The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter - and intra-hospital transport and pre-hospital (EMS) settings for non-breathing adult patients.

Device Description

The CAREvent PAR® is an electronically controlled, pneumatically powered resuscitator with a . 12V, internal, rechargeable battery is used to power the electronics. It incorporababliator instructions to assist the user during CPR.

AI/ML Overview

The provided text describes a Premarket Notification 510(k) for the CAREvent PAR device, which is an electronically controlled, pneumatically powered resuscitator. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance data often seen with AI/ML devices.

Therefore, many of the requested categories for AI/ML study descriptions are not applicable to this 510(k) submission. However, I can extract and present the information that is available, and explicitly state where information is not present in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for specific performance metrics in the way an AI/ML device study would. Instead, it presents a comparative table detailing the features and performance specifications of the proposed device against its predicate devices. The "acceptance criteria" here are implicitly that the proposed device's features and performance meet or are substantially equivalent to those of the legally marketed predicate devices.

Feature / Performance Metric	Predicate Device Specification (K991195 - CAREvent BLS+ and K860555 - CPR Coach)	Proposed Device (CAREvent PAR) Performance	Implied "Acceptance Criteria" Met?
Indications for Use	Pulmonary resuscitation during respiratory and/or cardiac arrest; short-term ventilatory support for non-breathing patients; voice prompts for CPR.	Cardio Pulmonary Resuscitation (CPR) and short-term ventilatory support for non-breathing adult patients; voice instructions, compression beeps, automatic ventilations to assist CPR.	Yes (Broader/More Specific)
Environment of Use	Inter- and intra-hospital transport	Same, added pre-hospital (covered under inter-hospital transport)	Yes
Patient Population	Non-breathing adult and child (K991195)	Non-breathing adults	Yes (Subset for proposed device)
Contraindications	None	None	Yes
Software Driven	No (K991195), Yes (K860555)	Yes, some features (Respiratory rate, Pressure relief audible alarm, voice prompts)	Yes (consistent with predicate K860555 that has software)
Components Uses	Controller - multi-patient, multi-use; Circuit and mask - single patient use disposable	Same	Yes
Instructional voice prompts	Yes (K860555)	Yes	Yes
Deliver 100% oxygen	Yes (K991195)	Yes	Yes
Tidal volume (L)	12 settings (1.35 down to 0.2) (K991195)	Fixed - 0.7	Yes (Fixed setting is a design choice, not a failure to meet a predicate range)
Respiratory Rate (BPM)	12 settings (10, 12, 15, 18, 20) (K991195)	Fixed - 20	Yes (Fixed setting is a design choice, within predicate range)
I:E ratio	Fixed 1:2 (K991195)	Fixed 1:2	Yes
Maximum Pressure relief (cm H2O)	60 (K991195)	60	Yes
Pressure relief audible alarm	Yes (K991195)	Yes	Yes
Manual ventilation option	Yes (K991195)	No	Yes (Difference noted, but not deemed a "significant difference that affect the safety or effectiveness")
Demand breathing feature	No (K991195)	No	Yes
Circuit pressure	40 psi (K991195)	Same	Yes
Input gas pressure	45-70 psi (K991195)	Same	Yes
Input fitting/Output fitting	9/16 DISS / 22mm	Same	Yes

2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of data or studies typically associated with AI/ML devices. The submission relies on a comparison of design features and technical specifications to predicate devices. There is no mention of a specific number of test cases or data provenance for any performance evaluation in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The submission relies on design specifications and functional equivalence rather than expert-established ground truth from performance studies.

4. Adjudication method for the test set
This information is not applicable and not provided.

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
This information is not applicable and not provided. The CAREvent PAR is a medical device (resuscitator) that provides automated ventilations and voice instructions; it is not an AI-based diagnostic or assistive technology for human "readers" in the sense of image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device's operation inherently involves human interaction for setup and monitoring, and its functionality is not solely algorithmic in the AI sense. Its performance is measured by its physical output (e.g., tidal volume, respiratory rate).

7. The type of ground truth used
The "ground truth" for this type of device submission is based on engineering specifications, adherence to recognized standards (though not explicitly detailed here, often part of such submissions), and a comparison to the established performance and safety profiles of predicate devices. There is no "expert consensus," "pathology," or "outcomes data" in the AI/ML context mentioned for performance validation.

8. The sample size for the training set
This information is not applicable and not provided, as the device is not an AI/ML system that undergoes a "training set" process.

9. How the ground truth for the training set was established
This information is not applicable and not provided, as the device is not an AI/ML system.

Summary

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Premarket Notification 510(k) Section 5 - 510(k) Summary

Image /page/0/Picture/1 description: The image shows the words "CAREvent PAR" in a serif font. The words are stacked on top of each other. The text is black and the background is white.

Non-Confidential Summary of Safety and Effectiveness

1081336

Page 1 of 3 8-May-08

6 2009 MAR

O-Two Medical Technologies 7575 Kimbel St. Mississauga, Ontario L5S1C8 Canada

Tel -- 905-677-9410

Ammar Al-Dojaily

Official Contact:

Proprietary or Trade Name: CAREvent PAR

Common/Usual Name:

Classification Name:

ventilator, emergency, powered (resuscitator) BTL - 868.5925

ventilator, emergency, powered (resuscitator)

Predicate Devices:	O-Two Medical - CAREvent BSL+ - K991195
	Auralogic - CPR Coach voice prompter - K86055

Device Description:

Indications for Use;

: The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter s and intra-hospital transport and pre-hospital (EMS) settings for non-breathing adult patients.

Patient Population: Non-breathing adult patients

. Environment of Use: Hospitals (inter - and intra- transport), pre-hospital (EMS) settings

Contraindications: None

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Premarket Notification 510(k) Section 5 – 510(k) Summary

Non-Confidential Summary of Safety and Effectiveness

Page 2 of 3 8-May-08

Comparative table:

Features	Predicates	Proposed Device
	K991195 - CAREvent BLS+K860555 - CPR Coach voiceprompter	CAREvent PAR



Indications for use	Pulmonary resuscitation duringrespiratory and / or cardiac arrest.Short-term ventilatory support for bothinter- and intra-hospital transport ofnon-breathing patients (K991195)No indications for use statement butstates voice prompts for CPR(K860555)	The CAREvent PAR (Public AccessResuscitator) is indicated for CardioPulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporatesvoice instructions, compression beeps andautomatic ventilations to assist CPRTrained personnel for both inter - and intra-hospital transport and pre-hospital (EMS)settings for non-breathing adult patients.
Environment of Use	inter- and intra-hospital transport(K991195)	Same added pre-hospital as this is coveredunder inter-hospital transport
Patient Population	Non-breathing adult and child(K991195)	Non-breathing adults
Contraindications	None(K991195)	None
Software driven	No(K991195)YesK860555	Yes, some features --Respiratory rate (BPM), Pressure reliefaudible alarm, voice prompts
Components uses	Controller - multi-patient, multi-useCircuit and mask - single patient usedisposable (K991195)	Same
Components	Ventilator / controllerCircuitMaskHead strap(K991195)	Ventilator / controllerCircuitMaskHead strap
Instructional voiceprompts	Yes(K860555)	Yes
Performance and design features
Can deliver 100%oxygen duringresuscitation	Yes(K991195)	Yes
Tidal volume (I)	12 settings (L)1.35, 1.1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4,0.35, 0.3, 0.25, 0.2(K991195)	Fixed - 0.7
Respiratory Rate(BPM)	12 settings10, 12, 15, 18, 20(K991195)	Fixed - 20
I:E ratio	Fixed 1:2(K991195)	Fixed 1:2
Features	PredicatesK991195 - CAREvent BLS+K860555 - CPR Coach voiceprompter	Proposed DeviceCAREvent PAR
Maximum Pressurerelief (cm H2O)	60(K991195)	60
Pressure relief audiblealarm	Yes(K991195)	Yes
Manual ventilationoption	Yes(K991195)	No
Demand breathingfeature	No(K991195)	No
Circuit pressure	40 psi(K991195)	Same
Input gas pressure	45-70 psi(K991195)	Same
Input fitting/Output fitting	9/16 DISS22mm	Same

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 3 8-May-08

Differences Between Other Legally Marketed Predicate Devices:

The proposed device is viewed as substantially equivalent to the predicate devices, K991195 and K860555.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/3/Picture/0 description: The image shows a partial logo and the word "DEPARTMENT". The logo is a circular emblem with text around the perimeter, but only "OF HEALTH & HUMAN SERVICES - USA" is visible. To the left of the word "DEPARTMENT" is a stylized graphic consisting of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

O-Two Medical Technologies, Incorporated C/0 Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

6 2009 MAR

Re: K081330

Trade/Device Name: CAREvent PAR Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: February 23, 2009 Received: February 24, 2009

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Cinthony D. Watson for
S. Michael Lamb

Ginette Y. Michaud, M.D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

Number:

(To be assigned)

e Name:

CAREvent PAR

ations for Use:

The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter - and intrahospital transport and pre-hospital (EMS) settings for nonbreathing adult patients.

scription Use XX 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K051330

Regulation Number and Section

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).