MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

K080670 · Atcor Medical · DSK · Apr 23, 2008 · Cardiovascular

Device Facts

• Record ID: K080670
• Device Name: MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
• Applicant: Atcor Medical
• Product Code: DSK · Cardiovascular
• Decision Date: Apr 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1110
• Device Class: Class 2

Intended Use

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 Story

SphygmoCor CvMS is a computerized diagnostic system for non-invasive cardiovascular assessment. Inputs include radial artery pressure waveforms captured via applanation tonometry, standard cuff blood pressure measurements for calibration, and ECG signals for timing. The system processes these inputs to derive ascending aortic blood pressure waveforms, central arterial indices, HRV, and PWV. Used in clinical settings by healthcare professionals; output provides clinicians with hemodynamic data to inform cardiovascular management decisions, serving as an alternative to invasive cardiac catheterization. PWV calculation involves measuring distance between two arterial sites (e.g., carotid-femoral) and dividing by the pulse transit time (PTT) derived from ECG-referenced pressure waveforms. Benefits include reduced patient risk compared to invasive monitoring.

Clinical Evidence

Clinical comparison study conducted comparing the modified SphygmoCor CvMS side-by-side with the predicate device. Results demonstrated similar performance between the two devices. No specific statistical metrics (e.g., sensitivity, specificity) were provided in the summary.

Technological Characteristics

System consists of a computer-based platform with applanation tonometry sensors (Tecason and RTV Silicon) and ECG leads/electrodes. Connectivity is via standard physiological sensor interfaces. Software-based calculation of central arterial indices, HRV, and PWV. Operates as a non-invasive diagnostic tool.

Indications for Use

Indicated for adult patients requiring non-invasive assessment of central arterial indices, including ascending aortic blood pressure, heart rate variability (HRV) during controlled exercise, and pulse wave velocity (PWV).

Regulatory Classification

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.

Predicate Devices

• SphygmoCor Cardiovascular Management System CvMS (K070795)
• Vascular Profiling System VP-2000 (K013434)

Submission Summary (Full Text)

{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 Ltd<br>Suite 11, 1059-1063 Victoria Road<br>West Ryde, NSW 2114<br>Australia | | |
| Establishment Number | 9710654 | | |
| Official Contact | John Abram<br>Manager, Regulatory Affairs and Quality Assurance<br>Suite 11, 1059-1063 Victoria Road<br>West Ryde, NSW 2114<br>Australia<br>Ph: [phone]<br>Fax: [phone]<br>[e-mail] | | |
| Secondary Contact | Doug Kurschinski<br>AtCor Medical, Inc. (USA)<br>Sr. VP - US Commercial Operations<br>Ph: 630-799-8215 | | |
| Classification(s) | | | |
| | Product Code | Classification Reference | Common/Usual Name |
| | DSK | 21 C.F.R. § 870.1110<br>(Class II) | computer, blood-pressure |
| | DRT | 21 C.F.R. § 870.2300<br>(Class II) | monitor, cardiac (incl. cardio-<br>tachometer & rate alarm) |
| Proprietary Name | SphygmoCor® Cardiovascular Management System (CvMS) | | |
| Predicate Device(s) | Primary (un-modified device) - K070795 SphygmoCor Cardiovascular<br>Management System CvMS (AtCor Medical Pty Ltd)<br>Secondary - K013434 Vascular Profiling System VP-2000 (Colin Corp) | | |
| Reason for submission | Modification to existing product | | |

Intended Use

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.

{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

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).

#### 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 Medical<br>SphygmoCor CVMS<br>(Primary Predicate Un-modified Device<br>K070795) | Golm Corporation<br>Vascular Profiling System VP-2000<br>(including pulse wave unit 10-100)<br>Secondary Predicate K013434) | AtCor, Medical<br>SphygmoCor CVMS<br>(Modified Device) | Equivalence | Performance | | | | |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | The SphygmoCor® Cardiovascular<br>Management System (CVMS) provides a<br>derived ascending aortic blood pressure<br>waveform and a range of central arterial<br>indices. The CvMS is used with a tonometer<br>over a radial artery calibrated with a standard<br>cuff blood pressure measurement. It is to be<br>used on those patients where information<br>related to ascending aortic blood pressure is<br>desired but in the opinion of the physician, the<br>risks of cardiac catheterization procedure or<br>other invasive monitoring may outweigh the<br>benefits. | VP-2000/1000 is a non-invasive diagnostic<br>system designed to assist in the detection of<br>peripheral vascular diseases. It has a<br>capability of measuring; non-invasive blood<br>pressures, heart rate, pulse wave, and heart<br>sound. It also has a capability of calculating<br>ABI (Ankle Brachial Index), Pulse Wave<br>Velocity and Augmentation Index. The<br>instrument is used in a vascular laboratory,<br>clinic, hospital, doctor's office, and other<br>medical facilities where the non-invasive<br>peripheral vascular test is conducted. It is<br>used on adult patients only. | The SphygmoCor® Cardiovascular Management<br>System (CVMS) provides a derived ascending aortic<br>blood pressure waveform and a range of central<br>arterial indices. The CvMS is used with a tonometer<br>over a radial artery calibrated with a standard cuff<br>blood pressure measurement. It is to be used on<br>those patients where information related to ascending<br>aortic blood pressure is desired but in the opinion of<br>the physician, the risks of cardiac catheterization<br>procedure or other invasive monitoring may outweigh<br>the benefits. | Equivalent; The<br>scope of this<br>comparison is<br>regarding the PWV<br>function only. | PWV Calculation | Not Applicable | PWV is calculated by measuring the distance<br>between distal and proximal sites then<br>dividing by the pulse transit time (PTT)<br>between the same sites. | PWW is calculated by measuring the distance between<br>distal and proximal sites then dividing by the Mean<br>DeltaT time (ΔT) between the same sites. | Equivalent to<br>Secondary |
| Hardware | The CvMS Heart Rate Variability (HRV) option<br>is intended for use in obtaining HRV<br>measurements in response to controlled<br>exercises. | Modular Hardware component for use in an<br>existing system. Physiological Sensors:<br>- Applanation Tonometry pressure sensors<br>- BP Ankle & Brachial Cuff<br>- ECG | The CvMS Heart Rate Variability (HRV) option is<br>intended for use in obtaining HRV measurements in<br>response to controlled exercises.<br><br>The CvMS Pulse Wave Velocity (PWV) option is<br>intended for use in obtaining PWV measurements.<br>The PWW option is used on adult patients only. | Equivalent;<br>Primary - Same<br>hardware<br>Secondary - Same<br>technology | Distance<br>Measurement | Not Applicable | Performed manually by clinician. | Performed manually by clinician. | Equivalent to<br>Secondary |
| Software | | Modular Software component for use in an<br>existing system. | Modular Software component for use in an existing<br>system. | Equivalent | Time Measurement | Not Applicable | Single recording using two pulse waveform<br>measurements with the cuff-based Arterial<br>Applanation Tonometer. | Two recordings in sequence are made at the distal<br>and proximal sites using Applanation tonometry in<br>conjunction with the ECG. The ECG serves as a<br>reference to determine the Mean DeltaT time (ΔT)<br>between the two sites. | Equivalent to<br>Secondary |
| Materials | | Non-invasive physiological Sensors for PWV<br>& HRV function:<br>Tonometer: Tecason™ & RTV Silicon<br>ECG: ECG cables and leads (FDA Cleared<br>K945034)<br>ECG Electrodes (FDA Cleared K946273) | Existing Non-invasive physiological Sensors for PWV<br>function:<br>Tonometer: Tecason™ & RTV Silicon<br>ECG: ECG cables and leads (FDA Cleared K945034)<br>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 [phone]. 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 [phone] or [phone] 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 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.

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