OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
Device Facts
| Record ID | K972020 |
|---|---|
| Device Name | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR |
| Applicant | Cas Medical Systems, Inc. |
| Product Code | DXW · Cardiovascular |
| Decision Date | May 5, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1270 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Oscillomate 9001D monitor non-invasively measures the blood pressure of adult and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic and pulse rate.
Device Story
Oscillomate 9001D is a compact, portable, battery-powered non-invasive blood pressure (NIBP) monitor for emergency care. Device uses an inflatable cuff to occlude the artery; oscillometric technique monitors pressure pulses during step-wise cuff deflation. System identifies peak amplitude of pressure pulses to calculate systolic and diastolic pressure; pulse rate derived from pulse counting. Device features motion artifact rejection for vehicular transport environments. Operated by clinicians in emergency settings; results displayed on LED screen. History mode stores up to 128 readings. Device provides equipment/measurement error alerts but lacks patient parameter alarms. Benefits include portable, durable blood pressure monitoring in transport and emergency scenarios.
Clinical Evidence
Clinical accuracy testing performed per AAMI/ANSI SP10: 1992 using a model 9010 test platform. Non-clinical testing included comparative studies in an ambulance to evaluate performance under motion, road noise, and vibration, showing equivalence to the predicate. Accuracy was also verified using a patient simulator across a range of input conditions, where the 9001D met acceptance criteria and outperformed the predicate. Additional testing included UL544, IEC 601-1, IEC 601-1-2, IEC 601-2-30, BS EN 1060-1, and environmental shock/vibration testing (IEC 68 series).
Technological Characteristics
ABS enclosure; rechargeable battery; LED display. Oscillometric sensing principle. Dimensions: 6.6" x 8.3" x 4.8"; Weight: 4.5 lb. Connectivity: Standalone. Standards: AAMI/ANSI SP-10: 1992, UL544, IEC 601-1, IEC 601-1-2, IEC 601-2-30, BS EN 1060-1, IEC 68 series (shock/vibration). Software includes cuff over-pressurization limits (290 mmHg software, 330 mmHg redundant switch) and inflation time-out (120 seconds).
Indications for Use
Indicated for adult and pediatric patients requiring non-invasive blood pressure and pulse rate monitoring, primarily in emergency care settings.
Regulatory Classification
Identification
An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.
Predicate Devices
- Protocol Systems, Inc. PROPAQ 100 Series Ultra-Portable Patient Monitor (K910772)
Submission Summary (Full Text)
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MAY 5 1008
# 510(K) SUMMARY
Name of device:
Oscillomate 9001D Non-invasive Blood Pressure Monitor
Submitted by:
CAS Medical Systems, Inc.
May 28, 1997
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Date prepared:
Contact person:
Ron Jeffrey Quality & Regulatory Affairs Manager
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| Device trade name: | Oscillomate® 9001D NIBP Monitor |
|----------------------|--------------------------------------------------------------|
| Common name: | Blood Pressure Monitor |
| Classification name: | Non-invasive Blood Pressure Measurement System<br>(870.1130) |
CAS is claiming substantial equivalence to the following legally marketed device:
## Propag model 106EL Portable Patient Monitor
# DEVICE DESCRIPTION
#### General information:
The 9001D monitor is compact, lightweight, and durable. The device is housed in and ABS enclosure. The device and all of its accessories are further enclosed in a ruqged Cordura nylon carry bag. Power is supplied by an internal rechargeable battery. An external battery charger is provided. Information is displayed in an easy to read LED display. Readings may be taken manually, or at preset intervals from 1 to 60 minutes. A message center display provides information and troubleshooting prompts. A history mode displays previous readings and time readings were taken.
The Oscillometric technique monitors the changes of pressure caused by the flow of blood through the artery. The monitor will inflate the cuff around the patients arm to a value that occludes the artery. The monitor then deflates the cuff in steps. As the cuff pressure goes down, blood continues to flow through the artery. The increasing blood flow causes the amplitude of the pressure pulses in the cuff to increase. As the monitor steps down further, the pulses will reach a peak amplitude and then start to decrease with additional pressure steps. The rising and falling of the amplitude of these pressure pulses as the cuff pressure is stepped down, creates a curve that is used to find the systolic pressure and diastolic pressure. Counting the pulses over a time period will give a pulse rate. Motion artifact rejection techniques are used to provide accurate results under most operating conditions.
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#### INTENDED USE
The 9001D is designed to measure the blood pressure of the adult or pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic, and pulse rate.
The Oscillomate 9001D is compact lightweight and portable, allowing it to be easily transported and used in a variety of clinical settings.
#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The tables on the following pages compare characteristics between the CAS Oscillomate 9001D and the predicate device "Propaq 106EL". There are no major differences in blood pressure technological characteristics between the two devices.
NOTE: The Propaq 106EL is a multi-parameter monitor with other functions aside from non-invasive blood pressure. The comparison table does not address the other parameters.
#### NON-CLINICAL PERFORMANCE TESTING AND SUBSTANTIAL EQUIVALENCE
The Oscillomate 9001D and the predicate device Propaq 106EL were evaluated in a patient transport environment that represents their primary area of use. A comparative study was made to evaluate both monitors in an ambulance. The series of tests measured subjects while the ambulance was in motion.
This test includes the protocol, data and final report. See 510(k) appendix 1.
The report concludes that the 9001D provides equivalent performance when encountering patient motion, road noise and vibration conditions in a vehicular transport environment.
The Oscillomate 9001D and the predicate device Propaq 106EL were compared for accuracy using a patient simulation device over a range of input conditions.
The test data concludes that the Oscillomate 9001D met the conditions for acceptance and outperformed the predicate device. See 510(k) appendix 2.
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### CLINICAL PERFORMANCE TESTING AND SUBSTANTIAL EQUIVALENCE
CAS submitted its NB module to AAMI/ANSI SP10: 1992 clinical accuracy testing using a model 9010 monitor as a test platform. The 9010 monitor, originally intended to be a dual parameter monitor with a pulse oximeter, was never developed or marketed. The NB module is unchanged from the testing performed in the study to its new use in the 9001D monitor.
The clinical testing includes a clinical trial protocol, data and analysis of results. See 510(k) appendix 10.
The Oscillomate 9001D meets the clinical performance criteria of AAMI/ANSI SP10: 1992. The predicate device makes the claim that it meets AAMI/ANSI SP10: 1987 standard for clinical accuracy with the NIBP portion of their monitor.
#### CONCLUSIONS DRAWN FROM CLINICAL AND NON-CLINICAL TESTS
CAS has tested and met all aspects of the AAMI/ANSI SP10: 1992 (510k section 5) which includes overall system efficacy, through clinical trial, environmental performance and stability, safety requirements, and performance requirements. For non-invasive blood pressure monitoring this is the standard to meet.
Other non-clinical testing has been performed as well. Included here are UL544, IEC 601-1, IEC 601-1-2, IEC 601-2-30, BS EN 1060-1, ISTA packaging shipping testing, and IEC 68 (series) environmental shock and vibration testing.
CAS has passed all submitted testing.
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#### List of Predicate Device
| Monitoring Function | Predicate Device | Date of Substantial Equivalence and K Number |
|-----------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------|
| Non-Invasive Blood Pressure(NIBP)<br>using oscillometric method | Protocol Systems, Inc. PROPAQ 100<br>Series Ultra-Portable Patient Monitor | K910772 NIBP Module referenced in K914838 January 10, 1992 |
| Feature | | CAS OSCILLOMATE | Protocol Propaq 100 series | Difference and | |
|--------------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | | 9001D | | Justification | |
| l. Intended Use | Physical environment | Hospital ER, Clinics, Emergency<br>Medical Service | Hospital, Air medical/emergency<br>transport, field medical application | CAS device is not designed as a<br>bed-side monitor. | |
| | Patient Population | Adult and Pediatric | Adult and Pediatric | None | |
| 2. Monitoring Mode -<br>using blood pressure<br>cuff | Non-invasive Blood Pressure | Uses single-hose, inflatable cuff to<br>determine systolic and diastolic. | Uses single-hose, inflatable cuff to<br>determine systolic, diastolic and<br>mean arterial pressure | None | |
| | Pulse Rate | Determines pulse rate through cuff<br>pressure pulsation | Determines pulse rate through cuff<br>pressure pulsation | None | |
| 3. NIBP Functions | Blood Pressure determining<br>method | Oscillometric, step-wise de-<br>pressurization of cuff | Oscillometric | None | |
| | Operating modes | MANUAL<br>Automatic cycles of 1, 2, 3, 4, 5,<br>10, 15, 30, 60, 90 minutes | MANUAL<br>Automatic cycles of 1, 2, 3, 5, 10,<br>15, 30 and 60 minutes<br>TURBOCUFF for 5 minutes | Continuous (TURBOCUFF)<br>measurements mode is only a<br>convenience feature. It does not<br>provide added benefit to the<br>patient when health provider is<br>operating the device next to the<br>patient in close quarters such as a<br>field situation. | |
| | Typical Determination Time | 25 seconds | 15 to 40 seconds | Similar | |
| | Calibration | Digital manometer mode | On-screen manometer | None | |
| | Alarms | Equipment/Measurement error<br>indications only | Patient parameters and<br>Equipment/Measurement errors | CAS device does not provide<br>patient parameter alarms for the<br>simple reason that patients are<br>closely observed during transport<br>It is not being used as a bed-side<br>monitoring device. | |
| 4. Blood pressure Range | Systolic | 25-255 mmHg | 30-250 mmHg | Both ranges cover majority of<br>patient population adequately. | |
| Feature | | | CAS OSCILLOMATE<br>9001D | Protocol Propaq 100 series | Difference and<br>Justification |
| 4. CONT. | MAP | | 18-255 mmHg | 25-240 mmHg | Same as above |
| | Diastolic | | 10-220 mmHg | 20-230 mmHg | Same as above |
| 5. NIBP System<br>Efficacy<br>(Voluntary Performance<br>Standards) | Blood Pressure Accuracy | | Meets ANSI/AAMI SP-10, 1992.<br>Mean difference in Systolic(and<br>Diastolic) pressure comparison: $\pm$ 5mmHg or less with a standard<br>deviation of 8 mmHg or less. | Meets ANSI/AAMI SP-10, 1987.<br>Mean Systolic(and Diastolic)<br>pressure comparison: $\pm$ 5mmHg or<br>less with a standard deviation of 8<br>mmHg or less. | None |
| 6. Pulse Rate Range | Design specification | | 40-240 beats per minute | 25-200 bpm | Both ranges cover majority of<br>patient population adequately. |
| 7. Pulse Rate Accuracy | Design specification | | $\pm$ 2 bpm or $\pm$ 2%, whichever is<br>greater | within $\pm$ of 6 bpm or 6%,<br>whichever is greater | No significant difference |
| 8. Measurements<br>Storage | Design specification | | Stores measurements within the<br>last 5 hours of up to 99 cycles | Up to 128 readings that are less<br>than 8 hours old | No significant difference |
| 9. AC Power Adapter | Input Requirement | | Optional 120 VAC or 100-240<br>VAC | Optional 100 VAC, 120 VAC or<br>220-240 VAC | No significant difference |
| 10. Battery Power | Battery Type | | Rechargeable sealed lead acid, 6V<br>3.2AH | Rechargeable sealed lead acid, 8V<br>3AH | No significant difference |
| | Low, or Dead Battery Alert | | Displays warning on battery<br>condition; does not make<br>measurement in dead battery<br>condition | Displays LOW BATT alarm | No significant difference |
| | Charge Time for a depleted<br>pack | | 12 hours | ~8 hours | Both provide overnight charging<br>method. |
| | Operating Time on a fully<br>charged pack | | 300 reading at 1-minute automatic<br>cycles; 7 hour continuous | 6.5 hours, NIBP every 15 minutes | CAS device is dedicated to BP<br>measurement only. It has more<br>reserved power to run<br>electromechanical components |
| 11. Alarm Indicators | Visual | | Blinking 8-character message<br>display | RED LED and on-screen message | No significant difference |
| | Aural | | Short Audio beeps for alert | Beeper | No significant difference |
| 12. Physical<br>Characteristics | Measurement Data Display | | RED 8-segment LED's | Backlit LCD or EL 276x128 pixel<br>graphical display | User preference item. No<br>graphical display for NIBP |
| | Message Display | | RED 8-character dot-matrix LED<br>message center | same as above | Same as above |
| | Unit Size (H x W x D) | | 7.5" x 8" x 5" | 6.6" x 8.3" x 4.8" | No significant difference |
| Feature | | CAS OSCILLOMATE 9001D | Protocol Propaq 100 series | Difference and Justification | |
| 12. CONT. | Unit Weight | 4.5 lb. | 5.8 lb.. | No significant difference | |
| | Unit mounting/carrying | A padded, fabric carrying bag is an integral part of the monitor, battery and cuff storage system. | Unit with carrying handle, optional carrying bag for transport. | CAS device is a more convenient and complete package for the intended environment. | |
| 13. Environmental | Operating Altitude | Tested to -500 to +10,000 ft. Measurement accuracy is referenced to local atmospheric pressure and will not be affected by operating altitude | -1,000 to +15,000 ft. | No significant difference | |
| | Operating Temperature | 0° to 50° C | 0° to 50° C | None | |
| | Operating Humidity | 15 to 90%(non-condensing) | 0 to 97%(non-condensing) | No significant difference | |
| | Storage Temperature | -20° to 70° C | -20° to 60° C | No significant difference | |
| | Storage Humidity | 15 to 95% | 0 to 97% | No significant difference | |
| | Electromagnetic Compatibility | EN 60601-1-2<br>IEC 801-1-2; IEC 801-1-3<br>IEC 801-1-4; IEC 801-1-5<br>CISPR - 11 | IEC-801-2, level 4 ESD<br>VDE 0871 class B EMI<br>FDA MDS-201-0004(emissions only) | CAS elected to use the current International Standards. | |
| | Shock & Vibration Resistance | IEC 68-2-27; SHOCK<br>IEC 68-2-6; Sin. VIBRATION<br>IEC 68-2-34; RANDOM VIBRATION, wide band | MIL-T-28800 | CAS elected to use FDA's Performance Standard for Infant Apnea Monitor as guidance for S&V resistant testing | |
| 14. Safety<br>Characteristics | Electrical | UL544, EN 60601-1 | UL, CSA, TUV and others | None | |
| | Cuff Over-Pressurization limits | Software Limit: 290 mm Hg<br>Redundant switch: 330mmHg<br>(Meets IEC 601-2-30, AAMI SP-10) | Software Limit: 260 mmHg<br>Redundant switch: 330mmHg<br>(Meets IEC 601-2-30, AAMI SP-10) | No significant difference | |
| | Prolonged Cuff Inflation time-out | Up to 120 seconds (Meets IEC 601-2-30, AAMI SP-10) | Up to 180 seconds (Meets IEC 601-2-30, AAMI SP-10) | CAS uses a shorter time for patient comfort | |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1898 MAY
Mr. Ron Jeffrey Quality Manager CAS Medical Systems, Inc. Technology Applied to Medicine 21 Business Park Drive Branford, CT 06405
Re : K972020 OSCILLOMATE 9001D NON-Invasive Blood Pressure Monitor Regulatory Class: II (Two) Product Code: DXW Dated: April 17, 1998 Received: April 28, 1998
Dear Mr. Jeffrey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any. obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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#### Page 2 - Mr. Ron Jeffrey
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: OSCILLOMATE 9001D NON-INVASIVE BLOOD PRESSURE MONITOR
Indications For Use:
The Oscillomate 9001D monitor non-invasively measures the blood pressure of adult and I he Oschnoliate 2001D inomer non agency care environment. The monitor automatically peniatic patients primarily in also entrigens in the Oscillometric measurement technique, determines systolic, diastolic and pulse rate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bete Lumperle
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
OR
Artistics
Over-The-Counter Use
(Optional Format 1-2-96)
.
