(58 days)
IB Neuro™ software allows the post-processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time. IB Neuro™ v1.0 plug-in accepts data from existing MRI systems, performs quality control checks and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TTP) and sends the maps to a PACS for subsequent viewing. These images when interpreted by a trained physician may yield information useful in clinical applications. Our advanced technology is designed to be compliant with healthcare standards such as DICOM and is easily and rapidly integrated into existing medical image visualization applications.
IB Neuro "" OsiriX Plugin is software designed to analvze dynamically acquired datasets. Using well-established algorithms, parametric perfusion maps can be generated such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TTP). The strength of our software is its ability to extend the productivity of any existing viewer, CAD workstation or PACS via a platform-independent base library that allows for quick and seamless integration into existing server and workstation applications. It also includes other critical features such as:
- Enables rapid creation of a complete array of critical perfusion parameter o maps of rCBV, CBF, MTT, TTP
- o Automated correction of contrast agent leakage for rCBV maps
- o Automated brain mask generation
- Ability to normalize parameters to normal appearing white matter (NAWM) o
- o Automated report generation
- View dynamic signal time course on a per-voxel basis o
- Interactive Arterial Input Function (AIF) selection o
- o Automatic export of perfusion parameter maps to DICOM images within the same study
Acceptance Criteria and Device Performance Study for IB Neuro™ v1.0
The provided document describes the 510(k) submission for IB Neuro™ v1.0. This submission primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific, quantifiable acceptance criteria or a table of reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). The primary performance claim is that the device "performs quality control checks and generates parametric perfusion maps" and for "image analysis and processing and generation of parametric maps to provide additional information beyond standard imaging."
Since there are no explicit acceptance criteria or quantitative performance metrics reported in the provided text, the table below reflects the general claims and the basis for the 510(k) clearance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Ability to accept data from existing MRI systems. | "IB Neuro™ v1.0 plug-in accepts data from existing MRI systems" |
| Parametric Map Generation: Ability to generate rCBV, CBF, MTT, and TTP maps. | "generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TTP)" |
| Quality Control: Performs quality control checks. | "performs quality control checks" |
| Data Export: Sends maps to PACS for subsequent viewing. | "sends the maps to a PACS for subsequent viewing." and "Automatic export of perfusion parameter maps to DICOM images within the same study" |
| Additional Features: Automated correction of contrast agent leakage, automated brain mask, normalization to NAWM, automated report generation, view dynamic signal time course, interactive AIF selection. | Device description lists these features. |
| Substantial Equivalence: Features and intended use are similar to predicate devices, and differences do not raise new safety/effectiveness questions. | "The intended use and performance characteristics for IB Neuro™ are substantially equivalent to the predicate devices" and "documentation supplied in this submission demonstrates that any difference in technological characteristics do not raise any new questions of safety or effectiveness." |
| Software Validation: Compliance with FDA's software validation guidance. | "Performance testing included software validation, verification and testing per FDA's software validation guidance." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document states: "Discussion of Clinical Tests Performed: N/A". This indicates that no clinical tests, and therefore no specific test set with a defined sample size, data provenance, or ground truth, were performed for this 510(k) submission. The clearance was based on demonstrating substantial equivalence to predicate devices and non-clinical software validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no clinical tests were performed, there was no test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
As no clinical tests were performed, there was no test set requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted as indicated by "Discussion of Clinical Tests Performed: N/A". Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
No standalone performance study of the algorithm's diagnostic accuracy metrics was conducted for this submission, as indicated by "Discussion of Clinical Tests Performed: N/A". The focus was on the software's functional capabilities and substantial equivalence.
7. Type of Ground Truth Used
No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used for this submission, as clinical tests were not performed.
8. Sample Size for the Training Set
The document does not provide information about a training set or its sample size. This is typical for submissions based on substantial equivalence and software validation, where the focus is on the software's ability to process and generate standard outputs rather than its performance against a diagnostic gold standard learned from data. The algorithms are described as "well-established."
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, the method for establishing ground truth for a training set is not applicable here.
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EXHIBIT #1
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Submitter's Identification:
MAY 1 5 2008
Imaging Biometrics, LLC 1035 Katherine Drive Elm Grove, WI 53122
Contact Person Michael Schmainda Phone: (262) 385-1796 Email: mike@imagingbiometrics.com
Date Summary Prepared: 3/4/2008
2. Name of the Device:
| Trade Name: | IB Neuro™ v1.0 |
|---|---|
| Classification Name:Classification:Product Code: | MR Diagnostic Device Accessory: 21 CFR 892.1000Class IILNH |
| Classification Name: | Picture Archiving and Communication Systems21 CFR 892.2050 |
| Classification: | Class II |
| Product Code: | LLZ |
3. Common or Usual Name:
IB Neuro™ 1.0 / PACS device
4. Predicate Device Information:
IB Neuro™ is substantially equivalent to the following legally marketed devices that are currently cleared by the FDA:
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| 510(k) | Trade Name | Manufacturer |
|---|---|---|
| K073167 | BrainStat Software Option for GESigna MR Scanners | GE Medical Systems3200 N. Grandview Blvd. W-827Waukesha, WI 53188 |
| K061429 | Dynamic MRI Software Option forC-Scan, E-ScanXQ and E-ScanOpera | ESAOTE S.p.A.Via Siffredi, 5816153 Genova - Italy |
| K984224 | Perfusion Package for MagnetomVision and Symphony MR Systems | Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, NJ 08830 |
5. Device Description:
IB Neuro "" OsiriX Plugin is software designed to analvze dynamically acquired datasets. Using well-established algorithms, parametric perfusion maps can be generated such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TTP). The strength of our software is its ability to extend the productivity of any existing viewer, CAD workstation or PACS via a platform-independent base library that allows for quick and seamless integration into existing server and workstation applications. It also includes other critical features such as:
- Enables rapid creation of a complete array of critical perfusion parameter o maps of rCBV, CBF, MTT, TTP
- o Automated correction of contrast agent leakage for rCBV maps
- o Automated brain mask generation
- Ability to normalize parameters to normal appearing white matter (NAWM) o
- o Automated report generation
- View dynamic signal time course on a per-voxel basis o
- Interactive Arterial Input Function (AIF) selection o
- o Automatic export of perfusion parameter maps to DICOM images within the same study
6. Intended Use:
IB Neuro™ software allows the processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time. IB Neuro™ v1.0 plug-in accepts data from existing MRI systems, performs quality control checks
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and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TTP) and sends the maps to a PACS for subsequent viewing. These images when interpreted by a trained physician may vield information useful in clinical applications. Our advanced technology is designed to easily and rapidly integrate into existing medical image visualization applications.
7. Substantial Equivalence/ Comparison to Predicate Devices:
The intended use and performance characteristics for IB Neuro™ are substantially equivalent to the predicate devices listed in section 4 above for image analysis and processing and generation of parametric maps to provide additional information bevond standard imaging.
8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Performance testing included software validation, verification and testing per FDA's software validation guidance.
9. Discussion of Clinical Tests Performed:
N/A
10. Conclusions:
The IB Neuro™ 1.0 device has a similar intended use and similar characteristics as the predicate devices. Moreover, documentation supplied in this submission demonstrates that any difference in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the IB Neuro™ device is substantially equivalent to predicate devices.
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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 consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2008
Mr. Michael Schmainda CEO Imaging Biometrics, LLC 1035 Katherine Dr. ELM GROVE WI 53122
Re: K080762
Trade/Device Name: IB Neuro™ v1.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 17, 2008 Received: March 18, 2008
Dear Mr. Schmainda:
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 i adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.
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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 act threact or any Federal statutes and regulations administered by other Federal agencies. You nust 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.
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 I ogally 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 Crant of Crane 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" (21 CFR 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 2-so-zing (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
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Exhibit B
Indications for Use
510(k) Number (if known):
IB Neuro™ v1.0
Indications For Use:
Device Name:
IB Neuro™ software allows the post-processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time. IB Neuro™ v1.0 plug-in accepts data from existing MRI systems, performs quality control checks and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TTP) and sends the maps to a PACS for subsequent viewing. These images when interpreted by a trained physician may yield information useful in clinical applications. Our advanced technology is designed to be compliant with healthcare standards such as DICOM and is easily and rapidly integrated into existing medical image visualization applications.
Prescription Use: X (Per 21 CFR 801 Subpart D)
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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080762
§ 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.