(90 days)
No
The summary describes a mechanical positioning device for MRI studies and does not mention any software or algorithms that would utilize AI or ML.
No
The device is described as a "new positioning device" for kinematic MRI studies of the knee, enabling evaluation of anatomy and dynamic interaction of tissues. Its intended use is for evaluation and imaging, not for treating or alleviating a medical condition.
No
The input describes a positioning device for kinematic MRI studies, which helps in evaluating the knee's anatomy and dynamic interaction of tissues. It does not state that the device itself performs diagnosis, but rather aids in the diagnostic process by facilitating specific imaging.
No
The device description explicitly states it is a "new positioning device" and describes its physical characteristics (adjustable angle), indicating it is a hardware device.
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 described device is a positioning device used during a kinematic MRI study of the knee. It helps to position the knee for imaging and evaluate its dynamic movement.
- Nature of the Test: MRI is an in vivo imaging technique, meaning it is performed on a living organism, not on samples taken from the body.
The device's purpose is to facilitate an imaging procedure (MRI) to visualize the knee's anatomy and movement, not to analyze biological samples. Therefore, it falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The new kinematic knee device will enable the physician to evaluate the anatomy of the knee and dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such dynamic evaluation may be useful for patellar tracking.
Product codes
Not Found
Device Description
Siemens is introducing a new positioning device that will be used for kinematic MRI studies of the knee. The new positioning device can be used for the left or right knee and is adjustable up to a maximum angle of 100 degrees.
The new device accessory is a positioning device which is manually operated by the user. No active components (i.e., motors) are used and there are no ferromagnetic materials that could affect the scan field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Not Found
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.
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.
0
JUN 19 1996
.
ri
ﻌﺘﺮﺍ - ﺗﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
Appendix 8:
510(k) Summary
'
1
SIEMENS
I.
General Information.
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
510 (k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- Establishment: • Address: Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830 · Registration Number: 2240869 • Contact Person: Kathleen M. Rutherford Manager, Regulatory Submissions (908) 321-4779 • Date of Summary Preparation: March 20, 1996 Device Name: · Trade Name: Kinematic Knee Device/ OPEN Magnetic Resonance Diagnostic · Classification Name: Device, CFR & 892.1000 • Classification: Class II · Performance Standards: None established under Section 514 of the Food, Drug, and
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination.
Device Description:
Siemens is introducing a new positioning device that will be used for kinematic MRI studies of the knee. The new positioning device can be used for the left or right knee and is adjustable up to a maximum angle of 100 degrees.
Cosmetic Act.
2
SIEWENS
Intended Use
The new kinematic knee device will enable the physician to evaluate the anatomy of the knee and dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such dynamic evaluation may be useful for patellar tracking.
Technological Characteristics
The MAGNETOM OPEN is a magnetic resonance (MR ) imaging system which uses time-varying magnetic field gradients and rf energy to spatially encode the anatomy of a patient. Introduction of the new kinematic knee device will not affect the technological characteristics of this system.
The new device accessory is a positioning device which is manually operated by the user. No active components (i.e., motors) are used and there are no ferromagnetic materials that could affect the scan field.
General Safety and Effectiveness Concerns:
The kinematic knee device will not affect the safety and performance parameters specified for the MAGNETOM OPEN system.
Substantial Equivalence:
The Siemens Kinematic Knee Device is substantially equivalent to the commercially available Resonex Kinematic MRI package. The Resonex Kinematic MRI Package was described in K924154 which received FDA premarket clearance on 11/23/92.
Kathleen Rutherford
Signature
Signature
3/20/96
Date