9303 NEONATAL/ADULT VITAL SIGNS MONITOR
Device Facts
| Record ID | K982776 |
|---|---|
| Device Name | 9303 NEONATAL/ADULT VITAL SIGNS MONITOR |
| Applicant | Cas Medical Systems, Inc. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Nov 2, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The 9303 Neonatal / Adult Monitor is intended for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and the temperature of the adult, pediatric and neonatal patient in the care of health care professionals.
Device Story
The 9303 Neonatal/Adult Vital Signs Monitor is a portable, battery-powered device used in clinical settings by healthcare professionals to monitor or spot-check patient vitals. It accepts inputs via NIBP cuffs, pulse oximetry sensors, and predictive temperature probes. The device utilizes oscillometric technology for blood pressure/pulse, red/infrared oximetry for SpO2/heart rate, and a microprocessor-based thermistor for temperature. Data is processed and displayed on an LED screen; a message center provides system status, alarms, and troubleshooting. The device features manual/automatic NIBP modes, a STAT mode for rapid measurements, and non-volatile memory for short-term history storage. Output is used by clinicians to assess patient status and make immediate clinical decisions. The device includes user-settable alarms for out-of-range parameters and supports optional printing of history data. It is designed for year 2000 compatibility.
Clinical Evidence
Clinical performance was validated through testing of individual components. NIBP technology meets AAMI/ANSI SP10:1992 criteria. The pulse oximeter component passed SpO2 clinical accuracy testing. The predictive thermometer component passed clinical testing for oral and rectal use in adults and children under three.
Technological Characteristics
Portable, battery-powered monitor with LED display. Technologies: Oscillometric NIBP, Red/Infrared pulse oximetry, Microprocessor-based thermistor predictive thermometer. Complies with EN 60601-1 safety standards. Includes non-volatile memory for data storage and time-stamping. Connectivity includes optional printer output.
Indications for Use
Indicated for non-invasive monitoring of blood pressure, oxygen saturation, pulse, and temperature in adult, pediatric, and neonatal patients under the care of healthcare professionals.
Regulatory Classification
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Predicate Devices
- Oscillomate 9300 NIBP by CAS Medical Systems (K925402)
- Oscillomate 9002D NIBP by CAS Medical Systems (K980879)
- Model 8500 by Nonin Medical, Inc. (K893221)
- SureTemp 679 by Welch Allyn (K964643, K943695)
Submission Summary (Full Text)
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K982776
Image /page/0/Picture/1 description: The image shows the logo for CAS Medical Systems, Inc. The logo includes the company name in bold, sans-serif font, along with the tagline "TECHNOLOGY APPLIED TO MEDICINE." Below the tagline is the address "21 BUSINESS PARK DRIVE, BRANFORD, CONNECTICUT 06405."
203-488-6056 (FAX) 203-488-9438
NOV 2 1998
Image /page/0/Picture/4 description: The image shows a document with the text '7 AUG 98 13 53' vertically aligned on the left side. To the right of this, also vertically aligned, is the text 'FDA/CDRH/ODE/DMC'. The word 'RECEIVED' is vertically aligned on the far left side of the image.
# 510(K) SUMMARY
Date prepared:
August 5, 1998
Contact:
Common names:
CAS Medical Systems, Inc. 21 Business Park DR. Branford CT. 06405 (203) 488-6056 Fax (203) 488-9438
Ron Jeffrey Contact person: Quality Assurance Manager
9303 Neonatal / Adult Vital Signs Monitor Device trade name:
> Physiological or Vital Signs Patient Monitor.
> > Includes the following parameters:
- Non-invasive Blood Pressure with Pulse . rate
- Pulse Oximeter & Pulse Rate ●
- Predictive Thermometer ●
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## Classification
| Classification Name | 21 CFR Section | Product Code | Class |
|---------------------------------------------------|----------------|--------------|-------|
| Monitor, Physiological, Patient | | 74MHX | 2 |
| Non-invasive Blood Pressure<br>Measurement System | 870.1130 | 74DXN | 2 |
| Oximeter | 870.2700 | 74DQA | 2 |
| Clinical Electric Thermometer | 880.2910 | 80FLL | 2 |
#### Predicate Devices
CAS is claiming substantial equivalence to the following legally marketed device:
| Aspect | Device | 510(k) number |
|--------------------------------|--------------------------------------------------|--------------------|
| Non-invasive Blood<br>Pressure | Oscillomate 9300 NIBP by<br>CAS Medical Systems | K925402 |
| Non-invasive Blood<br>Pressure | Oscillomate 9002D NIBP<br>by CAS Medical Systems | K980879 |
| Oximetry | Model 8500 by Nonin<br>Medical, Inc. | K893221 |
| Temperature | SureTemp 679 by Welch<br>Allyn | K964643<br>K943695 |
#### Device Description
The 9303 Neonatal / Adult Vital Signs Monitor is a prescription device intended for use only by health care professionals.
The monitor is designed to monitor and spot check adult, pediatric and neonatal patients for blood pressure, oxygen saturation, pulse and temperature noninvasively in a variety of clinical settings.
The monitor is portable, lightweight, and durable. The user selects either the adult or neonatal application for NIBP. Power is supplied by an internal lead acid rechargeable battery. The battery is charged by plugging monitor to an AC power source. Information is displayed in an easy to read LED display. NIBP Readings may be taken manually, or at automatic, operator selected intervals. A STAT mode is available for a rapid series of NIBP measurements. A message center display provides system alarm messages, operating modes, battery state and troubleshooting prompts. A history mode displays previous NIBP and Sp02 readings which can be sent to an optional printer. The monitor can operate in one
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of four languages which the operator may change. There are NIBP and Sp02 patient alarms to warn the user of any measurement parameter outside the range of a user set or factory default value. A test mode may be activated to test for pneumatic leaks and calibration. The predictive temperature function may be either oral, axillary or rectal with appropriate probe.
The 9303 monitor is year 2000 compatible. The monitor includes a time stamp function for the printout of NIBP values and a history function in non-volatile memory. The history function is a short term (hours) storage and is not effected by yearly changes. The monitor will show the year 2000 as "00". Accounting for leap year is not a problem.
### Intended Use
The 9303 Neonatal / Adult Monitor is intended for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and the temperature of the adult, pediatric and neonatal patient in the care of health care professionals.
#### Comparison of Technological Characteristics
The CAS 9303 Monitor and its monitoring parameters have essentially the same technological characteristics as the predicate devices with regard to design, materials and energy source. There are no new technological characteristics. The 9303 monitoring parameters and the predicate devices monitoring parameters utilize the following technologies:
- Non-invasive Blood Pressure and Pulse: Oscillometrics ●
- Pulse Oximetry and Heart Rate: Nonin Medical Inc.® Red and Infrared . Oximetry.
- Predictive Thermometer: SureTemp® Microprocessor based Thermister . Predictive Thermometer.
#### Nonclinical Tests
Several other tests were conducted to demonstrate safety and effectiveness of the 9303 and the monitoring parameters.
- Intra-device variability ●
- Environmental testing (Temperature and Humidity) ●
- Electromagnetic Compatibility ●
- . EN 60601-1 Safety - Medical Equipment
- . Mechanical Shock and Vibration
- Battery and AC Testing .
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## Clinical Tests
- The 9303 w/ NB NIBP Technology meets the clinical performance criteria of ● AAMI/ANSI SP10: 1992.
- The Nonin® Pulse Oximeter component has passed Sp02 clinical accuracy . testing.
- The SureTemp® Thermometer component has passed clinical testing orally . and rectal for adults and children under three.
## Conclusions
In accordance with 21 CFR part 807.92(b)(3) and as presented in this premarket notification, CAS Medical Systems, Inc. concludes that the new device, 9303 Adult / Neonate Vital Signs Monitor is safe and effective and substantially equivalent to the predicate devices as described.
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## Other Information
CAS Medical Systems, Inc. will update this summary with additional information if requested by the FDA.
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Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized symbol of three human profiles facing right, arranged in a way that they also resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1998
Mr. Ron Jeffery QA/RA Manager CAS Medical Systems, Inc. 21 Business Park Drive Branford, CT 06405
Re : K982776 Model 9303 Neonatal/Adult Vital Siqns Monitor Requlatory Class: II (two) Product Code: DQA Dated: August 5, 1998 Received: August 6, 1998
Dear Mr. Jeffery:
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 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). 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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
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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.
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 requlation (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, ² Misbranding by reference to premarket notification² (21CFR 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/dsma/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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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number: K9802776
Device Name: CAS Medical Systems, Inc. 9303 Neonatal/ Adult Vital Signs Monitor
Indications For Use:
The 9303 Neonatal/ Adult Vital Signs monitor is indicated for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients in the care of health care professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Dealla Tillah
diovascular, Respiratory, 510(k) Number
