(231 days)
No
The description explicitly states that "No diagnostic decisions are made by the program" and that it is not intended to replace a skilled technologist, focusing on data management and reporting efficiency. There is no mention of AI, ML, or any learning algorithms.
No
The device is a computer program designed to process, store, and report data from vascular diagnostic instruments. It explicitly states, "No diagnostic decisions are made by the program," and "The program is not intended to replace the need for a skilled vascular technologist." Its purpose is to enhance efficiency in reporting rather than to provide therapy or directly influence patient treatment.
Yes
Explanation: The "Intended Use" section states NIVP3 is used with "Hokanson vascular diagnostic instruments" to produce "comprehensive reports" that include "plethysmographic and Doppler waveforms and blood pressure measurements," all of which are diagnostic data. The "Device Description" also mentions that "No diagnostic decisions are made by the program," implying that the program processes data from diagnostic instruments to aid human diagnosis.
Yes
The device is described as a "computer program" and its function is to process data from external medical devices, store it, and generate reports. While it interacts with hardware (Hokanson instruments and a PC), the device itself is the software component that performs data management and reporting, not the hardware that acquires the data.
Based on the provided text, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that NIVP3 is a computer program used with vascular diagnostic instruments to process and report data from plethysmographic and Doppler waveforms and blood pressure measurements. These are measurements taken directly from the patient's body using non-invasive methods, not from samples taken from the body.
- No mention of samples: There is no mention of analyzing biological samples in the intended use or device description.
- Focus on data processing and reporting: The program's primary function is to collect, store, sort, retrieve, and print data from the connected instruments, and to improve the efficiency of the vascular technologist in creating reports.
Therefore, NIVP3 falls under the category of a medical device used for non-invasive physiological measurements and data management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NIVP3 is a computer program which is used with Hokanson vascular diagnostic instruments and an IBM compatible personal computer to produce comprehensive reports. These reports are stored in a computer database and may be sorted, retrieved, and printed. The program allows the user to select and record plethysmographic and Doppler waveforms and blood pressure measurements .. Patient demographics and history are also stored by the program. The user may enter comments to enhance the report.
Product codes
74 DOK
Device Description
Safety and effectiveness of NIVP3 are equal or better than for NIVP. The same non-invasive diagnostic instruments are used to provide data inputs to the computer. These are the MD35 Procord (K896034), the TL400 Totalab (K872517), the EC5R Plethysmograph (K932812), and the TD312 Calculating Cuff Inflator K842067). In each case optical isolation is employed to prevent electrical leakage from a computer power supply from reaching the diagnostic instrument, and from there being able to reach a patient. There is no direct electrical connection from the computer to the diagnostic instrument. Data is collected by the computer and incoming waveforms are displayed on the computer screen. The user selects the data to be retained and may edit decision points by moving cursors on the screen. The data is stored in a database using the ACCESS® database engine. A run-time version of ACCESS® is furnished with the program.
No diagnostic decisions are made by the program. The program is not intended to replace the need for a skilled vascular technologist, but is intended to increase the technologist's efficiency by eliminating the need for cutting out chart recordings and writing extensive reports. The advantages of using NIVP3 are that reports are neat and uniform and that patient records are easily stored and retrieved. In some cases tests, like arterial inflow, are semi automated since the program can perform some functions such as inflate a cuff or balance and calibrate the plethysmograph at the correct time to facilitate data collection. Extensive use is made of the Windows® help system to aid the user in operation of the program and give instructions on how to perform certain diagnostic tests.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
skilled vascular technologist / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K896034, K872517, K932812, K842067
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
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KA110510
OCT - 3 1997
510(k) Summarv
Safety and effectiveness of NIVP3 are equal or better than for NIVP. The same non-invasive diagnostic instruments are used to provide data inputs to the computer. These are the MD35 Procord (K896034), the TL400 Totalab (K872517), the EC5R Plethysmograph (K932812), and the TD312 Calculating Cuff Inflator K842067). In each case optical isolation is employed to prevent electrical leakage from a computer power supply from reaching the diagnostic instrument, and from there being able to reach a patient. There is no direct electrical connection from the computer to the diagnostic instrument. Data is collected by the computer and incoming waveforms are displayed on the computer screen. The user selects the data to be retained and may edit decision points by moving cursors on the screen. The data is stored in a database using the ACCESS® database engine. A run-time version of ACCESS® is furnished with the program.
No diagnostic decisions are made by the program. The program is not intended to replace the need for a skilled vascular technologist, but is intended to increase the technologist's efficiency by eliminating the need for cutting out chart recordings and writing extensive reports. The advantages of using NIVP3 are that reports are neat and uniform and that patient records are easily stored and retrieved. In some cases tests, like arterial inflow, are semi automated since the program can perform some functions such as inflate a cuff or balance and calibrate the plethysmograph at the correct time to facilitate data collection. Extensive use is made of the Windows® help system to aid the user in operation of the program and give instructions on how to perform certain diagnostic tests.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine and healthcare.
OCT - 3 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. D. Eugene Hokanson D.E. Hokanson, Incorporated 12840 Northeast 21st Place Bellevue, Washington 98005
Re: K970570 Non-Invasive Vascular Program (NIVP3) Version 5.17 Requlatory Class: II (two) Product Code: 74 DOK Dated: July 15, 1997 Received: July 17, 1997
Dear Mr. Hokanson:
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 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, Druq, 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 II (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.
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Page 2 - Mr. D. Eugene Hokanson
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) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639.
"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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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