(130 days)
The Integrated Stimulus Delivery System (ISDS), both Optimum and Premium models, is indicated for use by trained medical professionals to aid in the performance of functional Magnetic Resonance Imaging (fMRI) examinations based on Blood Oxygen Level Dependent (BOLD) contrast. The ISDS works with GE 1.5T and 3.0T Magnetic Resonance (MR) scanners with BrainWave™ software installed. The ISDS presents to the patient specific visual and audio stimuli with predetermined order and timing patterns and collects keypad responses; all ISDS functions are synchronized with the ongoing patient MR imaging examination.
For a patient undergoing a functional MR imaging examination the ISDS hardware components present visual and auditory stimuli to a patient and collect responses from that patient while the patient is in the bore of the MR scanner. Hardware components interface the ISDS computer system to the MR scanner in order to synchronize operation of the ISDS with the MR imaging procedure. The stimuli delivery (type of stimuli, stimuli presentation order, timing of stimuli presentation, etc.) is controlled by a proprietary software application.
The provided text describes a medical device, the Integrated Stimulus Delivery System (ISDS), and its intended use, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary for a submission to the FDA, detailing the device's description, intended use, and substantial equivalence to predicate devices. It states: "Summary of Testing: The ISDS has been tested and found to be safe and effective at meeting its requirements and intended use." However, it does not provide details about what those requirements were, nor does it present any specific performance metrics, study design, or results.
Therefore, I cannot populate the requested table or answer the specific questions regarding acceptance criteria and study details. The information necessary to do so is absent from the provided text.
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MAR - 5 2010
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Submitter: | Medical Numerics, Inc20410 Observation Drive, Suite 210Germantown, MD 20876 |
|---|---|
| Contact Person: | Douglas M. Tucker, PhD, MBABusiness Development |
| Telephone: | (240) 686-3460 extension 405 |
| FAX: | (240) 686-3464 |
| Preparation Date: | December 10, 2009 |
| Device Trade Name(s): | Integrated Stimulus Delivery System (ISDS) OptimumIntegrated Stimulus Delivery System (ISDS) Premium |
| Common Name: | functional MR Imaging (fMRI) Stimulus Delivery HardwareSystem |
| Device Classification: | Magnetic resonance diagnostic device (21 CFR 892.1000)Class IIProduct Code LNH |
| Equivalent Device Identification: | K080515 FMRI HARDWARE SYSTEMK052571 MINDSTATE FUNCTIONAL DATAACQUISITION DEVICE |
| Device Description: | For a patient undergoing a functional MR imaging examination |
the ISDS hardware components present visual and auditory stimuli to a patient and collect responses from that patient while the patient is in the bore of the MR scanner. Hardware components interface the ISDS computer system to the MR scanner in order to synchronize operation of the ISDS with the MR imaging procedure. The stimuli delivery (type of stimuli, stimuli presentation order, timing of stimuli presentation, etc.) is controlled by a proprietary software application.
Computer Sub-System
This Computer Sub-System provides general purpose computing capabilities for the ISDS. The computer system provides an environment for execution of the application of tware and provides physical infrastructure for interfacing with other components of the architecture (MR Interface, Stimulus Delivery Hardware) and external systems (MR host system and users).
ISDS
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PATIENT INTERFACE SUB-SYSTEM
The MR Scanner and Patient Response Interface Sub-System communicate patient responses and MR image acquisition events to the host computer. The MR Scanner interface enables the ISDS computer sub-system to synchronize operation with the MR scanner. The Patient Response Interface Sub-System collects responses from that patient while the patient is in the bore of the MR scanner.
STIMULUS DELIVERY SUB-SYSTEM
The Stimulus Delivery Sub-System communicates audio and video stimuli to the patient during the MR examination while the patient is in the bore of the MR Scanner.
APPLICATION SOFTWARE SUB-SYSTEM
The Application Software Sub-System provides the ISDS application functionality. Primary functionality includes the ability to develop new and modify existing fMRI paradigms, and to execute specific paradigms during an fMRI examination.
Image /page/1/Figure/7 description: The image shows a diagram of a system with several sub-systems. The sub-systems include a stimulus delivery sub-system, an application software sub-system, a computer sub-system, and a scanner/patient interface sub-system. The diagram also shows the connections between the sub-systems, as well as the network connection to/from the MR and the trigger from the MR.
Intended Use:
The Integrated Stimulus Delivery System (ISDS), both Optimum and Premium models, is indicated for use by trained medical professionals to aid in the performance of functional Magnetic Resonance Imaging (fMRI) examinations based on Blood Oxygen Level Dependent (BOLD) contrast. The ISDS works with GE 1.5T and 3.0T Magnetic Resonance (MR) scanners with BrainWave™ software installed. The ISDS presents to the patient specific visual and audio stimuli with predetermined order and timing patterns and collects keypad responses; all ISDS functions are synchronized with the ongoing patient MR imaging examination.
Section 5 Page 2
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Statement of Substantial Equivalence: The Integrated Stimulus Delivery System (ISDS) is substantially equivalent to the named predicate devices. All of the devices have similar intended uses and use the same or similar technology.
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Summary of Testing: The ISDS has been tested and found to be safe and effective at meeting its requirements and intended use.
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ISDS
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
MAR - 5 2010
Medical Numerics, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K093336
Trade/Device Name: Integrated Stimulus Delivery System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 19, 2010 Received: February 22, 2010
Dear Mr. Job:
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, Dr io 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 2017 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish firstber 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. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Arndt J. Hart
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Integrated Stimulus Delivery System
Indications For Use:
The Integrated Stimulus Delivery System (ISDS), both Optimum and Premium models, is indicated for use by trained medical professionals to aid in the performance of functional Magnetic Resonance Imaging (fMRI) examinations based on Blood Oxygen Level Dependent (BOLD) contrast. The ISDS works with GE 1.5T and 3.0T Magnetic Resonance (MR) scanners with BrainWave™ software installed. The ISDS presents to the patient specific visual and audio stimuli with predetermined order and timing patterns and collects keypad responses; all ISDS functions are synchronized with the ongoing patient MR imaging examination.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR · · Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510K | K093336 |
|---|---|
| ------ | --------- |
Page 1 of 1Medical Numerics, Inc. ISDS
Section 4 Page 1
§ 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.