(14 days)
No
The document describes image processing and analysis software but does not mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard image processing techniques and comparisons to a predicate device without AI/ML capabilities.
No
The device is a software suite used to process, analyze, and display medical images for diagnostic and treatment planning purposes, not to directly treat a medical condition. Its function is to provide information to trained professionals, not to deliver therapy.
Yes
The device aids in the "evaluation, detection and diagnosis of lesions, disease and organ function such as cancer, cardiovascular disease, and neurological disorders" and "detection, localization, and staging of tumors and diagnosing cancer patients" by processing, analyzing, and displaying medical images/data.
Yes
The device description explicitly states "The NexStar Liftoff PET Application Software Suite... is software used to process, analyze and display medical images" and "NexStar software is a Windows®-based suite of image display and processing applications". While it is deployable on hardware platforms, the device itself is described as software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: The core function of an IVD is to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The description clearly states that the software processes, analyzes, displays, and quantifies medical images/data from PET and CT scans. It does not interact with or analyze biological samples directly.
- The intended use is image-based diagnosis and planning: The intended use focuses on using the processed images for the evaluation, detection, diagnosis, and planning related to various medical conditions. This is a function of medical imaging software, not an IVD.
Therefore, while this device is a medical device used in diagnosis and treatment planning, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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:
- 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.
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.
Product codes
90 KPS
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals
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)
No performance standards have been developed for process and display applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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