Who is the manufacturer of Oscar 2?

Suntech Medical, Inc. filed the 510(k) submission for Oscar 2 (K151520).

What is the FDA product code for Oscar 2?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Oscar 2?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for Oscar 2?

Oscar 2, model 222 (K003004); Sphygmocor Xcel (K122129); ABPM 7100 PWA (K140928); Ambulo 2400 Ambulatory Blood Pressure Monitoring System (K133989).

Who can help prepare an FDA 510(k) submission like Oscar 2?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Oscar 2

K151520 · Suntech Medical, Inc. · DXN · Feb 19, 2016 · Cardiovascular

Device Facts

Record ID	K151520
Device Name	Oscar 2
Applicant	Suntech Medical, Inc.
Product Code	DXN · Cardiovascular
Decision Date	Feb 19, 2016
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 870.1130
Device Class	Class 2
Attributes	Pediatric

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 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.

Device Story

Portable ambulatory blood pressure monitor (ABPM) worn on waist belt; connects to brachial cuff. Oscillometric method senses arterial pressure waves during cuff deflation; calculates systolic/diastolic BP and heart rate. Optionally derives ascending aortic blood pressure waveform and central arterial indices using General Transfer Function (GTF). Used in physician offices, clinics, research centers, or patient homes; operated by clinicians or patients. Data stored on device; downloaded via USB or Bluetooth to AccuWin Pro PC software for display/analysis. Provides non-invasive alternative to cardiac catheterization for central BP assessment; aids diagnosis and treatment monitoring.

Clinical Evidence

Bench testing only. Device validated against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-1-11 (home use), IEC 80601-2-30 (automated sphygmomanometers), and ISO 81060-2 (clinical investigation of automated measurement).

Technological Characteristics

ABS enclosure; oscillometric sensing via brachial cuff; 3V power (2x AA batteries); USB and optional Bluetooth connectivity. Software-based processing using microprocessor. Tested to IEC 60601-1 Ed 3.1, IEC 60601-1-2:2007, IEC 80601-2-30:2009, and ISO 81060-2:2013.

Indications for Use

Indicated for adult and pediatric (>3 yrs) patients requiring non-invasive oscillometric ambulatory blood pressure monitoring (systolic/diastolic BP and heart rate). Optional central blood pressure and arterial indices indicated for adult patients where invasive monitoring risks outweigh benefits. Excludes neonates and pediatric subjects for central BP measurements.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

Oscar 2, model 222 (K003004)
Sphygmocor Xcel (K122129)
ABPM 7100 PWA (K140928)
Ambulo 2400 Ambulatory Blood Pressure Monitoring System (K133989)

Submission Summary (Full Text)

{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) | |-------------------------------------------------| |-------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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…

Oscar 2

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Submission Summary (Full Text)

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