Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devices with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only.

Device Description

The Criterion 40 is a microprocessor controlled device that measures and monitor patient airway pressure. produces continuous positive airway pressure. It measures low and high pressures and advises the user if the pressure fall outside the user-set ranges. It operates on AC / DC power and provides digital and graphically readouts of the pressure - real-time and peak pressures. It connects into the patient circuit with the use of a pressure tubing with integral in-line filter and a connector.

AI/ML Overview

The provided text describes the PROMEDIC INC Criterion 40 Airway Pressure Monitor, a microprocessor-controlled device designed to measure and monitor patient airway pressure. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics.

However, based on the information provided, we can infer some "acceptance criteria" through comparison with the predicate device and the stated functionalities. The reported device performance is directly drawn from the device's specifications.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria (Inferred from comparison with predicate) and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Inferred from Predicate/Function)	Reported Device Performance (Criterion 40)
Intended Use	Measurement and monitoring of patient airway pressure (high & low alarms) with positive pressure devices.	Is intended to measure airway pressure when used with positive pressure devices. Alarms when pressure falls outside user-set limits. Displays peak and real-time pressures.
Environment of Use	Hospital, sub-acute institutions, home care. Stationary and intra-institution transport.	Hospital, sub-acute institutions, home care. Stationary and intra-institution transport only.
Device Size	Comparable to predicate (7.5" x 6" x 4")	6.5" x 3.4" x 5"
Device Weight	Comparable to predicate (approx. 1 lb)	approx. 2 lb.
Controls	Solid-state pressure transducer, DC adaptable controls.	Microprocessor controlled, solid-state pressure transducer, AC/DC adaptable.
Power Specifications	9 V DC.	120 V AC, 60 Hz, 20 W or 230 V AC, 50 Hz, 60 mA, 12 V DC.
Output	Analog readout of pressures.	Digital readout of pressures.
Patient Interface Materials	PVC, K-resin for pressure tubing and airway connector tee.	PVC, K-resin for the pressure tubing and airway connector tee.
Patient Interface Method	Airway adapter in circuit or connection to face mask.	Airway adapter placed in the circuit or connection to a face mask.
Display of Information	Low/high pressure alarm setting, inadvertent off alarm, pressure gauge shows values (peak/real-time), power status alarm.	Low/high pressure alarm setting, status of alarm silence and time remaining, peak pressure, real-time pressure (bar graph), power source and status, audible and visual alarm.
Low Pressure Alarm Range	2 - 50 cm H2O (resolution not specified).	1 - 20 cm H2O, 1 cm H2O resolution.
High Pressure Alarm Range	2 - 100 cm H2O (resolution not specified).	5 - 99 cm H2O, 1 cm H2O resolution.
Peak Pressure Display	Determined by visual observation.	Displayed as value.
Real-time Pressure Display	Determined by visual observation only.	Displayed as bar graph.
Alarm Delay	Yes - 2 - 60 seconds.	Yes - 1 - 20 seconds.
AC/DC Operation	9 V DC, no AC capabilities.	120 V AC / 230 V AC and 12 V DC.
Accuracy of Pressure Alarm	+/- 3 cm H2O.	+/- (1 + 3% of reading) rounded up to nearest cm H2O.
Accuracy of Display (Peak/Bar Graph)	Not specified.	+/- (1 + 3% of reading) rounded up to nearest 0.5 cm H2O.
Alarms	Low pressure, high pressure, inadvertent off, low battery.	Low pressure, high pressure, loss of power, low battery.
Operating Temp/Humidity	16 °C - 34 °C, 20 - 90% RH.	5 °C to 45 °C, 15 - 95% RH.
Storage Temperatures	Not specified.	-40 °C to 60 °C @ 95% RH.
Battery Life	up to 2 months.	up to 24 hours for backup and transport use (primary power AC).
Zero Calibration	Yes.	Yes.
Pressure Tubing with In-line Filter & Airway Connector	Yes.	Yes.
Pole Mount	Yes.	Yes.
AC Power Supply	Not applicable.	Yes.
Electrical Safety Standards	CSA C22.2 No. 125 Risk Class 2, UL 260 / IEC 601-1.	IEC 601-1-2, UL 260 / IEC 601-1.

2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical or performance data for the Criterion 40. The submission is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data. The "study" here is a comparison of specifications and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is 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
Not applicable. This device is an airway pressure monitor, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself operates as a standalone monitor of airway pressure. The document describes its functional capabilities and comparison to a predicate device, which implies its direct performance without human interpretation being the primary measure. However, it's not an "algorithm-only" performance study in the AI sense. It's an electro-mechanical device performance evaluation based on specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence is based on:

Predicate Device Specifications: The established (and legally marketed) characteristics, intended uses, and performance of the Monaghan CM 5000 Airway Pressure Monitor (K871083) and its modifications.
Engineering and Design Standards: Compliance with electrical safety standards (IEC 601-1-2, UL 260 / IEC 601-1).
Internal Testing/Validation (Implied): While not detailed, the accuracy claims for pressure alarm and display (+/- (1 + 3% of reading)) would have been established through internal testing against calibrated reference standards.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.

Summary

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PROMEDIC INC

K992101
JAN - 6 2000

Criterion 40

Premarket Notification 510(k) Section 2 - Certification and Summaries

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Non-Confidential Summary of Safety and Effectiveness

page 1 of 4 January 4, 2000

Caradyne, Ltd.
Parkmore Business Park
Parkmore West
Galway, Ireland
Tel.	011-353-91-709010
Fax	011-353-91-758929

Official Contact:	John O'Dea, Ph.D. - General Manager
Proprietary or Trade Name:	Criterion 40
Common/Usual Name:	Airway Pressure Monitor
Classification Name:	Airway Pressure Monitor (includes gauges and / or alarm)
Device:	Criterion 40
Predicate Devices:	Monaghan, Ltd. CM 5000 Airway Pressure Monitor - K871083

Contraction of the program of the comments of the comments of the comments of the comments of the comments of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indicated Use --	Is intended to measure airway pressure when used with positivepressure devices. The device alarms when the airway pressure fallsoutside of the user selected high and low alarm limits and displayspeak pressure and real-time airway pressures. It may be used withpositive pressure devices which do not include pressuremeasurement capabilities, e.g. resuscitation bags or basic ventilators,or as an independent backup pressure monitor for devices withpressure measurement capability. The device has been designed forstationary and intra-institution transport only.
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Indicated Use --

Is intended to measure airway pressure when used with positivepressure devices. The device alarms when the airway pressure fallsoutside of the user selected high and low alarm limits and displayspeak pressure and real-time airway pressures. It may be used withpositive pressure devices which do not include pressuremeasurement capabilities, e.g. resuscitation bags or basic ventilators,or as an independent backup pressure monitor for devices withpressure measurement capability. The device has been designed forstationary and intra-institution transport only.

------------------

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Premarket Notification 510(k)

Criterion 40

Section 2 - Certification and Summaries

Non-Confidential Summary of Safety and Effectiveness

page 2 of 4 January 4, 2000

Environment of Use --

Hospital, sub-acute institutions, home care

Comments of the Claim Childers and Andrew Home of the September of Childers of Childers of Children

	For use with positive pressure devicesas a standalone or backup device tomeasure and monitor high and lowairway pressures	Standalone accessory to supplementpatient monitoring during ventilation(positive) to notify of undesirably lowand / or high pressures.
	Yes	Yes
	Any patient utilizing positivepressure devices and the cliniciandesires to have pressure monitoring.Hospital, Sub-acute Institutions,Home Care	Any patient utilizing positivepressure devices and the cliniciandesires to have pressure monitoring.Hospital, Sub-acute Institutions,Home Care
	Limited to stationary and intra-institution transport only	Limited to stationary and intra-institution transport only
Weights (lb.)	approx. 2 lb.	approx. 1 lb.
Size (W x H x D)	6.5" x 3.4" x 5"	7.5" x 6" x 4"
Controls	Microprocessor controlled, solid-statepressure transducer, AC / DCadaptable	Solid-state pressure transducer, DCadaptable
Power specifications	120 V AC, 60 Hz, 20 W or 230 VAC, 50 Hz, 60 mA, 12 V DC	9 V DC
Output	Digital readout of pressures	Analog readout of pressures
Materials whichinterface with patient	PVC, K-resin for the pressure tubingand airway connector tee	PVC, K-resin for the pressure tubingand airway connector tee
Patient interface	Airway adapter placed in the circuitor connection to a face mask	Airway adapter placed in the circuitor connection to a face mask
Display ofinformation	Low pressure alarm settingHigh pressure alarm settingStatus of alarm silence and timeremainingPeak pressureReal-time pressurePower source and statusAudible and visual alarm	Low pressure alarm settingHigh pressure alarm settingInadvertent off - audiblePressure gauge shows values (peakand real-time read upon visualobservation)Power status alarmAudible alarm
Low pressure alarmrange	1 - 20 cm H2O1 cm H2O resolution	2 - 50 cm H2Oresolution not specified

High pressure alarmrange	5 - 99 cm H2O1 cm H2O resolution	2 - 100 cm H2Oresolution not specified
Peak pressure	Displayed as value	Determined by visual observation
Real-time pressure	Displayed as bar graph	Determined by visual observation only
Alarm delay	Yes - 1 - 20 seconds	Yes - 2 - 60 seconds
AC / DC operation	120 V AC / 230 V AC and 12 V DC	9 V DC no AC capabilities
Accuracy of pressurealarm	+/- (1 + 3% of reading) rounded up tonearest cm H2O	+/- 3 cm H2O
Accuracy of display -Peak and Pressure bargraph	+/- (1 + 3% of reading) rounded up tonearest 0.5 cm H2O	Not specified
Alarms	Low pressureHigh pressureLoss of powerLow battery	Low pressureHigh pressureInadvertent offLow battery
Operating temperature/ humidity	5 °C to 45 °C, 15 - 95% RH	16 °C - 34 °C, 20 - 90% RH
Storage temperatures	-40 °C to 60 °C @ 95% RH	not specified
Battery life	up to 24 hours for backup andtransport use but primary powersupply is AC	up to 2 months
Zero calibration	Yes	Yes
Pressure tubing within-line filter andairway connector	Yes	Yes
Pole mount	Yes	Yes
AC power supply	Yes	Not applicable
IEC 601-1-2	Yes	CSA C22.2 No. 125 Risk Class 2
UL 260 / IEC 601-1	Yes	Yes
FDA PMNrequirementsNovember, 1993	Yes	Not Known
	None	None
	Comparable	Comparable

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Premarket Notification 510(k)

Section 2 - Certification and Summaries

Criterion 40

Non-Confidential Summary of Safety and Effectiveness

page 3 of 4

January 4, 2000

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Premarket Notification 510(k) Section 2 - Certification and Summaries Criterion 40

Non-Confidential Summary of Safety and Effectiveness page 4 of 4 January 4, 2000

The Criterion 40 Airway Pressure Monitor is viewed as substantially equivalent to the following predicate device - Monaghan CM 5000 Airway Pressure Monitor (APM) cleared under K871083 and other modifications under K873953, K925673, and K931394.

The differences between the Criterion 40 and the predicate device are minimal. There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices. They are viewed as substantially equivalent to the predicate devices since they:

1. Have the same intended uses
- 1.1 Intended for the measurement and monitoring patient airway pressure
- 1.2 Provide high and low alarms
1. Have the same environments for use
- 2.1 Used in hospitals, sub-acute institutions, home care settings
- 2.2 The device has been designed for stationary and intra-institution transport only.
1. Are similar in design
- 3.1 Utilize the same design and functional features
1. They employ the same technology
- 4.1 Utilize a pressure transducer
- 4.2 Utilized tubing to interface with patient circuit
1. Are made of identical materials
- 5.1 Utilize similar materials for the monitor and accessories

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 6 2000

Caradyne, Ltd. c/o Mr. Paul E. Dryden ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055-9501

Re: K992101 Criterion 40 - Airway Pressure Monitor Regulatory Class: II (two) Product Code: 73 CAP Dated: October 8, 1999 Received: October 12, 1999

Dear Mr. Dryden:

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 Regulations, 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. 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 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 requlations.

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Page 2 - Mr. Paul E. Dryden

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 qeneral 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,

Jean H Westenberg

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification 510(k) Section 2 - Certifications and Summaries Criterion 40

中特中一篇:中国新闻网 : 除:: (be

Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number:	K992101 (To be assigned)
Device Name:	Criterion 40 Airway Pressure Monitor
Intended Use :	Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devices with

510(k) Number:

K992101 (To be assigned)

Device Name:

Criterion 40 Airway Pressure Monitor

Intended Use :

ors, or cies with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

be the best that you can be.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Prescription Use V (Per CFR 801.109)

Over-the-counter use

Regulation Number and Section

§ 868.2600 Airway pressure monitor.

(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).