ULTRASOUND CAPTURE SYSTEM

K042042 · Heartlab, Inc. · LLZ · Sep 21, 2004 · Radiology

Device Facts

• Record ID: K042042
• Device Name: ULTRASOUND CAPTURE SYSTEM
• Applicant: Heartlab, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 21, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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-shelf" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.

Device Story

UCS captures analog video/audio from ultrasound systems via composite or S-video inputs; converts signals into DICOM-compliant image/audio files. Operates on standard Windows XP PC with high-resolution video acquisition interface. Used in clinical settings by healthcare professionals. Features include demographic data entry, cine-pedal triggered acquisition, and network transmission to DICOM storage systems. Benefits include integration of legacy analog ultrasound data into digital DICOM workflows, facilitating image management and clinical decision-making.

Clinical Evidence

Bench testing only. Validation included module verification, system integration testing, and final acceptance testing performed under design control procedures to ensure compliance with DICOM standards and performance requirements.

Technological Characteristics

PC-based system running Windows XP; high-resolution video acquisition interface. Inputs: composite or S-video. Outputs: DICOM 3.0 files (lossy JPEG compression, 10-12:1). Connectivity: Fast Ethernet. Standards: DICOM, ISO/IEC 10918-1 (JPEG), SMPTE, UL 544, UL 1950. User interface: keyboard, mouse, foot pedal.

Indications for Use

Indicated for capturing analog video and audio signals from ultrasound equipment with composite or S-video outputs for conversion into DICOM-compliant image and audio files for storage and transmission.

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

• CineCapture System (K990857)
• Echocardiography System (K992259)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

## CONTACT PERSON:

Richard Petrocelli Tel No: [phone]

## 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.
- 2. Performs automatic image acquisition triggered by the cine-pedal.
- 3. 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 –<br>Ultrasound Capture System | Predicate Device – Heartlab<br>CineCapture System | Predicate Device – Camtronics<br>Echocardiography System |
|---------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------|
| Image<br>Format | Lossy JPEG, DICOM 3.0 | JPEG, DICOM 3.0 | Lossy JPEG, DICOM 3.0 |
| Compression | Variable, 10-12:1<br>recommended compression | Lossless, 512x512, 2:1, 8 bit | Up to 30:1 |
| Video<br>Source | S-video, or composite | High-line signal | RGB, YC, or composite |
| Display | 1024x600 on small laptop,<br>1024x768 on standard<br>laptop and desktop<br>configurations | 15" flat panel with speaker,<br>up to 1024x768 | 17", 19", or 21" color<br>monitors, up to 1024x1024 24<br>bit depth |
| Operating<br>System | Windows XP | Windows 2000 | Windows 2000 |
| User<br>Interface | Keyboard, mouse, and foot<br>pedal | Keyboard, mouse, and foot<br>pedal | User multifunction remote<br>control, 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.
- 3. 21 CFR 1040.10 Fiberoptic communications Performance
- 4. Society of Motion Picture and Television Engineers (SMPTE)
- 5. ACR/NEMA Data Compression Standard
- 6. Underwriters Laboratories (U.L.) Standard No. 544 for Medical and Dental Equipment
- 7. ISO/IEC 10918-1 Digital Compression and Coding Continuous-Tone Still Images (IPEG)
- 8. 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
- 2. Requirement Reviews
- 3. Design Reviews
- 4. Testing on unit level (Module verification)
- 5. Integration testing (System verification)
- 6. Final acceptance testing (Validation)
- 7. 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: [phone] · FAX: [phone]

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

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 [phone] 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: [phone] ・ FAX: [phone]