(53 days)
Not Found
No
The summary describes a passive RF coil for an existing MRI system and does not mention any software or processing capabilities that would involve AI/ML.
No
The device is described as an "NMR device that produces images" that "yield information that can be useful in the determination of a diagnosis," indicating it is for diagnostic imaging, not for treating a disease or condition.
Yes
The device is a component of an NMR system that produces images. These images, when interpreted by a trained physician, yield information useful in determining a diagnosis.
No
The device description explicitly states that the HFO Shoulder Coil consists of a plastic enclosure containing coil elements, electronics circuitry, preamplifiers, a cable, and a cable connector. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The HFO Shoulder Coil is a component of an MRI system. It's a coil that receives radiofrequency signals from the patient's body during an MRI scan.
- Intended Use: The intended use is to produce images of the shoulder and adjacent regions using NMR principles. These images are then interpreted by a trained physician to aid in diagnosis. This is an in vivo (within the living body) process, not in vitro (outside the living body).
- No Specimen Analysis: The device does not analyze any specimens taken from the patient. It interacts directly with the patient's body.
Therefore, the HFO Shoulder Coil, as described, is a medical device used for imaging, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The HFO Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Region: Shoulder and adjacent regions
Nuclei Excited: Hydrogen
The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below.
The High Field Open (1.0T) Panorama system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2), and (3) display the soft tissue structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The HFO Shoulder Coil consists of a cup-shaped, plastic enclosure containing three coil elements for receiving of RF signals from the shoulder and adjacent region. The enclosure is placed on patient's shoulder for imaging. The enclosure contains tuning and decoupling electronics circuitry and preamplifiers. The coil enclosure has a cable attached to it and the cable connector is plugged into the system connector on the patient table. The cable provides the coil with supply and control voltages and transfers the received RF signals to the system. The cable connector contains coil interface circuitry for the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
NMR
Anatomical Site
Shoulder and adjacent regions, head, extremities and whole body.
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.
Invivo Corporation Shoulder Array Coil Set QSC-127-INT (K040288)
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
Koso120
Philips Medical Systems Premarket Notification [510(k)] Submission
510(K) SUMMARY
This summary is being submitted in accordance with 21 CFR 807.92.
MAR 1 0 2008
1. GENERERAL INFORMATION
1.1. Submitter Information
| Manufacturer's Name: | Philips Medical Systems
MR Technologies Finland Oy |
|----------------------|---------------------------------------------------------|
| Address: | Ayrities 4
PO Box 185
FIN-01510
Vantaa FINLAND |
Establishment Registration #
9680194
1.2. Contact Person Name and Information
| Contact: | Catherine M. Connell | |
|---|---|---|
| Title: | Quality & Regulatory Engineer | |
| Company: | Philips Medical Systems (Cleveland), Inc. | |
| Address: | 595 Miner Road | |
| Cleveland, OH 44143 OH | ||
| Telephone #: | (440) 482-5581 | |
| Telephone # | (440) 483-5581 | |
| Facsimile #: | (440) 483-2648 | |
| E-mail:catherine.connell@philips.com |
1.3. Trade name and common name of device
Trade name: HFO Shoulder Coil Magnetic resonance specialty Coil Common name:
1.4. Classification of the device
| Classification: | Coil, Magnetic Resonance, Specialty |
|---|---|
| Regulation: | 21 CFR 892.1000 |
| Class: | Class II |
| Procode: | MOS |
1.5. Predicate Device`
Invivo Corporation Shoulder Array Coil Set QSC-127-INT (K040288)
1
2. BASIS FOR SUBSTANTIAL EQUIVALENCE DETERMINATION 2.1. Device Description
The HFO Shoulder Coil consists of a cup-shaped, plastic enclosure containing three coil elements for receiving of RF signals from the shoulder and adjacent region. The enclosure is placed on patient's shoulder for imaging. The enclosure contains tuning and decoupling electronics circuitry and preamplifiers. The coil enclosure has a cable attached to it and the cable connector is plugged into the system connector on the patient table. The cable provides the coil with supply and control voltages and transfers the received RF signals to the system. The cable connector contains coil interface circuitry for the system.
2.2. Intended use
The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below. The High Field Open (1.0T) Panorama system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spinlattice relaxation time (T1), and spin-spin relaxation time (T2), and (3) display the soft tissue structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The HFO Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
| Anatomic Region: | Shoulder and adjacent regions |
|---|---|
| Nuclei Excited: | Hydrogen |
2.3. Safety Information
The use of the HFO Shoulder Coil does not result in any changes to the safety specifications for the safety parameters (i.e., static field, time-varying magnetic fields, SAR, or acoustic noise) of the Philips HFO (1.0T) Panorama system. The use of this device does not result in additional potential hazards when compared to currently marketed, receive-only coils.
2.4. Conclusion
The HFO Shoulder Coil is substantially equivalent to the Invivo Corporation Shoulder Array Coil Set QSC-127-INT.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a person embracing three lines, representing health and human services.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Philips Medical Systems MR Finland % Ms. Catherine Connell Quality & Regulatory Engineer Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143
MAR 1 0
Re: K080120
Trade/Device Name: HFO Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 4, 2008 Received: January 17, 2008
Dear Ms. Connell:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a stylized font. Below the letters, the word "Centennial" is written in cursive. There are three stars at the bottom of the logo.
3
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
HFO Shoulder Coil
1080120
Indications for Use:
The HFO Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Region: Shoulder and adjacent regions Nuclei Excited: Hydrogen
The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below.
The High Field Open (1.0T) Panorama system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2), and (3) display the soft tissue structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ammar M. Khan
510(k) Numbe