The Oscillomate 9002 NIBP / Sp02 Monitor Non-invasively measures blood pressure, I no obemomation and the pulse of the adult and pediatric patient in EMS environments by health care professionals. It is not designed for continuous unsupervised monitoring.

Device Description

The 9002D Oscillomate NIBP / SP02 Monitor is a prescription device intended for use only by health care professionals. The monitor is designed to monitor and spot check adult and pediatric patients for blood pressure, oxygen saturation, and pulse non-invasively in patient transport environments. The monitor is portable, lightweight, and durable. The device and all of its accessories are further enclosed in a rugged 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. NIBP 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 trends, previous readings and time readings were taken. Foreign language options and a data output port are included. The Sp02 function is derived from a pulse oximeter module mfg. by Nonin Medical, Inc.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Oscillomate® 9002D EMS NIBP/Sp02 Monitor, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Test	Acceptance Criteria (Implicit)	Reported Device Performance
NIBP Accuracy	Meets clinical performance criteria of AAMI/ANSI SP10: 1992	The Oscillomate 9002D meets the clinical performance criteria of AAMI/ANSI SP10: 1992.
SpO2 Accuracy	Clinical accuracy demonstrated	The Nonin® Pulse Oximeter component (used in the 9002D) has passed Sp02 clinical accuracy testing.
Safety	Complies with relevant safety standards	- Safety Medical and Dental Equipment (Implied compliance through successful testing) - Safety Medical Electrical Equipment (Implied compliance through successful testing)
Electromagnetic Compatibility (EMC)	Complies with relevant EMC standards	Electromagnetic Compatibility (Implied compliance through successful testing)
Environmental Testing	Operates reliably under specified environmental conditions	Environmental testing (Implied successful completion and compliance)
Intra-device variability	Acceptable level of variability	Intra-device variability (Implied successful testing and acceptable results)
Combined device accuracy testing	Acceptable combined device accuracy	Combined device accuracy testing (Implied successful testing and acceptable results)
SpO2 Accuracy vs. simulation	Acceptable accuracy against simulation	SpO2 accuracy vs. simulation (Implied successful testing and acceptable results)

Note: The provided document is a 510(k) summary, which often provides summary statements rather than detailed numerical acceptance criteria and performance data. The "acceptance criteria" are implied by meeting recognized standards (like AAMI/ANSI SP10) and successful completion of various bench and clinical tests without reported failures.

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

Sample Size (NIBP): Not explicitly stated in the provided text. The document only mentions that the device "meets the clinical performance criteria of AAMI/ANSI SP10: 1992." This standard defines requirements for test subject group size for clinical NIBP validation, but the actual number used in this specific study is not provided.
Sample Size (SpO2): Not explicitly stated in the provided text. It reports "The Nonin® Pulse Oximeter component has passed Sp02 clinical accuracy testing," implying that the testing was performed by Nonin, and the sample size for that test is not included here.
Data Provenance: Not explicitly stated. For NIBP validation to AAMI/ANSI SP10, typically clinical data from human subjects is used. For SpO2, typically clinical data from human subjects subject to various oxygen levels (hypoxia studies) are used. The country of origin and whether it was retrospective or prospective is not mentioned.

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

This information is not provided in the 510(k) summary. For NIBP, ground truth is typically established by trained technicians using auscultation (e.g., using a mercury manometer and stethoscope) as per the AAMI/ANSI SP10 standard. For SpO2, ground truth is typically established using a co-oximeter measuring arterial blood gas samples, analyzed by qualified laboratory personnel. The number and qualifications of experts involved in establishing this ground truth for the specific studies referenced are not detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set. For NIBP validation against a reference standard like auscultation, the comparison of automatic device readings to expert auscultatory readings might involve a form of comparison, but "adjudication" in the sense of resolving discrepancies among multiple independent readers is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The device in question is a physiological monitor (NIBP/SpO2) and not an AI-powered diagnostic imaging device or a system intended to assist human readers in interpretation. Therefore, this type of study is not applicable.

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

Yes, in essence, standalone performance was assessed. The entire submission focuses on the performance of the device (Oscillomate 9002D) itself in measuring NIBP and SpO2. The performance metrics (meeting AAMI/ANSI SP10 for NIBP and clinical accuracy for SpO2) inherently describe the algorithm's accuracy in producing those measurements without direct human intervention in the measurement process. The device's intended use is by "health care professionals," but this refers to their use of the device, not their real-time "human-in-the-loop" interpretation of a raw algorithm output.

7. The Type of Ground Truth Used

For NIBP: The ground truth would be established by direct auscultatory measurement, typically by trained observers using a mercury sphygmomanometer and stethoscope, as dictated by the AAMI/ANSI SP10 standard. This is a form of expert reference measurement.
For SpO2: The ground truth would be established by co-oximetry (measurement of arterial blood samples using a co-oximeter), which provides the most accurate measure of arterial oxygen saturation. This is a form of pathology/laboratory reference.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This device is from 1998, predating the widespread use of deep learning and large-scale "training sets" in the modern sense for medical devices like this. The device uses established oscillometric techniques for NIBP and optical absorption for SpO2. These methods are based on well-understood physiological principles and signal processing, rather than being "trained" on a large dataset in the way a contemporary AI model would be. Any internal calibration or algorithm development for such a device would not typically be referred to as a "training set" in this context.

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

Not Applicable / Not Provided. As explained in point 8, the concept of a "training set" and associated ground truth establishment in the modern AI sense is not directly relevant to this device from 1998. The algorithms were likely developed through engineering, physiological modeling, and testing against known benchmarks and reference standards, rather than large-scale data-driven training.

Summary

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The 1 6 1888

510(K) SUMMARY

Date prepared:

April 21, 1998

Contact:

CAS Medical Systems, Inc. 21 Business Park DR. Branford CT. 06405 (203) 488-6056 Fax (203) 488-9438

Contact person:

Ron Jeffrey Quality & Regulatory Affairs Manager

Trade name:

ﺮ

Common names:

Oscillomate® 9002D EMS NIBP/Sp02 Monitor

Physiological or Vital Signs Patient Monitor.

Includes the following parameters:

Non-invasive Blood Pressure with . Pulse rate
Pulse Oximeter & Heart Rate .

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Classification

Classification Name	21 CFR Section	Product Code	Class
Monitor, Physiological, Patient			2
Non-invasive Blood PressureMeasurement System	870.1130	74DXN	2
Oximeter	870.2700	74DQA	2

Predicate Devices

CAS is claiming substantial equivalence to the following legally marketed device:

Aspect	Device	510(k) number
Monitor	Propaq 100 SERIESMulti-parameter PatientMonitor	K910772
NIBP	Oscillomate 9001D NIBPby CAS Medical Systems	K972020 *
Oximetry	Model 8500 by NoninMedical, Inc.	K893221

As of the date of this submission this device was pending 510k approval.

Device Description

The 9002D Oscillomate NIBP / SP02 Monitor is a prescription device intended for use only by health care professionals.

The monitor is designed to monitor and spot check adult and pediatric patients for blood pressure, oxygen saturation, and pulse non-invasively in patient transport environments.

The monitor is portable, lightweight, and durable. The device and all of its accessories are further enclosed in a rugged 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. NIBP 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 trends, previous readings and time readings were taken. Foreign language options and a data output port are included. The Sp02 function is derived from a pulse oximeter module mfg. by Nonin Medical, Inc.

Intended Use

The Oscillomate 9002 NIBP / SP02 monitor non-invasively measures blood pressure, oxygen saturation, and the pulse of the adult and pediatric patient in

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EMS environments by health care professionals. It is not designed for continuous unsupervised monitoring.

Comparison of Technological Characteristics

The CAS Oscillomate 9002D NIBP / SP02 monitor and its monitoring parameters have essentially the same technological characteristics as the Oscillomate 9001 predicate devices with regard to design, materials and energy source. There are no new technological characteristics. With regard to the Propaq 100 SERIES monitors there are minor differences. The differences are shown below.

Some of the Propaq 100 series use Electroluminescent (EL) displays as an . option. The 9002D uses an LED display only
The Propaq 100 series have an in-service mode that simulates patient data . for training. The 9002D does not have this mode.
The 9002D monitor is designed to operate in a protective carry bag. Propaq . 100 series do not have a carry bag.
The Propaq 100 series have alarms for set limits. The 9002D monitor does . not have patient alarms.
The 9002D monitor has 4 patient controlled foreign language choices. This is . not available on the Propag 100 series monitors.
The Propag 100 series with Sp02 have a tone pitch indicator which varies to . reflect changes in oxygen saturation. This feature is not present in the 9002D monitor.

All devices are microprocessor driven electronic devices using the Oscillometric technique for NIBP and the absorption of red and infrared light passing through tissue for the oxyhemoglobin saturation (%Sp02) values.

Nonclinical Tests

Several bench tests were conducted to demonstrate safety and effectiveness of the Oscillomate 9002D and the monitoring parameters.

. Intra-device variability
Combined device accuracy testing ●
SP02 accuracy vs. simulation .
Environmental testing .
Electromagnetic Compatibility .
Safety Medical and Dental Equipment .
Safety Medical Electrical Equipment .

Clinical Tests

The Oscillomate 9002D meets the clinical performance criteria of AAMI/ANSI . SP10: 1992.
The Nonin® Pulse Oximeter component has passed Sp02 clinical accuracy . testing.

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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, the Oscillomate 9002D NIBP / SP02 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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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, arranged in a stacked formation.

JUL 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ron Jeffrey CAS Medical Systems, Inc. Technology Applied to Medicine 21 Business Park Drive Branford, CT 06405

Re: K980879 OSCILLOMATE 9002 NIBP / Sp02 Monitor Regulatory Class: II (Two) Product Code: DQA Dated: June 23, 1998 Received: June 24, 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 to 895. A substantially equivalent determination assumes compliance 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 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 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, "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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510(k) Number (if known):__

Image /page/6/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '980879'. The characters are written in a clear, legible font, and they appear to be underlined.

Device Name: _ OSCILLOMATE 9002 NIBP / Sp02 MONITOR

Indications For Usc:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Setre K. Kemperle
(Divisi

Division
and Neur:
510(k) Number K980879

Prescription Use / (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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).