(70 days)
Not Found
No
The document describes a passive RF coil for MRI and does not mention any software or processing capabilities that would involve AI/ML.
No
The device is described as a diagnostic tool used to produce images that assist in diagnosis, rather than to treat a condition.
No.
The document states that the MRDD Philips GYROSCAN NT systems are diagnostic devices, and the Synergy Shoulder coil is compatible with them. However, the Synergy Shoulder coil itself is an external RF receive-only coil designed for optimal imaging, which is a component used with a diagnostic device, not a diagnostic device in itself.
No
The device description explicitly details physical hardware components including coil elements, pre-amplifiers, electronic circuitry, and cables.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is an external RF coil used with an MRI system to image the internal structure of the shoulder, head, body, or extremities. It does not process or analyze biological samples taken from the patient.
- The device is an accessory to an imaging system. It is a component of a Magnetic Resonance (MR) system, which is an imaging modality used for diagnostic purposes, but the coil itself is not performing an in vitro test.
Therefore, this device falls under the category of a medical device used for diagnostic imaging, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Due to its shape and size the RF external Synergy Shoulder coil allows a variety of applications but with the main purpose of optimal imaging of the shoulder structure. It is compatible to be used with the Philips GYROSCAN NT systems which are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon H and 3 P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Synergy Shoulder coil is a synergy RF receive only coil which is compatible for use with the MRDD Philips GYROSCAN NT systems. It is designed for a variety of applications but with the main purpose for optimal imaging of the shoulder. The coil consists of a pair of elliptical flexible coil elements (dimensions 14x17cm per element). Two version of the coil will be available, i.e. for the 1.5 Tesla ( 63MHz) and 1.0 Tesla (42MHz) MRDD systems. Close to the coil elements the synergy pre-amplifiers and electronic circuitry are mounted in a box which is sealed together with the coil elements. A "bazooka" cable is applied for RF filtering. The "bazooka"cables are fed into a combined (driver) box and connected to MR system (scanner). The Synergy Shoulder coil is an external RF coil made of routinely-used materials. The technological characteristics are based on the same concept as with the other synergy coils which have been cleared as part of the MRDD Philips GYROSCAN NT Release 6 series systems (ref.K980645).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRDD
Anatomical Site
shoulder structure, head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained 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
AUG = 2 K935
Image /page/0/Picture/1 description: The image shows a cropped portion of the word "PHILIPS" in a bold, sans-serif font. The letters are black against a white background. The image is cropped, so only the first few letters of the word are visible.
Philips Medical Systems
P.O. Box 10000, 5680 DA Best, The Netherlands
XJB-148-3727/bf 1999-04-08
Page 1 of 2
510(k) Summary of Safety and Effectiveness.
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Company Name | : | Philips Medical Systems North America Company. |
|---|---|---|
| Address | : | 710 Bridgeport Avenue |
| Shelton, CT 06484. | ||
| Registration No. | : | 1217116 |
| Contact person | : | Peter Altman |
| Device (Trade) Name | : | Synergy Shoulder coil |
| Classification Name | : | Magnetic Resonance Specialty Coil. |
| Classification | : | Class II. |
| Product code | : | MOS |
| Performance standards | : | NEMA voluntary standards, FDA MRDD guidance's, UL and IEC |
| 601 appropriate safety standards and/or draft standards are used. | ||
| Common/Usual Name | : | RF external Synergy Shoulder coil |
Predicate Device(s).
The Philips RF external E1 flexible coil and other current synergy coils as part of the commercially cleared MRDD Philips GYROSCAN NT Release 6 series systems with FDA ref.K980645.
Intended use.
Due to its shape and size the RF external Synergy Shoulder coil allows a variety of applications but with the main purpose of optimal imaging of the shoulder structure. It is compatible to be used with the Philips GYROSCAN NT systems which are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon H and 3 P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis..
Device Description and Technological Characteristics
The Synergy Shoulder coil is a synergy RF receive only coil which is compatible for use with the MRDD Philips GYROSCAN NT systems. It is designed for a variety of applications but with the main purpose for optimal imaging of the shoulder. The coil consists of a pair of elliptical flexible coil elements (dimensions 14x17cm per element). Two version of the coil will be available, i.e. for the 1.5 Tesla ( 63MHz) and 1.0 Tesla (42MHz) MRDD systems.
1
Image /page/1/Picture/0 description: The image shows the Philips logo. On the left is the Philips shield logo, which is a shield shape with four stars and a wavy line inside. To the right of the shield is the word "PHILIPS" in large, bold, sans-serif font. The logo is black and white.
Philips Medical Systems
P.O. Box 10000, 5680 DA Best, The Netherlands
XJB-148-3727/bf 1999-04-08 Page 2 of 2
Close to the coil elements the synergy pre-amplifiers and electronic circuitry are mounted in a box which is sealed together with the coil elements. A "bazooka" cable is applied for RF filtering. The "bazooka"cables are fed into a combined (driver) box and connected to MR system (scanner). The Synergy Shoulder coil is an external RF coil made of routinely-used materials. The technological characteristics are based on the same concept as with the other synergy coils which have been cleared as part of the MRDD Philips GYROSCAN NT Release 6 series systems (ref.K980645).
General Safety and effectiveness.
The safety and effectiveness of the Synergy Shoulder coil are the same as with the other current synergy coils which are cleared as part of the GYROSCAN NT Release 6 systems (ref.K980645) It does not induce other safety issues and warnings than already valid for the current cleared RF external coils.
Substantial Equivalence.
The Synergy Shoulder coil is substantially equivalent to the predicate device RF external E1 flexible coil as part of the commercially cleared Philips GYROSCAN NT Release 6 series systems with FDA ref.K980645.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 1999
Peter Altman Director of Regulatory Affairs Philips Medical Systems 710 Bridgeport Avenue Shelton, Connecticut 06484-0917 Re:
K991765 Synergy Shoulder Coil for Gyroscan Dated: May 20, 1999 Received: May 24, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Altman:
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 II (Special Controls) or dass 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/dsmaldsmamain.html".
Sincerely yours,
CAPT Daniel C. Schultz, M.D.
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
3
Image /page/3/Picture/0 description: The image shows the Philips logo. The logo consists of a shield-like shape on the left and the word "PHILIPS" in bold, sans-serif font on the right. The shield contains a stylized depiction of waves and stars, representing the company's history in radio and electronics.
Philips Medical Systems
P.O. Box 10000, 5680 DA Best, The Netherlands
XJB-148-3727/bf 1999-04-08
Page 1 of 1.
K 991765 510(k) Number (if known): Unknown Philips Synergy Shoulder Coil. Device Name :
Indication For Use :
Due to its shape and size the RF external Synergy Shoulder coil allows a variety of applications but with the main purpose of optimal imaging of the shoulder structure. It is compatible to be used with the Philips GYROSCAN NT systems which are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thinh A. Sigmon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Device
510(k) Number K491765
OR Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)