MEDICLUNG, RELEASE 1

K033412 · Medicsight · OEB · Dec 30, 2003 · Radiology

Device Facts

• Record ID: K033412
• Device Name: MEDICLUNG, RELEASE 1
• Applicant: Medicsight
• Product Code: OEB · Radiology
• Decision Date: Dec 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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 ROI. 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.

Device Story

MedicLung 1 is a PC-based, stand-alone software for lung CT image analysis; assists radiologists/clinicians in evaluating lung lesions. Inputs: 2D/3D CT image data. Operation: user selects ROI manually or via single/double seed points; software performs semi-automatic boundary detection; user performs interactive fine-tuning. Outputs: 2D/3D visualizations; quantitative measurements of lesion volume and characteristics. Clinical use: tracking changes in nodules over time. Benefits: aids in lesion evaluation and longitudinal monitoring.

Clinical Evidence

Bench testing only. Performance validated through testing to demonstrate substantial equivalence to predicate devices in functional features and intended use.

Technological Characteristics

PC-based, stand-alone software application. Functions as an image analysis tool for 2D/3D CT data. Features include manual drawing tools and semi-automatic ROI extraction via seed-point selection and boundary fine-tuning. Provides quantitative volumetric measurement.

Indications for Use

Indicated for use by radiologists and clinicians to assist in the evaluation, visualization, and measurement of lung lesions (e.g., nodules) using 2D and 3D CT image data. No specific age or gender restrictions provided.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• GE ADVANCED LUNG ANALYSIS-1 (K013381)
• LUNGCARE CT SOFTWARE PACKAGE (K022013)

Submission Summary (Full Text)

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K03 34/2

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# 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:<br>Name: | Medicsight PLC. |
|------------------------|--------------------------------------------|
| Address: | 46 Berkeley Square<br>London W1J 5AT<br>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 |

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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:

K037412

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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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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 [phone] or [phone] 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

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