(81 days)
No
The document describes a standard MRI device and its image reconstruction capabilities, with no mention of AI or ML technologies.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and/or spectra that "may assist in diagnosis," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as magnetic resonance diagnostic devices (MRDD's)" and that the images/spectra "may assist in diagnosis."
No
The device description explicitly states it is a "magnetic resonance diagnostic device (MRDD)" and mentions hardware components like the "XP1000 Compaq (Alpha processor)" for image reconstruction, indicating it is a hardware system with integrated software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is characteristic of an imaging device used for in-vivo diagnosis.
- Device Description: The description reinforces that it's an MRDD and a successor to a previous MRDD.
- Input Imaging Modality: The input is Magnetic Resonance, which is an imaging technique applied to the patient's body, not a sample taken from the patient.
- Anatomical Site: The device is used on the "head, body or extremities," indicating direct application to the patient.
IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates on the patient directly using magnetic resonance imaging.
N/A
Intended Use / Indications for Use
The Philips Gyroscan INTERA (Release 7) series have the same intended use as its predecessor and predicate device Gyroscan NT Release 6. The Gyroscan INTERA systems 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
LNH / LNI.
Device Description
The new Philips MRDD being the successor of Gyroscan NT (Rel.6), is the Release 7 series called the Gyroscan INTERA series. The Gyroscan INTERA is based on the same platform as its predicate device Gyroscan NT (re.K980645) with the same technological characteristics and intended use .
Gyroscan INTERA series are available in Gyroscan INTERA (0.5T), Gyroscan INTERA 1.6T (1.5T) and the CV version Gyroscan INTERA (1.5T)
The main enhanced and new feature of the Gyroscan INTERA series are:
- The new look in its appearance to emphasis its compactness. .
- Hardware features to improve user friendliness such as the operator's console and the use of . LCD monitor displays.
- Patients comfort by forced air flow through the magnet bore and comfort zone with Patient . Observation provision. The patient can view the environment outside the bore and the built-in camera is used to observe the patient in the magnet bore.
- Save laser light cross beam is applied for reference for the patient positioning. .
- A ceiling suspended Examination Room Operator's console with tracker-ball control and 20 . inch LCD display.
- Enhanced and new functionality's : .
-
- RF receive only Synergy Pediatric Coil
-
- The use of the XP1000 Compaq (Alpha processor) allowing image reconstruction up to 40 images/second.
-
- Real-time Interactive Imaging.
-
- On-line calculation of the ADC maps (Diffusion package)
-
- On-line calculation of TTP, Negative Integral, Index, and MTT maps (Perfusion package).
-
- Three-points Plan scan ( enhancement Free Style Plan Scan).
-
- Vector ECG signals for MR scan synchronization (triggering) and gating.
-
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
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)
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters. The characters appear to be 'K99 25 33'. The handwriting is somewhat stylized, with the numbers being slightly more rounded.
Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" written above a circular emblem. The emblem features four stars arranged around two wavy lines. The logo is presented in black and white, with the word "PHILIPS" in bold, uppercase letters.
OCT 1 8 1999
Page 1 of 2
510(k) Summary
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 | : | Philips Gyroscan INTERA (*) |
| Classification Name | : | Magnetic Resonance Diagnostic Device (MRDD). |
| Classification | : | Class II. |
| Product code | : | LNH / LNI. |
| 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 | : | Philips Gyroscan INTERA (Release 7 series). |
Predicate Device(s).
The Philips cleared MRDD Philips GYROSCAN NT Release 6 series systems with FDA ref.K980645.
Intended use.
The Philips Gyroscan INTERA (Release 7) series have the same intended use as its predecessor and predicate device Gyroscan NT Release 6. The Gyroscan INTERA systems 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 new Philips MRDD being the successor of Gyroscan NT (Rel.6), is the Release 7 series called the Gyroscan INTERA series. The Gyroscan INTERA is based on the same platform as its predicate device Gyroscan NT (re.K980645) with the same technological characteristics and intended use .
(*)Gyroscan INTERA series are available in Gyroscan INTERA (0.5T), Gyroscan INTERA 1.6T (1.5T) and the CV version Gyroscan INTERA (1.5T)
1
The main enhanced and new feature of the Gyroscan INTERA series are:
- The new look in its appearance to emphasis its compactness. .
- Hardware features to improve user friendliness such as the operator's console and the use of . LCD monitor displays.
- Patients comfort by forced air flow through the magnet bore and comfort zone with Patient . Observation provision. The patient can view the environment outside the bore and the built-in camera is used to observe the patient in the magnet bore.
- Save laser light cross beam is applied for reference for the patient positioning. .
- A ceiling suspended Examination Room Operator's console with tracker-ball control and 20 . inch LCD display.
- Enhanced and new functionality's : .
-
- RF receive only Synergy Pediatric Coil
-
- The use of the XP1000 Compaq (Alpha processor) allowing image reconstruction up to 40 images/second.
-
- Real-time Interactive Imaging.
-
- On-line calculation of the ADC maps (Diffusion package)
-
- On-line calculation of TTP, Negative Integral, Index, and MTT maps (Perfusion package).
-
- Three-points Plan scan ( enhancement Free Style Plan Scan).
-
- Vector ECG signals for MR scan synchronization (triggering) and gating.
-
Safety parameters.
The safety parameters of the Gyroscan INTERA Release 7 remains the same as with its predecessor and predicate device Gyroscan NT Release 6 series ( re. K980645).
General Safety and effectiveness.
The safety and effectiveness of the Gyroscan INTERA a re the same as with its predicate device the GYROSCAN NT Release 6 systems (ref.K980645)
It does not induce other safety issues and warnings than already valid for its predecessor and predicate device.
Substantial Equivalence.
The Gyroscan INTERA (Release 7 series) is substantially equivalent to the predicate device Philips GYROSCAN NT Release 6 series systems with FDA ref.K980645.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 1999
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917
Re:
Gyroscan Intera (Release 7 Series) Dated: July 28, 1999 Received: July 29, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic 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 vour 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 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".
Sincerely yours,
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
| 510(k) Number (if known): | Unknown K992533 |
|---|---|
| Device Name : | Philips Gyroscan INTERA. |
Indication For Use :
The Philips Gyroscan INTERA (Release 7) series are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique crosssectional 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)
Prescription Use
(Per 21 CFR 801.109) ✓
OR Over-The-Counter Use
(Optional Format 1-2-96)
David h. Segears
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological I 510(k) Number