O_TWO CPAP SYSTEM

K112546 · O-Two Medical Technologies, Inc. · BYE · Dec 27, 2011 · Anesthesiology

Device Facts

• Record ID: K112546
• Device Name: O_TWO CPAP SYSTEM
• Applicant: O-Two Medical Technologies, Inc.
• Product Code: BYE · Anesthesiology
• Decision Date: Dec 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

o two CPAP System provides constant positive airway pressure to spontaneously breathing patients in respiratory distress (e.g., pulmonary emphysema, congestive heart failure). Device is an open system with no moving parts; utilizes a 'vectored flow valve' to create resistance to expiration and additive flow to inspiration. Oxygen flow through valve is varied to raise/lower baseline pressure, keeping alveoli open, forcing fluid into interstitium, and improving medication delivery. Used in hospital and pre-hospital (EMS) environments by qualified medical personnel. Output is constant positive airway pressure delivered via face mask. Optional manometer displays pressure. Device design limits airway pressure rise above 30 cm H2O in case of unintentional exhaust port blockage. Benefits include improved respiratory function and medication delivery.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and functional comparisons to predicate devices.

Technological Characteristics

Open system, no moving parts. Materials: Polycarbonate, PVC, brass. Operates via vectored flow valve using variable oxygen flow (0-25 L/min) to maintain CPAP levels (0-20 cmH2O). Unlimited peak flow on demand. Safety feature: design limits airway pressure rise above 30 cm H2O during exhaust port blockage. Patient connection via face mask. Non-electronic/mechanical device.

Indications for Use

Indicated for spontaneous breathing adult and pediatric patients requiring respiratory support in hospital or EMS settings for treatment of respiratory distress. Contraindicated for patients undergoing procedures with flammable anesthetic gases or hyperbaric treatment.

Regulatory Classification

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.

Predicate Devices

• Boussignac CPAP Device (K013884)
• CAREvent Handheld CPAP System (K093862)

Submission Summary (Full Text)

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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 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.

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

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# Indications for Use:

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.

# 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 CPAP<br>Device<br>(K013884) | CAREvent Handheld<br>CPAP System<br>(K093862) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended Use | o_two CPAP System<br>is intended to provide<br>a constant positive<br>airway pressure to<br>spontaneously<br>breathing patients. | The BoussignacB C.<br>P.A. P. Device is<br>intended to provide<br>CPAP to<br>spontaneously breathing<br>patients. | Provide constant<br>positive airway<br>pressure for<br>spontaneous breathing<br>respiratory support |
| Environments<br>of use | Hospital, pre-hospital<br>(EMS) environments | Hospital and pre-<br>hospital environment. | Hospital, pre-hospital<br>(EMS) environments |
| Patient<br>population | Spontaneous breathing<br>adult and pediatric<br>patients | Spontaneous breathing<br>adult and pediatric<br>patients | Spontaneous breathing<br>adult and pediatric<br>patients |
| Operating<br>principles | An open system with no<br>moving parts and uses a<br>"vectored flow valve" to<br>create a wall of<br>resistance to expiration<br>and an additive flow to<br>inspiration. By varying<br>the oxygen flow through<br>the valve the baseline<br>pressure can be raised or<br>lowered to maintain a<br>positive airway<br>pressure. The rise in<br>baseline pressure keeps<br>alveoli from collapsing,<br>forces fluid in the lungs<br>back into the interstitium<br>and improves medication<br>delivery. | An open system with no<br>moving parts and uses a<br>"virtual valve" to create<br>a wall of resistance to<br>expiration and an<br>additive flow to<br>inspiration. By varying<br>the oxygen flow through<br>the valve the baseline<br>pressure can be raised or<br>lowered to maintain a<br>positive airway<br>pressure. The rise in<br>baseline pressure keeps<br>alveoli from collapsing,<br>forces fluid in the lungs<br>back into the interstitium<br>and improves medication<br>delivery. | Pneumatic, demand<br>flow system |

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| Input range | 0-25 L/min variable<br>flow source | 0-25 L/min variable flow<br>source | 45 to 87 PSI |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Patient<br>connection | Face Mask. | Face Mask. | Tubing with external<br>expiratory valve,<br>manometer and mask |
| Displays | Manometer (optional) | Manometer (optional) | Manometer |
| Safety<br>features | Open system and main<br>body design which<br>limits airway pressure<br>rise above 30 cm H2O<br>in case of un<br>intentional exhaust port<br>blockage. | Open system design but<br>exhaust port could be<br>un intentionally blocked<br>causing a dangerous<br>rise in patient airway<br>pressure. | Internal high pressure<br>release (at 40 cmH2O),<br>anti-suffocation valve<br>on patient valve port |
| Patient<br>support<br>modes | CPAP | CPAP | CPAP |
| Peak Flow on<br>Demand<br>(L/min) | Unlimited (open<br>system). | Unlimited (open<br>system). | 120 |
| CPAP levels<br>(cmH2O) | 0 - 20 | 0-10 | 0 - 20 |
| Materials in<br>gas pathway | Polycarbonate, PVC<br>and brass | Polycarbonate, PVC | Polycarbonate, PC,<br>Brass, Aluminum &<br>stainless steel |
| Accessories | N/A | Mask, Manometer and<br>Nebulizer. | Disposable patient<br>circuit with mask, head<br>strap, manometer,<br>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.

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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.

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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 [phone] or [phone] 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

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# Indications for Use Statement

510(k) Number:

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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