Delineate the outline of the left ventricular wall automatically and/or manually in angiographic X-ray images - either monoplane or biplane analysis; Absolute measurements of ventricular volumes - calculation of derived parameters; Quantification of the motion of the ventricular wall by applying several established models - Estimation of the dimensions of the myocardiac wall.

Device Description

The CAAS II LVA-Biplane Option is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark II, CAAS II. It functions in the same manner as other left ventricular analysis software packages. In the End Diastolic (ED) and End Systolic (ES) images (of a monoplane or biplane run), available from various image sources, the outline of the left ventricular contour is either drawn manually or detected automatically. From these contours the ventricular volumes, the ejection fraction and other related parameters are determined using either the Area Length or the Simpson's rule model. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall between ED and ES is quantified from these ventricular contours using four clinically and scientifically established models: the Centerline, Regional, Radial and Slager wall motion models. Finally myocardium dimensions can be estimated from the ED ventricular contour and a manually drawn outline of the epicardium. All results of the analysis are available on screen as well as hardcopy.

AI/ML Overview

The provided 510(k) summary for the CAAS II LVA-Biplane Option does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The document primarily focuses on establishing substantial equivalence to predicate devices and describing the device's functionality.

It asserts that "the automatic contour detection of the CAAS II LVA-Biplane Option is equivalent to the predicate devices. For the predicate devices manufactured by Philips the automatic contour detection has been shown to generate identical results in tests were the contours were compared on a pixel-by-pixel bases." However, it does not provide details of this comparison for the CAAS II LVA-Biplane Option itself.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify quantitative acceptance criteria for the CAAS II LVA-Biplane Option's performance or report its performance against such criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not available. The document states that the automatic contour detection for Philips predicate devices "has been shown to generate identical results in tests were the contours were compared on a pixel-by-pixel bases." However, it does not provide details about these tests (sample size, data provenance) for the predicate devices, nor does it conduct such a test for the CAAS II LVA-Biplane Option directly, only stating its automatic contour detection is "equivalent."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not available. No information is provided regarding the establishment of ground truth by experts for any test sets related to the CAAS II LVA-Biplane Option.

4. Adjudication Method for the Test Set

Not available. No test set or ground truth establishment details are provided, so no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document does not describe any MRMC comparative effectiveness study for the CAAS II LVA-Biplane Option.

6. If a Standalone (Algorithm Only) Performance Study was Done

Partially. The document implies that the "automatic contour detection" feature was evaluated for the predicate devices, and the CAAS II LVA-Biplane Option is asserted to be equivalent due to this predicate data. However, a dedicated standalone study for the CAAS II LVA-Biplane Option is not detailed. The statement "For the predicate devices manufactured by Philips the automatic contour detection has been shown to generate identical results in tests were the contours were compared on a pixel-by-pixel bases" suggests some form of standalone evaluation of the algorithm's output against a reference.

7. The Type of Ground Truth Used

Based on the statement for the predicate devices: "contours were compared on a pixel-by-pixel bases," the ground truth for contour detection would likely have been expert consensus or highly accurate manual tracings for the predicate evaluations. However, this is not explicitly stated for the CAAS II LVA-Biplane Option.

8. The Sample Size for the Training Set

Not available. There is no mention of a training set or its size.

9. How the Ground Truth for the Training Set was Established

Not available. As no training set is mentioned, information on how its ground truth was established is also absent.

In summary, the 510(k) submission for the CAAS II LVA-Biplane Option relies heavily on demonstrating substantial equivalence to predicate devices, particularly those by Philips, by asserting similar technological characteristics and functionality. It does not present a dedicated study with defined acceptance criteria and performance metrics for the CAAS II LVA-Biplane Option itself to demonstrate compliance with specific performance thresholds. The reference to "pixel-by-pixel" comparison for predicate device contour detection suggests a method of evaluating accuracy, but the specifics are lacking.

Summary

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Pie Medical Imaging B.V.

JUL 1 4 1998

510(k) Summary

CAAS II LVA-Biplane Option

This summary statement complies with 21 CFR, section 807.92(c).

Date summary prepared: 08 June 1998

This premarket notification has been submitted by Pie Medical Imaging B.V. and covers the CAAS II LVA-Biplane option. The address is:

Pie Medical Imaging B.V. Philipsweg 1 6227 AJ Maastricht The Netherlands

tel: +31.43.3824600 fax: +31.42.3824601

Tel .:

Fax:

The contact person is Frank Aniba, Quality Assurance Manager.

The trade name is

CAAS II LVA-Biplane Option. The common name for this type of device is Left Ventricular Analysis Software and the classification name is Image Processing System (90 LLZ).

The above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class II.

The CAAS II LVA-Biplane Option is substantially equivalent to the Philips CD-Medical CDM 3500 View Station, K945460, and the Philips Integris H/HM family of angiographic imaging systems, K925302, and the Siemens AWOS Angiographic Workstation, K922804.

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510(k) Summary

The intended use of the CAAS II LVA-Biplane Option is 1) Delineate the outline of the left ventricle automatically on either one (monoplane) or two (biplane) sets of two images of the heart; 2) Absolute measurement of ventricular volumes at the End Diastolic and End Systolic phase of a heart cycle, together with the Ejection Fraction and other to these volumes related parameters; 3) Quantification of the motion of the ventricular wall between the End Diastolic and End Systolic phase of a heart cycle; 4) Estimation of myocardium dimensions.

The CAAS II LVA-Biplane Option is equivalent in technological characteristics to the predicate devices mentioned in this summary:

· The CAAS II LVA-Biplane Option is indicated in the same diagnostic application as the predicate devices.
· The CAAS II LVA-Biplane Option uses, like the predicate devices, only unprocessed and uncompressed images as input to for the analysis.
· The automatic contour detection of the CAAS II LVA-Biplane Option is equivalent to the predicate devices. For the predicate devices manufactured by Philips the automatic contour detection has been shown to generate identical results in tests were the contours were compared on a pixel-by-pixel bases.
· Both monoplane and biplane analysis methods are available in the CAAS II LVA-Biplane Option. Not all of the predicate devices have the biplane method implemented.
· The Area Length and the Simpson's rule volume models are available in the CAAS II LVA-Biplane Option. Not all of the predicate devices have the Simpson's rule model implemented.
· The regression formulas available in the CAAS II LVA-Biplane Option are a combination of those available in the predicate devices and can be found in clinical and scientific literature.
· The Wall Motion analysis models available in the CAAS II LVA-Biplane Option which are based on clinical and scientific literature are a combination of those available in the predicate devices.

The CAAS II LVA-Biplane Option is subject to the same Ouality Assurance systems in development and production as other products currently marketed by Pie Medical Imaging.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 4 1998 . III JI

Frank Aniba Quality Assurance Manager Pie Medical Equipment B.V. Philipsweg 1 Maastricht Netherlands

Re:

K982203 CAAS II LVA-Biplane Option Dated: June 16, 1998 Received: June 22, 1998 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI

Dear Mr. Aniba:

We have reviewed your Section 5100k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivaliance compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510ks 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrl/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number (if known):

Device Name:

CAAS II LVA-Biplane Option

Indications For Use:

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

concurrence of CDRH, Office of device Evaluation (ODE)

David C. Beynon
Division files 050

Abdominal, EN

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use -

(Optional Format 1-2-96)

page 1 of 1

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.