(38 days)
No Reference Device(s) K/DEN numbers were found in the text.
No
The summary describes an MRI coil, which is a hardware component for image acquisition, and does not mention any software or processing capabilities that would involve AI/ML.
No
Explanation: This device is an MRI coil used for imaging, not for treating any medical condition.
No
This device is an MRI coil, which is a component used to acquire images for diagnostic purposes, but it does not itself perform the diagnosis.
No
The device description explicitly states it is a "Phased Array Shoulder Coil" and includes a "Synergy MultiConnect," which are hardware components used in MRI systems.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The provided description clearly states the device is a "Phased Array Shoulder Coil" for "Magnetic resonance imaging (MRI) of the shoulder." This is a component of an imaging system that works on the patient's body to create images. It does not perform tests on samples taken from the body.
Therefore, based on the provided information, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Magnetic resonance imaging (MRI) of the shoulder.
Product codes
90MOS
Device Description
Model 415PH-64/42: Phased Array Shoulder Coil With Model 855PH: Synergy MultiConnect. Compatible with a Philips 1.5T/1.0T MRI System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Shoulder and other related joint structures.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
- JUN 1 3 2002
510(k) Summary of Safety and Effectiveness
្នំ
ប្រទេស
K02/433
,
| Device Name | Model 415PH-64/42: Phased Array Shoulder Coil
With Model 855PH: Synergy MultiConnect | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Applicability | Compatible with a Philips 1.5T/1.0T MRI System | |
| Reason for 510(k) | Control mechanism change to an existing product | |
| Classification Name | Magnetic Resonance Diagnostic Device | |
| Device Classification Panel | Radiology | |
| Device Classification Number | 892.1000 | |
| Product Code | 90MOS | |
| Common Name | Magnetic Resonance Imaging Coil | |
| Proprietary Name | Model 415PH-64/42: Phased Array Shoulder Coil | |
| Establishment Registration Number | 2183683 | |
| Address of MFG Facility | IGC-Medical Advances Inc.
10437 Innovation Drive
Milwaukee, WI 53226 | |
| Point of Contact | Jerry Frohlich
Manager, Regulatory Affairs
414.258.3808 Ext. 206 | |
| Classification | Class II | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2
weighted imaging. 2D, 3D time of flight, phase
contrast imaging. | |
| Anatomic Regions | Shoulder and other related joint structures. | |
| Performance Standards | None Established under Section 514 | |
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment, Part
1: General Requirements for Safety |
| | UL 94 | Tests for Flammability of Plastic
Materials |
| | IEC 601-1 | General Safety Requirements for
Medical Electrical Equipment |
1
Overview
The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health (CDRH) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notifications that offered clarification of these concerns. Due to considerable technological advances in MRDDs, CDRH issued an updated guidance document on November 14, 1998. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The GE 1.5T Signa MRI system operated with the Medical Advances UltraImage "Temporal Lobe Array Coil is substantially equivalent to the same system operated with the legally marketed predicate devices listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels:
Safety Parameters
| Maximum Static Magnetic Field: | No change |
|---|---|
| Rate of Magnetic Field Strength Change: | No change |
| RF Power Deposition: | No change |
| Acoustic Noise Levels: | No change |
| Biocompatibility: | No change |
Imaging Performance Purameters
| Specification Volume: | No change |
|---|---|
| Signal-to-Noise Ratio: | No change |
| Image Uniformity: | No change |
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| Geometric Distortion: | No change |
|---|---|
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
General Safety and Effectiveness Concerns
The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures sufe and effective use of the device.
Substantial Equivalence Summary
The Philips 1.5T Intera MRI system operated with the Medical Advances Phased Array Shoulder Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate devices. The use of these coils does not affect the Philips Intera system safety parameter specifications.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. R. Jerry Frohlich Manager, Ouality Assurance and Regulatory Affairs IGC-Medical Advances, Inc. 10437 Innovation Dr. MILWAUKEE WI 53226
Re: K021433
JUN 1 3 2002
Trade/Device Name: Model 415PH Series: Phased Array Coil with Synergy MultiConnect Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: May 3, 2002 Received: May 6, 2002
Dear Mr. Frohlich:
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 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); 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.
4
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
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
5
Page _ 1 of __________________________________________________________________________________________________________________________________________________________________
.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Model 415PH Series: Medical Advances Phased Array Shoulder Coil with Synergy MultiConnect
Indications for Use:
Magnetic resonance imaging (MRI) of the shoulder.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96
David G. Tegenon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 4021433 510(k) Number _