(90 days)
Not Found
Not Found
No
The summary describes a standard MRI system with hardware and software enhancements, but no mention of AI/ML for image analysis or interpretation.
No
The device is used for diagnostic imaging to assist in diagnosis, not for therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "magnetic resonance diagnostic device" and that its images "may assist in diagnosis."
No
The device description explicitly details hardware components like magnetic field strengths, gradient types, data acquisition systems, and computer technology enhancements, indicating it is a hardware-based medical device with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as producing cross-sectional images of the whole body based on 'H metabolites. These images are interpreted by a trained physician to assist in diagnosis. This is characteristic of an in vivo imaging device, not an in vitro diagnostic device.
- Device Description: The description details a magnetic resonance diagnostic device with various configurations and functionalities related to image acquisition and processing. This aligns with the description of an MRI machine, which is an in vivo imaging modality.
- Lack of IVD Characteristics: An IVD device typically involves testing samples (like blood, urine, tissue) outside the body to provide diagnostic information. The provided information does not mention any sample handling or analysis outside the body.
Therefore, the INTERA-SENSATION Family Release 1-series magnetic resonance diagnostic device is an in vivo diagnostic device, specifically a Magnetic Resonance Imaging (MRI) system.
N/A
Intended Use / Indications for Use
The INTERA-SENSATION Family Release 1-series magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes
LNH
Device Description
The INTERA-SENSATION Release 1 family is the successor of the current (Gyroscan) INTERA family Release 10-series. It consists of various configurations with magnetic field strengths (1.0T, 1.5T & 3.0T) and different optional gradient types.
The INTERA-SENSATION Release 1 family is based on the same platform with the same functionalities as its predecessor.
The main differences with the its predecessors (/ predicate devices) are:
- new appearance (covers) .
- data acquisition system supports 1,4,6,8 and 16 channels and is prepared for 32 channels
- Advanced shimming and SUPER QUASAR gradient.
- Added new functionality: Examcards, MobiFlex, MobiView, O-flow, Real Time Bold Imaging, Re-scan, and CareTrak
- Enhancements related to the use of up to date computer technology such as larger electronic data storage (memory) capacity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD)
Anatomical Site
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.
The Philips Medical Systems INTERA-SENSATION Family Release 1-series is the successor of the already cleared (predicate device) Gyroscan INTERA family release 10-series with static magnetic field strengths of 1.0, 1.5 and 3.0 Tesla.
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
Ko3 i 815
SEP 1 0 2003
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.
General information
| Company Name | : | Philips Medical Systems Nederland BV |
|---|---|---|
| Address | : | Veenpluis 4-6 |
| Best, Netherlands, 5684 PC | ||
| Registration No. | : | 3003768277 |
| Contact person | : | Lynn Harmer. |
| Manager, regulatory Submissions | ||
| Tel: (425) 487-7312 | ||
| Fax: (425) 487-8666 | ||
| Lynn.Harmer@Philips.com | ||
| Device (Trade) Name | : | INTERA-SENSATION¹ family. |
| Classification Name | : | Magnetic Resonance Diagnostic Device (MRDD). |
| Classification | : | Class II. |
| Product code | : | LNH |
| Performance standards | : | NEMA voluntary standards, FDA MR Diagnostic |
| Device Guidance, UL and IEC 601 appropriate safety | ||
| standards and/or draft standards are used |
Predicate Device(s):
The Philips Medical Systems INTERA-SENSATION Family Release 1-series is the successor of the already cleared (predicate device) Gyroscan INTERA family release 10-series with static magnetic field strengths of 1.0, 1.5 and 3.0 Tesla.
Indications for use:
The INTERA-SENSATION Family Release 1-series magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis
l This is not the final system name and will change. At the moment of this writing the system name is not known yet.
1
Device description:
The INTERA-SENSATION Release 1 family is the successor of the current (Gyroscan) INTERA family Release 10-series. It consists of various configurations with magnetic field strengths (1.0T, 1.5T & 3.0T) and different optional gradient types.
The INTERA-SENSATION Release 1 family is based on the same platform with the same functionalities as its predecessor.
The main differences with the its predecessors (/ predicate devices) are:
- new appearance (covers) .
- . data acquisition system supports 1,4,6,8 and 16 channels and is prepared for 32 channels
- Advanced shimming and SUPER QUASAR gradient. .
- Added new functionality: Examcards, MobiFlex, MobiView, O-flow, Real . Time Bold Imaging, Re-scan, and CareTrak
- Enhancements related to the use of up to date computer technology such as ● larger electronic data storage (memory) capacity.
General Safety and Effectiveness.
The INTERA SENSATION Release 1-series family does not induce any other risks than already indicated for the predicate devices. .It has the same safety and effectiveness as its predecessor.
Substantial Equivalence.
It is the opinion of Philips Medical Systems that the Philips INTERA SENSATION Release 1-series family is substantially equivalent to its predecessor.
End
2
Image /page/2/Picture/1 description: The image shows a circular logo with an abstract depiction of an eagle in the center. The eagle is composed of three curved lines that suggest its head, body, and tail feathers. Encircling the eagle is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES' in a clockwise direction. The logo is rendered in black and white, giving it a simple and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2003
Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431
Re: K031815
Trade/Device Name: INTERA SENSATION' Release 1 Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 LNH Dated: June 5, 2003 Received: June 12, 2003
Dear Ms. Harmer:
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 adultcration.
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.
3
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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
4
510(k) Number (if known):
Device Name :
INTERA SENSATION Release 1 family.
Indication For Use :
The indication for use for the INTERA SENSATION Release 1-series remains the same as the previous released predicate device(s), i.e. the capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis
KO31815
( 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)
, i
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David M. Syverson
(Division Sign-Off) Division of Reproductive, and Radiological Device 510(k) Number
1 This is not the final system name and will change. At the moment of this writing the system name is not known yet.