The Oscar 2, Model 250 system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with AccuWin Pro, a PC-based computer program for the recording of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses.

Optionally, The Model 250 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These 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 (excludes pediatic subjects).

BlueTooth, wireless connectivity will be offered as an option.

Device Description

The Oscar 2 monitor is worn by the patient on a waist belt and is connected to an ABPM blood pressure cuff around the non-dominant upper arm. The cuff is inflated automatically at intervals which can be programmed during setup. Blood pressure is measured by the oscillometric method which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured.

The Oscar 2 is a small hand-held or portable device, approximately 120 x 72 x 32 mm in size and weighs approximately 284 g including batteries. For convenience during a 24 hour study, the device can be worn with an optional pouch on a belt shoulder strap. The ABPM cuff is connected to the device, and the control buttons provide stop/start, day/night switch, event marking and dosage response capabilities. The LCD graphic screen allows for function monitoring and appropriate icon display. The device uses a microprocessor with software, which is not accessible to the user. The unit is powered by two (2) "AA" batteries located at the rear of the device. A USB port connection is used to download the patient information into the AccuWin Pro™ v4 software located on a separate PC. The AccuWin components include a flash drive and a USB cable.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the SunTech Medical Oscar 2, Model 250, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically a comprehensive clinical trial report with detailed acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding specific performance numbers, sample sizes for test/training sets, expert qualifications, and adjudication methods for the new device's own performance studies is not directly present in this document. The document primarily states that the device was tested to applicable standards and demonstrated substantial equivalence to predicates.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported numerical performance for the Oscar 2, Model 250 itself. Instead, it states that the device was tested to harmonized standards, implying that it met the requirements of those standards relevant to non-invasive blood pressure measurement. The key standard referenced for clinical investigation is ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type.

Likely Implied Acceptance Criteria (from ISO 81060-2:2013, general for NIBP devices):

While not explicitly stated in the document with actual results, conformance to ISO 81060-2:2013 typically requires the following for blood pressure measurement accuracy:

Metric (Implied by ISO 81060-2:2013)	Acceptance Criteria (General)	Reported Device Performance (Not in document, implied by passing standard)
Mean Difference (Device vs. Reference)	≤ ±5 mmHg for Systolic and Diastolic BP	Implied to meet this criterion by passing the standard.
Standard Deviation of Differences	≤ 8 mmHg for Systolic and Diastolic BP	Implied to meet this criterion by passing the standard.
Individual Differences	For 80% or more of readings,	Implied to meet this criterion by passing the standard.
		device and reference readings differ by ≤ ±5 mmHg.
	For 90% or more of readings,	device and reference readings differ by ≤ ±10 mmHg.
	For 95% or more of readings,	device and reference readings differ by ≤ ±15 mmHg.

For Central Blood Pressure (CBP) Algorithm: The document states the device derives CBP and that the SphygmoCor® XCEL (a predicate device) also provides derived ascending aortic BP and central arterial indices. The acceptance criteria for the accuracy of a derived central blood pressure waveform and parameters are not detailed in this 510(k) summary. Given its reliance on the SphygmoCor® XCEL algorithm, it's likely they would have aimed to demonstrate comparable performance to that predicate, which itself would have had its own validation studies.

Study Details for the SunTech Medical Oscar 2, Model 250:

Sample size used for the test set and the data provenance:
- The document states that the device was tested to ISO 81060-2:2013. This standard generally requires a minimum of 85 participants for clinical investigation of automated non-invasive sphygmomanometers. However, the exact sample size used for this specific device's test set (Oscar 2, Model 250) is not specified in the provided text.
- Data Provenance: Not specified. Typically, such studies are prospective, but this document does not state it. The country of origin of the data is also not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. For NIBP validation under ISO 81060-2, manual reference blood pressure measurements are typically taken by a minimum of two trained observers (experts) following a specific protocol (e.g., auscultatory method). Their qualifications would typically involve being trained and validated against a mercury sphygmomanometer, but the exact information for this study is not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. For NIBP validation, the "2+1" method (two observers, with a third if their readings differ significantly) or similar expert consensus is standard for establishing reference blood pressure. However, the document does not detail the method used.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an automated non-invasive blood pressure monitor and does not involve human "readers" interacting with an AI to interpret images or data in a diagnostic context that would necessitate an MRMC study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance study was conducted implicitly. The statement that the device was "tested to the applicable requirements of the following standards and requirements" including ISO 81060-2:2013 indicates that the device's algorithmic performance in measuring blood pressure was assessed independently against a reference standard. The nature of an automated sphygmomanometer being a measurement device means its primary function is standalone measurement. While human operators apply the cuff and initiate measurements, the core blood pressure calculation is algorithmic (standalone).
- The Central Blood Pressure (CBP) algorithm's performance is also implicitly standalone, deriving the waveform and parameters from the brachial cuff measurements.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For brachial blood pressure measurement validation (per ISO 81060-2), the ground truth is typically established by simultaneous, direct arterial measurement using an invasive catheter (less common in routine validation) or, more commonly, manual auscultatory measurements obtained by trained observers using a mercury sphygmomanometer (or equivalent validated reference cuff device) on the contralateral arm or sequentially. The document implies the latter through its reference to ISO 81060-2.
- For the derived central blood pressure, the ground truth would typically be invasive central blood pressure measurements, though the document relies on substantial equivalence to a predicate that also derives this non-invasively. The validation of the derivation itself would typically involve comparison to invasive central measurements.
The sample size for the training set:
- Not specified. This document does not provide details about a training set for the NIBP or CBP algorithms. For a device like this, the algorithms would typically be developed and potentially refined using various datasets, but a distinct "training set" for regulatory submission is not usually detailed in this type of 510(k) summary unless the AI component is novel and centrally a "machine learning" algorithm in the modern sense. Given the age of the submission (2016) and the nature of an oscillometric algorithm, it's more likely based on established physiological models and signal processing rather than deep learning requiring large, explicitly defined training sets.
How the ground truth for the training set was established:
- Not applicable/Not specified, as no specific "training set" details are provided. If implicitly part of algorithm development, the ground truth would be established similarly to the test set (e.g., expert-referenced blood pressure values).

Summary

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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three human profiles facing right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2016

Suntech Medical, Inc. Charles Setzer Ouality & Regulatory Affairs Manager 507 Airport Blvd, Suite 117 Morrisville, North Carolina 27560

Re: K151520

Trade/Device Name: Oscar 2 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 26, 2016 Received: January 27, 2016

Dear Charles Setzer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours

Mitchell Stein

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151520

Page 1 of 1

Device Name

Oscar 2, Model 250

Indications for Use (Describe)

BlueTooth, wireless connectivity will be offered as an option.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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SunTech Medical, Inc. Abbreviated 510(k) Submission Oscar 2, Model 250 510(k) Summary

(1) Submitter information

Name:	SunTech Medical, Inc
Address:	507 Airport BoulevardSuite 117Morrisville, North Carolina 27560-8200
Telephone:	919.654.2334
FAX:	919.654.2301
Contact person:	Charles Setzer (Official Correspondent).SunTech Medical507 Airport BoulevardSuite 117Morrisville, North Carolina 27560-8200Tel: 919-654-2334Fax: 919-654-2301
Date prepared:	26JAN2016

(2) Name of Device

Trade Name:	Oscar 2, Model 250
Common Name:	NIBP Monitor
Classification name:	Noninvasive Blood Pressure Measurement System,DXN 870.1130

(3) Legally-marketed predicate devices

The Oscar 2, model 250, is a modification of the Oscar 2, model 222, ambulatory blood pressure monitor, K003004

The Oscar2, model 250, uses Atcor Medical's Sphygmocor Xcel, K122129, as a predicate device for the implementation of central BP.

The Oscar2, model 250, uses I.E.M. GmbH's ABPM 7100 PWA, K140928, with Hyperrtension Management Software Client 4.7 as a predicate device for central BP outside the medical clinic and for bluetooth operations.

The Oscar2, model 250, uses Mortara Instruments' Ambulo 2400 Ambulatory Blood Pressure Monitoring System, K133989, as a predicate for use of ABPM in the pediatric population.

The Oscar 2, model 250, is substantially equivilent to these devices.

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K151520 Page 2 of 10

(4) Description

(5) Intended Use

The Oscar 2, Model 250 system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with AccuWin Pro, a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses.

Optionally, The Model 250 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided noninvasively through the use of a brachial cuff.

BlueTooth, wireless connectivity will be offered as an option.

(6) Comparison to Predicate Devices

The device has the same basic construction as the primary predicate device. Both modified and original devices share the same specifications, measurement ranges, and intended uses. The devices are manufactured from the same types of materials using the same production methods and are intended for the same patient populations.

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PREDICATE DEVICE TABLE

	NEW DEVICE	PRIMARYPREDICATE	SECONDARYPREDICATE (A)	SECONDARYPREDICATE (B)	SECONDARYPREDICATE (C)	COMPARISON
ATRIBUTE	SUNTECH MEDICAL INC.OSCAR 2, MODEL 250	SUNTECH MEDICAL INC.OSCAR 2, MODEL 222(K003004)	ATCOR MEDICAL PTYLTDSPHYGMOCOR XCELSYSTEM(K122129)	I.E.M GMBH.ABPM 7100 PWA(K140928)	MORTARA INSTRUMENTSAMBULO 2400(K133989)
Indications forUse	The Oscar 2, Model 250system is a non-invasiveoscillometricambulatory bloodpressure monitor that isintended to be used withAccuWin Pro, a PC-based computer programfor the recording anddisplaying of up to 250measurements ofsystolic and diastolicblood pressure and heartrate. It is intended foruse as an aid or adjunctto diagnosis andtreatment when it isnecessary to measure anadult and pediatric (>3yrs.) patient's systolicand diastolic bloodpressures over anextended period of time.The system is only formeasurement, recording,and display. It makes nodiagnoses.Optionally, the Model250 will provide aderived ascending aorticblood pressurewaveform and a range of	The Oscar 2, Model 222system is a non-invasiveoscillometricambulatory bloodpressure monitor that isintended to be used withAccuWin Pro, a PC-based computer programfor the recording anddisplaying of up to 250measurements ofsystolic and diastolicblood pressure and heartrate. It is intended foruse as an aid or adjunctto diagnosis andtreatment when it isnecessary to measure anadult patient's systolicand diastolic bloodpressures over anextended period of time.The system is only formeasurement, recording,and display. It makes nodiagnoses.	The SphygmoCor®XCEL provides aderived ascending aorticblood pressurewaveform and a range ofcentral arterial indices.These measurements areprovided non-invasivelythrough the use of aBrachial cuff.It is to be used on thosepatients whereinformation related toascending aortic bloodpressure is desired butthe risks of cardiaccatheterizationprocedure or otherinvasive monitoring mayoutweigh the benefits.Additionally, theSphygmoCor XCELSystem automaticallymeasures Systolic bloodpressure and Diastolicblood pressure.The SphygmoCor XCELPulse Wave Velocity(PWV) option isintended to obtain PWV	The ABPM 7100 is anautomatedmicroprocessorcontrolled ambulatoryblood pressure monitor(ABPM) whichmonitors, accumulatesand stores: heart beat(rate), systolic anddiastolic data of anindividual adult patient(in the patient'senvironment) for asession which may last24 hours.The ABPM 7100 incombination withHypertensionManagement SoftwareClient Server (HMS-CS)provides a derivedascending aortic bloodpressure waveform anda range of centralarterial indices. Use ofthe Augmentation IndexAIx only is restricted topatients of age 40 andabove.It is used with a standardcuff blood pressure	The Ambulo 2400Ambulatory BloodPressure Monitor isindicated for use inadult & pediatricpatient populations; it isnot indicated for usewith neonates.The Ambulo 2400Ambulatory BloodPressure Monitor isdesigned to measuresystolic and diastolicblood pressure and pulserate of adults andpediatric patients, usingthe oscillometric methodon a cuffed arm.	The Oscar 2, Model 250 is identical tothe Primary Predicate and SecondaryPredicates B & C (Table 2)in the non-invasive BP mode for useas an aid or adjunct for diagnosis andtreatment when it is necessary tomeasure an adult patient's systolic anddiastolic blood pressures over anextended period of time (i.e. ABPM)Oscar 2, Model 250 is identical in itsindications for use for adults andpediatrics (>3 yrs) using Predicate C(Table 2)The Oscar 2, Model 250 identical toPredicate A and Predicate B (Table 2)regarding indications for Central BPsubjectsOscar 2, Model 250 excludes PulseWave Velocity (PWV).
	NEW DEVICE	PRIMARYPREDICATE	SECONDARYPREDICATE (A)	SECONDARYPREDICATE (B)	SECONDARYPREDICATE (C)	COMPARISON
ATRIBUTE	SUNTECH MEDICAL INC.OSCAR 2, MODEL 250	SUNTECH MEDICAL INC.OSCAR 2, MODEL 222(K003004)	ATCOR MEDICAL PTYLTDSPHYGMOCOR XCELSYSTEM(K122129)	I.E.M GMBH.ABPM 7100 PWA(K140928)	MORTARA INSTRUMENTSAMBULO 2400(K133989)
	central arterial indices.These measurements areprovided non-invasivelythrough the use of abrachial cuff. It is to beused on those patientswhere informationrelated to ascendingaortic blood pressure isdesired but the risks ofcardiac catheterizationprocedure or otherinvasive monitoring mayoutweigh the benefits.(excludes pediatricsubjects)BlueTooth wirelessconnectivity will beoffered as an option		measurements. ThePWV option is used onadult patients only.	measurement.It is used in thosepatients whereinformation related tothe ascending aorticblood pressure is desiredbut in the opinion of thephysician, the risk ofcardiac catheterizationprocedure or otherinvasive monitoring mayoutweigh the benefits.BlueTooth wirelessconnectivity is offeredas an option		The Oscar 2, Model 250 issubstantially equivalent to SecondaryPredicates (B)
SYSTEMPHOTO	Image: SunTech Medical Inc. OSCAR 2, MODEL 250	Image: SunTech Medical Inc. OSCAR 2, MODEL 222	Image: ATCOR MEDICAL PTY LTD SPHYGMOCOR XCEL SYSTEM	Image: I.E.M GMBH. ABPM 7100 PWA	Image: MORTARA INSTRUMENTS AMBULO 2400	The Oscar 2, Model 250 is identical tothe Primary Predicate andsubstantially equivalent to theSecondary Predicates(B & C)
Location of Use(primary)	Physician's office,clinic, research center(under supervision ofphysician) and patienthome environment	Physician's office,clinic, research center(under supervision ofphysician) and patienthome environment	Physician's office,clinic, research center(under supervision ofphysician) and patienthome environment	Physician's office,clinic, research center(under supervision ofphysician) and patienthome environment	Physician's office,clinic, research center(under supervision ofphysician) and patienthome environment	The Oscar 2, Model 250 is identical tothe Primary Predicate and SecondaryPredicates(B & C)
	NEW DEVICE	PRIMARYPREDICATE	SECONDARYPREDICATE (A)	SECONDARYPREDICATE (B)	SECONDARYPREDICATE (C)	COMPARISON
ATRIBUTE	SUNTECH MEDICAL INC.OSCAR 2, MODEL 250	SUNTECH MEDICAL INC.OSCAR 2, MODEL 222(K003004)	ATCOR MEDICAL PTYLTDSPHYGMOCOR XCELSYSTEM(K122129)	I.E.M GMBH.ABPM 7100 PWA(K140928)	MORTARA INSTRUMENTSAMBULO 2400(K133989)
Product Code	DXN	DXN	DXN	DXN	DXN	Identical to all predicates
SystemComponents	• Electronics Module(Oscar 2, Model 250)• SunTech BP Cuff• Software download• Operator's Manual• Cables• Pouch	• Electronics Module(M222)• SunTech BP Cuff• Software Disc• Operator's Manual• Cables• Pouch	• Electronics Module(EM4 Hardware)• SunTech BP Cuff• Software Disc• Operator's Manual• Cables• Power Supply Adaptor	• Electronics Module(M 7100)• BP Cuff• Software Disc• Operator's Manual• Pouch	• Electronics Module(M 7100)• BP Cuff• Software Disc• Operator's Manual• Pouch	The Oscar 2, Model 250 issubstantially equivalent to allpredicates
Energy Used orDelivered	Mechanical Force viaBP Cuff	Mechanical Force viaBP Cuff	Mechanical Force viaBP Cuff	Mechanical Force viaBP Cuff	Mechanical Force viaBP Cuff	The Oscar 2, Model 250 is identical toall predicates
Interface	USB Interface CableWireless - BlueTooth	Interface Cable	Interface Cable	USB Interface CableWireless - BlueTooth	USB Interface Cable	The Oscar 2, Model 250 is identical tothe Secondary Predicate B
MechanicalSafety	Cuff Related Risks	Cuff Related Risks	Cuff Related Risks	Cuff Related Risks	Cuff Related Risks	The Oscar 2, Model 250 is identical toall predicates
PatientConnections	BP Cuff	BP Cuff	BP Cuff	BP Cuff	BP Cuff	The Oscar 2, Model 250 is identical toall predicates
Human Factors	• Ambulatory or officeuse with resultsdisplayed using PCDesktop interface• Graphical User Interface(GUI) on desktopinterface• Use of cuff aroundlimb• Stop button• Functional buttons• Device statusIndicators	• Ambulatory or officeuse with resultsdisplayed using PCDesktop interface• Graphical User Interface(GUI) on desktopinterface• Use of cuff aroundlimb• Stop button• Functional Buttons• Device statusIndicators	• Office use with resultsdisplayed using PCDesktop interface• Graphical User Interface(GUI)• Use of cuff aroundlimb• Stop buttons• Functional Buttons• Device statusIndicators	• Ambulatory or officeuse with resultsdisplayed using PCDesktop interface• Graphical User Interface(GUI) on desktopinterface• Use of cuff aroundlimb• Stop button• Functional Buttons• Device statusIndicators	• Ambulatory or officeuse with resultsdisplayed using PCDesktop interface• Graphical User Interface(GUI) on desktopinterface• Use of cuff aroundlimb• Stop button• Functional Buttons• Device statusIndicators	The Oscar 2, Model 250 is identical tothe Primary Predicate and SecondaryPredicates (B & C).The Oscar 2, Model 250 issubstantially equivalent to theSphygmoCor XCEL with thedifference that the Oscar 2, Model 250is intended for both ambulatory oroffice use while the SphygmoCorXCELis intended for office use only.
ATRIBUTE	NEW DEVICE	PRIMARYPREDICATE	SECONDARYPREDICATE (A)	SECONDARYPREDICATE (B)	SECONDARYPREDICATE (C)	COMPARISON
	SUNTECH MEDICAL INC.OSCAR 2, MODEL 250	SUNTECH MEDICAL INC.OSCAR 2, MODEL 222(K003004)	ATCOR MEDICAL PTYLTDSPHYGMOCOR XCELSYSTEM(K122129)	I.E.M GMBH.ABPM 7100 PWA(K140928)	MORTARA INSTRUMENTSAMBULO 2400(K133989)
NIBPAlgorithm	SunTech Oscar 2	SunTech Oscar 2	SunTech Adv. MiniOEM BP	I.E.M	Mortara	The Oscar 2, Model 250 is identical tothe Primary Predicate and SecondaryPredicate (A)
CBP Algorithm	SphygmoCor® XCEL	N / A	SphygmoCor® XCEL	I.E.M	N / A	The Oscar 2, Model 250 is identical tothe Secondary Predicate (A
StandardsCompliance	Test to most recentlyHarmonized Standard
AAMI/IEC60601-1ElectricalSafety&ApplicableCollateralStandards	60601-1Ed. 3.1 : 2012&60601-1-660601-1-11	YES	YES	YES	YES	The Oscar 2, Model 250 is tested tothe currently effective edition, Ed. 3.1: 2012, of the standard & applicableCollateral Standards
IEC 60601-1-2EMC	60601-1-2:2007	YES	YES	YES	YES	The Oscar 2, Model 250 is tested tothe currently effective edition, 60601-1-2:2007, of the standard
AAMI/IEC80601-2-30	80601-2-30:2009	YES	YES	YES	YES	The Oscar 2, Model 250 is tested tothe currently effective edition, 80601-2-30:2009, of the standard
ISO 81060-2	81060-2:2013	SP 10	YES	YES	YES	The Oscar 2, Model 250 is tested tothe currently effective standard,81060-2:2013.
SoftwareSection
User Interface	• Microsoft Windowsbased User Interface.• Dedicated screens forkey functions.• User feedback of dataquality & errors• Reporting of finalresults	• Microsoft Windowsbased User Interface.• Dedicated screens forkey functions.• User feedback of dataquality & errors• Reporting of finalresults	• Microsoft Windowsbased User Interface.• Dedicated screens forkey functions.• User feedback of dataquality & errors• Reporting of finalresults	• Microsoft Windowsbased User Interface.• Dedicated screens forkey functions.• User feedback of dataquality & errors• Reporting of finalresults	• Microsoft Windowsbased User Interface.• Dedicated screens forkey functions.• User feedback of dataquality & errors• Reporting of finalresults	The Oscar 2, Model 250 is identical tothe Primary Predicate device andSubstantially Equivalent to allSecondary Predicates
ATRIBUTE	NEW DEVICE	PRIMARYPREDICATE	SECONDARYPREDICATE (A)	SECONDARYPREDICATE (B)	SECONDARYPREDICATE (C)	COMPARISON
	SUNTECH MEDICAL INC.OSCAR 2, MODEL 250	SUNTECH MEDICAL INC.OSCAR 2, MODEL 222(K003004)	ATCOR MEDICAL PTYLTDSPHYGMOCOR XCELSYSTEM(K122129)	I.E.M GMBH.ABPM 7100 PWA(K140928)	MORTARA INSTRUMENTSAMBULO 2400(K133989)
SoftwareOperatingPlatform	Microsoft Windows® 7,8	Microsoft Windows®XP, Vista, 7, 8	Microsoft Windows®XP, Vista, 7, 8	Microsoft Windows®XP, Vista, 7	Microsoft Windows®XP, Vista, 7	The Oscar 2, Model 250 is identical toall Predicates in that it uses an MSWindows (7 & 8) platformThe Oscar 2 will not be backwardcompatible to Windows XP and Vista
Stored DataViewing	PC screen	PC screen	PC screen	PC screen	PC screen	The Oscar 2, Model 250 isidentical to all predicates
PC Software	AccuWin Pro	AccuWin Pro	SphygmoCor	HMS-CS 4.7CardioPerfect	Hypertension DiagnosticSuite	The Oscar 2, Model 250 is identical tothe Primary Predicate and SecondaryPredicate AThe Oscar 2, Model 250 issubstantially equivalent to SecondaryPredicates B & C
SYSTEMPERFORMANCE
Power	3 VoltTwo "AA" alkaline orrechargeable batteries	3 VoltTwo "AA" alkaline orrechargeable batteries	External Power 100-240VAC, 50-60Hz Supply	3 VoltTwo "AA" alkaline orrechargeable batteries	3 VoltTwo "AA" alkaline orrechargeable batteries	The Oscar 2, Model 250 is identical tothe Primary Predicate device andSecondary Predicates B & C
Dimensions	120 x 72 x 32 mm	120 x 72 x 32 mm	99 x 190 x 17 mm	121 x 80 x 33 mm	121 x 80 x 33 mm	The Oscar 2, Model 250 is identical tothe Primary Predicate
Weight	0.28 kg	0.28 kg	Weight 0.7 kg(1.5 lbs)	0.22 kg	0.22 kg	The Oscar 2, Model 250 is identical tothe Primary Predicate
EnclosureMaterial	ABS	ABS	Polycarbonate	unknown	unknown	Model 250 is identical to the PrimaryPredicate
Pressure Range	Systolic: 40 - 260mmHgDiastolic: 25 - 200mmHg	Systolic: 40 - 260mmHgDiastolic: 25 - 200mmHg	40-260 mmHg	Systolic: 60 - 290mmHgDiastolic: 30 - 195mmHg	Systolic: 60 - 290mmHgDiastolic: 30 - 195mmHg	The Oscar 2, Model 250 is identical toPrimary Predicate and substantiallyequivalent to all Secondary Predicates
	NEW DEVICE	PRIMARY	SECONDARY	SECONDARY	SECONDARY	COMPARISON
ATRIBUTE	SUNTECH MEDICAL INC.OSCAR 2, MODEL 250	PREDICATESUNTECH MEDICAL INC.OSCAR 2, MODEL 222(K003004)	PREDICATE (A)ATCOR MEDICAL PTYLTDSPHYGMOCOR XCELSYSTEM(K122129)	PREDICATE (B)I.E.M GMBH.ABPM 7100 PWA(K140928)	PREDICATE (C)MORTARA INSTRUMENTSAMBULO 2400(K133989)
Measurement	Determines brachial BPfrom oscillometricwaveform pulsescaptured duringdeflation of the cuff.Derives the aorticwaveform profile fromthe brachial arterywaveform and providesa collection of pressureand timinghemodynamicparameter.The key clinicalparameters are:1. Systolic and DiastolicBlood Pressure2. Heart Rate3. Central BloodPressure(Sp/Dp/MAP/Pp)4. Central AugmentationIndex & Pressure, andIndex at HR 75	Determines brachial BPfrom oscillometricwaveform pulsescaptured duringdeflation of the cuff.The key clinicalparameters are:Systolic and1.Diastolic BloodPressureHeart Rate2.	Determines brachial BPfrom oscillometricwaveform pulsescaptured duringdeflation of the cuff.Derives the aorticwaveform profile fromthe brachial arterywaveform and providesa collection of pressureand timinghemodynamicparametersThe key clinicalparameters are:Systolic and1.Diastolic BloodPressure2.Heart Rate3.Central BloodPressure(Sp/Dp/MAP/Pp)Central4.AugmentationIndex & Pressure,and Index at HR 755.Pulse PressureAmplification6.Ejection Duration7.SubendocardialViability Ratio8.SphygmoCorReference Age	Determines brachial BPfrom oscillometricwaveform pulsescaptured duringdeflation of the cuff.Derives the aorticwaveform profile fromthe brachial arterywaveform and providesa collection of pressureand timinghemodynamicparameters.The key clinicalparameters are:Systolic and1.Diastolic BloodPressureHeart Rate2.3.Central BloodPressure(Sp/Dp/MAP/Pp)Central4.AugmentationIndex & Pressure	Determines brachial BPfrom oscillometricwaveform pulsescaptured duringdeflation of the cuff.The key clinicalparameters are:Systolic and1.Diastolic BloodPressure2.Heart Rate	The Oscar 2, Model 250 is identical toall the Predicates regarding thedetermination of the BP signalThe Oscar 2, Model 250 is identical toSecondary Predicate A andsubstantially equivalent to SecondaryPredicate B regarding thedetermination of theCentral BP signalThe Oscar 2, Model 250 has identicalmeasurements to both Primary andSecondary Predicate A regardingfeatures 1 & 2and substantially equivalent toSecondary PredicatesB & CThe Oscar 2, Model 250 has identicalmeasurements to the SecondaryPredicate A regarding features3 & 4and is substantially equivalent toSecondary Predicate BThe Oscar 2, Model 250 does not usethe key clinical parameters 5 - 8 foundin the Secondary Predicate A.
	NEW DEVICE	PRIMARYPREDICATE	SECONDARYPREDICATE (A)	SECONDARYPREDICATE (B)	SECONDARYPREDICATE (C)	COMPARISON
ATRIBUTE	SUNTECH MEDICAL INC.OSCAR 2, MODEL 250	SUNTECH MEDICAL INC.OSCAR 2, MODEL 222(K003004)	ATCOR MEDICAL PTYLTDSPHYGMOCOR XCELSYSTEM(K122129)	I.E.M GMBH.ABPM 7100 PWA(K140928)	MORTARA INSTRUMENTSAMBULO 2400(K133989)
Method	• Capture brachialarterial waveformsnon-invasively withCuff• Apply oscillometricalgorithm to capturedwaveforms todetermine brachialBP• Brachial BP resultsstored for laterdownload and display• Calibrate usingBrachial BP• Single StepMeasurement• Measure Brachialarterial waveformnon-invasively withCuff• Digitize peripheralarterial waveform(brachial).• Firmware applies aGeneral TransferFunction (GTF) toperipheral waveformto derive centralpressure waveformand parameters• Calculated parametersstored for laterdownload and display	• Capture brachialarterial waveformsnon-invasively withCuff• Apply oscillometricalgorithm to capturedwaveforms todetermine brachialBP• Brachial BP resultsstored for laterdownload and display	• Capture brachialarterial waveformsnon-invasively withCuff• Apply oscillometricalgorithm to capturedwaveforms todetermine brachialBP• Brachial BP resultsused for CBPmeasurement and sentto PC software• Calibrate usingBrachial BP• Single StepMeasurement• Measure Brachialarterial waveformnon-invasively withCuff• Digitize peripheralarterial waveform(brachial) and useserial communicationsto send to PCsoftware.• PC software applies aGeneral TransferFunction (GTF) toperipheral waveformto derive centralpressure waveformand parameters	• Capture brachialarterial waveformsnon-invasively withCuff• Apply oscillometricalgorithm to capturedwaveforms todetermine brachialBP• Brachial BP resultsstored for laterdownload and display• Calibrate usingBrachial BP• Single StepMeasurement• Measure Brachialarterial waveformnon-invasively withCuff• Digitize peripheralarterial waveform(brachial)• PC software applies aGeneral TransferFunction (GTF) toperipheral waveformto derive centralpressure waveformand parameters	• Capture brachialarterial waveformsnon-invasively withCuff• Apply oscillometricalgorithm to capturedwaveforms todetermine brachialBP• Brachial BP resultsstored for laterdownload and display	The Oscar 2, Model 250 issubstantially the same regardingmeasurements methods to bothPrimary and Secondary Predicate (A)

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(7) Testing and Validations

The Oscar 2, Model 250 has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results.

IEC 60601-1:2012. Medical electrical equipment Part 1: General requirements . for basic safety and essential performance
IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
. IEC 60601-1-6:2013. Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-11:2012, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical
IEC 80601-2-30:2013, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
. ISO 81060-2:2013, Non-invasive sphygmomanometers -Part 2: Clinical investigation of automated measurement type

(8) Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, SunTech Medical concludes that the Oscar 2, Model 250 is substantially equivalent to the predicate devices described herein.

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).