(78 days)
K.980645, K973799
No
The description focuses on a software option that applies regional saturation of magnetization and analyzes the deformation of this pattern. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as a diagnostic tool used to evaluate regional heart wall motion and blood flow, and its intended use is to assist in diagnosis, not to provide therapy.
Yes
The text explicitly states: "The indication for use of the GYROSCAN NT and GYROSCAN CV systems remains the same, i.e. for use as diagnostic devices". The RestGrid option is a software option for these systems, inheriting their diagnostic purpose.
Yes
The device is explicitly described as a "software option" to existing hardware systems (Philips GYROSCAN NT and GYROSCAN CV). It applies a technique (regional saturation of magnetization) and uses the resulting pattern deformation to evaluate cardiac motion or blood flow, which is a software-based analysis of data acquired by the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the RestGrid Option on the Gyroscan NT and Gyroscan CV is used to evaluate regional heart wall motion and blood flow in a non-invasive study. It uses Magnetic Resonance imaging to produce images and/or spectra of the internal structure and/or function of the body.
- No Sample Analysis: There is no mention of analyzing samples taken from the body. The device works by applying regional saturation of magnetization and observing the deformation of this pattern.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The RestGrid Option on the Gyroscan NT and Gyroscan CV is used to evaluate regional heart wall motion and blood flow in a non-invasive study.
The RestGrid is a software option to the Philips GYROSCAN NT and GYROSCAN CV systems.
This option is used to evaluate regional heart wall motion in both the left and right side of the heart and blood flow in a non-invasive study.
The indication for use of the GYROSCAN NT and GYROSCAN CV systems remains the same, i.e. 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
90 LNH
Device Description
RestGrid is a software option available for the Gyroscar-NT platforms: ACS-NT, T10-NT, T5-NT and the Gyroscan-CV.
RestGrid applies regional saturation of magnetization to the tissue. The saturation is spatially modulated resulting in a series of equally spaced saturation lines or bands. Deformation of the saturation pattern is used to evaluate regional cardiac motion or blood flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Heart (left and right side of the heart), 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)
K.980645, K973799
Reference Device(s)
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
K98 2834
OCT 2 9 1998
Page 1 of 2
510(k) Summary of Safety and Effectiveness.
This summary of 510(k) safety and effectiveness 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 |
| Telephone Number | : | 203-926-7031 |
| Prepared | : | July 1998. |
| Device Name | : | RestGrid package / GYROSCAN NT. |
| Classification Name | : | Magnetic Resonance Diagnostic Device. |
| Classification | : | Class II. |
| Performance standards | : | NEMA voluntary standards, FDA MRI guidances, UL |
| and IEC 601 relevant safety standards and/or draft | ||
| standards are used. | ||
| Common/Usual Name | : | RestGrid/ Tagging studies / SPAMM / CSPAMM |
| Predicate Device(s) | : | - RestSlab technique Gyroscan NT (ref.K.980645) |
- Cardiac Tagging Techniques / Magnetom Vision
(ref.K973799). |
Device Description :
RestGrid is a software option available for the Gyroscar-NT platforms: ACS-NT, T10-NT, T5-NT and the Gyroscan-CV.
RestGrid applies regional saturation of magnetization to the tissue. The saturation is spatially modulated resulting in a series of equally spaced saturation lines or bands. Deformation of the saturation pattern is used to evaluate regional cardiac motion or blood flow.
Intended Use :
The RestGrid Option on the Gyroscan NT and Gyroscan CV is used to evaluate regional heart wall motion and blood flow in a non-invasive study..
Technological Characteristics:
The technological characteristics remain identical to other Gyroscan NT systems. Spatially modulated saturation of the magnetization of the tissue is introduced for imposing the patterns of saturation lines.
General Safety and Effectiveness Concerns
The safety parameters of the MR systems remain the same as with the FDA cleared Gyroscan NT systems (re.K963990) and within the limits of the FDA documents: "Attachment 1 of Guidance for content and review of a magnetic resonance device 510(k) application" and draft "MRI Guidance Update for dB/dt dd. 10-11-'95".
1
Substantial Equivalence
Philips believes the RestGrid Software Package to be substantially equivalent to saturation techniques applied in commercially available RestSlabs (FDA re.K980645) and to Siemens Cardiac Tagging (FDA re.K973799).
2
Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
OCT 2 9 1998
Peter Altman Director of Regulatory Affairs Philips Medical Systems 710 Bridgeport Avenue Shelton, CT 06484
Re:
RestGrid Package for Philips Gyroscan NT and Gyroscan CV Dated: August 11, 1998 Received: August 12, 1998 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 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. 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 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 ritro 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, piease 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/odri/dsmaldsmamain.html".
Sincerely yours,
William Yip
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/14 description: The image shows a partial view of the Department of Health & Human Services logo. The logo features a stylized depiction of an eagle or bird-like figure, rendered in black. The words "DEPARTMENT OF HEALTH & H" are partially visible, arranged vertically along the left side of the logo.
3
| 510(k) Number (if known): | Unknown |
|---|---|
| Device Name : | RestGrid package option for GYROSCAN NT and GYROSCAN CV. |
Indication For Use :
The RestGrid is a software option to the Philips GYROSCAN NT and GYROSCAN CV systems.
This option is used to evaluate regional heart wall motion in both the left and right side of the heart and blood flow in a non-invasive study.
The indication for use of the GYROSCAN NT and GYROSCAN CV systems remains the same, i.e. 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.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chrid C. Feguson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological I
510(k) Number K982834
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________