Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes an electronically controlled, pneumatically powered resuscitator with voice instructions and automatic ventilations, but there is no mention of AI, ML, or related concepts. The device's functions appear to be based on pre-programmed logic rather than adaptive learning.

Therapeutic

Yes
The device is indicated for "Cardio Pulmonary Resuscitation (CPR) and short-term ventilatory support," which are therapeutic interventions.

Diagnostic

No

The device is indicated for providing ventilatory support and assisting with CPR, which are therapeutic interventions, not diagnostic ones. It helps with treatment rather than identifying or characterizing a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "electronically controlled, pneumatically powered resuscitator" with a battery, indicating it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for Cardio Pulmonary Resuscitation (CPR) and ventilatory support. This involves directly assisting a patient's breathing and circulation, which are physiological functions.
Device Description: The device is a resuscitator that provides ventilation and voice instructions for CPR. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information for diagnosis or monitoring of a disease state through in vitro methods.

IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens and provide diagnostic information. This device operates in vivo (within the living body) by providing ventilatory support.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 - and intra-hospital transport and pre-hospital (EMS) settings for non-breathing adult patients.

Product codes (comma separated list FDA assigned to the subject device)

BTL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Non-breathing adult patients

Intended User / Care Setting

CPR Trained personnel for both inter - and intra-hospital transport and pre-hospital (EMS) settings

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K991195, K860555

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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:

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.

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

1

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 voice
prompter	CAREvent PAR



Indications for use	Pulmonary resuscitation during
respiratory and / or cardiac arrest.
Short-term ventilatory support for both
inter- and intra-hospital transport of
non-breathing patients (K991195)

2

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.

3

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.

4

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

5

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