(66 days)
The device is intended to be used by health care professionals in the field of echocardiography. The device is capable of transferring ultrasound images over long distances as digital files. It is used to transmit echocardiograms over the Internet for the purpose of interpretation of echocardiograms at a remote location. It is anticipated that it will be used when echocardiograms must be performed in a location where no interpreting cardiologist is present, and will facilitate prompt interpretation of echocardiograms. It should be particularly useful in rural areas of the United States.
Echoencoder is a combined software-hardware system that is composed of three parts: 1) a system for conversion of analog echocardiographic video to a Quicktime movie file format, and subsequent automated transfer of that file to an Internet server; 2) a system for conversion of digital echocardiographic video to a Quicktime movie file format, and subsequent automated transfer of that file to an Internet server; and 3) an optional Server based database system for tracking of interpretations of the video so obtained.
The system for analog video conversion is composed of a Macintosh computer equipped with the echoencoder software, and a video cassette recording device equipped with a video digitizer. The cassette recorder is interfaced with the computer via a firewire cable. The operator inserts a video cassette into the video cassette recorder, and uses the software program to convert the video into a Quicktime movie, perform MPEG-4 based video compression to compress the file by approximately 50:1, and transfer the file to a server where it can be subsequently reviewed by a Cardiologist.
The system for digital video conversion is also composed of a Macintosh computer equipped with the echoencoder software, and is interfaced with a health care provider's network server. The operator selects the file to be converted, generally in DICOM format, and the software subsequently converts the video into a Quicktime movie, performs MPEG-4 based video compression to compress the file by approximately 25:1, and transfers the file to a server where it can be subsequently reviewed by a Cardiologist.
The server based database product is, by the customer's option, interfaced with the above described Echoencoder system. This system that is based on the software product Filemaker Pro, and allows for electronic report generation and review.
The provided text describes a 510(k) submission for the "Echoencoder" device but does not contain acceptance criteria or a study proving the device meets specific performance criteria.
The document focuses on demonstrating substantial equivalence to predicate devices (Tel-Echo System K990052 and EchoLINK K980060) based on intended use and technological characteristics, rather than a performance study with defined acceptance criteria.
Therefore, many of the requested sections regarding performance studies, sample sizes, expert ground truth, and adjudication methods cannot be extracted from this document.
Here's an attempt to answer the questions based on the available information, noting the missing data:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The submission focuses on substantial equivalence based on function and technology, not specific performance metrics. | Not provided in the document. The document describes features of the device (e.g., compression ratios, image resolution) but does not present data from a performance study against acceptance criteria. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No performance study with a test set is described.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No performance study with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No performance study with a test set requiring 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 comparative effectiveness study is mentioned. The device is a "conversion and transfer software system," not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies a standalone function of the software in converting and transferring files, but it doesn't describe a formal standalone performance study with defined metrics. The focus is on the technical capability of conversion and transfer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No performance study requiring ground truth is described.
8. The sample size for the training set
- Not applicable. The device is not a machine learning or AI-based system that typically requires a training set in the context of diagnostic accuracy. It's a data conversion and transfer system.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not a machine learning device.
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K03 23,24
OCT = 2 2003
- 510(k) Summary
| Date prepared: | 7/1/03 |
|---|---|
| Name of contact person: | James P. Loehr, M.D. |
| Icardiogram, Incorporated | |
| 100 East Six Forks Road | |
| Suite 305 | |
| Raleigh, NC 27609 | |
| 919-534-2150 (telephone) | |
| 919-534-2168 (fax) | |
| Device trade name: | Echoencoder |
| Common Name: | Echocardiogram encoding and transfer software system |
| Classification Name: | Class II |
| 892.2031 Medical image digitizer | |
| 892.2050 Picture archiving and communications system |
Predicate substantially equivalent devices:
| K990052 Tel-Echo System | |
|---|---|
| K980060 EchoLINK |
Device description:
Echoencoder is a combined software-hardware system that is composed of three parts: 1) a system for conversion of analog echocardiographic video to a Quicktime movie file format, and subsequent automated transfer of that file to an Internet server; 2) a system for conversion of digital echocardiographic video to a Quicktime movie file format, and subsequent automated transfer of that file to an Internet server; and 3) an optional Server based database system for tracking of interpretations of the video so obtained.
The system for analog video conversion is composed of a Macintosh computer equipped with the echoencoder software, and a video cassette recording device equipped with a video digitizer. The cassette recorder is interfaced with the computer via a firewire cable. The operator inserts a video cassette into the video cassette recorder, and uses the software program to convert the video into a Quicktime movie, perform MPEG-4 based video compression to compress the file by approximately 50:1, and transfer the file to a server where it can be subsequently reviewed by a Cardiologist.
The system for digital video conversion is also composed of a Macintosh computer equipped with the echoencoder software, and is interfaced with a health care provider's network server. The operator selects the file to be converted, generally in DICOM format, and the software subsequently converts the video into a Quicktime movie, performs MPEG-4 based video compression to compress the file by approximately 25:1, and transfers the file to a server where it can be subsequently reviewed by a Cardiologist.
The server based database product is, by the customer's option, interfaced with the above described Echoencoder system. This system that is based on the software product Filemaker Pro, and allows for electronic report generation and review.
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Intended Use
The device is intended to be used by health care professionals in the field of echocardiography. It is anticipated that it will be used when echocardiograms must be performed in a location where no interpreting cardiologist is present, and will facilitate prompt interpretation of echocardiograms. The device is capable of transferring ultrasound images over long distances as digital files.
Substantial Equivalency Comparison
There are technological differences between Echoencoder and the equivalent devices, but these differences do not alter the effectiveness or safety of the new device.
Echoencoder is substantially equivalent to the EchoLINK device in that both provide for conversion of analog data to a digital format. The EchoLINK device uses MPEG-2 video compression at a ratio of 55:1, and provides full audio sound; depending on the source video, Echoencoder uses a compression ratio of between 20:1. Echoencoder uses a MPEG-4 compression method, which allows for a wide range of final data transmission speeds, resulting in the creation of a Quicktime movie which can be viewed full-screen by a free viewer on any computer platform. Both products provide a method for remote viewing of echocardiograms, and both provide a method of report generation. The Echoencoder method produces an image which is 640 x 480 pixels instead of 325 x 245 for MPACS.
The Tel-Echo system is also designed for remote echocardiography interpretation and uses MPEG compression. It differs from Echoencoder in the type of MPEG used, and sends the video to an Internet server as opposed to transfer directly to an interpreting cardiologist by the Tel-Echo system.
Conclusion
Echoencoder, EchoLINK, and Tel-Echo are all used for the same purpose, to convert echocardiographic video into digital files for transfer over communications lines. All use compression techniques that are comparable in degree, and all use MPEG, although the Echoencoder technique is unique in that it uses MPEG-4 and can be viewed using a free video player (Quicktime).
Based on the intended use and comparisons with legally marketed devices noted here, Echoencoder is substantially equivalent, safe, and at least as effective as the EchoLINK and Tel-Echo products.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
James Loehr. M.D. President . Icardiogram, Inc. 100 East Six Forks Road, Ste. 305 RALEIGH NC 27609
Re: K032324
Trade/Device Name: Echoencoder Regulation Number: 21 CFR §892.2030 Regulation Name: Medical image digitizer Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 1, 2003 Received: July 30, 2003
Dear Dr. Loehr:
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 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) 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 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes 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) 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), please contact the Office of Compliance at one 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
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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1132324
INDICATION FOR USE
Icardiogram, Incorporated Applicant:
Applied for 510(k) Number:
Echoencoder Device name:
Indication for Use:
The device is intended to be used by health care professionals in the field of echocardiography. The device is capable of transferring ultrasound images over long distances as digital files. It is used to transmit echocardiograms over the Internet for the purpose of interpretation of echocardiograms at a remote location. It is anticipated that it will be used when echocardiograms must be performed in a location where no interpreting cardiologist is present, and will facilitate prompt interpretation of echocardiograms. It should be particularly useful in rural areas of the United States.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH. Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
OR
Prescription Use Per 21 CFR 801.109
Over-the-Counter (Optional Format 1-2-96)
David G. Ligman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K082324
§ 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).