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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the SphygmoCor Px device, addressing your specific questions, with the caveat that the supplied document is a 510(k) summary and not a full study report, so some details are not explicitly stated.

The SphygmoCor Px is a computerized tool designed to provide calibrated central aortic pressure waveforms non-invasively. It achieves this by using a non-invasive tonometer over the radial artery, calibrated with a conventional brachial cuff measurement. Its primary function is to derive the central aortic blood pressure waveform and associated arterial indices.

Acceptance Criteria and Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device (SphygmoCor Mx) rather than specific numerical acceptance criteria for performance metrics like accuracy, sensitivity, or specificity. The core acceptance criterion for the SphygmoCor Px is that its non-invasive radial artery waveform acquisition method is substantially equivalent to the invasive method used by the predicate device for generating central aortic pressure waveforms.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial equivalence of non-invasive radial artery pressure waveforms to invasively measured waveforms.	A study by Kelly et al. "demonstrated that the two sets of input radial artery waveforms are substantially equivalent." This implies that the waveforms acquired non-invasively by the SphygmoCor Px system (using the Millar tonometer and brachial cuff calibration) are comparable enough to the invasively acquired waveforms (using a catheter in the radial artery by the SphygmoCor Mx) such that the subsequent signal processing (which is the same for both devices) yields equivalent central aortic pressure waveforms. The document also cites "other publications, and the experience of the clearance of the Colin 7000 and the Millar tonometer itself" as further support for substantial equivalence.
Compliance with electrical and environmental safety standards.	The entire system "has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard" for input voltages of 110 and 220 volts. This demonstrates the device meets safety standards for safe use.

Acceptance Criterion (Implicit)

Reported Device Performance

Substantial equivalence of non-invasive radial artery pressure waveforms to invasively measured waveforms.

A study by Kelly et al. "demonstrated that the two sets of input radial artery waveforms are substantially equivalent." This implies that the waveforms acquired non-invasively by the SphygmoCor Px system (using the Millar tonometer and brachial cuff calibration) are comparable enough to the invasively acquired waveforms (using a catheter in the radial artery by the SphygmoCor Mx) such that the subsequent signal processing (which is the same for both devices) yields equivalent central aortic pressure waveforms. The document also cites "other publications, and the experience of the clearance of the Colin 7000 and the Millar tonometer itself" as further support for substantial equivalence.

Compliance with electrical and environmental safety standards.

The entire system "has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard" for input voltages of 110 and 220 volts. This demonstrates the device meets safety standards for safe use.

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The provided text does not specify the sample size for the Kelly et al. study.
- Data Provenance: The document implies the study was conducted by Kelly et al., but does not state the country of origin of the data. The study compared invasive and non-invasive radial artery pressure waveforms. Given the nature of medical device development, it's highly likely to be a prospective study designed for this comparison.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not mention the use of experts to establish ground truth for the test set in the way often seen for AI/image analysis devices. The comparison is between two methods of acquiring radial artery waveforms, with the invasive catheter measurement serving as the de facto "ground truth" for waveform acquisition. Therefore, a separate expert consensus for the test set, beyond the physician's role in performing the invasive procedure, is not described or apparently necessary for this type of comparison.
Adjudication Method for the Test Set:
- Given the nature of the comparison (invasive vs. non-invasive waveform acquisition), adjudication methods like 2+1 or 3+1 are not applicable and are not mentioned. The comparison is objective, based on signal analysis.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed or described. The device is a "Blood Pressure Computer" that calculates a waveform, not an diagnostic imaging device where human readers interpret outputs. The comparison is at the level of the input data (radial artery waveforms).
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- The document implies a standalone performance comparison in the context of the Kelly et al. study. The comparison is specifically between the invasively acquired radial waveform and the non-invasively acquired radial waveform. The SphygmoCor Px then processes the non-invasive waveform using the same signal processing software as the predicate device (SphygmoCor Mx). Therefore, the "algorithm only" performance is assessed by confirming the equivalence of the input waveforms to this shared algorithm. Once the input is equivalent, the algorithmic output is assumed to be equivalent.
Type of Ground Truth Used:
- The ground truth for the comparison in the Kelly et al. study implicitly involves invasively measured radial artery pressure waveforms acquired via catheter. This is considered the gold standard for direct arterial pressure measurement.
Sample Size for the Training Set:
- The document does not mention a separate "training set" as one would typically see for machine learning or AI models. The SphygmoCor Px uses existing signal processing software that was presumably developed and validated over time. The Kelly et al. study is a validation study comparing the input data streams, not a training study for the algorithm itself.
How the Ground Truth for the Training Set Was Established:
- As there's no explicitly mentioned "training set" for the SphygmoCor Px's algorithm, this question is not directly applicable to the information provided. The signal processing algorithms for deriving central aortic pressure waveforms were likely developed and validated against invasive central aortic pressure measurements (e.g., from cardiac catheterization) in previous research, which forms the basis for both the SphygmoCor Mx and Px. However, the details of that initial algorithm development and validation are not supplied in this 510(k) summary.

Summary

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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 signal processing electronics module is attached to a PC computer through a serial RS-232C port.

C. Indications for Use

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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:

(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)

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

Division of Cardiovascular & Respiratory Devices
510(k) Number K012487

Regulation Number and Section

§ 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).