TEL-ECHO SYSTEM

K990052 · Innovative Medical Solutions, Inc. · LLZ · Feb 19, 1999 · Radiology

Device Facts

• Record ID: K990052
• Device Name: TEL-ECHO SYSTEM
• Applicant: Innovative Medical Solutions, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Tel-Echo System is intended to acquire echocardiographic images during a cardiac ultrasound exam and transfer them to another location for viewing. This system is intended for tele-echocardiography applications.

Device Story

Tel-Echo System facilitates tele-echocardiography; acquires cardiac ultrasound images in parallel with existing recording methods (e.g., VCR); transmits images over telephone lines for remote review. Used in clinics to send exams to main clinics, physician homes, or offices for on-call coverage. System acts as communication conduit; does not archive data; relies on existing medical records (VCR tapes/digital media). Enables remote clinical review of echocardiographic exams; supports timely cardiac assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tele-echocardiography system; utilizes MPEG standard compression for image transmission; supports selectable compression ratios; operates over telephone lines/wide area networks; non-archiving communication device.

Indications for Use

Indicated for tele-echocardiography applications to acquire and transfer cardiac ultrasound images for remote viewing by clinicians.

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

• Network Concepts, Inc. Univision System (K964803)
• VMI Technologies EchoVacs (K971776)
• MPACS EchoLink (K980060)

Submission Summary (Full Text)

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# ATIVE MEDICAL SOLUTIONS

1250 Newport Drive Oconomowoc, WI 53066

K990052

## 9.0 510(k) Summary

#### Submitter

Innovative Medical Solutions 1250 Newport Drive Oconomowoc, WI 53066

#### Contact

Lawrence E. Sieb, Jr. Tel: [phone] Fax: [phone]

### Device Name

Classification: Unclassified Common/usual name: Tele-echocardiography system, a PACS (Picture Archive and Communications) device Proprietary Name: Tel-Echo System

#### Intended Use

The Tel-Echo System is intended to acquire echocardiographic images during a cardiac ultrasound exam and transfer them to another location for viewing. This system is intended for tele-echocardiography applications.

#### Device Description

The Tel-Echo System is designed specifically to transmit cardiac ultrasound (echocardiographic) exams over telephone lines for remote review. This application is usually referred to as tele-echocardiography.

A Tel-Echo System may send complete exams from a remote clinic to the main clinic. It may also send selected images to a physician's home or office for "on call" coverage. The Tel-Echo System acquires echocardiographic images in parallel with the VCR(Video Cassette Recorder) or other recording method. This VCR tape or equivalent digital media comprise the exam record and not the Tel-Echo system, which is for communication only.

# Comparisons to Predicate Device

The substantial equivalent devices are: the Network Concepts, Inc. Univision System, FDA 510K Number K964803; VMI Technologies EchoVacs product, FDA 510K Number K971776; and the MPACS EchoLink product, FDA 510K Number K980060.

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In reviewing the comparison between Innovative Medical's Tel-Echo system and the predicate devices, two differences are noted. One is that the Innovative Medical system and the MPACS system offer a choice of MPEG compression ratios while the Network Concepts and the VMI Technologies systems only offer one. The use of different compression ratios allows the user to match the speed of the data transfer with the bandwidth of different types of telecommunications line.

The other difference between the predicate devices and the Innovative Medical Tel-Echo system is that the predicate devices all offer an archive capability to replace the video cassette currently employed for archive. The Innovative Medical Solutions system does not offer archive capability and relies upon the user keeping the current medical record whether that be a video cassette or other media.

#### Conclusion

All of the predicate devices and Innovative Medical Solutions' Tel-Echo system are intended for use in an echocardiography laboratory. All of the predicate devices and the Innovative Medical Solutions' Tel-Echo system use similar technology to acquire exams for subsequent review over a wide area network and use MPEG standard compression. Thus, for tele-echocardiography, the Innovative Medical Solutions' device is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1999

Lawrence E. Sieb. Jr. President Innovative Medical Solutions 1250 Newport Drive Oconomowoc. WI 53066

Re:

K990052 Tel-Echo System Dated: January 6, 1999 Received: January 7, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Sieb:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or 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 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,

Robert Daniel O'Shaughnessy, M.D.

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

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#### 1 Page 1 of

510 (k) NUMBER (IF KNOWN): K990052

Tel-Echo System DEVICE NAME:

INDICATIONS FOR USE:

The Tel-Echo System is intended to acquire echocardiographic images during The Ter Lond Oyotom to intendoransfer them to another location for viewing. This system is intended for tele-echocardiography applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

・・

Prescription Use (Per 21 CFR 801.109) OR

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

Thiel h. Segnon

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev.

510(k) Number K990052