(34 days)
Not Found
No
The summary describes standard MRI technology and image processing without mentioning AI, ML, or related concepts. The performance studies focus on compliance with standards and traditional verification/validation.
No
The device is used to produce images for diagnosis, not to provide therapy.
Yes
The device is an MRI system, which produces images used by a trained physician to determine a diagnosis. This function aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "1Tesla Permanent MRI system" and describes the physical process of generating MR images using magnetic fields and RF pulses, indicating it is a hardware device with associated software for image processing.
No, 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 Wrist 3 MRI System is an imaging device that produces images of the internal structure of the wrist and hand using magnetic resonance. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for producing images to aid in diagnosis, not for performing diagnostic tests on biological specimens.
The device is a medical imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Wrist 3 MRI System is intended for use as a magnetic resonance imaging device for producing axial, sagittal, coronal, and oblique images of the internal structure of the Wrist and Hand. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH, MOS
Device Description
The Wrist 3 MRI System is a 1Tesla Permanent MRI system producing MR images of the wrists and hands. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Wrist and Hand
Indicated Patient Age Range
Patients requiring MR images of the wrist and Hand
Intended User / Care Setting
trained physician / Hospital or clinical setting
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)
Nonclinical Testing:
The Wrist 3 MRI System and its applications were tested to comply with the below voluntary consensus standards.
- IEC/ES 60601-1
- IEC 60601-1-2
- IEC 60601-2-33
- NEMA MS-1
- NEMA MS-3
- NEMA MS-2
- NEMA MS-12
- NEMA MS-5
In addition System and Software verification and Validation testing were performed to demonstrate performance of the device as part of design controls activity.
The following design control activities were applied to the development of the system:
- Risk Management
- Requirements Management
- Design Reviews
- Unit level module verification
- System Integration verification
- Performance verification
- Safety and EMC testing
- Simulated use validation testing
- Sample clinical images
Clinical Tests:
The subject of this premarket submission, Wrist 3 MRI System, did not require clinical studies to support substantial equivalence.
Conclusion: Based on bench testing and sample clinical images. Aspect Imaging LTD believes that the Wrist 3 MRI System is substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K130692 M2 Wrist 2 MRI System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2016
Aspect Imaging Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K160185
Trade/Device Name: Wrist 3 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS Dated: February 22, 2016 Received: February 23, 2016
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160185
Device Name Wrist 3 MRI System
Indications for Use (Describe)
The Wrist 3 MRI System is intended for use as a magnetic resonance imaging device for producing axial, sagittal, coronal, and oblique images of the internal structure of the Wrist and Hand. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Aspect Imaging. The logo consists of a stylized cube made up of three layers in shades of blue, green, and yellow. To the right of the cube is the company name, "aspectimaging," written in a sans-serif font, with the "t" in "aspect" stylized to resemble a plus sign.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | February 16, 2016 | |
|---|---|---|
| Submitter: | Aspect Imaging Ltd. | |
| 27 Shaked St. | ||
| Industrial Area Hevel Modi'in | ||
| P.O. Box 926 | ||
| Shoham, 6085001 | ||
| ISRAEL | ||
| Primary Contact Person: | Israel A. Citron | |
| VP Quality Assurance and Regulatory Affairs | ||
| Aspect Imaging LTD | ||
| Tel: +972-73-223-9000 Ext 90 | ||
| Fax: +972-3-716-5606 | ||
| E mail: icitron@aspectimaging.com | ||
| Device Trade Name: | Wrist 3 MRI System | |
| Common/Usual Name: | MRI System | |
| Product Classification | II | |
| Classification Name: | Magnetic Resonance Diagnostic Device (21 CFR 892.1000) | |
| Product Code: | LNH, MOS | |
| Predicate Device(s): | K130692 M2 Wrist 2 MRI System | |
| Device Description: | The Wrist 3 MRI System is a 1Tesla Permanent MRI system | |
| producing MR images of the wrists and hands. During MRI scan, | ||
| body parts to be imaged are held within a uniform static magnetic | ||
| field, and are subject to sequences of RF pulses and gradient | ||
| magnetic fields. The signal from the precession of the | ||
| magnetization created by these fields is sampled and processed to | ||
| produce image data. | ||
| Intended Use: | The Wrist 3 MRI System is intended for use as a magnetic | |
| resonance imaging device for producing axial, sagittal, coronal, | ||
| and oblique images of the internal structure of the Wrist and Hand. | ||
| When interpreted by a trained physician, these images provide | ||
| information that can be useful in determining a diagnosis | ||
| Technology: | The Wrist 3 MRI System employs the same fundamental | |
| scientific technology as its predicate device (M2 Wrist 2 MRI | ||
| System K130692). | ||
| Comparison of | ||
| Specifications | Predicate Device | |
| M2 Wrist 2 MRI System | ||
| (K130692) | Proposed Device | |
| Wrist 3 MRI System | ||
| Intended Use/Indication for Use | The M2 Wrist II MRI System | |
| is indicated for use as a | ||
| magnetic resonance imaging | ||
| device for producing transverse, | ||
| sagittal and coronal images of | ||
| the internal structure of the wrist | ||
| (in patients with an arm length > | ||
| 320 mm). When interpreted by a | ||
| trained physician, the resultant | ||
| MR images provide information | ||
| that can be useful in determining | ||
| a diagnosis. | The Wrist 3 MRI System is | |
| intended for use as a magnetic | ||
| resonance imaging device for | ||
| producing axial, sagittal, | ||
| coronal, and oblique images of | ||
| the internal structure of the | ||
| Wrist and Hand. When | ||
| interpreted by a trained | ||
| physician, these images provide | ||
| information that can be useful in | ||
| determining a diagnosis. | ||
| Patient Population | Patients requiring MR images of the | |
| wrist | Patients requiring MR images of the | |
| wrist and Hand | ||
| Anatomical Sites | Wrist | Wrist and Hand |
| Environment of Use | Hospital or clinical setting | Hospital or clinical setting |
| Energy Used and/or delivered | Magnetic Resonance | Magnetic Resonance |
| Human Factors | The M2 Wrist 2 MRI System is | |
| designed similar to other | ||
| commercially available MRI | ||
| Systems and therefore is familiar | ||
| and easy for use for the user. | ||
| Furthermore, the device contains a | ||
| user-friendly software interface | ||
| through which the user may easily | ||
| access all device functions. | The Wrist 3 MRI System is | |
| designed similar to other | ||
| commercially available MRI | ||
| Systems and therefore is familiar | ||
| and easy for use for the user. | ||
| Furthermore, the device contains a | ||
| user-friendly software interface | ||
| through which the user may easily | ||
| access all device functions. | ||
| Hardware Changes | ||
| Magnet: | ||
| - Physical Dimensions | 125x87x82 cm | 138x87x82 cm |
| - Bore opening | 76x200 mm | 85x220 mm |
| - Weight | ||
| Field Strength | ||
| Gradient: | 1050 Kg | |
| 1 Tesla Permanent Magnet | 1300 (1700 with Trolley) Kg | |
| 1 Tesla Permanent Magnet | ||
| -Strength | 190 mT/m | 215 mT/m |
| -Rise Time | 0.475mSec | 0.200mSec |
| -Slew Rate | 400 T/m/Sec | 1074 T/m/Sec |
| Computer: | ||
| -Display: | 24" LCD Desktop Display | 15" Touch Display |
| RF Coils | 1 Coil | 2 Coils: Small/Large |
| Coil Type | TX/RX | TX/RX |
| Coil Geometry | Oval | Oval |
| Inner dimensions (mm) | 50X108X86 | 60X100X169 / 75X135X192 |
| Coil Design | Linear Volume | Linear Volume |
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Image /page/4/Picture/0 description: The image shows the logo for Aspect Imaging. The logo consists of a teal and green geometric shape on the left, followed by the word "aspectimaging" in a dark purple sans-serif font. The geometric shape appears to be a stylized representation of a cube or layered structure.
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Image /page/5/Picture/0 description: The image shows the logo for Aspect Imaging. The logo consists of a geometric shape on the left and the text "aspectimaging" on the right. The geometric shape is made up of four stacked squares, each a different color: blue, green, yellow, and purple. The text "aspectimaging" is written in a sans-serif font, with "aspect" in purple and "imaging" in gray.
Determination of Substantial Equivalence:
Summary of Nonclinical Testing:
The Wrist 3 MRI System and its applications were tested to comply with the below voluntary consensus standards.
- IEC/ES 60601-1
- IEC 60601-1-2
- 트 IEC 60601-2-33
- 트 NEMA MS-1
- NEMA MS-3
- 트 NEMA MS-2
- NEMA MS-12
- NEMA MS-5
In addition System and Software verification and Validation testing were performed to demonstrate performance of the device as part of design controls activity.
The following design control activities were applied to the development of the system:
- Risk Management
- Requirements Management
- Design Reviews
- 트 Unit level module verification
- 트 System Integration verification
- I Performance verification
- Safety and EMC testing
- I Simulated use validation testing
- Sample clinical images
Summary of Clinical Tests:
The subject of this premarket submission, Wrist 3 MRI System, did not require clinical studies to support substantial equivalence.
- Conclusion: Based on bench testing and sample clinical images. Aspect Imaging LTD believes that the Wrist 3 MRI System is substantially equivalent to its predicate device.