The SphygmoCor® Cardiovascular Management System (CvMS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The CvMS is used with a tonometer over a radial artery calibrated with a standard cuff blood pressure measurement. It is to be used on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The CvMS Heart Rate Variability (HRV) option is intended for use in obtaining HRV measurements in response to controlled exercises.

The CvMS Pulse Wave Velocity (PWV) option is intended for use in obtaining PWV measurements. The PWV option is used on adult patients only.

Device Description

The SphygmoCor CvMS device (un-modified device) is a computerized tool for providing a derived ascending aortic blood pressure waveform and a range of central anterial indices. The CvMS is used with a tonometer over the radial artery to capture a pressure waveform which is used to derive central pressure and is calibrated with a standard blood pressure cuff measurement. The CvMS is intended for use on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. In addition, the CvMS incorporates an option to enable users to measure Heart Rate Variability (HRV) in response to controlled exercises.

The SphygmoCor CvMS with the PWV option (modified device) is a software addition to the SphygmoCor CvMS device (K070795). This software feature provides an additional central arterial indice - Pulse Wave Velocity (PWV).

AI/ML Overview

The provided document describes the SphygmoCor Cardiovascular Management System (CvMS), with a specific focus on the Pulse Wave Velocity (PWV) option.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria for the PWV measurement or a detailed performance report against such criteria. Instead, it states that "All tests confirmed the product met the acceptance criteria" and that a clinical comparison study "demonstrated similar performance between the two devices" (the modified SphygmoCor CvMS with PWV and its predicate).

While explicit acceptance criteria are not provided, the implied acceptance criteria are:

The software verifies and validates correctly.
The device performs similarly to the predicate device in a clinical comparison.

Acceptance Criteria (Implied)	Reported Device Performance
Software verification passed	"Software verification" performed and product "met the acceptance criteria"
Software validation (System Verification) passed	"Software validation (System Verification)" performed and product "met the acceptance criteria"
Clinical comparison demonstrates similar performance to predicate	"clinical comparison study was conducted which compared SphygmoCor CvMS side-by-side with the predicate. The tests results demonstrated similar performance between the two devices."
No alteration of safety and effectiveness	"AtCor Medical has determined that the PWV software addition has not altered the safety and effectiveness of the device"

2. Sample Size Used for the Test Set and Data Provenance

The document states, "a clinical comparison study was conducted." However, it does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given that the predicate device is also a non-invasive blood pressure and cardiac monitor, the "ground truth" for the comparison would likely be the measurements provided by the predicate device itself.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The clinical comparison mentioned is between two devices, not an assessment of human reader performance with and without AI assistance. Therefore, there is no effect size given for human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance

The document does not explicitly present a standalone (algorithm only) performance study with metrics like sensitivity, specificity, or accuracy. The focus is on the performance of the device (which includes the software/algorithm) as a whole, compared to a predicate device. The software verification and validation activities are mentioned, implying that the algorithm's functionality was tested, but not in terms of traditional standalone diagnostic performance metrics.

7. Type of Ground Truth Used

The type of ground truth for the clinical comparison study was based on the performance of a legally marketed predicate device. Specifically, the unmodified SphygmoCor CvMS (K070795) and the Vascular Profiling System VP-2000 (K013434) were used as predicates for equivalence. The study aimed to show "similar performance" to these established devices rather than against an independent, gold-standard ground truth like pathology or long-term outcomes data.

8. Sample Size for the Training Set

The document only refers to a clinical comparison study and internal design/verification activities. It does not mention a separate training set or its sample size for the development of the PWV algorithm. It describes the PWV option as a "modular software addition" that calculates PWV using existing tonometry and ECG capabilities from the predicate device. This suggests that the algorithm leverages established physiological principles rather than being a machine learning model requiring a distinct training set in the typical sense.

9. How Ground Truth for the Training Set Was Established

Since a distinct "training set" for a machine learning algorithm is not mentioned, the document does not describe how ground truth for such a set was established. The PWV calculation method is explicitly defined as "measuring the distance between the two arteries and then dividing by At" (where At is the time difference between two pressure waveforms using ECG as a timing reference), indicating a deterministic algorithmic approach rather than a learned model from a labeled dataset.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for AtCor Medical, along with the text "K080670/S1" and "Pi/5". The AtCor Medical logo is a stylized "AtCor" with the word "MEDICAL" underneath. To the right of the logo is a black square with white dots. The text "K080670/S1" and "Pi/5" are handwritten and appear to be some sort of identification or tracking number.

510(k) Summary - SpнygмoCor CvMS

Date Prepared	5th March 2008		APR 23 2008
Submitter	AtCor Medical Pty LtdSuite 11, 1059-1063 Victoria RoadWest Ryde, NSW 2114Australia
Establishment Number	9710654
Official Contact	John AbramManager, Regulatory Affairs and Quality AssuranceSuite 11, 1059-1063 Victoria RoadWest Ryde, NSW 2114AustraliaPh: +61 2 9874 8761Fax: +61 2 9874 9022j.abram@atcormedical.com
Secondary Contact	Doug KurschinskiAtCor Medical, Inc. (USA)Sr. VP - US Commercial OperationsPh: 630-799-8215
Classification(s)
	Product Code	Classification Reference	Common/Usual Name
	DSK	21 C.F.R. § 870.1110(Class II)	computer, blood-pressure
	DRT	21 C.F.R. § 870.2300(Class II)	monitor, cardiac (incl. cardio-tachometer & rate alarm)
Proprietary Name	SphygmoCor® Cardiovascular Management System (CvMS)
Predicate Device(s)	Primary (un-modified device) - K070795 SphygmoCor CardiovascularManagement System CvMS (AtCor Medical Pty Ltd)Secondary - K013434 Vascular Profiling System VP-2000 (Colin Corp)
Reason for submission	Modification to existing product

Intended Use

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains the text "K080670/S1 P2/5" in the upper right corner. Below this text is the logo for AtCor Medical. The logo consists of the text "AtCor MEDICAL" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size below "AtCor". To the right of the text is a stylized graphic of a square with rounded corners and a series of dots emanating from it.

The CvMS Heart Rate Variability (HRV) option is intended for use in obtaining HRV measurements in response to controlled exercises.

The CvMS Pulse Wave Velocity (PWV) option is intended for use in obtaining PWV measurements. The PWV option is used on adult patients only.

Device Description

Description of Modification

The PWV option provides a modular software addition to the SphygmoCor CvMS (K070795). This simple software addition allows Pulse Wave Velocity to be calculated between two sites in the arterial tree (typically carotid-femoral). This is achieved by capturing arterial pressure waveforms (using tonometry) simultaneously with ECG data. The tonometry and ECG capabilities are unchanged from the predicate device.

The PWV software then calculates the time difference (.st) between the two pressure waveforms using the ECG as a timing reference. The PWV is then simply calculated by measuring the distance between the two arteries and then dividing by At.

Device Comparison to Predicate(s)

A device comparison is provided in the table below which shows the differences between the Predicate devices and the modified device. In summary, the modified device has the following similarities to the previously cleared predicate devices:

ం Similar intended use
ಂ Same operating principle
Similar technologies ்
0 Same manufacturing process

{2}------------------------------------------------

Atcor �

Comparison Table

	AtCor MedicalSphygmoCor CVMS(Primary Predicate Un-modified DeviceK070795)	Golm CorporationVascular Profiling System VP-2000(including pulse wave unit 10-100)Secondary Predicate K013434)	AtCor, MedicalSphygmoCor CVMS(Modified Device)	Equivalence	Performance
Intended Use	The SphygmoCor® CardiovascularManagement System (CVMS) provides aderived ascending aortic blood pressurewaveform and a range of central arterialindices. The CvMS is used with a tonometerover a radial artery calibrated with a standardcuff blood pressure measurement. It is to beused on those patients where informationrelated to ascending aortic blood pressure isdesired but in the opinion of the physician, therisks of cardiac catheterization procedure orother invasive monitoring may outweigh thebenefits.	VP-2000/1000 is a non-invasive diagnosticsystem designed to assist in the detection ofperipheral vascular diseases. It has acapability of measuring; non-invasive bloodpressures, heart rate, pulse wave, and heartsound. It also has a capability of calculatingABI (Ankle Brachial Index), Pulse WaveVelocity and Augmentation Index. Theinstrument is used in a vascular laboratory,clinic, hospital, doctor's office, and othermedical facilities where the non-invasiveperipheral vascular test is conducted. It isused on adult patients only.	The SphygmoCor® Cardiovascular ManagementSystem (CVMS) provides a derived ascending aorticblood pressure waveform and a range of centralarterial indices. The CvMS is used with a tonometerover a radial artery calibrated with a standard cuffblood pressure measurement. It is to be used onthose patients where information related to ascendingaortic blood pressure is desired but in the opinion ofthe physician, the risks of cardiac catheterizationprocedure or other invasive monitoring may outweighthe benefits.	Equivalent; Thescope of thiscomparison isregarding the PWVfunction only.	PWV Calculation	Not Applicable	PWV is calculated by measuring the distancebetween distal and proximal sites thendividing by the pulse transit time (PTT)between the same sites.	PWW is calculated by measuring the distance betweendistal and proximal sites then dividing by the MeanDeltaT time (ΔT) between the same sites.	Equivalent toSecondary
Hardware	The CvMS Heart Rate Variability (HRV) optionis intended for use in obtaining HRVmeasurements in response to controlledexercises.	Modular Hardware component for use in anexisting system. Physiological Sensors:- Applanation Tonometry pressure sensors- BP Ankle & Brachial Cuff- ECG	The CvMS Heart Rate Variability (HRV) option isintended for use in obtaining HRV measurements inresponse to controlled exercises.The CvMS Pulse Wave Velocity (PWV) option isintended for use in obtaining PWV measurements.The PWW option is used on adult patients only.	Equivalent;Primary - SamehardwareSecondary - Sametechnology	DistanceMeasurement	Not Applicable	Performed manually by clinician.	Performed manually by clinician.	Equivalent toSecondary
Software		Modular Software component for use in anexisting system.	Modular Software component for use in an existingsystem.	Equivalent	Time Measurement	Not Applicable	Single recording using two pulse waveformmeasurements with the cuff-based ArterialApplanation Tonometer.	Two recordings in sequence are made at the distaland proximal sites using Applanation tonometry inconjunction with the ECG. The ECG serves as areference to determine the Mean DeltaT time (ΔT)between the two sites.	Equivalent toSecondary
Materials		Non-invasive physiological Sensors for PWV& HRV function:Tonometer: Tecason™ & RTV SiliconECG: ECG cables and leads (FDA ClearedK945034)ECG Electrodes (FDA Cleared K946273)	Existing Non-invasive physiological Sensors for PWVfunction:Tonometer: Tecason™ & RTV SiliconECG: ECG cables and leads (FDA Cleared K945034)ECG Electrodes (FDA Cleared K946273)	Equivalent;

K080670/si

中315

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the word "Atcores" in a vertical orientation. The letters are large and bold, with "Atc" stacked on top of "ores". To the right of the word, the word "Medical" is written vertically in smaller letters. There is also a logo at the top of the image.

...

Summary Comparison to Predicate Devices

K080670/si
P4/5

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for AtCor Medical, which is in bold black font. To the right of the logo is a black square with a white arrow pointing up and to the right, surrounded by three dots. Above the logo is the text "K080670/si" and below that is "P 5/5".

Testing Summary

Design and Verification activities were performed on the SphygmoCor CvMS as a result of the risk analysis and product requirements in accordance with 21 CFR 820.30.

These tests included:

o Software verification
Software validation (System Verification) ്

All test confirmed the product met the acceptance criteria.

Furthermore, a clinical comparison study was conducted which compared SphygmoCor CvMS side-byside with the predicate. The tests results demonstrated similar performance between the two devices.

Conclusion

AtCor Medical has determined that the PWV software addition has not altered the safety and effectiveness of the device based on the company's design control procedures and test results from V&V and clinical comparison testing. The SphygmoCor CvMS System is substantially equivalent to the predicate devices.

{5}------------------------------------------------

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2008

Atcor Medical c/o Mr. John Abram Manager, Regulatory Affairs & Quality Assurance 11/1059-1063 Victoria Road West Ryde NSW Australia, 2114

Re: K080670

Modification to Sphygmocor Cardiovascular Management System Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II (two) Product Code: DSK, DRT Dated: April 01, 2008 Received: April 04, 2008

Dear Mr. Abram:

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.

{6}------------------------------------------------

Page 2 - Mr. John Abram

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. 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, pcrmits 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Bfimmerman fr

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Image /page/7/Picture/2 description: The image shows the logo for AtCor Medical. The logo features the company name in a bold, sans-serif font, with the word "MEDICAL" in smaller letters underneath. To the right of the name is a graphic of a square with dots around it. The logo is simple and professional, conveying a sense of reliability and expertise.

Indication for Use

510(k) Number (if known):

Device Name:

SPHYGMOCOR CVMS-PWV

Indication for Use

The CvMS Heart Rate Variability (HRV) option is intended for use in obtaining HRV measurements in response to controlled exercises.

The CvMS Pulse Wave Velocity (PWV) option is intended for use in obtaining PWV measurements. The PWV option is used on adult patients only.

Prescription Use _ X AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

Blummo
Division Sign Off

Page 1 of_____________________________________________________________________________________________________________________________________________________________________

5" March 2008

Division of Cardiovascular Devices
510(k) Number K080670

Page 15

Regulation Number and Section

§ 870.1110 Blood pressure computer.

(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).