(44 days)
Not Found
No
The summary describes a receiver coil for an MRI system and does not mention any AI or ML capabilities.
No
The device is described as a "diagnostic imaging device accessory" and is indicated for use in producing images for diagnosing conditions, not for treating them.
Yes
The device is described as "a diagnostic imaging device accessory" and is used to produce images of various soft tissues and vascular structures, which are then used for diagnosis.
No
The device description explicitly states it is a "receiver only coil," which is a hardware component used in Magnetic Resonance imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of vascular structures and soft tissue". This describes a device used in vivo (within the living body) to acquire images, not a device used in vitro (outside the living body) to examine specimens like blood, urine, or tissue samples.
- Device Description: It's described as a "receiver only coil for the Magnetom Symphony system". This is a component of an MRI system, which is an imaging modality used on patients.
- Input Imaging Modality: The input modality is "Magnetic Resonance", which is an in vivo imaging technique.
- Anatomical Site: The anatomical sites listed (abdomen, pelvis, lower limbs) are parts of the human body being imaged directly.
- Performance Studies: The performance studies focus on metrics like "SNR and Image uniformity", which are relevant to the quality of the acquired images from the patient, not the analysis of biological samples.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate the acquisition of images from within the body.
N/A
Intended Use / Indications for Use
The Siemens Magnetom CP Angio Array Coil is indicated for use as a diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of vascular structures and soft tissue of the abdomen, pelvis and lower limbs. The design of this coil facilitates imaging larger peripheral vascular areas.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The CP Peripheral Angio Array Coil is a receiver only coil for the Magnetom Symphony system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
abdomen, pelvis and lower limbs
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)
Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The new CP peripheral Angio Array Coil was tested for SNR and Image uniformity and the results presented in this submission show that they are equivalent to the currently available Siemens coils.
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
FEB 4 2000
Appendix 11: PMN Truthful and Accurate Statement
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.
I. General Information.
Establishment:
-
Siemens Medical Systems, Inc. • Address: 186 Wood Avenue South Iselin, N.J. 08830
2240869 Registration Number: -
Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions (732) 321-4625 (732) 321-4841
Date of Summary Preparation: 12/21/99
Device Name:
CP Peripheral Angio Array Coil for the Magnetom Symphony • Trade Name:
- Classification Name: Magnetic Resonance Diagnostic Device, CFR § 892.1000
· Classification: Class II
· Performance Standards: None established under Section 514 of the Food, Drug, and Cosmetic Act.
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
• Device Description:
The CP Peripheral Angio Array Coil is a receiver only coil for the Magnetom Symphony system.
• Intended Use
The Siemens Magnetom CP Angio Array Coil is indicated for use as a diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of vascular structures and soft tissue of the abdomen, pelvis and lower limbs. The design of this coil facilitates imaging larger peripheral vascular areas.
• Technological Characteristics
The magnet. RF system, and gradient system, of the MAGNETOM Symphony configured with the new CP Angio Array Coil is substantially equivalent to the standard MAGNETOM Symphony system with the currently marketed family of coils (which were described in K971684).
· General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Symphony system with the new CP peripheral Angio Array Coil is substantially equivalent to standard operation of the commercially available MAGNETOM Symphony system. The following safety parameter with action levels:
- Maximum Static Field Strength -
- Rate of Change in Magnetic Field -
- RF Power deposition -
- Acoustic Noise Levels -
and performance levels:
- -Specification Volume
- Signal to Noise -
- -Image Uniformity
- Geometric distortion -
- High contrast spatial resolution -
- -Slice profile, thickness and gap
specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification. The new CP peripheral Angio Array Coil was tested for SNR and Image uniformity and the results presented in this submission show that they are equivalent to the currently available Siemens coils.
2
• Substantial Equivalence:
Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
Re:
CP Peripheral Angio Array Coil/ MAGNETOM Symphony System Dated: December 21, 1999 Received: December 22, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Yieh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sinceraty you
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) に 99 イヨノ5
Device Name: CP Peripheral Angio Array Coil for the MAGNETOM SYMPHONY
Indications for Use:
The Siemens Magnetom CP Peripheral Angio Array Coil is primarily indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images of vascular structures and soft tissue of the abdomen, pelvis and lower limbs. The design of this coil facilitates imaging larger peripheral vascular areas.
(please do not write below this line- continue on another page if needed)
OR
Concurrence of CDRH, Office of Device Evaluation
Prescription Use >
Over-The-Counter Use
Verrill G. Hynson
(Division Sign-Off) Division of Reproductive, Abdominat, ENT, and Radiological Devices 510(k) Number