel Hand-Wrist Coil is designed as receive only for high resolution diagnostic imaging of regional structures of the wrist and hand. The 16-Channel Hand-Wrist Coil is manufactured of materials that are similar to those used to manufacture the predicate device.
This submission is a 510(k) premarket notification for a 1.5T 16-Channel Hand-Wrist Coil. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance
The provided document does not contain explicit acceptance criteria or reported device performance metrics in a tabular or descriptive format. This is typical for a 510(k) summary for a medical device accessory like an MR coil, where the substantial equivalence argument relies on comparing the new device to a legally marketed predicate device rather than presenting performance metrics against predefined criteria.
The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The document states: "When compared to the predicate device, 1.5T 8-Channel Hand-Wrist Coil - K050622, cleared 04/08/05, substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics."
Therefore, the "reported device performance" is essentially that it functions similarly to the predicate device for imaging the wrist and hand, as an aid to diagnosis, with the implication of improved performance due to the higher channel count (16 vs 8), though specific metrics are not provided.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific clinical "test set" or associated data provenance. As this is a 510(k) for an MRI coil, the "testing" would primarily focus on engineering verification and validation (e.g., signal-to-noise ratio, image uniformity, SAR compliance) rather than a clinical trial with a patient test set for diagnostic accuracy. Such technical verification data is typically included in the full 510(k) submission but summarized only for substantial equivalence in the public summary.
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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)
Since there is no described clinical "test set" requiring ground truth establishment, this information is not applicable and not provided in the document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similar to point 3, as no clinical "test set" with diagnostic outcomes is described, an adjudication method is not applicable and not provided.
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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 device is an MRI coil, which is a hardware accessory, not an AI software intended for diagnostic aid. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not discussed in the document.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a hardware accessory (MRI coil), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable and not discussed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No clinical "ground truth" is discussed for this device, as it's a hardware component rather than a diagnostic algorithm requiring performance evaluation against known disease states. The focus is on the technical performance of the coil itself (e.g., image quality, safety).
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The sample size for the training set
This document pertains to a hardware device (MRI coil), not a software algorithm that requires a training set. Therefore, a "training set" and its sample size are not applicable and not mentioned.
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How the ground truth for the training set was established
As there is no training set for this hardware device, this question is not applicable and not addressed.
In summary:
The provided 510(k) summary for the 1.5T 16-Channel Hand-Wrist Coil focuses on demonstrating substantial equivalence to a predicate device based on design, indications for use, and technological characteristics. It does not contain information typically found in submissions for diagnostic AI algorithms or other devices requiring extensive clinical performance studies with patient data and expert interpretations. The "study" proving the device meets criteria is the argument for substantial equivalence supported by (unspecified in this summary) engineering verification and validation testing, which is typical for such hardware accessories.
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K103/49
510(k) Summary of Safety and Effectiveness 1.5T 16-Channel Hand-Wrist Coil
JAN - 3 2010
| Submitted By: | Invivo Corporation3545 SW 47TH Ave.Gainesville, FL 32608 |
|---|---|
| Date: | October 22, 2010 |
| Contact Person: | Elizabeth Wheeler, Regulatory Affairs EngineerTel: (352) 336-0010, ext 164 Fax: (352) 336-1410 |
| Proprietary Name: | 1.5T 16-Channel Hand-Wrist Coil |
| Common Name: | Coil, Magnetic Resonance, Specialty |
| Classification Name and Reference: | 21 CFR 892.1000, A magnetic resonance diagnosticdevice, for general diagnostic use to present imageswhich reflect the spatial distribution and/or magneticresonance spectra which reflect frequency anddistribution of nuclei exhibiting nuclear magneticresonance, class II. |
| Device Product Code and Panel Code: | MOS / Radiology / 90 |
Device Description:
The design of the 1.5T 16-channel Hand-Wrist Coil is based on design features of the predicate device. · 1.5T 8-Channel Hand-Wrist Coil. The 16-Channel Hand-Wrist Coil is designed as receive only for high resolution diagnostic imaging of regional structures of the wrist and hand. The 16-Channel Hand-Wrist Coil is manufactured of materials that are similar to those used to manufacture the predicate device.
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with GE 1.5T MR scanners as an accessory to produce images of the wrist and hand regions, as an aid to diagnosis.
Technological Characteristics:
The fundamental scientific technology of a radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest.
The fundamental scientific technology of the subject device described in this submission has not been altered from the predicate device.
Substantial Equivalence Information:
When compared to the predicate device, 1.5T 8-Channel Hand-Wrist Coil - K050622, cleared 04/08/05, substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing its wings and a circular border around the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written along the circular border.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Elizabeth Wheeler Regulatory Engineer Invivo Corporation 3545 SW 47" Ave. GAINESVILLE FL 36208
JAN - 3 2010
Re: K103149
Trade/Device Name: 1.5T 16-Channel Hand-Wrist Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 22, 2010 Received: October 25, 2010
Dear Ms Wheeler:
and the works of the country of the states
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801, and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
JAN - 3 2010
510(k) Number (if known):
Device Name: 1.5T 16-Channel Hand-Wrist Coil
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with GE 1.5T MR scanners as an accessory to produce images of the wrist and hand regions, as an aid to diagnosis.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Mull D'O'h
(Division Sign-Off)
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Office of to Vitro D
510K K103149
§ 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.