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.

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 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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the CAS Medical Systems, Inc. 9303 Neonatal/Adult Vital Signs Monitor, structured to answer your questions.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary provides a high-level overview of clinical performance criteria met, rather than detailed numerical acceptance criteria and reported device performance for each parameter. However, based on the information provided, we can infer the following:

Parameter	Acceptance Criteria	Reported Device Performance
Non-invasive Blood Pressure (NIBP)	Meets clinical performance criteria of AAMI/ANSI SP10: 1992.	The 9303 w/ NB NIBP Technology meets the clinical performance criteria of AAMI/ANSI SP10: 1992.
Pulse Oximetry (SpO2)	Passed SpO2 clinical accuracy testing.	The Nonin® Pulse Oximeter component has passed SpO2 clinical accuracy testing.
Predictive Thermometer	Passed clinical testing orally and rectally for adults and children under three.	The SureTemp® Thermometer component has passed clinical testing orally and rectal for adults and children under three.

Important Note: The document does not provide the specific numerical thresholds for "meeting clinical performance criteria" or "passing clinical accuracy testing." These standards (AAMI/ANSI SP10, etc.) would contain those detailed metrics.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not explicitly state the sample sizes used for the clinical tests for NIBP, Pulse Oximetry, or Predictive Thermometer.

Regarding data provenance:

The document implies that the clinical testing for the NIBP component was conducted on the 9303 device itself.
For Pulse Oximetry (Nonin®) and Predictive Thermometer (SureTemp®), the document states that these "components" have passed clinical testing, suggesting that the clinical data supporting these components may have originated from the manufacturers of those specific technologies (Nonin Medical, Inc. and Welch Allyn, Inc.), likely from their own regulatory submissions. It does not state if new clinical tests were performed on the integrated 9303 device specifically for these components beyond what their original manufacturers may have provided.
The provenance (e.g., country of origin, retrospective/prospective) for any of these clinical tests is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The 510(k) summary does not provide information on the number of experts or their qualifications used to establish ground truth for any of the clinical tests mentioned.

4. Adjudication Method for the Test Set

The 510(k) summary does not provide information on any adjudication method used for the clinical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the 510(k) summary. This type of study is typically associated with imaging devices where human interpretation is a primary outcome, which is not the case for a vital signs monitor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone system for measuring vital signs. The clinical tests described (meeting AAMI/ANSI SP10, SpO2 accuracy, thermometer accuracy) are inherently assessments of the algorithm/device-only performance without human intervention during the measurement process, other than a healthcare professional initiating the measurement. So, in essence, the "standalone" performance is what was tested.

7. The Type of Ground Truth Used

Based on the nature of vital signs monitoring devices:

Non-invasive Blood Pressure (NIBP): For AAMI/ANSI SP10 compliance, ground truth is typically established by invasive arterial blood pressure measurements (for accuracy testing) or by reference oscillometric devices that themselves have been validated against invasive methods.
Pulse Oximetry (SpO2): Ground truth for SpO2 accuracy testing is traditionally established using co-oximetry (blood gas analysis) on arterial blood samples, with induced hypoxemia in human volunteers.
Predictive Thermometer: Ground truth for thermometer accuracy is established by continuous core body temperature measurements (e.g., rectal, esophageal, or pulmonary artery catheter) using highly accurate reference thermometers.

The document only states that the components "passed clinical accuracy testing" or "meets clinical performance criteria," implying the use of established ground truth methods for these physiological parameters.

8. The Sample Size for the Training Set

The 510(k) summary does not mention any "training set." This term is usually relevant for machine learning or AI-driven devices. As this device predates widespread AI in medical devices (1998) and relies on established physiological measurement technologies (oscillometry, oximetry, thermistors), there would not typically be a distinct "training set" in the modern sense. The "training" of such devices would be inherent in their engineering design, calibration, and validation against physical and physiological models.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned in the context of machine learning/AI, this question is not applicable based on the provided document. The device's underlying technologies (oscillometry, oximetry, thermistors) are based on well-understood physical principles and established calibration standards, rather than statistical models trained on large datasets.

Summary

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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

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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 PressureMeasurement 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 BloodPressure	Oscillomate 9300 NIBP byCAS Medical Systems	K925402
Non-invasive BloodPressure	Oscillomate 9002D NIBPby CAS Medical Systems	K980879
Oximetry	Model 8500 by NoninMedical, Inc.	K893221
Temperature	SureTemp 679 by WelchAllyn	K964643 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.

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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.

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.

Other Information

CAS Medical Systems, Inc. will update this summary with additional information if requested by the FDA.

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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:

(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

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).