SPHYGMOCOR XCEL

K122129 · Atcor Medical · DXN · Nov 16, 2012 · Cardiovascular

Device Facts

• Record ID: K122129
• Device Name: SPHYGMOCOR XCEL
• Applicant: Atcor Medical
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The SphygmoCor® XCEL system provides a derived ascending aortic blood pressure waveform and a r no ophygmood " Toller director in the measurements are provided non-invasively through the use of a Brachial cuff. It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. Additionally, the SphygmoCor® XCEL System automatically measures Systolic blood pressure and Diastolic blood pressure. The SphygmoCor XCEL Pulse Wave Velocity (PWV) option is intended to obtain PWV measurements. The PWV option is used on adult patients only.

Device Story

System performs non-invasive cardiovascular measurements; inputs include brachial cuff oscillometric signals and carotid/femoral arterial pulses via tonometer/cuff. Device processes signals via Windows-based software to derive central aortic blood pressure waveforms and arterial stiffness indices (PWV). Used in clinical settings by healthcare providers; output displayed on GUI. Assists clinicians in managing cardiovascular conditions by providing central hemodynamic data without invasive catheterization. Benefits include reduced procedural risk for patients requiring central pressure monitoring.

Clinical Evidence

Bench testing only. System verification and validation confirmed compliance with AAMI/IEC 60601-1, AAMI/IEC 80601-2-30, and ISO 81060-2 standards. Side-by-side equivalence testing performed for PWA and PWV functions against predicate devices demonstrated that measured and calculated parameters met predefined acceptance criteria.

Technological Characteristics

Components: electronics module, tonometer pressure transducer, brachial/thigh cuffs. Connectivity: USB to Windows PC. Sensing: Oscillometric (brachial) and tonometer (carotid/femoral). Software: Windows-based application for signal processing and GUI. Standards: AAMI/IEC 60601-1, AAMI/IEC 80601-2-30, ISO 81060-2, IEC 60601-1-2.

Indications for Use

Indicated for adult patients requiring non-invasive cardiovascular measurements, including derived ascending aortic blood pressure waveforms, systolic/diastolic blood pressure, and pulse wave velocity (PWV) as an adjunct to manage cardiovascular conditions, particularly when invasive monitoring risks outweigh benefits.

Regulatory Classification

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.

Predicate Devices

• SphygmoCor CvMS System (K070795)
• SphygmoCor CvMS-PWV System (K080670)
• Cheetah Reliant (K083093)

Submission Summary (Full Text)

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

K122129

Image /page/0/Picture/1 description: The image shows the logo for AtCor Medical. The logo has the text "AtCor" in large, bold letters. Below that, in smaller letters, is the word "MEDICAL". To the right of the text is a graphic of a heart with a dotted line leading away from it.

SphygmoCor XCEL - Traditional 510(k) Premarket Notification

## 510(k) Summary - SphygmoCor XCEL

In accordance with 21 CFR 807.92 the following summary of information is provided:

NOV 1 6 2012

113

| Date Prepared | July 13, 2012 | | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------|-------|
| 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 | Classification | Common/Usual Name | Class |

| Product<br>Code | Classification<br>Reference | Common/Usual Name | Class |
|-----------------|-----------------------------|-------------------------------------------------------|-------|
| DSK | 21 C.F.R.<br>§ 870.1110 | computer, blood-pressure | II |
| DXN | 21 C.F.R.<br>§ 870.1130 | System, Measurement, Blood-<br>Pressure, Non-Invasive | II |

Proprietary/Trade Name

SphygmoCor® XCEL

Predicate Device(s)

Primary

- The SphygmoCor XCEL's Pulse Wave Analysis (PWA) feature is substantially equivalent 1) to primary predicate:
- AtCor Medical Pty Ltd's SphygmoCor CvMS System (K070795) in . technological characteristics and intended use.
- 2) The SphygmoCor XCEL's Pulse Wave Velocity (PWV) feature is substantially equivalent to primary predicate:
- AtCor Medical Pty Ltd's SphygmoCor CvMS-PWV System (K080670) in ● technological characteristics and intended use.

#### Secondary

- 3) The SphygmoCor XCEL's Non-Invasive Blood Pressure measurement (NIBP) feature is substantially equivalent to secondary predicate:
- Cheetah Medical's Cheetah Rellant (K083093) (SunTech Medical Advantage ● Mini OEM BP module incorporated in Cheetah Reliant BP Monitor)

Reason for submission New Device

Copyright @ 2012 AtCor Medical Ply Ltd. Commercial In Confusioners of Registered Trademark of AlCor Medical Pry Lid

Page 20 of 139

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

Image /page/1/Picture/1 description: The image shows the logo for AtCor Medical. The logo has the text "AtCor" in bold, with the word "MEDICAL" underneath it in a smaller font. To the right of the text is a graphic of a heart shape with a dotted line extending from the top right corner. The logo is simple and professional, and the heart shape suggests that the company is involved in the medical field.

#### Intended Use

The SphygmoCor® XCEL system provides a derived ascending aortic blood pressure waveform and a r no ophygmood " Toller director in the measurements are provided non-invasively through the use of a Brachial cuff.

It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

Additionally, the SphygmoCor® XCEL System automatically measures Systolic blood pressure and Diastolic blood pressure.

The SphygmoCor XCEL Pulse Wave Velocity (PWV) option is intended to obtain PWV measurements. The PWV option is used on adult patients only.

#### Device Description

The SphygmoCor XCEL System is indicated to perform non-invasive cardiovascular measurements as an adjunct to manage various cardiovascular conditions. The device can be used in any of 2 modes:

- 3. Pulse Wave Analysis Measurement (PWA or CP) A brachial cuff is used to measure the peripheral blood pressure and arterial pulses to derive the central blood pressure waveform and corresponding parameters. The brachial blood pressure measurement is calculated using the oscillometric technique. This feature is implemented essentially by a 30 party NIBP Module (SunTech Medical Advantage Mini OEM BP module).
- 4. Pulse Wave Velocity Measurement (PWV) Using a non-invasive Tonometer pressure sensor and Cuff, this mode measures the time difference between the Carotid and Femoral arterial pulses measured simultaneously. To determine the carotid to femoral pulse wave velocity, the distance measured between the two arterial sites is divided by measured time difference. This Pulse Wave Velocity (PWV) is an indicator of arterial stiffness. Higher PWV's are associated with increased arterial stiffness.

The main system components include an electronics hardware module, a tonometer pressure transducer and brachial & thigh cuffs. The basic device operation involves patient's physiological signals being gathered by the electronics hardware module via the patient-contacting cuff and/or tonometer pressure sensor. These signals are then transferred via USB communications to a PC running the Microsoft Windows-based SphygmoCor XCEL Software application. This software application provides the functionality to process the physiological signals and derive the central blood pressure waveform and various other central arterial indices (including Pulse Wave Velocity). The software application also provides a GUI-based interface to allow the operator to initiate measurements and to display the measured waveforms and parameters to the operator.

### Technological Characteristics Comparison

The SphygmoCor XCEL's Pulse Wave Analysis (PWA) feature is the same as the predicate SphygmoCor CvMS System (K070795) in technological characteristics and intended use, except that it is uses a brachial arterial signal (captured via a brachial cuff) as compared to the radial arterial signal (captured via a tonometer) as its primary physiological input. However, the same validated General (Gaptares (GTF) methodology which derives the central pressure waveform is used in both devices. Additionally, once the central pressure waveform is derived, the same software is used to calculate all parameters.

The SphygmoCor XCEL's Pulse Wave Velocity (PWV) feature is the same as SphygmoCor CvMS-PWV System (K080670) in technological characteristics and intended use, except measurement on the new device is a single step measurement due to the simultaneous measurement of arterial signals from the carotid and femoral sites. In K080670, a 2-step measurement was required to measure the arterial signals at the carotid and femoral sites (using ECG as a timing reference). In addition, the new device uses a thigh cuff to measure the femoral arterial waveform instead of a tonometer which is used in K080670.

Page 21 of 139

**Page 21 of 1631**

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

Image /page/2/Picture/0 description: The image shows the logo for AtCor Medical. The logo consists of the word "AtCor" in bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. To the right of the word "Cor" is a graphic of a square with a corner cut off, and a series of dots leading away from the cut-off corner. The logo is black and white.

SphygmoCor XCEL - Traditional 510(k) Premarket Notification

The SphygmoCor XCEL's Non-Invasive Blood Pressure (NIBP) feature is the same as Cheetah The Sphygmooool XOEL 3 Non myaarracteristics and intended use. They both use the same 3rd party Renant (Nobooby in technological enotage Mini OEM BP module) to measure NIBP.

## Performance Data

The SphygmoCor XCEL System was designed and tested to demonstrate compliance to the following FDA consensus standards:

- Medical electrical equipment -- Part 1: General requirements for safety
- AAMI/IEC 60601-1:2005 (300 Ed.), CSA C22.2 No 60601.1 (2008), ANSI/AAMI O ES60601-1 (2005+A2)
- Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential . performance of automated non-invasive sphygmomanometers
- AAMI/IEC 80601-2-30:2009 o
- Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type .
- ISO 81060-2:2009 o
- Medical electrical equipment Part 1: General requirements for safety Section 2. Collateral . Standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-2:2007 0

Biocompatibility testing clauses were not applied since all patient-contacting applied parts in the Blocompaniblity testing oldudos were neven previously cleared in predicates

System Verification and Validation testing was completed to demonstrate that the integration of the System Vehiloation one validation tooking he predetined Product System Requirements. This included solward and hardware caninations testing between common components of the new device and the predicates.

The software was designed and developed according to a robust software development process, and rine soltware was accegned withing information is provided in accordance with:

- "FDA guidance: The content of premarket submissions for software contained in medical . devices, 11 May 05; and
- devideo; 11 may of and . staff, 11 Jan 02.

The software verification and vaildation test results indicate that the SphygmoCor XCEL complies with its predetermined specification.

Finally, Side-by-Side Equivalence testing was performed for both the PWA and PWV functions of the I thany, Olde Equivagainst the identified predicates. These comparison tests demonstrated ophygmood NOWE byoten agained and calculated parameters between the predicates and satisfactorily passed the acceptance criteria.

#### Conclusion

The indications for use, technological characteristics, and principles of operation of the SphygmoCor The mare the same or similar to the predicate devices. The performance data demonstrates that the new device is as safe and effective as the predicate devices. Thus the SphygmoCor XCEL System is substantially equivalent to the predicate devices.

Page 22 of 139

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

Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUM AN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

AtCor Medical Pty. Ltd. c/o Mr. John Abram Manager, Regulatory Affairs and Quality Assurance Suite 11, 1059-1063 Victoria Road West Ryde, NSW 2114 Australia

Re: K122129

Trade/Device Names: SphygmoCor XCEL Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN, DSK Dated: November 1, 2012 Received: November 6, 2012

Dear Mr. Abram:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to Conninetee phorts to May 20, 1978, the accordance with the provisions of the Federal Food, DNL, devices that have boon 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 I he general controls proctice, 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 additional controls. Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

## 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Oliver

Owen P. Faris -S 2012.11.16 14:09:42 -05'00'

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

Enclosure

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

Image /page/5/Picture/0 description: The image shows the logo for AtCor Medical. The logo has the text "AtCor" in bold, with the word "MEDICAL" in smaller letters underneath. To the right of the text is a graphic of a heart with several dots around it.

SphygmoCor XCEL - Traditional 510(k) Premarket Notification

## Indication for Use

## K122129

510(k) Number (if known):

Device Name:

SPHYGMOCOR XCEL SYSTEM

#### Indication for Use

The SphygmoCor® XCEL System provides a derived ascending aortic blood pressure waver the use of for The Sphygmood " XCLL Gystein provided a sense accessions was are provided non-invasively through the use of a Brachial cuff.

It is to be used on those patients where information related to ascending and the benefits if is to be used on those patients williation related to associaling and outself the benefits.

Additionally, the SphygmoCor XCEL System automatically measures Systolic blood pressure and Additionally, the SphygmoCol " XCEL Pystelli adolford in the Sphython option is intended to Diastolic blood pressure. The Ophygmobile is used on adult patients only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

Page 18 of 1631

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

| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

| Owen P. Faris - S | |
|-------------------|-------------|
| 2012.11.16 | Page 1 of 1 |
| 14:12:07 -05'00' | |

Copyright © 2012 AlCor Medical Pty Ltd. Commercial In Confidence. SphygmoCor® is a Registered Trademark of AlCor Medical Pty Ltd
Page 18 of 1391/1