o two CPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients in the hospital environment and emergency medical service applications to treat patients in respiratory distress.

Device Description

The o two CPAP device provides a constant positive airway pressure to the lungs of patients in respiratory distress from Pulmonary Emphysema, Congestive Heart Failure and a number of other obstructive airway conditions. This open system has no moving parts and uses a "vectored flow valve" to create a wall of resistance to expiration and an additive flow to inspiration. By varying the oxygen flow through the valve the baseline pressure can be raised or lowered to maintain a positive airway pressure. The rise in baseline pressure keeps alveoli from collapsing, forces fluid in the lungs back intro the interstitium and improves medication delivery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "o_two CPAP System". This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might find for a novel AI/software medical device.

Therefore, the requested information elements related to AI/software performance studies, such as sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and training set details, are not applicable to this 510(k) submission.

The "study" in this context is the comparison against predicate devices to establish substantial equivalence based on design, materials, indications for use, performance, and function.

Here's the information that can be extracted and a clear indication of what is not present given the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for novel performance. Instead, it demonstrates that the o_two CPAP System is comparable to its predicate devices in various characteristics. The "performance" is implied by its similarity to the predicate devices and its stated functional principles.

Characteristic	Predicate Devices (Implied Acceptance Criteria: Similar Performance)	O_two CPAP System (Reported Device Performance)
Intended Use	Boussignac CPAP Device: Intended to provide CPAP to spontaneously breathing patients. CAREvent Handheld CPAP System: Provide constant positive airway pressure for spontaneous breathing respiratory support.	o_two CPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients.
Environments of Use	Boussignac CPAP Device: Hospital and pre-hospital environment. CAREvent Handheld CPAP System: Hospital, pre-hospital (EMS) environments.	Hospital, pre-hospital (EMS) environments.
Patient Population	Boussignac CPAP Device: Spontaneous breathing adult and pediatric patients. CAREvent Handheld CPAP System: Spontaneous breathing adult and pediatric patients.	Spontaneous breathing adult and pediatric patients.
Operating Principles	Boussignac CPAP Device: Open system with no moving parts using a "virtual valve" to create resistance to expiration and additive flow to inspiration; varying oxygen flow adjusts baseline pressure to maintain positive airway pressure, keeping alveoli from collapsing, forcing fluid back into interstitium, and improving medication delivery. CAREvent Handheld CPAP System: Pneumatic, demand flow system.	An open system with no moving parts and uses a "vectored flow valve" to create a wall of resistance to expiration and an additive flow to inspiration. By varying the oxygen flow through the valve, the baseline pressure can be raised or lowered to maintain a positive airway pressure. The rise in baseline pressure keeps alveoli from collapsing, forces fluid in the lungs back into the interstitium and improves medication delivery.
Input Range	Boussignac CPAP Device: 0-25 L/min variable flow source. CAREvent Handheld CPAP System: 45 to 87 PSI.	0-25 L/min variable flow source.
Patient Connection	Boussignac CPAP Device: Face Mask. CAREvent Handheld CPAP System: Tubing with external expiratory valve, manometer and mask.	Face Mask.
Displays	Boussignac CPAP Device: Manometer (optional). CAREvent Handheld CPAP System: Manometer.	Manometer (optional).
Safety Features	Boussignac CPAP Device: Open system design but exhaust port could be unintentionally blocked causing a dangerous rise in patient airway pressure. CAREvent Handheld CPAP System: Internal high-pressure release (at 40 cmH2O), anti-suffocation valve on patient valve port.	Open system and main body design which limits airway pressure rise above 30 cm H2O in case of unintentional exhaust port blockage.
Patient Support Modes	Boussignac CPAP Device: CPAP. CAREvent Handheld CPAP System: CPAP.	CPAP.
Peak Flow on Demand	Boussignac CPAP Device: Unlimited (open system). CAREvent Handheld CPAP System: 120.	Unlimited (open system).
CPAP Levels (cmH2O)	Boussignac CPAP Device: 0-10. CAREvent Handheld CPAP System: 0-20.	0-20.
Materials in Gas Pathway	Boussignac CPAP Device: Polycarbonate, PVC. CAREvent Handheld CPAP System: Polycarbonate, PC, Brass, Aluminum & stainless steel.	Polycarbonate, PVC and brass.

2. Sample size used for the test set and the data provenance:

Not applicable. This submission is a substantial equivalence claim, not a clinical trial or performance study on a test set in the context of an AI/software device. The comparison is based on the technical specifications and intended use of the device against legally marketed predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. See point 2.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. See point 2.

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 is a hardware medical device (CPAP system), not an AI/software device intended to assist human readers.

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

Not applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices as determined by their prior clearance by the FDA. The o_two CPAP System is deemed substantially equivalent based on its design and performance characteristics matching or exceeding those of the predicates.

8. The sample size for the training set:

Not applicable. This is a hardware medical device, not an AI/software device trained on data.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

{0}------------------------------------------------

K112546

o two CPAP System

Non-Confidential Summary of Safety and Effectiveness

O-Two Medical Technologies 7575 Kimbel St. Mississauga, Ontario L5S1C8 Canada Tel - 905-677-9410

Ammar Al-Dojaily Official Contact: Aug. 24, 2011 Application Date: Proprietary or Trade Name: o_two CPAP System CPAP device Common/Usual Name: Positive End Expiratory Pressure Breathing Apparatus Classification Name: (21 CFR 868.5965, product code: BYE) Class II Device Class: Anesthesiology Classification Panel: CAREvent Handheld CPAP System Predicate Devices: • Manufactured by O-Two Medical Technologies Inc. · 510(k) number K093862 Boussignac CPAP Device · Manufactured by Vygon S. A. · 510(k) number K013884

Device Description:

The device is a restricted medical device intended for use by qualified medical personnel under the direction of a physician.

{1}------------------------------------------------

Indications for Use:

Patient Population:

Spontaneous breathing adult and pediatric patients requiring respiratory support.

Contraindications:

Patients undergoing procedures with flammable anesthetic gases; .
Patients undergoing hyperbaric treatment. ●

Comparative table:

Characteristic	O_two CPAP System	Boussignac CPAPDevice(K013884)	CAREvent HandheldCPAP System(K093862)
Intended Use	o_two CPAP Systemis intended to providea constant positiveairway pressure tospontaneouslybreathing patients.	The BoussignacB C.P.A. P. Device isintended to provideCPAP tospontaneously breathingpatients.	Provide constantpositive airwaypressure forspontaneous breathingrespiratory support
Environmentsof use	Hospital, pre-hospital(EMS) environments	Hospital and pre-hospital environment.	Hospital, pre-hospital(EMS) environments
Patientpopulation	Spontaneous breathingadult and pediatricpatients	Spontaneous breathingadult and pediatricpatients	Spontaneous breathingadult and pediatricpatients
Operatingprinciples	An open system with nomoving parts and uses a"vectored flow valve" tocreate a wall ofresistance to expirationand an additive flow toinspiration. By varyingthe oxygen flow throughthe valve the baselinepressure can be raised orlowered to maintain apositive airwaypressure. The rise inbaseline pressure keepsalveoli from collapsing,forces fluid in the lungsback into the interstitiumand improves medicationdelivery.	An open system with nomoving parts and uses a"virtual valve" to createa wall of resistance toexpiration and anadditive flow toinspiration. By varyingthe oxygen flow throughthe valve the baselinepressure can be raised orlowered to maintain apositive airwaypressure. The rise inbaseline pressure keepsalveoli from collapsing,forces fluid in the lungsback into the interstitiumand improves medicationdelivery.	Pneumatic, demandflow system

{2}------------------------------------------------

Input range	0-25 L/min variableflow source	0-25 L/min variable flowsource	45 to 87 PSI
Patientconnection	Face Mask.	Face Mask.	Tubing with externalexpiratory valve,manometer and mask
Displays	Manometer (optional)	Manometer (optional)	Manometer
Safetyfeatures	Open system and mainbody design whichlimits airway pressurerise above 30 cm H2Oin case of unintentional exhaust portblockage.	Open system design butexhaust port could beun intentionally blockedcausing a dangerousrise in patient airwaypressure.	Internal high pressurerelease (at 40 cmH2O),anti-suffocation valveon patient valve port
Patientsupportmodes	CPAP	CPAP	CPAP
Peak Flow onDemand(L/min)	Unlimited (opensystem).	Unlimited (opensystem).	120
CPAP levels(cmH2O)	0 - 20	0-10	0 - 20
Materials ingas pathway	Polycarbonate, PVCand brass	Polycarbonate, PVC	Polycarbonate, PC,Brass, Aluminum &stainless steel
Accessories	N/A	Mask, Manometer andNebulizer.	Disposable patientcircuit with mask, headstrap, manometer,oxygen hose

Differences Between Other Legally Marketed Predicate Devices:

The proposed device is viewed as substantially equivalent to the predicate devices, K013884 and K093862, in terms of design, materials of composition, indications for use, performance, and function.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Ammar Al-Dojaily Engineering Manager O-Two Medical Technologies 7575 Kimbel Street Mississauga, Ontario CANADA L5S 1C8

DEC 2 7 2011

Re: K112546

Trade/Device Name: o two CPAP System Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: December 21, 2011 Received: December 21, 2011

Dear Mr. Al-Dojaily:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Al-Dojaily

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety /ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Indications for Use Statement

510(k) Number:

o_two CPAP System Device Name:

Indications for Use:

o two CPAP System is intended to provide a constant positive airway pressure to o_two of x ~ System is in the hospital environment and emergency medical service applications to treat patients in respiratory distress.

Prescription Use_X_ (21 CFR 801 Subpart C) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K112546

Regulation Number and Section

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).