(47 days)
LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to
- visualize chest CT datasets acquired in low or normal dose;
- mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;
- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)
- generate automatic reports.
LMS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients.
LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.
LMS-Lung/TRACK provides visualization and analysis tools for chest CT images acquired in low or normal dose.
LMS-Lung/TRACK segments pulmonary lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics such as size, volume and intensity. Alternatively, the user can do its own 2D measurements on the lesion.
LMS-Lung/TRACK matches and compares lesions identified by the physician present in two different datasets of the same patient acquired at different dates. It computes the differences of volume and diameters and volume growth.
LMS-Lung/Track provides tool to generate report with snapshots, and results.
The provided 510(k) summary for HD70868 (LMS-Lung/TRACK) does not contain a specific section outlining acceptance criteria or a detailed study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on functional comparison and safety analysis.
Therefore, many of the requested details, such as specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, and ground truth information for both test and training sets, are not explicitly provided within this document.
The document mainly highlights the device's intended use and features, and compares them with predicate devices, concluding that it is substantially equivalent and does not raise new safety risks.
Based on the provided text, here's what can be inferred or directly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The document focuses on feature comparison and substantial equivalence to predicate devices rather than specific quantitative performance metrics against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not provided in the document.
4. Adjudication Method for the Test Set
Not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not reported or implied in the document. The document does not describe any MRMC studies or human reader improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not directly stated as a formal study result. However, the device description strongly implies standalone algorithmic functions for "segmenting pulmonary lesions," "comput[ing] its characteristics such as size, volume and intensity," and "match[ing] and compar[ing] lesions identified by the physician present in two different datasets." The performance of these automatic functions in isolation is not quantitatively detailed with acceptance criteria in this document.
7. The Type of Ground Truth Used
Not provided in the document.
8. The Sample Size for the Training Set
Not provided in the document.
9. How the Ground Truth for the Training Set was Established
Not provided in the document.
Summary of what is present:
- Device Name: LMS-Lung/TRACK
- Intended Use: Visualization, marking, automatic/manual measurement of lung nodule characteristics (diameter, volume), comparison of CT scans over time for lesion evolution, and report generation in adult patients for diagnostic thoracic CT examinations. Not for patients with prior thoracotomy.
- Comparison to Predicate Devices: The document primarily establishes substantial equivalence by comparing the functionalities of LMS-Lung/TRACK with three predicate devices (CA-1500, Lung nodule assessment and comparison option, Primelung). Key comparable features include input CT scans, interactive 2D and 3D visualization, segmentation of lung lesions, extraction and computation of lesion characteristics (2D and 3D), manual measurement, lesion matching over time, lesion comparison over time, and report generation.
- Safety: A hazard analysis was conducted, concluding that residual risks were acceptable when weighed against the intended benefits.
The provided 510(k) summary is a high-level overview establishing substantial equivalence for market clearance and does not delve into the detailed performance validation studies that would contain the specific information requested.
{0}------------------------------------------------
HD70868
510(k) Summary
Submitter's Information
MAY 1 5 2007
Submitted by MEDIAN Technologies Le Solaris 120 rue Albert Caquot 06560 Sophia Antipolis France Fax: +33 93 333 777
Contact: Fredrik Brag, CEO Fredrik.brag@mediantechnologies.com Tel: +33 93 333 777
Questions or requests for further information should be addressed to: Michael Auffret, VP Product Management Michael.auffret@mediantechnologies.com Tel: +33 4 92 90 65 84
Date summary was prepared: May 9, 2007
Name of Device
Proprietary name: LMS-Lung/TRACK Common name: Lung nodule visualization and analysis software package Classification Name: Class II, 21 CFR 892.2050, LLZ
Predicate Devices
| Manufacturer | R2 Technology,inc. | Philips medicalsystems | AcculmageDiagnosticsCorporation |
|---|---|---|---|
| Trade Name | CA-1500 | Lung noduleassessment andcomparisonoption | Primelung |
| 510(k)Number | K040028 | K023785 | K024149 |
Device Description
LMS-Lung/TRACK provides visualization and analysis tools for chest CT images acquired in low or normal dose.
LMS-Lung/TRACK segments pulmonary lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics
{1}------------------------------------------------
such as size, volume and intensity. Alternatively, the user can do its own 2D measurements on the lesion.
LMS-Lung/TRACK matches and compares lesions identified by the physician present in two different datasets of the same patient acquired at different dates. It computes the differences of volume and diameters and volume growth.
LMS-Lung/Track provides tool to generate report with snapshots, and results.
Intended use
LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to
- visualize chest CT datasets acquired in low or normal dose: -
- mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;
- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)
- generate automatic reports.
f.MS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients.
LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.
| Manufacturer | R2Technology | PhilipsMedicalSystems | AcculmageDiagnosticsCorporation | MEDIANTechnologies |
|---|---|---|---|---|
| ProductName | CA-1500 | Lung nodule assessmentand comparison option | Primelung | LMS-Lung/TRACK |
| 510(k)Number | K040028 | K023785 | K024149 | |
| CT scans oflungs as Input | √ | √ | √ | √ |
| Interactive 2Dand 3Dvisualizingtools | √ | √ | √ | √ |
| Segmentationof lung lesions(i.e.boundariesdetection) | √ | √ | √ | √ |
Substantial Equivalence Comparison Chart
LMS-Lung/Track software 510(k) K070868
Amendment page 3 of 4
{2}------------------------------------------------
| Manufacturer | R2 Technology | PhilipsMedicalSystems | AcculmageDiagnosticsCorporation | MEDIANTechnologies |
|---|---|---|---|---|
| ProductName | CA-1500 | Lung nodule assessmentand comparison option | Primelung | LMS-Lung/TRACK |
| Extraction andcomputationof lesioncharacteristics(2D and 3D) | ✓ | ✓ | ✓ | ✓ |
| Manualmeasurement | ✓ | ✓ | ✓ | ✓ |
| Lesionmatching overtime | ✓ | ✓ | ✓ | ✓ |
| Lesioncomparisonover time | ✓ | ✓ | ✓ | ✓ |
| ReportGenerator | ✓ | ✓ | ✓ | ✓ |
Safety
A comprehensive hazard analysis was carned out on MEDIAN Technologics' LMS-Lung/TRACK software. It concluded that residual risks were acceptable when weighed against the intended benefits of the system.
Conclusion
LMS-Lung/TRACK software does not raise new safety risks and is equivalent in function to existing legally marketed devices. I MS-Lung/TRACK software is therefore substantially equivalent with respect to safety and effectiveness to the predicate devices.
Amendment page 4 of 4
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Median Technologies % Mr. Chas Burr Principal Consultant Chas Burr Q/R Services, Inc. 11 Mystic Avenue WINCHESTER MA 01890-2920
MAY 1 5 2007
Re: K070868
Trade/Device Name: LMS-Lung/TR ACK Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications syste Regulatory Class: II Product Code: LLZ and JAK Dated: March 26, 2007 Received: March 29, 2007
Dear Mr. Burr:
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 maxi. 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 (Premarket Approval), 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.
Image /page/3/Picture/10 description: The image is a black and white circular logo or seal. The text "1906-2006" is at the top of the circle. The letters "PA" are in the center of the circle in a bold, blocky font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the circle.
Protecting and Promoting Public Health
{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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. B rogdon 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): K070868
Device Name: LMS-Lung/TRACK
Indications for Use:
LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to
- visualize chest CT datasets acquired in low or normal dose;
- mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;
- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)
- generate automatic reports.
LMS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients.
LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Croston
Division Sian-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
LMS-Lung/Track software 510(k) K070868
Amendment page 1 of 4
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).