(64 days)
Not Found
No
The description mentions "semiautomatic detection" based on user-selected seed points, which is a common image processing technique and does not necessarily imply AI/ML. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML models.
No
The device is an image analysis software application that assists clinicians in the evaluation of lung lesions, providing diagnostic information rather than directly treating or preventing disease.
Yes
The software "assists radiologists and other clinicians in the evaluation of lung lesions" and provides "quantitative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes." This directly supports clinical assessment and decision-making, which are hallmarks of a diagnostic device.
Yes
The device is described as a "PC-based, stand-alone, non-invasive, image analysis software application" and its description focuses solely on software functionalities for image processing and analysis, with no mention of accompanying hardware components.
Based on the provided information, MedicLung I is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MedicLung I's function: MedicLung I is a software application that analyzes medical images (CT scans) of the lung. It assists clinicians in evaluating lung lesions based on visual and quantitative information derived from these images.
- No biological samples: The software does not interact with or analyze any biological samples taken from the patient. Its input is image data.
Therefore, MedicLung I falls under the category of medical image analysis software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MedicLung I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROL. MedicLung I provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.
Product codes (comma separated list FDA assigned to the subject device)
OEB
Device Description
MedicLung™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of nodules and other lesions in the lug. The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of nodules and other lesions, and measurement of nodule characteristics such as size and volume.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and other clinicians
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
'I'cst data are provided to validate the performance of the system and its substantial equivalence to the predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 892.2050 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).
0
K03 34/2
Image /page/0/Picture/1 description: The image shows a logo for a company called "medicsight". The logo is a square shape that is divided into nine smaller squares. The center square is white, and the surrounding squares are black. The company name is written in lowercase letters below the square logo.
DEC 3 0 2003
Appendix E
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92( c ).
| Submitted by:
| Name: | Medicsight PLC. |
|---|---|
| Address: | 46 Berkeley Square |
| London W1J 5AT | |
| UK | |
| Telephone: | 44 (0) 207 598 4070 |
| Facsimile: | 44 (0) 207 598 4071 |
| Contact: | Carol MacDonald, RA QA Manager |
| Date of summary: | 22 September 2003 |
Device Information:
| Trade Name: | MedicLung™ Release 1 |
|---|---|
| Common Name: | Medical imaging software for CT scanners |
| Classification Name: | Computed Tomography X-Ray System, Accessor |
| Regulation Number: | 892.1750 |
Predicate Devices:
Medicsight MedicLung 1 is substantially equivalent to the following devices:
| Manufacturer | Device | 510(k) No |
|---|---|---|
| GE | GE ADVANCED LUNG ANALYSIS-1 | K013381 |
| SIEMENS | LUNGCARE CT SOFTWARE PACKAGE | K022013 |
1
Image /page/1/Picture/0 description: The image shows a logo for a company called "medicsight". The logo consists of a square shape with a circle in the center. The square is made up of smaller squares, and the circle is white. The text "medicsight" is written in a sans-serif font below the square.
Device Description:
MedicLung™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of nodules and other lesions in the lug. The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of nodules and other lesions, and measurement of nodule characteristics such as size and volume.
Intended Use:
MedicLung I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the cvaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROL. MedicLung I provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.
Comparison to Predicate Device:
As in the predicate devices, GE Advanced LungAnalysis-1 and Siemens LunCarcC'1, Mediclung 1 assists users in assessing CT images for the identification and evaluation of nodules and other lesions in the colon.
'I'cst data are provided to validate the performance of the system and its substantial equivalence to the predicate devices. The functional features and the intended use of MedicLung 1 are substantially equivalent to the predicate devices.
Safety:
A comprehensive hazard analysis was carried out on MedicLung 1, which concluded that any residual risks were as low as reasonably practicable and judged as acceptable when weighed against the intended benefits of use of the system.
Conclusion:
MedicLung 1 docs not raisc any new potcntial safety risks and is equivalent in performance to existing legally marketed devices. MedicLung 1 is therefore substantially cquivalent with respect to safety and effectiveness to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2009
Ms. Carol MacDonald Regulatory & Quality Director Medicsight 46 Berkeley Square London W1J5AT UNITED KINGDOM
Re: K033412
Trade/Device Name: Medicsight MedicLung 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OEB Dated: October 24, 2003 Received: November 5, 2003
Dear Ms. MacDonald:
This letter corrects our substantially equivalent letter of December 30, 2003.
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.
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Page 2
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 (OS) 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 os 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 892.xxx | (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 Biometrics' (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 Manufactures, 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/cdrh/industry.suppot/index.html.
Sincerely yours.
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX A
Page of
510(k) Number (if known): 长ひろろくくこ
Medicsight MedicLung 1.0 Device Name:
Indications for Use:
MedicLung I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semiautomatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROI. MedicLunq I provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Nancy C. Broadbent
(Division Sign-Off) 0
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number Ko 33412
3