(203 days)
Not Found
No
The description focuses on signal processing and waveform analysis using a computerized tool, without mentioning AI or ML techniques.
No
The device is described as a computerized tool for the assessment of blood pressure and for providing information related to ascending aortic pressure and central arterial indices. Its intended use is diagnostic, providing information to a physician, not therapeutic intervention.
Yes
Explanation: The device is used to derive an ascending aortic blood pressure waveform and central arterial indices, providing information related to the ascending aortic pressure. This information is used by a physician to assess blood pressure, which is a diagnostic activity.
No
The device description explicitly mentions a "SphygmoCor electronics module" and its connection to a PC computer, indicating the presence of hardware components beyond just software.
Based on the provided information, the SphygmoCor Px is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- SphygmoCor Px Function: The SphygmoCor Px measures and analyzes physiological signals (radial artery pressure waveform) from the patient's body using a non-invasive tonometer. It then uses this information, along with a cuff blood pressure measurement, to derive a central arterial pressure waveform and indices.
- No Specimen Examination: The device does not examine any biological specimens derived from the human body. It directly interacts with the patient's circulatory system to acquire a pressure signal.
Therefore, the SphygmoCor Px falls under the category of a non-invasive physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SphygmoCor Px is indicated for use in those patients where information related to the ascending aortic pressure is desired, but in the opinion of the physician, the risks of the intra-arterial radial artery pressure recording procedure may outweigh the benefits of using the SphygmoCor Mx system with an invasive radial pressure input.
The SphygmoCor Px provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The SphygmoCor is used with a tonometer over the radial artery calibrated with a standard cuff blood pressure measurement. It is to be used in those patients where information related to the ascending aortic pressure is desired but in the opinion of the physician, the risks of the cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
Product codes (comma separated list FDA assigned to the subject device)
DSK
Device Description
The SphygmoCor SCOR-Px is a computerized tool for the assessment of blood pressure. The SphygmoCor can calculate the calibrated ascending aortic pressure probater - 110 g the radial artery pressure waveform recorded non-invasively from a radial artery tonometer and a brachial cuff measurement.
An eight-second segment of the radial artery pressure signal is processed in the SphygmoCor electronics module to derive the calibrated ascending aorta pressure waveform and to derive central pressure waveform parameters.
The signal processing electronics module is attached to a PC computer through a serial RS-232C port.
The patient's study report appears on the PC computer and displays the measured (radial) and calculated (central) waveforms, allows input of patient information, and provides the operator with instructions. It uses an IBM-compatible computer (notebook or desktop) to run the SphygmoCor computer software suite.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Radial artery, ascending aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A study was carried by Kelly et al. out that compared the radial artery pressure waveforms measured invasively with a catheter in the radial artery to radial artery pressure waveforms produced by the noninvasive Millar tonometer calibrated with a brachial cuff measurement. This Kelly study demonstrated that the two sets of input radial artery waveforms are substantially equivalent. The entire system has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard. Testing was done to demonstrate compliance with this standard for input voltages of both 110 and 220 volts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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FEB 2 1 2002
510(k) Summary
SphygmoCor™ Px
Common/Classification Name: Blood Pressure Computer as classified per 21 CFR 870.1110
AtCor Medical Pty Ltd. West Ryde Corporate Centre 11/1059-1063 Victoria Road West Ryde NSW 2114 Australia
011-61-2-9874-8761 011-61-2-9876-9022 (Fax) Contact: Ross Harricks, CEO
Legally Marketed Predicate Devices A.
The SphygmoCor SCOR-Px is substantially equivalent to the SphygmoCor Mx cleared under K002742. Both systems have the same intended use, which is to provide the calibrated central aortic pressure waveform.
Device Description B.
The SphygmoCor SCOR-Px is a computerized tool for the assessment of blood pressure. The SphygmoCor can calculate the calibrated ascending aortic pressure probater - 110 g the radial artery pressure waveform recorded non-invasively from a radial artery tonometer and a brachial cuff measurement.
An eight-second segment of the radial artery pressure signal is processed in the SphygmoCor electronics module to derive the calibrated ascending aorta pressure waveform and to derive central pressure waveform parameters.
The signal processing electronics module is attached to a PC computer through a serial RS-232C port.
The patient's study report appears on the PC computer and displays the measured (radial) and calculated (central) waveforms, allows input of patient information, and provides the operator with instructions. It uses an IBM-compatible computer (notebook or desktop) to run the SphygmoCor computer software suite.
C. Indications for Use
The SphygmoCor Px is indicated for use in those patients where information related to the ascending aortic pressure is desired, but in the opinion of the physician, the risks of the intra-arterial radial artery pressure recording procedure may outweigh the benefits of using the SphygmoCor Mx system with an invasive radial pressure input.
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Kol2487 p. 2/2
D. Substantial Equivalence Summary
The primary function of both types of devices is to provide the calibrated central aortic blood pressure waveform. The SphygmoCor Mx requires the pressure catheter to be placed directly in the radial artery to acquire the radial artery pressure waveform and, simultaneously, pressurements. The SphygmoCor Px uses the signal from a non-invasive tonometer placed over the radial artery to obtain the waveform, with the systolic and diastolic pressure calibrations being obtained from a conventional brachial cuff measurement. The SphygmoCor Px derives from this calibrated radial artery waveform the central aortic blood pressure waveform and a range of central arterial indices of ventricular-vascular interaction.
Since the SphygmoCor Mx and Px use the same input signal processing software, differences in the calculated central aortic blood pressure waveforms would only be due to differences in the patient characteristics. A study was carried by Kelly et al. out that compared the radial artery pressure waveforms measured invasively with a catheter in the radial artery to radial artery pressure waveforms produced by the noninvasive Millar tonometer calibrated with a brachial cuff measurement. This Kelly study demonstrated that the two sets of input radial artery waveforms are substantially equivalent. Other publications, and the experience of the clearance of the Colin 7000 and the Millar tonometer itself, additionally support substantial equivalence of the SphygmoCor Px to the predicate.
E. Technological Characteristics
See Device Description, above.
F. Performance Testing
The entire system has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard. Testing was done to demonstrate compliance with this standard for input voltages of both 110 and 220 volts. The biocompatibility testing clause of the standard was not applied since the only patient contact material is in the previously cleared tonometer. This testing demonstrates that the SphygmoCor Px meets electrical and environmental safety standards for safe use.
G. Conclusions
AtCor Medical has demonstrated through its comparison of performance with the predicate device that the SphygmoCor Px is equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing left. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2002
AtCor Medical Pty. Ltd. c/o Jur Strobos, M.D. Olsson, Frank & Weeda, P.C. 1400 16th Street, NW Suite 400 Washington, DC 20036
Re: K012487
Trade Name: SphygmoCor Px Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: II (two) Product Code: DSK Dated: November 28, 2001 Received: November 28, 2001
Dear Dr. Strobos:
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 such 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.
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Page 2 - Jur Strobos, M.D.
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 or any I odetar butter and equirements, 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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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). 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,
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Device Name: SphygmoCor Px
Indications for Use:
The SphygmoCor Px provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The SphygmoCor is used with a tonometer over the radial artery calibrated with a standard cuff blood pressure measurement. It is to be used in those patients where information related to the ascending aortic pressure is desired but in the opinion of the physician, the risks of the cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
(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)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012487