CAREVENT HANDHELD CPAP SYSTEM

K093862 · O-Two Medical Technologies, Inc. · BTL · May 6, 2010 · Anesthesiology

Device Facts

• Record ID: K093862
• Device Name: CAREVENT HANDHELD CPAP SYSTEM
• Applicant: O-Two Medical Technologies, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: May 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.

Device Story

Pneumatically powered CPAP device providing constant positive airway pressure to spontaneously breathing patients. Input: pressurized gas (45-87 PSI). Operation: demand flow system with single control for CPAP pressure (0-20 cmH2O). Output: CPAP delivered via face mask. Used in pre-hospital (accident scenes, EMS vehicles) and hospital (emergency, surgery, recovery, air transport) settings by qualified medical personnel. Includes disposable patient circuit, face mask, and airway pressure manometer. Safety features include internal high-pressure release (40 cmH2O) and anti-suffocation valve. Provides respiratory support to benefit patients requiring CPAP therapy during transport or clinical care.

Clinical Evidence

No clinical data. Safety and efficacy established through bench testing per ISO 10651-5:2006, including performance testing for patient valve function, mechanical shock, vibration, delivered oxygen concentration, dead space, pressure limitation, demand valve function, and resistance to breathing. Environmental testing and durability of markings also performed.

Technological Characteristics

Pneumatic demand flow system. Materials in gas pathway identical to CAREvent ATV+ (K051469). Dimensions/form factor: rugged, lightweight enclosure. Energy source: pneumatic (45-87 PSI). Connectivity: none. Sterilization: disposable accessories. No software/algorithm.

Indications for Use

Indicated for spontaneous breathing adult and pediatric patients requiring respiratory support. Contraindicated for patients undergoing procedures with flammable anesthetic gases or hyperbaric treatment.

Regulatory Classification

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.

Predicate Devices

• CAREvent ATV+ Transport Ventilator (K051469)
• MACS CPAP System (K080692)
• PortO2Vent CPAP Oxygen Delivery System (K021520)

Submission Summary (Full Text)

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CAREvent Handheld CPAP System

K093862

# 510(k) Summary

O-Two Medical Technologies 7575 Kimbel St. Mississauga, Ontario L5S1C8 Canada MAY - 6 2010 Tel - 905-677-9410 Official Contact: David Zhang Date the Summary was prepared: 11-Dec-2009 Proprietary or Trade Name: CAREvent Handheld CPAP System Common/Usual Name: CPAP device Classification Name: Powered emergency ventilator (21 CFR 868.5925, product code: BTL) and Positive End Expiratory Pressure Breathing Apparatus (21 CFR 868.5965, product code: BYE) Device Class: Class II Classification Panel: Anesthesiology Predicate Devices: CAREvent ATV+ Transport Ventilator · Manufactured by O-Two Medical Technologies Inc. · 510(k) number K051469 MACS CPAP System · Manufactured by Airon Corporation · 510(k) number K080692 PortO2Vent CPAP Oxygen Delivery System · Manufactured by Emergency Respiratory Products · 510(k) number K021520

## Device Description:

The proposed CAREvent Handheld CPAP System is a pneumatically powered device designed to provide CPAP (Constant Positive Airway Pressure) to spontaneously breathing patients who require respiratory support. The patient can breathe spontaneously through the

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device while the device provides constant positive airway pressure via a face mask. It has only one control for the adjustment of CPAP pressure from 0 to 20 cmH2O.

The device may be used in pre-hospital transport applications including accident scene, emergency rescue vehicles, hospital transport applications including emergency, surgery, post anesthesia/ recovery and air transport via helicopter or fixed wing.

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

The main accessories for the proposed device are Patient Circuit, Face Mask and Airway Pressure Manometer. They are all disposable for single-patient use.

## Indications for Use:

The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.

## Patient Population:

Spontaneous breathing adult and pediatric patients require respiratory support.

#### Contraindications:

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

## Summary of Technological Characteristics:

| Technological<br>Characteristics | CAREvent<br>Handheld CPAP<br>System | CAREvent ATV+<br>Ventilator<br>(K051469) | MACS CPAP<br>System<br>(K080692) | PortO₂Vent CPAP<br>(K021520) |
|----------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | Provide CPAP for<br>spontaneous<br>breathing patients<br>require respiratory<br>support | Pulmonary resuscitation<br>during respiratory and/<br>or cardiac arrest. The<br>CPAP subsystem<br>provides CPAP for<br>spontaneous breathing<br>patients | Provide CPAP for<br>spontaneous<br>breathing patients<br>via mask or endo-<br>tracheal tube | Provide CPAP for<br>spontaneous<br>breathing patients<br>via mask |
| Environments<br>of use | Hospital, pre-hospital<br>(EMS) environments | Pre-hospital, intra-<br>hospital and inter-<br>hospital transport | Hospital, pre-<br>hospital (EMS) and<br>sub-acute/ alternate<br>site facility<br>environments | Hospital, pre-<br>hospital (EMS)<br>environments |
| Patient<br>population | Spontaneous<br>breathing adult and<br>pediatric patients | Non-breathing and<br>Spontaneous breathing<br>patients (body weight<br>above 5 kg) | Spontaneous<br>breathing adult and<br>pediatric patients | Spontaneous<br>breathing adult and<br>pediatric patients |

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

CAREvent Handheld CPAP System

| Operating<br>principles | Pneumatic, demand<br>flow system | Pneumatic, demand flow system | Pneumatic, demand<br>flow system | Pneumatic, demand<br>flow system |
|-----------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Input pressure | 45 to 87 PSI | 45 to 70 PSI | 40 to 70 PSI | 40 to 70 PSI |
| Patient circuit | Tubing with external<br>expiratory valve,<br>manometer and<br>mask | Tubing with external<br>expiratory valve and<br>mask | Tubing with external<br>expiratory valve and<br>mask | Tubing with external<br>expiratory valve and<br>mask |
| Enclosure | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight |
| Displays | Manometer | Manometer | Manometer | Manometer |
| Safety features | Internal high<br>pressure release (at<br>40 cmH2O), anti-<br>suffocation valve on<br>patient valve port | Internal high pressure<br>release, anti-suffocation<br>valve | Internal high<br>pressure release (at<br>42 cmH2O), anti-<br>suffocation valve | Internal high<br>pressure release (at<br>35 cmH2O), anti-<br>suffocation valve |
| Patient support<br>modes | CPAP | IMV, CPAP | CPAP | CPAP |
| Peak Flow on<br>Demand<br>(L/min) | 120 | > 100 | 140 | 100 |
| CPAP levels<br>(cmH2O) | 0 - 20 | 0 - 20 | 0 - 20 | 0 - 20 |
| Internal oxygen<br>control | Pure oxygen only | 2 position, 100% or 60% | 2 position, 100% or<br>65% | Pure oxygen only |
| Materials in gas<br>pathway | Identical to<br>CAREvent ATV+<br>ventilator | Cleared in K052469 | Unknown | Unknown |
| Accessories | Disposable patient<br>circuit with mask,<br>head strap,<br>manometer, oxygen<br>hose | Disposable patient<br>circuit with mask, head<br>strap, oxygen hose | Disposable patient<br>circuit with mask,<br>head strap, oxygen<br>hose | Disposable patient<br>circuit with mask,<br>head strap, oxygen<br>hose |

## Summary of Non-Clinical Testing

・

The essential performance of the CAREvent Handheld CPAP System has been comprehensively tested as per requirements of ISO 10651-5:2006 and are summarized as follows:

## Summary of Bench Testing - CAREvent® Handheld CPAP System

| Scope | Standard applied/<br>Acceptance criteria | Testing Org. | Test Result | Title of Test Report | |
|-----------------------------------|-------------------------------------------------------------|------------------------------------------------------|-------------------------------------|------------------------------|-----------------------------------------------------------------------------------------|
| Safety & Essential<br>Performance | ISO10651-5:2006<br>Product Specifications | O-Two Medical | Comply | ISO10651-5:2005<br>checklist | |
| | Premarket Notification 510(k)<br>Section 5 - 510(k) Summary | | | | |
| | Patient Valve<br>function after<br>contamination | ISO10651-5:2006<br>Clause 6.1.1 | O-Two Medical | Comply | Functional Test of<br>CARevent CPAP after<br>Contamination with<br>Vomits |
| | Function Test<br>after Reassembly | ISO10651-5:2006<br>Clause 6.1.3 | O-Two Medical | Comply | Function Test After<br>Reassembly |
| | Mechanical Shock | ISO10651-5:2006<br>Clause 6.3.1, 6.3.3 | O-Two Medical | Comply | Drop Test/ Immersion in<br>Water of CAREvent<br>CPAP |
| | | ISO10651-5:2006<br>Clause 6.3.2 | O-Two Medical | Comply | Splash-proof Test |
| | Delivered oxygen<br>concentration | ISO10651-5:2006<br>Clause 7.1.1 | O-Two Medical | Comply | Delivered Oxygen<br>Concentration of<br>CAREvent CPAP |
| | Inadvertent PEEP<br>& Continuing<br>Expiratory Pressur | ISO10651-5:2006<br>Clause 7.1.3, 7.1.4 | O-Two Medical | Comply | Inadvertent PEEP &<br>Inadvertent Continuing<br>Expiratory Pressure of<br>CAREvent CPAP |
| | Dead Space | ISO10651-5:2006<br>Clause 7.1.5 | O-Two Medical | Comply | Dead Space of<br>CAREvent CPAP |
| | Pressure limitation | ISO10651-5:2006<br>Clause 7.2.4, 7.2.5 | O-Two Medical | Comply | Pressure Limitation of<br>CAREvent CPAP |
| | Demand Valve | ISO10651-5:2006<br>Clause 7.2.9 | O-Two Medical | Comply | Demand Valve Function<br>of CAREvent CPAP |
| | Durability of<br>Markings | ISO10651-5:2006<br>Clause 8.2.2 | O-Two Medical | Comply | Durability of Markings |
| | Inspiratory &<br>Expiratory<br>Resistance | ISO10651-5:2006<br>Clause 7.1.2 | O-Two Medical | Comply | Resistance of CARevent<br>CPAP to Spontaneous<br>Breathing |
| | Expiratory flow<br>characteristics | Adequatly to reduce<br>carbon dioxide<br>rebreathing | O-Two Medical | Comply | Expiratory<br>Characteristics Test |
| | Static pressure<br>testing | +/- 10% | O-Two Medical | Comply | Static Pressure of<br>CAREvent CPAP |
| | Accuracy of<br>pressure gauge | +/- 4% of the full<br>range | O-Two Medical | Comply | CAREvent CPAP<br>Pressure Gauge Accuracy<br>Test |
| | Environmental | ISO10651-5:2006<br>Clause 6.2 | BET Service Inc.<br>/ O-Two Medical | Comply | CPAP Unit<br>Environmental test-<br>Mar.25-26, 2010<br>Nov. 2009 |
| Vibration/<br>Shock | Sinusodial<br>vibration | IEC60068-2-6 Test Fc | Exova | Comply | Vibration & Shock Testing<br>on CAREvent handheld<br>CPAP System |
| | Random vibration | IEC60068-2-36 Test<br>Fdb | | Comply | CPAP System<br>Report # 10-03-C0058 |
| | Bump | IEC60068-2-29 Test Eb | | Comply | |

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# Premarket Notification 510(k)

.

.

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Based on the above Non-Clinical testing results, the CAREvent Handheld CPAP System performs as intended according to its performance specification. Positive results from the Vibration and Shock testing also indicated that safety and efficacy of the device will not be adversely affected during transport and storage .

## Substantial Equivalence:

The CAREvent Handheld CPAP System shares substantial equivalency with the MACS CPAP System and PortO2 Vent CPAP Oxygen Delivery System as follows:

- All devices have the same intended use as well as target patient population; .
- They are all pneumatic controlled; .
- . They are all designed with the same operating principles:
- . The essential clinical function of each device is significantly similar;
- . The range of clinical function of each device is similar or significantly overlap;
- . The accessories for all the devices are similar.

The CAREvent Handheld CPAP System also uses the similar components as the CPAP subsystem inside CAREvent ATV+ Ventilator. So the materials in gas pathway of CAREvent Handheld CPAP System are identical to the materials of CAREvent ATV+ which had been cleared in K052469.

Although clinical testing was not performed on the CAREvent Handheld CPAP System. safety and efficacy of the device are established through the non-clinical testing. There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

#### Conclusion:

The proposed device is substantially equivalent to the predicate devices. K051469. K080692 and K021520.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract, curved lines that resemble a bird in flight or a symbolic representation of human services.

#### Public Health Service

MAY - 6 2010

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

Mr. David Zhang Quality Assurance Manager O- Two Medical Technologies, Incorporated 7575 Kimbel Street Mississauga, Ontario Canada L5S 1C8

Re: K093862

Trade/Device Name: Carevent Handheld CPAP System Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator, Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BTL, BYE Dated: April 26, 2010 Received: April 30, 2010

Dear Mr. David Zhang:

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. David Zhang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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.

Wh 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

Enclosure

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# Indications for Use Statement

Page __ of

510(k) Number:

(To be assigned)

Device Name:

CAREvent Handheld CPAP System

Indications for Use:

The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.

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)

L Schullton

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

K093862 510(k) Number: