(259 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and derived central arterial indices using a microprocessor and software, with no mention of AI or ML techniques for data analysis or interpretation.
No.
The device is strictly for measurement, recording, and display of blood pressure and heart rate, and explicitly states it "makes no diagnoses" and its measurements are "provided as an aid or adjunct to diagnosis and treatment," rather than for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states, "It is intended for use as an aid or adjunct to diagnosis and treatment..."
No
The device description clearly outlines a physical hardware component (the Oscar 2 monitor) that is worn by the patient and connected to a blood pressure cuff. While it includes software (AccuWin Pro and the microprocessor software), it is not solely software.
Based on the provided information, the Oscar 2, Model 250 system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Oscar 2 Function: The Oscar 2 system is a non-invasive device that measures blood pressure and heart rate directly from the patient's body using a cuff. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "non-invasive oscillometric ambulatory blood pressure monitor" and "to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time." This is a direct physiological measurement, not an in vitro test.
- Device Description: The description details a device worn on the body with a cuff, further confirming its non-invasive nature.
Therefore, the Oscar 2, Model 250 system falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brachial cuff around the non-dominant upper arm.
Indicated Patient Age Range
adult and pediatric (> 3yrs.)
Intended User / Care Setting
Physician's office, clinic, research center (under supervision of physician) and patient home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003004, K122129, K140928, K133989
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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)
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.
| 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
SunTech Medical, Inc. Abbreviated 510(k) Submission Oscar 2, Model 250 510(k) Summary
(1) Submitter information
| Name: | SunTech Medical, Inc |
|---|---|
| Address: | 507 Airport Boulevard |
| Suite 117 | |
| Morrisville, North Carolina 27560-8200 | |
| Telephone: | 919.654.2334 |
| FAX: | 919.654.2301 |
| Contact person: | Charles Setzer (Official Correspondent). |
| SunTech Medical | |
| 507 Airport Boulevard | |
| Suite 117 | |
| Morrisville, North Carolina 27560-8200 | |
| Tel: 919-654-2334 | |
| Fax: 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.
4
K151520 Page 2 of 10
(4) 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.
(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.
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 (excludes pediatric subjects).
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.
5
PREDICATE DEVICE TABLE
| | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE (A) | SECONDARY
PREDICATE (B) | SECONDARY
PREDICATE (C) | COMPARISON |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ATRIBUTE | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 250 | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 222
(K003004) | ATCOR MEDICAL PTY
LTD
SPHYGMOCOR XCEL
SYSTEM
(K122129) | I.E.M GMBH.
ABPM 7100 PWA
(K140928) | MORTARA INSTRUMENTS
AMBULO 2400
(K133989) | |
| Indications for
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 | The Oscar 2, Model 222
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 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. | The SphygmoCor®
XCEL provides 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 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 | The ABPM 7100 is an
automated
microprocessor
controlled ambulatory
blood pressure monitor
(ABPM) which
monitors, accumulates
and stores: heart beat
(rate), systolic and
diastolic data of an
individual adult patient
(in the patient's
environment) for a
session which may last
24 hours.
The ABPM 7100 in
combination with
Hypertension
Management Software
Client Server (HMS-CS)
provides a derived
ascending aortic blood
pressure waveform and
a range of central
arterial indices. Use of
the Augmentation Index
AIx only is restricted to
patients of age 40 and
above.
It is used with a standard
cuff blood pressure | The Ambulo 2400
Ambulatory Blood
Pressure Monitor is
indicated for use in
adult & pediatric
patient populations; it is
not indicated for use
with neonates.
The Ambulo 2400
Ambulatory Blood
Pressure Monitor is
designed to measure
systolic and diastolic
blood pressure and pulse
rate of adults and
pediatric patients, using
the oscillometric method
on a cuffed arm. | The Oscar 2, Model 250 is identical to
the Primary Predicate and Secondary
Predicates B & C (Table 2)
in the non-invasive BP mode for use
as an aid or adjunct for diagnosis and
treatment when it is necessary to
measure an adult patient's systolic and
diastolic blood pressures over an
extended period of time (i.e. ABPM)
Oscar 2, Model 250 is identical in its
indications for use for adults and
pediatrics (>3 yrs) using Predicate C
(Table 2)
The Oscar 2, Model 250 identical to
Predicate A and Predicate B (Table 2)
regarding indications for Central BP
subjects
Oscar 2, Model 250 excludes Pulse
Wave Velocity (PWV). |
| | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE (A) | SECONDARY
PREDICATE (B) | SECONDARY
PREDICATE (C) | COMPARISON |
| ATRIBUTE | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 250 | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 222
(K003004) | ATCOR MEDICAL PTY
LTD
SPHYGMOCOR XCEL
SYSTEM
(K122129) | I.E.M GMBH.
ABPM 7100 PWA
(K140928) | MORTARA INSTRUMENTS
AMBULO 2400
(K133989) | |
| | 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 the benefits.
(excludes pediatric
subjects)
BlueTooth wireless
connectivity will be
offered as an option | | measurements. The
PWV option is used on
adult patients only. | measurement.
It is used in those
patients where
information related to
the ascending aortic
blood pressure is desired
but in the opinion of the
physician, the risk of
cardiac catheterization
procedure or other
invasive monitoring may
outweigh the benefits.
BlueTooth wireless
connectivity is offered
as an option | | The Oscar 2, Model 250 is
substantially equivalent to Secondary
Predicates (B) |
| SYSTEM
PHOTO | 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 to
the Primary Predicate and
substantially equivalent to the
Secondary Predicates
(B & C) |
| Location of Use
(primary) | Physician's office,
clinic, research center
(under supervision of
physician) and patient
home environment | Physician's office,
clinic, research center
(under supervision of
physician) and patient
home environment | Physician's office,
clinic, research center
(under supervision of
physician) and patient
home environment | Physician's office,
clinic, research center
(under supervision of
physician) and patient
home environment | Physician's office,
clinic, research center
(under supervision of
physician) and patient
home environment | The Oscar 2, Model 250 is identical to
the Primary Predicate and Secondary
Predicates
(B & C) |
| | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE (A) | SECONDARY
PREDICATE (B) | SECONDARY
PREDICATE (C) | COMPARISON |
| ATRIBUTE | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 250 | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 222
(K003004) | ATCOR MEDICAL PTY
LTD
SPHYGMOCOR XCEL
SYSTEM
(K122129) | I.E.M GMBH.
ABPM 7100 PWA
(K140928) | MORTARA INSTRUMENTS
AMBULO 2400
(K133989) | |
| Product Code | DXN | DXN | DXN | DXN | DXN | Identical to all predicates |
| System
Components | • 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 is
substantially equivalent to all
predicates |
| Energy Used or
Delivered | Mechanical Force via
BP Cuff | Mechanical Force via
BP Cuff | Mechanical Force via
BP Cuff | Mechanical Force via
BP Cuff | Mechanical Force via
BP Cuff | The Oscar 2, Model 250 is identical to
all predicates |
| Interface | USB Interface Cable
Wireless - BlueTooth | Interface Cable | Interface Cable | USB Interface Cable
Wireless - BlueTooth | USB Interface Cable | The Oscar 2, Model 250 is identical to
the Secondary Predicate B |
| Mechanical
Safety | Cuff Related Risks | Cuff Related Risks | Cuff Related Risks | Cuff Related Risks | Cuff Related Risks | The Oscar 2, Model 250 is identical to
all predicates |
| Patient
Connections | BP Cuff | BP Cuff | BP Cuff | BP Cuff | BP Cuff | The Oscar 2, Model 250 is identical to
all predicates |
| Human Factors | • Ambulatory or office
use with results
displayed using PC
Desktop interface
• Graphical User Interface
(GUI) on desktop
interface
• Use of cuff around
limb
• Stop button
• Functional buttons
• Device status
Indicators | • Ambulatory or office
use with results
displayed using PC
Desktop interface
• Graphical User Interface
(GUI) on desktop
interface
• Use of cuff around
limb
• Stop button
• Functional Buttons
• Device status
Indicators | • Office use with results
displayed using PC
Desktop interface
• Graphical User Interface
(GUI)
• Use of cuff around
limb
• Stop buttons
• Functional Buttons
• Device status
Indicators | • Ambulatory or office
use with results
displayed using PC
Desktop interface
• Graphical User Interface
(GUI) on desktop
interface
• Use of cuff around
limb
• Stop button
• Functional Buttons
• Device status
Indicators | • Ambulatory or office
use with results
displayed using PC
Desktop interface
• Graphical User Interface
(GUI) on desktop
interface
• Use of cuff around
limb
• Stop button
• Functional Buttons
• Device status
Indicators | The Oscar 2, Model 250 is identical to
the Primary Predicate and Secondary
Predicates (B & C).
The Oscar 2, Model 250 is
substantially equivalent to the
SphygmoCor XCEL with the
difference that the Oscar 2, Model 250
is intended for both ambulatory or
office use while the SphygmoCor
XCELis intended for office use only. |
| ATRIBUTE | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE (A) | SECONDARY
PREDICATE (B) | SECONDARY
PREDICATE (C) | COMPARISON |
| | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 250 | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 222
(K003004) | ATCOR MEDICAL PTY
LTD
SPHYGMOCOR XCEL
SYSTEM
(K122129) | I.E.M GMBH.
ABPM 7100 PWA
(K140928) | MORTARA INSTRUMENTS
AMBULO 2400
(K133989) | |
| NIBP
Algorithm | SunTech Oscar 2 | SunTech Oscar 2 | SunTech Adv. Mini
OEM BP | I.E.M | Mortara | The Oscar 2, Model 250 is identical to
the Primary Predicate and Secondary
Predicate (A) |
| CBP Algorithm | SphygmoCor® XCEL | N / A | SphygmoCor® XCEL | I.E.M | N / A | The Oscar 2, Model 250 is identical to
the Secondary Predicate (A |
| Standards
Compliance | Test to most recently
Harmonized Standard | | | | | |
| AAMI/IEC
60601-1
Electrical
Safety
&
Applicable
Collateral
Standards | 60601-1
Ed. 3.1 : 2012
&
60601-1-6
60601-1-11 | YES | YES | YES | YES | The Oscar 2, Model 250 is tested to
the currently effective edition, Ed. 3.1
: 2012, of the standard & applicable
Collateral Standards |
| IEC 60601-1-2
EMC | 60601-1-2:2007 | YES | YES | YES | YES | The Oscar 2, Model 250 is tested to
the currently effective edition, 60601-
1-2:2007, of the standard |
| AAMI/IEC
80601-2-30 | 80601-2-30:2009 | YES | YES | YES | YES | The Oscar 2, Model 250 is tested to
the 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 to
the currently effective standard,
81060-2:2013. |
| Software
Section | | | | | | |
| User Interface | • Microsoft Windows
based User Interface.
• Dedicated screens for
key functions.
• User feedback of data
quality & errors
• Reporting of final
results | • Microsoft Windows
based User Interface.
• Dedicated screens for
key functions.
• User feedback of data
quality & errors
• Reporting of final
results | • Microsoft Windows
based User Interface.
• Dedicated screens for
key functions.
• User feedback of data
quality & errors
• Reporting of final
results | • Microsoft Windows
based User Interface.
• Dedicated screens for
key functions.
• User feedback of data
quality & errors
• Reporting of final
results | • Microsoft Windows
based User Interface.
• Dedicated screens for
key functions.
• User feedback of data
quality & errors
• Reporting of final
results | The Oscar 2, Model 250 is identical to
the Primary Predicate device and
Substantially Equivalent to all
Secondary Predicates |
| ATRIBUTE | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE (A) | SECONDARY
PREDICATE (B) | SECONDARY
PREDICATE (C) | COMPARISON |
| | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 250 | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 222
(K003004) | ATCOR MEDICAL PTY
LTD
SPHYGMOCOR XCEL
SYSTEM
(K122129) | I.E.M GMBH.
ABPM 7100 PWA
(K140928) | MORTARA INSTRUMENTS
AMBULO 2400
(K133989) | |
| Software
Operating
Platform | 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 to
all Predicates in that it uses an MS
Windows (7 & 8) platform
The Oscar 2 will not be backward
compatible to Windows XP and Vista |
| Stored Data
Viewing | PC screen | PC screen | PC screen | PC screen | PC screen | The Oscar 2, Model 250 is
identical to all predicates |
| PC Software | AccuWin Pro | AccuWin Pro | SphygmoCor | HMS-CS 4.7
CardioPerfect | Hypertension Diagnostic
Suite | The Oscar 2, Model 250 is identical to
the Primary Predicate and Secondary
Predicate A
The Oscar 2, Model 250 is
substantially equivalent to Secondary
Predicates B & C |
| SYSTEM
PERFORMANCE | | | | | | |
| Power | 3 Volt
Two "AA" alkaline or
rechargeable batteries | 3 Volt
Two "AA" alkaline or
rechargeable batteries | External Power 100-240
VAC, 50-60Hz Supply | 3 Volt
Two "AA" alkaline or
rechargeable batteries | 3 Volt
Two "AA" alkaline or
rechargeable batteries | The Oscar 2, Model 250 is identical to
the Primary Predicate device and
Secondary 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 to
the 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 to
the Primary Predicate |
| Enclosure
Material | ABS | ABS | Polycarbonate | unknown | unknown | Model 250 is identical to the Primary
Predicate |
| Pressure Range | Systolic: 40 - 260
mmHg
Diastolic: 25 - 200
mmHg | Systolic: 40 - 260
mmHg
Diastolic: 25 - 200
mmHg | 40-260 mmHg | Systolic: 60 - 290
mmHg
Diastolic: 30 - 195
mmHg | Systolic: 60 - 290
mmHg
Diastolic: 30 - 195
mmHg | The Oscar 2, Model 250 is identical to
Primary Predicate and substantially
equivalent to all Secondary Predicates |
| | NEW DEVICE | PRIMARY | SECONDARY | SECONDARY | SECONDARY | COMPARISON |
| ATRIBUTE | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 250 | PREDICATE
SUNTECH MEDICAL INC.
OSCAR 2, MODEL 222
(K003004) | PREDICATE (A)
ATCOR MEDICAL PTY
LTD
SPHYGMOCOR XCEL
SYSTEM
(K122129) | PREDICATE (B)
I.E.M GMBH.
ABPM 7100 PWA
(K140928) | PREDICATE (C)
MORTARA INSTRUMENTS
AMBULO 2400
(K133989) | |
| Measurement | Determines brachial BP
from oscillometric
waveform pulses
captured during
deflation of the cuff.
Derives the aortic
waveform profile from
the brachial artery
waveform and provides
a collection of pressure
and timing
hemodynamic
parameter.
The key clinical
parameters are:
- Systolic and Diastolic
Blood Pressure - Heart Rate
- Central Blood
Pressure
(Sp/Dp/MAP/Pp) - Central Augmentation
Index & Pressure, and
Index at HR 75 | Determines brachial BP
from oscillometric
waveform pulses
captured during
deflation of the cuff.
The key clinical
parameters are:
Systolic and
Diastolic Blood
Pressure
Heart Rate
2. | Determines brachial BP
from oscillometric
waveform pulses
captured during
deflation of the cuff.
Derives the aortic
waveform profile from
the brachial artery
waveform and provides
a collection of pressure
and timing
hemodynamic
parameters
The key clinical
parameters are:
Systolic and
1.
Diastolic Blood
Pressure
2.
Heart Rate
3.
Central Blood
Pressure
(Sp/Dp/MAP/Pp)
Central
4.
Augmentation
Index & Pressure,
and Index at HR 75
5.
Pulse Pressure
Amplification
6.
Ejection Duration
7.
Subendocardial
Viability Ratio
8.
SphygmoCor
Reference Age | Determines brachial BP
from oscillometric
waveform pulses
captured during
deflation of the cuff.
Derives the aortic
waveform profile from
the brachial artery
waveform and provides
a collection of pressure
and timing
hemodynamic
parameters.
The key clinical
parameters are:
Systolic and
1.
Diastolic Blood
Pressure
Heart Rate
2.
3.
Central Blood
Pressure
(Sp/Dp/MAP/Pp)
Central
4.
Augmentation
Index & Pressure | Determines brachial BP
from oscillometric
waveform pulses
captured during
deflation of the cuff.
The key clinical
parameters are:
Systolic and
1.
Diastolic Blood
Pressure
2.
Heart Rate | The Oscar 2, Model 250 is identical to
all the Predicates regarding the
determination of the BP signal
The Oscar 2, Model 250 is identical to
Secondary Predicate A and
substantially equivalent to Secondary
Predicate B regarding the
determination of the
Central BP signal
The Oscar 2, Model 250 has identical
measurements to both Primary and
Secondary Predicate A regarding
features 1 & 2
and substantially equivalent to
Secondary Predicates
B & C
The Oscar 2, Model 250 has identical
measurements to the Secondary
Predicate A regarding features
3 & 4
and is substantially equivalent to
Secondary Predicate B
The Oscar 2, Model 250 does not use
the key clinical parameters 5 - 8 found
in the Secondary Predicate A. |
| | NEW DEVICE | PRIMARY
PREDICATE | SECONDARY
PREDICATE (A) | SECONDARY
PREDICATE (B) | SECONDARY
PREDICATE (C) | COMPARISON |
| ATRIBUTE | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 250 | SUNTECH MEDICAL INC.
OSCAR 2, MODEL 222
(K003004) | ATCOR MEDICAL PTY
LTD
SPHYGMOCOR XCEL
SYSTEM
(K122129) | I.E.M GMBH.
ABPM 7100 PWA
(K140928) | MORTARA INSTRUMENTS
AMBULO 2400
(K133989) | |
| Method | • Capture brachial
arterial waveforms
non-invasively with
Cuff
• Apply oscillometric
algorithm to captured
waveforms to
determine brachial
BP
• Brachial BP results
stored for later
download and display
• Calibrate using
Brachial BP
• Single Step
Measurement
• Measure Brachial
arterial waveform
non-invasively with
Cuff
• Digitize peripheral
arterial waveform
(brachial).
• Firmware applies a
General Transfer
Function (GTF) to
peripheral waveform
to derive central
pressure waveform
and parameters
• Calculated parameters
stored for later
download and display | • Capture brachial
arterial waveforms
non-invasively with
Cuff
• Apply oscillometric
algorithm to captured
waveforms to
determine brachial
BP
• Brachial BP results
stored for later
download and display | • Capture brachial
arterial waveforms
non-invasively with
Cuff
• Apply oscillometric
algorithm to captured
waveforms to
determine brachial
BP
• Brachial BP results
used for CBP
measurement and sent
to PC software
• Calibrate using
Brachial BP
• Single Step
Measurement
• Measure Brachial
arterial waveform
non-invasively with
Cuff
• Digitize peripheral
arterial waveform
(brachial) and use
serial communications
to send to PC
software.
• PC software applies a
General Transfer
Function (GTF) to
peripheral waveform
to derive central
pressure waveform
and parameters | • Capture brachial
arterial waveforms
non-invasively with
Cuff
• Apply oscillometric
algorithm to captured
waveforms to
determine brachial
BP
• Brachial BP results
stored for later
download and display
• Calibrate using
Brachial BP
• Single Step
Measurement
• Measure Brachial
arterial waveform
non-invasively with
Cuff
• Digitize peripheral
arterial waveform
(brachial)
• PC software applies a
General Transfer
Function (GTF) to
peripheral waveform
to derive central
pressure waveform
and parameters | • Capture brachial
arterial waveforms
non-invasively with
Cuff
• Apply oscillometric
algorithm to captured
waveforms to
determine brachial
BP
• Brachial BP results
stored for later
download and display | The Oscar 2, Model 250 is
substantially the same regarding
measurements methods to both
Primary and Secondary Predicate (A) |
6
7
8
9
10
11
12
(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.