(43 days)
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.
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.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it describes a 510(k) submission for the "Tel-Echo System," which is a tele-echocardiography device. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria.
The 510(k) summary states, "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." This indicates the device is a communication tool, not a diagnostic one that would typically require validation of clinical performance (e.g., diagnostic accuracy metrics).
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study proving performance, as this information is not present in the provided text. The document is concerned with the functional equivalence of the communication capabilities rather than diagnostic performance.
However, I can extract information related to the comparison with predicate devices, which serves as the basis for its regulatory clearance:
Summary of Device Comparison and Regulatory Basis:
| Feature | Tel-Echo System (Innovative Medical Solutions) | Predicate Devices (Network Concepts Univision, VMI Technologies EchoVacs, MPACS EchoLink) |
|---|---|---|
| Intended Use | Acquire echocardiographic images and transfer them to another location for viewing; tele-echocardiography applications. | Perform tele-echocardiography applications (implied for all, explicitly stated for MPACS EchoLink). |
| Technology | Transmits cardiac ultrasound exams over telephone lines for remote review; uses MPEG standard compression. | Transmit exams for subsequent review over a wide area network; use MPEG standard compression. |
| Compression Ratios | Offers a choice of MPEG compression ratios to match data transfer speed with telecommunications bandwidth. | Network Concepts and VMI Technologies offer only one compression ratio. MPACS offers a choice. |
| Archive Capability | Does not offer archive capability; relies on user to keep current medical record (VCR tape or other media). | All predicate devices offer an archive capability to replace VCRs. |
| Function | Communication only; exam record is the VCR tape or equivalent digital media. | Communication and in some cases, archiving. |
Study Details (Not applicable as a performance study with acceptance criteria was not described):
As the provided text does not describe a performance study with specific acceptance criteria validating the device's clinical efficacy, most of the requested information is not available. The submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily focusing on its communication function and the technical aspects of data transfer and compression.
Given this, I cannot answer questions 1-9 directly as requested for a performance study. The 510(k) process for this device focused on functional comparison rather than a clinical performance study with acceptance criteria.
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ATIVE MEDICAL SOLUTIONS
1250 Newport Drive Oconomowoc, WI 53066
9.0 510(k) Summary
Submitter
Innovative Medical Solutions 1250 Newport Drive Oconomowoc, WI 53066
Contact
Lawrence E. Sieb, Jr. Tel: 414-569-5716 Fax: 414-567-0689
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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
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 (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/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
§ 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).