(117 days)
Not Found
No
The device description focuses on a mechanical system with no moving parts and a "vectored flow valve" to create pressure. There is no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes.
The device is intended to treat patients in respiratory distress by providing constant positive airway pressure, which is a therapeutic function. It also directly mentions treating conditions like Pulmonary Emphysema and Congestive Heart Failure.
No
Explanation: The device is a CPAP system used to treat respiratory distress by providing constant positive airway pressure. It does not diagnose any condition.
No
The device description clearly describes a physical device with a "vectored flow valve" and no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The o two CPAP System directly interacts with the patient's respiratory system to provide positive airway pressure. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use is to treat patients in respiratory distress by providing positive airway pressure, not to diagnose a condition through laboratory testing.
- Device Description: The description focuses on the mechanical function of the device in delivering air pressure, not on analyzing biological samples.
Therefore, the o two CPAP System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
BYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified medical personnel under the direction of a physician; hospital environment and emergency medical service applications
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
Device
(K013884) | CAREvent Handheld
CPAP System
(K093862) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended Use | o_two CPAP System
is intended to provide
a constant positive
airway pressure to
spontaneously
breathing patients. | The BoussignacB C.
P.A. P. Device is
intended to provide
CPAP to
spontaneously breathing
patients. | Provide constant
positive airway
pressure for
spontaneous breathing
respiratory support |
| Environments
of use | Hospital, pre-hospital
(EMS) environments | Hospital and pre-
hospital environment. | Hospital, pre-hospital
(EMS) environments |
| Patient
population | Spontaneous breathing
adult and pediatric
patients | Spontaneous breathing
adult and pediatric
patients | Spontaneous breathing
adult and pediatric
patients |
| Operating
principles | 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. | An open system with no
moving parts and uses a
"virtual 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. | Pneumatic, demand
flow system |
2
| Input range | 0-25 L/min variable
flow source | 0-25 L/min variable flow
source | 45 to 87 PSI |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Patient
connection | Face Mask. | Face Mask. | Tubing with external
expiratory valve,
manometer and mask |
| Displays | Manometer (optional) | Manometer (optional) | Manometer |
| Safety
features | Open system and main
body design which
limits airway pressure
rise above 30 cm H2O
in case of un
intentional exhaust port
blockage. | Open system design but
exhaust port could be
un intentionally blocked
causing a dangerous
rise in patient airway
pressure. | Internal high pressure
release (at 40 cmH2O),
anti-suffocation valve
on patient valve port |
| Patient
support
modes | CPAP | CPAP | CPAP |
| Peak Flow on
Demand
(L/min) | Unlimited (open
system). | Unlimited (open
system). | 120 |
| CPAP levels
(cmH2O) | 0 - 20 | 0-10 | 0 - 20 |
| Materials in
gas pathway | Polycarbonate, PVC
and brass | Polycarbonate, PVC | Polycarbonate, PC,
Brass, Aluminum &
stainless steel |
| Accessories | N/A | Mask, Manometer and
Nebulizer. | Disposable patient
circuit with mask, head
strap, 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
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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