(29 days)
The ONI MSK Extreme™ MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
The MSK Extreme™ MR Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.
This is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) would.
Based on the provided text, the device is the MSK Extreme™ MRI Scanner. The document focuses on demonstrating substantial equivalence to existing MRI scanners (OrthOne Extremity MRI Scanner (K001773), Philips Medical Systems Achieva 1.5T (K052013), and MAGNETOM Systems with Software syngo MR 2006A (1.5T Symphony version) (K052164)).
Here's an analysis of the requested information based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics for the MSK Extreme™ MRI Scanner in a comparison table. The submission relies on demonstrating substantial equivalence.
Instead, it states:
"In addition to being technologically equivalent to the predicate devices, the MSK Extreme™ MR Scanner has been subjected to performance testing and it has been determined that the MSK Extreme™ MR Scanner is suitable for its intended use."
This indicates that general performance testing was conducted to ensure suitability, rather than meeting pre-defined quantitative acceptance criteria against a clinical benchmark for a new claim.
2. 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 provide any information regarding a specific test set sample size or data provenance (country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary focused on substantial equivalence for an imaging device of this nature, where the primary "test" is often focused on engineering and image quality compared to the predicate, rather than an outcome-based clinical trial.
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)
The document does not provide any information about experts used to establish ground truth or their qualifications. The "ground truth" for an MRI scanner's performance in a 510(k) context would likely be the image quality and diagnostic capabilities being comparable to the predicate devices, which is generally assessed by qualified personnel within the manufacturing and regulatory review process, but not typically detailed as an "expert panel" for ground truth establishment for a test set in the submission summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for a test set.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an MRI scanner, a hardware device for image acquisition, not an AI-powered diagnostic tool. Therefore, a study assessing human reader improvement with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not mention any standalone algorithm performance testing. This device is an MRI scanner, not an algorithm, so this type of testing is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the document does not detail a specific "ground truth" methodology in the context of a clinical study with patients and outcomes. For an MRI scanner in a 510(k), the "ground truth" for demonstrating equivalence largely revolves around technical specifications, phantom imaging, and potentially comparing images from the new device to those from predicate devices to ensure similar diagnostic quality.
8. The sample size for the training set
The document does not mention any training set or its sample size. This is an MRI hardware device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how its ground truth was established.
Summary of what the document DOES state:
- Acceptance Criteria/Performance (Implicit): The device (MSK Extreme™ MRI Scanner) was subjected to performance testing and determined to be "suitable for its intended use" and "technologically equivalent" to predicate devices (OrthOne Extremity MRI Scanner (K001773), Philips Medical Systems Achieva 1.5T (K052013), and MAGNETOM Systems with Software syngo MR 2006A (1.5T Symphony version) (K052164)). The primary "acceptance criterion" for a 510(k) is often simply demonstrating substantial equivalence to a legally marketed predicate device.
- Study Type: This is a 510(k) Premarket Notification, which primarily involves demonstrating substantial equivalence (safety and effectiveness) to predicate devices through a comparison of technological characteristics and performance data. It is not typically a full-scale clinical trial with detailed metrics as would be found in a PMA.
- Non-clinical Data: The device is manufactured using similar processes and equivalent materials as its predicate, and its indications for use have not changed. This non-clinical data supports the claim of substantial equivalence.
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K080048
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510(k) Summary
| Submitter: | ONI Medical Systems, Inc.301 Ballardvale Street, Suite 4Wilmington, MA 01887USA | FEB - 6 2008 |
|---|---|---|
| Contact Person: | Mark PuopoloQuality Assurance/Regulatory Affairs Manager781.262.5539978.658.0898mpuopolo@onicorp.com | |
| Date Prepared: | January 4, 2008 | |
| Trade Name: | MSK Extreme™ MRI Scanner | |
| Common Name: | Magnetic Resonance Diagnostic Device | |
| ClassificationName: | Magnetic Resonance Diagnostic Device | |
| Predicate Device: | OrthOne Extremity MRI Scanner (K001773)Philips Medical Systems Achieva 1.5T(K052013)MAGNETOM Systems with Software syngo MR 2006A(1.5T Symphony version) (K052164) | |
| DeviceDescription: | The MSK Extreme™ MR Scanner utilizes asuperconducting magnet to acquire 2D single-sliceand multi-slice and 3D volume images. A widevariety of pulse sequences are provided to theoperator, including spin echo, fast spin echo, 2D and3D gradient echo acquisitions. Imaging options suchas inversion recovery, flow compensation andfat/water suppression are provided to suppressartifacts due to physiological motion and improveimage quality. The system is used as a stationarysystem. | |
| Statement ofIntended Use: | The MSK Extreme™ MR Scanner is intended foruse as a diagnostic imaging device to produce axial,sagittal, coronal and oblique images of the internalstructures of the leg (excluding the thigh), knee,ankle, foot, forearm, elbow, wrist and hand. |
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| Summary ofTechnologicalCharacteristics: | In addition to being technologically equivalent to thepredicate devices, the MSK Extreme™ MR Scanner has beensubjected to performance testing and it has been determinedthat the MSK Extreme™ MR Scanner is suitable for itsintended use. |
|---|---|
| Summary of Non-clinical Data: | The MSK Extreme™ MR Scanner is manufactured under thesame conditions, using the similar processes and equivalentmaterials, as the ONI OrthOne Extremity MRI Scanner, thelegally marketed ONI predicate device. In addition to beingtechnologically equivalent, the indications for use have notchanged. |
. . . . . . .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 2008
Mr. Mark Puopolo Quality Assurance/Regulatory Affairs Manager ONI Medical Systems, Inc. 301 Ballardvale Street, Suite 4 WILMINGTON MA 01887-4405
Re: K080048
Trade/Device Name: MSK Extreme™ MRI Scanner Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 4, 2008 Received: January 8, 2008
Dear Mr. Puopolo:
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 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.
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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/cdrb/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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Image /page/4/Picture/0 description: The image shows the logo for ONI Medical Systems, Inc. The logo consists of the letters "ONI" in a stylized font, with the letters overlapping each other and surrounded by a dark circle. To the right of the circle, the words "ONI Medical Systems, Inc." are written in a simple, sans-serif font. The text is aligned to the left and the words "Medical Systems, Inc." are stacked below the word "ONI".
Indications for Use
510(k) Number (if known):
Device Name: MSK Extreme™ MRI Scanner
Indications: The ONI MSK Extreme™ MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K080048 |
§ 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.