The Ultrasound Capture System™ (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelf" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.

Device Description

Allows demographic (Patient Name, ID etc.) input consistent with the DICOM standard for image storage.
Performs automatic image acquisition triggered by the cine-pedal.
Performs network transmission of images in DICOM format to a DICOM compatible storage system.

AI/ML Overview

The provided text describes the Heartlab Inc. Ultrasound Capture System (UCS), a device for capturing analog ultrasound video and audio and converting it to DICOM files.

Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the design control activities that were performed to ensure the device met its specifications. However, it does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., image quality, conversion speed, accuracy of DICOM conversion) and their corresponding reported device performance values in a direct comparison.

Instead, the document states:
"All verification and validation activities were performed by the designated individual(s), and the results demonstrated that the predetermined acceptance criteria were met."

This implies that acceptance criteria were established internally as part of the design control process, but the specific details and the performance against them are not disclosed in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices based on functional characteristics and adherence to industry standards.

The closest to "acceptance criteria" are the mentioned design control measures and adherence to standards:

Acceptance Criteria (Inferred from Standards & Design Control)	Reported Device Performance (Summary Statement)
Conformance to DICOM standard (image format, demographic input, network transmission)	"Allows demographic (Patient Name, ID etc.) input consistent with the DICOM standard for image storage.""Performs network transmission of images in DICOM format to a DICOM compatible storage system.""Image Format: Lossy JPEG, DICOM 3.0"
Compliance with 21 CFR 1020.10 (Video Monitor Performance)	Device designed in accordance with this standard. (No specific performance data given)
Compliance with 21 CFR 1040.10 (Fiberoptic communications Performance)	Device designed in accordance with this standard. (No specific performance data given)
Compliance with SMPTE standards	Device designed in accordance with this standard. (No specific performance data given)
Compliance with ACR/NEMA Data Compression Standard	Device designed in accordance with this standard. (No specific performance data given)
Compliance with UL Standards 544 & 1950 (Safety)	Device designed in accordance with these standards. (No specific performance data given)
Compliance with ISO/IEC 10918-1 (JPEG compression)	Device designed in accordance with this standard. (No specific performance data given)"Compression: Variable, 10-12:1 recommended compression"
Software designed, developed, tested, and validated according to written Design Control procedures.	"The software utilized was designed, developed, tested and validated according to written Design Control procedures.""All verification and validation activities were performed... results demonstrated that the predetermined acceptance criteria were met."
Risk analysis performed and hazards controlled by Risk Management Plan.	"Potential hazards have been studied and controlled by a Risk Management Plan."

2. Sample size used for the test set and the data provenance:

The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The testing described (unit, integration, acceptance, performance) likely refers to software and system functionality testing, not a clinical study involving a dataset of patient images. Therefore, details like country of origin or retrospective/prospective nature are not applicable for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since there's no mention of a clinical or image-based test set requiring ground truth established by experts, this information is not provided. The device converts analog signals to DICOM; it does not perform diagnostic interpretation.

4. Adjudication method for the test set:

Not applicable, as no clinical or image-based test set requiring expert adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was conducted or mentioned. This device is an image capture and conversion system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone system in terms of its function (capturing and converting). The performance testing mentioned ("Performance testing" under Design Control) would assess its ability to perform these functions independently. However, this is not an "algorithm only" in the sense of an AI algorithm performing a diagnostic task. The document implies that the system's performance (e.g., successful capture, correct DICOM conversion, maintaining specified compression ratios) was verified, but specific quantitative results are not provided in this public summary.

7. The type of ground truth used:

Given the nature of the device (capture and conversion), the "ground truth" for its verification and validation would likely involve:

Known input signals: Using standardized analog video/audio signals (e.g., test patterns, known cine loops from an ultrasound machine) to verify correct capture.
DICOM standard conformance: Verifying that the output files adhere strictly to the DICOM 3.0 standard.
Data integrity: Comparing captured digital images/audio with the original analog source to ensure no loss or degradation beyond expected compression.
Metadata accuracy: Verifying that demographic and study information is correctly embedded in the DICOM headers.

No clinical "ground truth" (e.g., pathology, outcomes data, expert consensus on disease presence) is relevant for this type of device.

8. The sample size for the training set:

Not applicable. This device is an image capture and conversion system, not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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K042042

510(k): Ultrasound Capture System (UCS)

SEP 2 1 2004

This is a summary of 510(k) safety and effectiveness information is being submitted in accordance with the SMDA 1990 and 21 CFR 807.92.

DATE:

27 July 2004

SUBMITTER:

Heartlab Inc. One Crosswind Road Westerly, RI 02891 Phone: (401) 596-0592 Fax: (401) 596-8562

CONTACT PERSON:

Richard Petrocelli Tel No: (401) 596-0592

IDENTIFICATION OF THE PRODUCT

TRADE NAME:	Ultrasound Capture System™ (UCS)
COMMON NAME:	Ultrasound Capture System / EcoCapture
CLASSIFICATION NAME:	Image Processing System, LLZ

DEVICE DESCRIPTION / INTENDED USE:

The Ultrasound Capture System™ (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelt" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.

1. Allows demographic (Patient Name, ID etc.) input consistent with the DICOM standard for image storage.
1. Performs automatic image acquisition triggered by the cine-pedal.
1. Performs network transmission of images in DICOM format to a DICOM compatible storage system.

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SUBSTANTIAL EQUIVALENCE INFORMATION:

Ultrasound Capture System (UCS) is considered comparable and substantially equivalent to the following predicate devices currently in commercial distribution:

Model	Manufacturer
CineCapture System (K990857)	Heartlab, Inc.
Echocardiography System (K992259)	Camtronics, Ltd.

Predicate device specifications comparison:

	Principal Device –Ultrasound Capture System	Predicate Device – HeartlabCineCapture System	Predicate Device – CamtronicsEchocardiography System
ImageFormat	Lossy JPEG, DICOM 3.0	JPEG, DICOM 3.0	Lossy JPEG, DICOM 3.0
Compression	Variable, 10-12:1recommended compression	Lossless, 512x512, 2:1, 8 bit	Up to 30:1
VideoSource	S-video, or composite	High-line signal	RGB, YC, or composite
Display	1024x600 on small laptop,1024x768 on standardlaptop and desktopconfigurations	15" flat panel with speaker,up to 1024x768	17", 19", or 21" colormonitors, up to 1024x1024 24bit depth
OperatingSystem	Windows XP	Windows 2000	Windows 2000
UserInterface	Keyboard, mouse, and footpedal	Keyboard, mouse, and footpedal	User multifunction remotecontrol, and mini-remote
Network	Fast Ethernet	Fast Ethernet	Fast Ethernet
DICOM	Yes	Yes	Yes

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STANDARDS:

Ultrasound Capture System (UCS) is designed in accordance with product safety and performance requirements set forth in the following standards:

1. Digital Imaging and Communications in Medicine (DICOM)
21 CFR 1020.10 Video Monitor Performance Requirements 2.
1. 21 CFR 1040.10 Fiberoptic communications Performance
1. Society of Motion Picture and Television Engineers (SMPTE)
1. ACR/NEMA Data Compression Standard
1. Underwriters Laboratories (U.L.) Standard No. 544 for Medical and Dental Equipment
1. ISO/IEC 10918-1 Digital Compression and Coding Continuous-Tone Still Images (IPEG)
1. Underwriters Laboratories (U.L.) Standard No. 1950 Safety Standards

SUMMARY OF DESIGN CONTROL ACTIVITIES:

The software utilized was designed, developed, tested and validated according to written Design Control procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance. Potential hazards have been studied and controlled by a Risk Management Plan.

The following quality assurance design control measures were applied to the development of the Ultrasound Capture System™ product:

1. Risk Analysis
1. Requirement Reviews
1. Design Reviews
1. Testing on unit level (Module verification)
1. Integration testing (System verification)
1. Final acceptance testing (Validation)
1. Performance testing

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DECLARATION OF CONFORMITY (807.87(g) / 21 CFR 820.30)

All verification and validation activities were performed by the designated individual(s), and the results demonstrated that the predetermined acceptance criteria were met.

Danil n. hytind
Signature

Signature

Daniel Reifsteck, VP of Engineering Operations Typed Name

7/28/04
Dated

The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30, and the records are available for review.

Zuri Katilu

Signature

Lori Kahler, Quality Assurance Manager Typed Name

7-25-04

Dated

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CONCLUSIONS:

The principles of operation of the Ultrasound Capture System are substantially equivalent to the currently marketed products. This system poses no added risk to safety.

This concludes this 510(k) Summary.

Richard Petrocelli, President Heartlab, Inc

Attachments: Appendix A - Indications For Use Appendix B -- Ultrasound Capture System (UCS) Datasheet Appendix C - Predicate Device Promotional Material - Heartlab -CineCapture System Appendix D - Predicate Device Promotional Material - Camtronics - Echocardiography System

ONE CROSSWIND ROAD ・ WESTERLY, RI ・ 02891 PHONE: 401-596-0592 · FAX: 401-596-8562

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.

Public Health Service

SEP 2 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr Richard Petrocelli Official Correspondent . Heartlab, Inc. One Crosswind Road WESTERLY RI 02891 Re: K042042

Trade/Device Name: Ultrasound Capture System (UCS) Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: July 27, 2004 Received: August 3, 2004

Dear Mr. Petrocelli:

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 for use stated in the encreate) to 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 r ou may, therefere, mainer 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 If your device to such additional controls. Existing major regulations affecting your device can hay oe subject to sacer as a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toaso o determination that your device complies with other requirements of the Act that I DA has matutes 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to obgin maring of substantial equivalence of your device to a legally premarket notification: The PDF intellight on 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 If you desire specific advise for your be of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions 011 594-4639. Also, please note the regulation entitled, "Misbranding Other of Comphanoous (2017 2211 221 121 Part 807.97) you may obtain. Other general by receive to premance netitious. Er the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1901) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Boyden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/7/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in a bold, sans-serif font and is white against a black background. Below "Heartlab" is the phrase "CARDIAC SOLUTIONS" in a smaller, sans-serif font, also white against a black background.

Attachment

042

Ultrasound Capture System™ (UCS) Device Name:

Indications For Use:

The Ultrasound Capture System™ (UCS) system captures analog video and audio from any The Ultrasound Capture System™ (UCS) system catales aspured video to DICOM image
ultrasound with a composite or S-video output and converter running the ultrasound with a composite of 3-Vice outpat alta off-the-shelf' personal computer running the and audio files. OCS soltware runs on a bandard - on theo acquisition interface.

Prescription Use

David A. Lyman

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number_

ONE CROSSWIND ROAD · WESTERLY, RI · 02891 PHONE: 401-596-0592 ・ FAX: 401-596-8562

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).