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:

1. 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).
1. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SphygmoCor XCEL, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a discrete table of acceptance criteria with specific performance thresholds and corresponding device performance values for the SphygmoCor XCEL in a direct comparison. However, it states that "Side-by-Side Equivalence testing was performed for both the PWA and PWV functions of the SphygmoCor XCEL System against the identified predicates. These comparison tests demonstrated equivalence between the measured and calculated parameters between the predicates and satisfactorily passed the acceptance criteria."

This implies the acceptance criteria were based on demonstrating equivalence to the predicate devices. The type of acceptance criteria would likely be related to statistical equivalence in derived parameters (e.g., central blood pressure waveform and associated indices for PWA, and pulse wave velocity for PWV).

General Acceptance: The device was deemed to have "satisfactorily passed the acceptance criteria," meaning it achieved equivalence to the predicate devices.

Study Details

The document describes several tests performed, broadly categorized as:

Compliance to FDA Consensus Standards: This involved testing against AAMI/IEC 60601-1, AAMI/IEC 80601-2-30, ISO 81060-2, and IEC 60601-1-2. These are general safety, essential performance, and EMC standards, not direct clinical performance metrics.
System Verification and Validation testing: This demonstrated that the integration of software and hardware met predefined Product System Requirements.
Software Verification and Validation testing: Ensured compliance with predetermined specifications.
Side-by-Side Equivalence testing: This is the most relevant for clinical performance and demonstrating substantial equivalence.

Given the nature of the submission (510(k) for substantial equivalence to predicate devices), the "study" primarily consists of the Side-by-Side Equivalence testing.

1. Acceptance Criteria and Reported Device Performance

Parameter/Feature	Acceptance Criteria (Implied)	Reported Device Performance
PWA Function	Equivalence to SphygmoCor CvMS System (K070795) in measured and calculated parameters.	"satisfactorily passed the acceptance criteria" and demonstrated "equivalence between the measured and calculated parameters."
PWV Function	Equivalence to SphygmoCor CvMS-PWV System (K080670) in measured and calculated parameters.	"satisfactorily passed the acceptance criteria" and demonstrated "equivalence between the measured and calculated parameters."
NIBP Function	Equivalence to Cheetah Reliant (K083093)	Implied equivalence as it uses the same 3rd party OEM module (SunTech Medical Advantage Mini OEM BP module).

Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the SphygmoCor XCEL itself. The acceptance criteria are framed in terms of equivalence.

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

Sample Size for Test Set: The document does not explicitly state the number of subjects or cases used for the "Side-by-Side Equivalence testing."
Data Provenance: The submitter is AtCor Medical Pty Ltd, Australia. The document does not specify the country of origin of the data for the equivalence testing. It is a retrospective or concurrent comparison study against predicate devices, as it evaluates the new device side-by-side with existing, cleared devices.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: The document does not mention the use of experts to establish ground truth for this specific equivalence testing.
Qualifications of Experts: Not applicable, as experts are not mentioned in this context. The study compares the new device's readings to those of predicate devices, which are already accepted as providing valid measurements.

4. Adjudication Method for the Test Set

Adjudication Method: The document does not describe an adjudication method. This is likely because the "ground truth" for the equivalence study is the measurements obtained from the predicate devices, rather than a subjective expert assessment requiring adjudication.

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

MRMC Study: No, the document does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a measurement system, not an AI-assisted diagnostic imaging interpretation tool.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

Standalone Performance Study: The "Side-by-Side Equivalence testing" can be considered a form of standalone performance evaluation in the context of a measurement device. It assesses the device's output (measurements) directly against predicate devices. The system performs automatic measurements, and the comparison is of these automated outputs. The performance data section refers to "System Verification and Validation testing" and "Software verification and validation test results" which also fall under standalone testing.

7. Type of Ground Truth Used

Type of Ground Truth: For the "Side-by-Side Equivalence testing," the ground truth is effectively the measurements obtained from the predicate devices (SphygmoCor CvMS System for PWA, SphygmoCor CvMS-PWV System for PWV, and Cheetah Reliant for NIBP). The assumption is that these predicate devices provide an accepted and validated measurement.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not specify a sample size for a training set. While the device uses software, the context is not of a machine learning or AI model that requires a distinct training set in the typical sense for a 510(k) submission of this nature. The "General Transfer Function (GTF) methodology" mentioned for deriving the central pressure waveform is a validated algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable in the context of this 510(k) submission as no distinct training set for a new machine learning algorithm is described. The GTF methodology for PWA is stated to be "validated," implying its performance has been established previously, likely using invasive catheter measurements as the ground truth in its initial development and validation.

Summary

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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 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	Classification	Common/Usual Name	Class

ProductCode	ClassificationReference	Common/Usual Name	Class
DSK	21 C.F.R.§ 870.1110	computer, blood-pressure	II
DXN	21 C.F.R.§ 870.1130	System, Measurement, Blood-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.
1. 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

1. 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

Page 20 of 139

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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.

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:

1. 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).
1. 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.

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

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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

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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.

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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 (800) 638-2041 or (301) 796-7100 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

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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)

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(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'

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).