Colon CAR 1.2 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 colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. 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 single or double seed points followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images.

Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.

Device Description

Colon CAR™ (Computer Assisted Reader) 1.2 is a software tool designed to assist radiologists and other clinicians in the evaluation of polyps and other lesions in the colon. 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 polyps and measurement of polyp characteristics such as size and volume. The further feature of Colon CAR™ 1.2 as compared to the cleared device is a Polyp Enhanced Viewing Filter (PEV), the results of which are presented in a Joint Reader filter view (enhanced and non-enhanced data viewed simultaneously). The PEV filter identifies intra-colonic filling defects protruding into the colonic lumen, thereby highlighting potential polyp candidates for further interrogation by the reporting radiologist. This filter is fully adjustable and, in deciding the desired characteristics of the objects to be highlighted, the radiologist may specify the degree of object sphericity (or roundness), the height of the protruding object in relation to its base (object 'flatness') as well as select an approximate object diameter range.

AI/ML Overview

The provided text does not contain specific acceptance criteria or an explicit study describing the device's performance against such criteria. The document is a 510(k) summary for the Medicsight Colon CAR 1.2, focusing on its substantial equivalence to a predicate device rather than presenting detailed performance statistics or an independent study to prove acceptance criteria.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Substantial Equivalence to Predicate Device (MedicColon 1.0, K033102)	"The functional features and the intended use of Colon CAR 1.2 are substantially equivalent to the predicate device. The modifications to the original device did not introduce any new potential safety risks."
Safety: No new potential safety risks	"A comprehensive hazard analysis was carried out on Colon CAR 1.2, 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."
Effectiveness: Equivalent to legally marketed device	"Colon CAR 1.2 is equivalent in performance to the existing legally marketed device."

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document mentions "Test data are provided to validate the performance of the system," but does not specify the size of this test set.
Data Provenance: Not explicitly stated. The document mentions "Medicsight PLC." is located in "London W1J 5AT UK," but there is no information about the origin of the test data (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth:

Not explicitly stated. The document refers to "radiologists and other clinicians" as intended users, but there is no information about experts used to establish ground truth for any test sets.

4. Adjudication Method for Test Set:

Not explicitly stated. No details are provided regarding how ground truth was established or if any adjudication process was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not explicitly stated. The document does not describe an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size. The device is described as "a software tool designed to assist radiologists," implying human-in-the-loop, but no comparative effectiveness study is presented.

6. Standalone Performance Study:

Not explicitly stated. While the device is "PC-based, stand-alone, non-invasive, image analysis software," the document does not present a standalone performance study of the algorithm without human-in-the-loop. The "Polyp Enhanced Viewing Filter (PEV)" is described as highlighting "potential polyp candidates for further interrogation by the reporting radiologist," indicating an assisted workflow rather than a standalone diagnostic output.

7. Type of Ground Truth Used:

Not explicitly stated. Given the context of colon polyp detection, common ground truths include expert consensus (e.g., colonoscopy findings, pathology reports), but the document does not specify.

8. Sample Size for Training Set:

Not explicitly stated. There is no information provided about a training set or its size.

9. How Ground Truth for Training Set was Established:

Not explicitly stated. Since no training set is mentioned, there is no information on how its ground truth might have been established.

Summary of Missing Information:

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on functional comparisons and hazard analysis rather than detailed performance studies with explicit acceptance criteria and corresponding results. The document lacks the specific details requested regarding test set size, data provenance, expert qualifications, ground truth establishment methods, and detailed performance metrics that would be found in a comprehensive clinical or technical study report.

Summary

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MEDI@SIGHT

K042674

OCT 1 9 2004

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 SquareLondon W1J 5ATUK
Telephone:	44 (0) 207 598 4070
Facsimile:	44 (0) 207 598 4071
Contact:	Carol MacDonald, RA QA Director
Date of summary:	24th September 2004
Device Information:

evice Information:

Trade Name:	Colon CAR™ Release 1.2
Common Name:	Medical imaging software for CT scanners
Classification Name:	Computed Tomography X-Ray System, Accessory
Regulation Number:	892.1750

Predicate Device:

Medicsight Colon CAR 1.2 is substantially equivalent to the following commercially available device:

Manufacturer	Device	510(k) No.	Clearance Date
MEDICSIGHT	MedicColon 1.0	K033102	November 5th 2003

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MEDI®SIGHT

Device Description:

Intended Use:

Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the nonenhanced view.

Comparison to Predicate Device:

As in the predicate device, MedicColon 1.0, Colon CAR 1.2 assists users in assessing CT images for the identification and evaluation of colonic polyps.

Test data are provided to validate the performance of the system and its substantial equivalence to the predicate device. The functional features and the intended use of Colon CAR 1.2 are substantially equivalent to the predicate device. The modifications to the original device did not introduce any new potential safety risks.

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MEDI@SIGHT

Safety:

A comprehensive hazard analysis was carried out on Colon CAR 1.2, 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:

Colon CAR 1.2 does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed device. Colon CAR 1.2 is therefore substantially equivalent with respect to safety and effectiveness to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of the bird's body and wings. The text is in a simple, sans-serif font and is evenly spaced around the circle.

Public Health Service

MAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol MacDonald Regulatory & Quality Director Medicsight 46 Berkeley Square London W1J5AT UNITED KINGDOM

Re: K042674 Trade/Device Name: Medicsight Colon CAR 1.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: NWE Dated: September 27, 2004 Received: September 29, 2004

Dear Ms. MacDonald:

This letter corrects our substantially equivalent letter of October 19, 2004.

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)	(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.

Heike Leuren

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): Ko 4z 2 24

Device Name: Medicsight Colon CAR 1.2

Indications for Use:

Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C hogdon

Prescription Use_

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042674

Regulation Number and Section

§ 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).