(14 days)
Software contained in the PET Application Suite process, analyze, display, and quantify medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:
- The evaluation, detection and diagnosis of lesions, disease and organ function such as cancer. cardiovascular disease, and neurological disorders.
- The detection, localization, and staging of tumors and diagnosing cancer patients.
- Treatment planning and interventional radiology procedures.
The PET Application Suite includes software that provides a quantified analysis of regional cerebral activity from PET images.
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.
The NexStar Liftoff PET Application Software Suite (referred to as NexStar or Liftoff within the submission) is software used to process, analyze and display medical images and may be sold with Philips nuclear medicine PET/CT Systems or systems marketed by Philips. The PET Software Application Suite is a full suite of applications, including both review and processing.
The NexStar Liftoff PET Application Software Suite is basically the same as the processing and reconstruction software cleared with the predicate device (GEMINI TF, K052640), with the extension of Image Fusion Software to include Metabolic Analysis and Cardiac Realignment.
NexStar software is a Windows®-based suite of image display and processing applications and is deployable on hardware platforms, which meet the minimum requirements needed to run the software.
The provided text is a 510(k) summary for the Philips Medical Systems' NexStar Liftoff PET Application Software Suite. It primarily focuses on demonstrating substantial equivalence to a predicate device (GEMINI Raptor System, K052640) rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of clinical performance.
Therefore, much of the requested information regarding acceptance criteria and performance study details is not available in the provided document. The document explicitly states: "No performance standards have been developed for process and display applications." and "No performance standards have been developed for process and display applications." (repeated)
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance. | The submission does not specify quantifiable clinical acceptance criteria for sensitivity, specificity, accuracy, or similar performance metrics for lesion detection, diagnosis, or quantification. |
| Substantial Equivalence: The primary "acceptance criterion" for this 510(k) was to demonstrate that the NexStar Liftoff PET Application Software Suite is substantially equivalent to its predicate device (GEMINI Raptor System, K052640) in terms of intended use and technological characteristics. | The FDA reviewed the submission and determined that the device is substantially equivalent to the predicate device, allowing it to be marketed. The differences (deployment on various hardware platforms, enhancements to processing applications, extension of Image Fusion Software to include Metabolic Analysis and Cardiac Realignment) were deemed not to raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document does not describe a clinical test set with human cases for performance evaluation. The evaluation was primarily a comparison of technical characteristics to a predicate device.
- Data Provenance: Not applicable. No clinical data set is described for testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. No clinical test set requiring ground truth establishment by experts is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or described in the provided document. The document focuses on technical equivalence to a predicate device rather than comparative human-AI performance.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no such study was described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No, a standalone performance study with quantifiable metrics like sensitivity, specificity, or accuracy for the algorithm itself was not described in the provided document. The submission is for application software that processes, analyzes, and displays images for use by trained professionals, implying a human-in-the-loop scenario, but no specific performance study, standalone or otherwise, is detailed.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No clinical performance study requiring a specific type of ground truth (e.g., pathology, outcomes data, expert consensus) is described. The "ground truth" for this submission was essentially the established safety and effectiveness of the predicate device, to which this device claimed substantial equivalence in its updates and changes.
8. The Sample Size for the Training Set
- Sample Size: Not specified. The document does not mention or describe a training set for machine learning or AI algorithms. The "software" described focuses on processing, analysis, and display, which typically relies on established algorithms and image processing techniques rather than a large, continuously-trained machine learning model in the context of a 2008 submission.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as no training set requiring ground truth for machine learning was described.
{0}------------------------------------------------
JUN - 4 2008
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
A. Submitter/ Contact Person: Philips Medical Systems (Cleveland), Inc. 595 Miner Rd. Cleveland, OH 44143
Melinda Novatny Tel: (440) 483-4255 Fax: (440) 483-2300
- Device Trade Name: NexStar Liftoff PET Application Software Suite B. Common Name: PET Application Software
Classification Name: System, Emission Computed Tomography, (892.1200)
21CFR 892.1200, Class II Device Class:
Product Code: 90 KPS
Classification Panel: Radiology
- C. Date prepared: April 11, 2008
- D. Predicate Device: GEMINI Raptor System (GEMINI TF) (K052640)
E. Performance Standards:
No performance standards have been developed for process and display applications.
F. Intended Use:
Software contained in the PET Application Suite process, analyze, display, and quantify medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:
- o The evaluation, detection and diagnosis of lesions, disease and organ function such as cancer. cardiovascular disease, and neurological disorders.
- The detection, localization, and staging of tumors and ു diagnosing cancer patients.
- Treatment planning and interventional radiology o procedures.
The PET Application Suite includes software that provides a quantified analysis of regional cerebral activity from PET images.
Section X .- 1
{1}------------------------------------------------
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.
(1. Device Description/ Comparison with Predicate Device:
The NexStar Liftoff PET Application Software Suite (referred to as NexStar or Liftoff within the submission) is software used to process, analyze and display medical images and may be sold with Philips nuclear medicine PET/CT Systems or systems marketed by Philips. The PET Software Application Suite is a full suite of applications, including both review and processing.
The NexStar Liftoff PET Application Software Suite is basically the same as the processing and reconstruction software cleared with the predicate device (GEMINI TF, K052640), with the extension of Image Fusion Software to include Metabolic Analysis and Cardiac Realignment.
NexStar software is a Windows®-based suite of image display and processing applications and is deployable on hardware platforms, which meet the minimum requirements needed to run the software.
H. System Performance Test/ Summary of Studies:
No performance standards have been developed for process and display applications.
』、 Comparison to Predicate Devices:
The basic differences in the system include the following:
- . Deployment of software on hardware platforms meeting minimum level of requirements
- Enhancements to processing applications .
In conclusion, the device is substantially equivalent to the predicate device based upon similar intended use, and technological comparison.
{2}------------------------------------------------
Third Party Review Quality Assessment
Section 1 – Submission Information
510(k) No.: K081426 Third Party Organization: Underwriters Laboratories, Inc. Third Party's Primary Reviewer(s): Jeff D. Rongero ODE/OIVD Division: DRARD Branch/Team: Radiological Devices Branch Section 2 - 510(k) Decision Third party recommendation: SE √_____ NSE _____
ODE/OIVD final decision: SE √_____ NSE ______________________________________________________________________ Other (specify): __ Other (specify): _____________________________________________________________________________________________________________________________________________________________
Section 3 - Assessment of Third Party Review
| Review Element | Rating (check one) | ||
|---|---|---|---|
| Adequate | Minor Issue(s) | Major Issue(s) | |
| a. Determination of device eligibility for third party review | √ | ||
| b. Extent of pre-submission consultation with ODE/OIVD division | |||
| c. Organization and format of review documentation | √ | ||
| d. Determination of 510(k) administrative completeness (screening review) | √ | ||
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | √ | ||
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | √ | ||
| g. Rationale for conclusions and recommendation | √ | ||
| h. Use of guidance documents and standards | √ | ||
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | √ | ||
| j. Scope of reviewer expertise and use of consulting reviewers | √ | ||
| k. Other (specify): |
Comments (explanation of ratings/issues): ____________________________________________________________________________________________________________________________________
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Section 4 – ODE/OIVD Assessor Information
Assessed by: Sunder Rajan_ Date: 28-May-2008 Tel. No.: 240 276 3968
Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k).
DMC-Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2008
Philips Medical Systems (Cleveland), Inc. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
Re: K081426
Trade/Device Name: NexStar Liftoff PET Application Software Suite Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: May 20, 2008 Received: May 21, 2008
Dear Mr. Rongero:
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 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.
{4}------------------------------------------------
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR 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 Reporting (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
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): Not Known
Device Name: NexStar Liftoff PET Application Software Suite
Software contained in the PET Application Suite process, analyze, display, and quantify medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolical data at different angles. Trained professionals use the images in:
- The evaluation, detection and diagnosis of lesions, disease and organ function such as cancer, . cardiovascular disease, and neurological disorders.
- The detection, localization, and staging of tumors and diagnosing cancer patients. .
- Treatment planning and interventional radiology procedures. .
- The PET Application Suite includes software that provides a quantified analysis of regional cerebral ♥ activity from PET images.
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of leftventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium
Prescription Use √ Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page
Jongu Mthang
(Division Sign-C Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.