(29 days)
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is used for diagnostic imaging, not for treating conditions. Its output is diagnostic information (images) for interpretation by medical experts.
Yes
The "Intended Use" section states that the device produces images that "can provide diagnostically useful information" when interpreted by a medical expert. While it doesn't perform the diagnosis itself, it produces the images necessary for diagnosis. Therefore, it is a diagnostic device.
No
The device description explicitly states it utilizes a superconducting magnet and is a stationary system, indicating it is a hardware-based MRI scanner, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ONI MSK Extreme™ MR Scanner is a medical imaging device that uses magnetic resonance to produce images of the internal structure of limbs and joints. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it is a "magnetic resonance imaging device" for imaging specific anatomical sites.
- Device Description: The description details the technology used for image acquisition (superconducting magnet, pulse sequences) and image quality improvement, all related to the imaging process itself, not the analysis of biological samples.
Therefore, the ONI MSK Extreme™ MR Scanner falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MSK Extreme™ MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
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.
Product codes
LNH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OrthOne Extremity MRI Scanner (K001773), Philips Medical Systems Achieva 1.5T (K052013), MAGNETOM Systems with Software syngo MR 2006A (1.5T Symphony version) (K052164)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K080048
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510(k) Summary
| Submitter: | ONI Medical Systems, Inc.
301 Ballardvale Street, Suite 4
Wilmington, MA 01887
USA | FEB - 6 2008 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mark Puopolo
Quality Assurance/Regulatory Affairs Manager
781.262.5539
978.658.0898
mpuopolo@onicorp.com | |
| Date Prepared: | January 4, 2008 | |
| Trade Name: | MSK Extreme™ MRI Scanner | |
| Common Name: | Magnetic Resonance Diagnostic Device | |
| Classification
Name: | 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) | |
| Device
Description: | 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. | |
| Statement of
Intended Use: | The MSK Extreme™ MR Scanner is intended for
use as a diagnostic imaging device to produce axial,
sagittal, coronal and oblique images of the internal
structures of the leg (excluding the thigh), knee,
ankle, foot, forearm, elbow, wrist and hand. | |
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K080048
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| Summary of
Technological
Characteristics: | 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. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Non-
clinical Data: | The MSK Extreme™ MR Scanner is manufactured under the
same conditions, using the similar processes and equivalent
materials, as the ONI OrthOne Extremity MRI Scanner, the
legally marketed ONI predicate device. In addition to being
technologically equivalent, the indications for use have not
changed. |
. . . . . . .
2
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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Page 2
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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Page 1 of | 1 |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K080048 |