(67 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on visualization and analysis tools, not AI/ML capabilities.
No
The device is described as software for visualization and analysis of medical images, intended to assist physicians in analyzing lung regions and generating reports. Its function is diagnostic support rather than direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states the software is "intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters". This analysis of "regions of the lung" to identify "nodules and other lung parameters" falls under the definition of diagnosing a condition or disease.
Yes
The device is described as a "comprehensive software package" and an "additional software option" to an existing imaging workstation. The description focuses solely on the software's visualization, analysis, and reporting functionalities for CT datasets, without mentioning any associated hardware components developed or included with this specific submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the visualization and analysis of thoracic CT datasets to help a reading physician analyze regions of the lung. This involves processing medical images, not analyzing biological samples or specimens from the human body.
- Device Description: The device is described as a software module for a diagnostic imaging workstation. It provides visualization and analysis tools for viewing regions of the lung and generating reports. This aligns with medical imaging software, not IVD devices.
- Input Modality: The input is thoracic CT datasets, which are medical images, not biological samples.
- Anatomical Site: The focus is on the lung, which is an organ within the body, not a biological sample being tested in vitro.
- No mention of analyzing biological samples: The entire description revolves around processing and analyzing medical images. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide information about a person's health. This device operates on medical images acquired from within the body.
N/A
Intended Use / Indications for Use
PrimeLunq is a comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the user to analyze lunq nodules and other lung parameters, and to generate an automatic report.
Comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters, and to generate an automatic report.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The Acculmage PrimeLung software module is an additional software option to K990241, AccuView Diagnostics Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plug-ins. The AccuShade plug-in is not currently marketed, the AccuMIP plug-in is currently marketed with the name ProjectorPro. The Acculmage PrimeLung plug-in provides visualization and analysis tools for viewing regions of the lung, and generating reports with patient information, images, results and recommendations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
thoracic CT datasets
Anatomical Site
lung, lung nodules
Indicated Patient Age Range
Not Found
Intended User / Care Setting
reading 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
The test plan covers all aspects of the functionality, exercising every user interface button, all menus and submenus, as well as all configurable items, including the measurement tool, segmentation tool and report generator tool.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
From the Graphic User Interface test results: The Graphic User Interface, its menus and buttons conform as per the PrimeLung functional specification.
From a functionality point of view, all functionality works as described in the PrimeLung Functional Specification.
From Comparison Tool test results:
The testing performed showed that auto-matching comparison tool provides very reliable results with 100% of matching accuracy on the specified data sets.
From Report Generator Test results:
ests results show that the report generator can be created and results can be printed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% of matching accuracy on the specified data sets.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K022013, K013381, K990241/ K012106
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Section 1
Ko24149
510(K) Summary
(as required by 21 CFR § 807.92)
Date:
A. Submitter's Information:
| Name: | Acculmage Diagnostics Corporation |
|---|---|
| Address: | 400 Grandview Drive |
| South San Francisco, CA 94080 | |
| Telephone Number: | (650) 875-0192 |
| Fax Number: | (650) 875-0194 |
| Contact Name: | Oscar Gils Carbó |
| Contact Email address: | oscar@accuimage.com |
| B. Device Information: | |
| Proprietary Name: | PrimeLung |
| Common or Usual Name: | Lung nodule visualization and analysis software |
| package. | |
| Classification: | Class II 21 CFR 892.2050 LLZ |
| Substantial Equivalence: | The Acculmage PrimeLung option is Substantially |
| Equivalent to the Siemens Medical Solutions | |
| Lungcare CT Software Package, to the GE Medical | |
| Systems Advanced Lung Analysis, and to the | |
| Acculmage AccuView Workstation with AccuScore | |
| software module. | |
| Device Description: | The Acculmage PrimeLung software module is an |
| additional software option to K990241, AccuView | |
| Diagnostics Imaging Workstation with AccuScore, | |
| AccuAnalyze, AccuShade, AccuVRT and AccuMIP | |
| plug-ins. The AccuShade plug-in is not currently | |
| marketed, the AccuMIP plug-in is currently | |
| marketed with the name ProjectorPro. The | |
| Acculmage PrimeLung plug-in provides | |
| visualization and analysis tools for viewing regions | |
| of the lung, and generating reports with patient | |
| information, images, results and recommendations. |
1
K02-4149
Intended Use:
PrimeLunq is a comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the user to analyze lunq nodules and other lung parameters, and to generate an automatic report.
C. Technological Characteristics of the Device as compared to Predicate Devices:
| Manufacturer | Siemens Medical
Solutions | GE Medical
Systems | Acculmage Diagnostics
Corp. | Acculmage
Diagnostics Corp. |
|-------------------------------------------------------------------|----------------------------------------------------|---------------------------------|---------------------------------------------------------|------------------------------------------------------------|
| Product Name | LungCare CT Software | Advanced Lung
Analysis | AccuView Workstation with
AccuScore, etc. | PrimeLung |
| 510(k) Number | K022013 | K013381 | K990241/ K012106 | |
| Computer Platform | PC Workstation with
Windows Operating
System | Sun Workstation | PC Workstation with
Windows Operating System | PC Workstation with
Windows Operating
System |
| Type of CT Scanner
for which it is
applicable | Standard or low-dose
spiral CT scanners | At least helical CT
scanners | Helical, Multidetector and
Electron Beam CT scanners | Helical, Multidetector
and Electron Beam CT
scanners |
| Draw, Edit, Delete
ROI (possible
nodules | Yes | Yes | Yes | Yes |
| Image Processing
Tools | MIP, MPR, 3D Volume
Rendering | Yes | MIP, MPR, 3D Volume
Rendering | MIP, MPR, 3D Volume
Rendering |
| Segmentation of lung
nodule | Yes | Yes | n/a | Yes |
| Volume
measurements,
Comparator tool for
nodule matching | Yes | Yes | n/a | Yes |
| Report Generator | Yes | Unknown | Yes | Yes |
Substantial Equivalence Comparison Chart
D. Brief Discussion of Test Results Submitted:
The test plan covers all aspects of the functionality, exercising every user interface button, all menus and submenus, as well as all configurable items, including the measurement tool, segmentation tool and report generator tool.
E. Conclusions from Test Results:
From the Graphic User Interface test results: The Graphic User Interface, its menus and buttons conform as per the PrimeLung functional specification.
From a functionality point of view, all functionality works as described in the PrimeLung Functional Specification.
From Comparison Tool test results:
The testing performed showed that auto-matching comparison tool provides very reliable results with 100% of matching accuracy on the specified data sets.
From Report Generator Test results:
ests results show that the report generator can be created and results can be printed.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2003
Mr. Oscar Gils Carbó Vice President Acculmage Diagnostics Corporation 400 Grandview Drive SOUTH SAN FRANCISCO CA 94080 Re: K024149
Trade/Device Name: PrimeLung Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: December 6, 2002 Received: December 16, 2002
Dear Mr. Carbó:
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 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.
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.
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
3
This letter will allow you to begin marketing your device as des
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
4
Section 1.1
Ko2449
INDICATIONS FOR USE
Applicant:
Acculmage Diagnostics Corporation
510(k) Number: K024149
PrimeLung Device Name:
Indications for Use:
Comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters, and to generate an automatic report.
Prescription Use
(Per 21 CFR 801.109)
Nancy Hodsdon
(Division Sig Division of Re and Radiolog 510(k) Num