ECHOCARDIOGRAPHY SYSTEM SERIES 95000

K992259 · Camtronics, Ltd. · LLZ · Sep 8, 1999 · Radiology

Device Facts

• Record ID: K992259
• Device Name: ECHOCARDIOGRAPHY SYSTEM SERIES 95000
• Applicant: Camtronics, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

A digital image capture, storage, and review system for echocardiography.

Device Story

System provides digital image transport and archive solution for hospitals; replaces VCR-based systems. Inputs: RGB, YC, or composite video signals from echo machines. Transforms inputs via JPEG compression (up to 30:1) for digital storage. Outputs: digital images for review on high-resolution monitors (17", 19", or 21"). Used in cardiac echo departments; operated by clinical staff. Facilitates high-speed digital link between echo machines and review stations; eliminates manual VCR tape handling. Enables digital archival of exams; improves workflow efficiency and storage convenience for healthcare providers.

Clinical Evidence

No clinical data; not required for determination of substantial equivalence for this class of device.

Technological Characteristics

System components: Image Acquisition Unit, Review Station, Image Server. Hardware: Pentium II processors, Windows NT 4.0 OS. Connectivity: Fast Ethernet, DICOM compliant. Video inputs: RGB, YC, composite. Compression: JPEG (up to 30:1). Storage: Internal hard disk, CD-R, DLT tape. Display: 1024x1024 24-bit color monitors.

Indications for Use

Indicated for use as a digital image capture, storage, and review system for echocardiography in clinical settings.

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

• MPACS, LLC "EchoLINK" (K980060)

Submission Summary (Full Text)

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K992259

Image /page/0/Picture/1 description: The image shows the logo for Camtronics Medical Systems. The logo consists of a stylized "C" shape with three horizontal lines inside, followed by the text "Camtronics" in a bold, sans-serif font. Below "Camtronics" is the text "MEDICAL SYSTEMS" in a smaller font. The date "SEP 8 1999" is printed below the logo.

510(k) Summary

Date prepared: June 30, 1999 Name of contact person: Robert Kriedermann Device trade name: Echocardiography System Common name: Echocardiography System Classification name: Picture Archiving and Communications System Predicate substantially equivalent devices: K980060 MPACS, LLC "EchoLINK"

Device description and intended use: The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.

## Predicate device specifications comparison:

| | Principal Device | Predicate Device<br>MPACS "EchoLINK" K980060 |
|-------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------|
| | Camtronics<br>Echocardiography System | |
| Image Acquisition Unit | | |
| Compression type and<br>ratio | JPEG, up to 30:1 | MPEG2 up to 55:1 |
| Video source | RGB, YC, or composite input | S-Video or Composite, NTSC or<br>PAL |
| Computer/operating<br>system | Pentium II/Windows NT4.0 | Pentium II, 350 MH/Windows<br>NT4.0 |
| User interface | User multifunction remote<br>control, and mini-remote | Keypad and trackball |
| Review Station | | |
| Image storage media | Internal hard disk, CD-R | Internal hard disk, removable 3.5"<br>magneto-optical disk |
| Display | 17", 19", or 21" color monitors,<br>up to 1024x1024 24 bit depth | 21" color monitor, 1024x768, 24<br>bit color depth |
| Computer/operating<br>system | Pentium II, 400 MHz/windows<br>NT 4.0 | Pentium II, 350 MHz/Windows<br>NT4.0 |
| User interface | Keyboard, mouse, and rotary<br>playback control | Keyboard and mouse |
| Image Server | | |
| Media | CD-R, or DLT tape, or others<br>as available | 100 CD-R |
| Storage capacity | up to 2 weeks of studies on-<br>line, and approx 1 year near-<br>line | 20 minutes per CD-R at 4Mb/s<br>MPEG2 |
| Network | | |
| Type | Fast Ethernet | Fast Ethernet |
| DICOM | Yes | Yes |

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Page 2 Camtronics Echocardiography System 510(k) Summary June 30, 1999

Performance data: Not required for determination of substantial equivalence for this class of device.

Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.

Substantial equivalence summary: The Camtronics Echocardiography System is a comparable type and substantially equivalent to a legally marketed predicate device. The intended use of the Camtronics Echocardiography System is the same as that of the predicate device "EchoLINK" marketed by MPACS, LLC. No new safety or effectiveness issues are raised with the Camtronics Echocardiography System. The subject device has substantially equivalent technological characteristics, features, specifications, materials, modes of operation, and intended uses as a legally marketed predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 SEP

Robert Kriedermann Regulatory Specialist Camtronics, Ltd. 900 Walnut Ridge Drive P.O. Box 950 Hartland, Wisconsin 53029 Re:

K992259 Camtronics Echocardiography System Dated: June 30, 1999 Received: July 6, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Kriedermann:

We have reviewed your Section 510(k) 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 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). 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. Iisting 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes 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 device as described in your 510(k) 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 (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head, represented by three curved lines.

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## l Page of

K992259 510(k) NUMBER (IF KNOWN) : Echocardiography System DEVICE NAME :

INDICATIONS FOR USE:

A digital image capture, storage, and review system for echocardiography.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﮨﮯ (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

David A. Syzman

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992259

Over-The-Counter-Use
(Optional Format 1-2-