(140 days)
The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.
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 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.
The CAREvent Handheld CPAP System (K093862) underwent non-clinical bench testing to demonstrate its safety and essential performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Scope | Standard Applied / Acceptance Criteria | Test Result |
|---|---|---|
| Safety & Essential Performance | ISO10651-5:2006 Product Specifications | Comply |
| Patient Valve function after contamination | ISO10651-5:2006 Clause 6.1.1 | Comply |
| Function Test after Reassembly | ISO10651-5:2006 Clause 6.1.3 | Comply |
| Mechanical Shock (Drop Test/Immersion) | ISO10651-5:2006 Clause 6.3.1, 6.3.3 | Comply |
| Mechanical Shock (Splash-proof) | ISO10651-5:2006 Clause 6.3.2 | Comply |
| Delivered oxygen concentration | ISO10651-5:2006 Clause 7.1.1 | Comply |
| Inadvertent PEEP & Continuing Expiratory Pressure | ISO10651-5:2006 Clause 7.1.3, 7.1.4 | Comply |
| Dead Space | ISO10651-5:2006 Clause 7.1.5 | Comply |
| Pressure limitation | ISO10651-5:2006 Clause 7.2.4, 7.2.5 | Comply |
| Demand Valve | ISO10651-5:2006 Clause 7.2.9 | Comply |
| Durability of Markings | ISO10651-5:2006 Clause 8.2.2 | Comply |
| Inspiratory & Expiratory Resistance | ISO10651-5:2006 Clause 7.1.2 | Comply |
| Expiratory flow characteristics | Adequately to reduce carbon dioxide rebreathing | Comply |
| Static pressure testing | +/- 10% | Comply |
| Accuracy of pressure gauge | +/- 4% of the full range | Comply |
| Environmental | ISO10651-5:2006 Clause 6.2 | Comply |
| Vibration (Sinusoidal) | IEC60068-2-6 Test Fc | Comply |
| Vibration (Random) | IEC60068-2-36 Test Fdb | Comply |
| Bump | IEC60068-2-29 Test Eb | Comply |
2. Sample size used for the test set and the data provenance:
The studies were non-clinical bench tests. The specific sample sizes for each test are not explicitly detailed in the provided summary, but it's implied that sufficient samples were tested to meet the "Comply" criteria for each standard. All testing was performed internally by O-Two Medical Technologies or by BET Service Inc. and Exova, indicating the data provenance is from laboratory testing of the device itself. The data is prospective in nature as it involves testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This was a non-clinical bench study assessing device performance against engineering standards and specifications, not clinical outcomes based on human expert assessment.
4. Adjudication method for the test set:
Not applicable. The tests were objective measurements against quantitative physical and performance standards.
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 device is a medical hardware device (CPAP system), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is not an algorithm or AI system. Its performance as a standalone medical device was evaluated through the non-clinical bench tests.
7. The type of ground truth used:
The ground truth used for these non-clinical tests were the established industry standards (ISO 10651-5:2006, IEC60068-2-6, IEC60068-2-36, IEC60068-2-29) and the device's own product specifications, along with specific quantitative criteria (e.g., +/- 10% for static pressure, +/- 4% for pressure gauge accuracy, adequately reducing carbon dioxide rebreathing).
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for this type of non-clinical device performance testing.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, this question is not relevant.
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CAREvent Handheld CPAP System
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:
| TechnologicalCharacteristics | CAREventHandheld CPAPSystem | CAREvent ATV+Ventilator(K051469) | MACS CPAPSystem(K080692) | PortO₂Vent CPAP(K021520) |
|---|---|---|---|---|
| Intended Use | Provide CPAP forspontaneousbreathing patientsrequire respiratorysupport | Pulmonary resuscitationduring respiratory and/or cardiac arrest. TheCPAP subsystemprovides CPAP forspontaneous breathingpatients | Provide CPAP forspontaneousbreathing patientsvia mask or endo-tracheal tube | Provide CPAP forspontaneousbreathing patientsvia mask |
| Environmentsof use | Hospital, pre-hospital(EMS) environments | Pre-hospital, intra-hospital and inter-hospital transport | Hospital, pre-hospital (EMS) andsub-acute/ alternatesite facilityenvironments | Hospital, pre-hospital (EMS)environments |
| Patientpopulation | Spontaneousbreathing adult andpediatric patients | Non-breathing andSpontaneous breathingpatients (body weightabove 5 kg) | Spontaneousbreathing adult andpediatric patients | Spontaneousbreathing adult andpediatric patients |
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Premarket Notification 510(k) Section 5 – 510(k) Summary
CAREvent Handheld CPAP System
| Operatingprinciples | Pneumatic, demandflow system | Pneumatic, demand flow system | Pneumatic, demandflow system | Pneumatic, demandflow system |
|---|---|---|---|---|
| Input pressure | 45 to 87 PSI | 45 to 70 PSI | 40 to 70 PSI | 40 to 70 PSI |
| Patient circuit | Tubing with externalexpiratory valve,manometer andmask | Tubing with externalexpiratory valve andmask | Tubing with externalexpiratory valve andmask | Tubing with externalexpiratory valve andmask |
| Enclosure | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight |
| Displays | Manometer | Manometer | Manometer | Manometer |
| Safety features | Internal highpressure release (at40 cmH2O), anti-suffocation valve onpatient valve port | Internal high pressurerelease, anti-suffocationvalve | Internal highpressure release (at42 cmH2O), anti-suffocation valve | Internal highpressure release (at35 cmH2O), anti-suffocation valve |
| Patient supportmodes | CPAP | IMV, CPAP | CPAP | CPAP |
| Peak Flow onDemand(L/min) | 120 | > 100 | 140 | 100 |
| CPAP levels(cmH2O) | 0 - 20 | 0 - 20 | 0 - 20 | 0 - 20 |
| Internal oxygencontrol | Pure oxygen only | 2 position, 100% or 60% | 2 position, 100% or65% | Pure oxygen only |
| Materials in gaspathway | Identical toCAREvent ATV+ventilator | Cleared in K052469 | Unknown | Unknown |
| Accessories | Disposable patientcircuit with mask,head strap,manometer, oxygenhose | Disposable patientcircuit with mask, headstrap, oxygen hose | Disposable patientcircuit with mask,head strap, oxygenhose | Disposable patientcircuit with mask,head strap, oxygenhose |
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/Acceptance criteria | Testing Org. | Test Result | Title of Test Report | |
|---|---|---|---|---|---|
| Safety & EssentialPerformance | ISO10651-5:2006Product Specifications | O-Two Medical | Comply | ISO10651-5:2005checklist | |
| Premarket Notification 510(k)Section 5 - 510(k) Summary | |||||
| Patient Valvefunction aftercontamination | ISO10651-5:2006Clause 6.1.1 | O-Two Medical | Comply | Functional Test ofCARevent CPAP afterContamination withVomits | |
| Function Testafter Reassembly | ISO10651-5:2006Clause 6.1.3 | O-Two Medical | Comply | Function Test AfterReassembly | |
| Mechanical Shock | ISO10651-5:2006Clause 6.3.1, 6.3.3 | O-Two Medical | Comply | Drop Test/ Immersion inWater of CAREventCPAP | |
| ISO10651-5:2006Clause 6.3.2 | O-Two Medical | Comply | Splash-proof Test | ||
| Delivered oxygenconcentration | ISO10651-5:2006Clause 7.1.1 | O-Two Medical | Comply | Delivered OxygenConcentration ofCAREvent CPAP | |
| Inadvertent PEEP& ContinuingExpiratory Pressur | ISO10651-5:2006Clause 7.1.3, 7.1.4 | O-Two Medical | Comply | Inadvertent PEEP &Inadvertent ContinuingExpiratory Pressure ofCAREvent CPAP | |
| Dead Space | ISO10651-5:2006Clause 7.1.5 | O-Two Medical | Comply | Dead Space ofCAREvent CPAP | |
| Pressure limitation | ISO10651-5:2006Clause 7.2.4, 7.2.5 | O-Two Medical | Comply | Pressure Limitation ofCAREvent CPAP | |
| Demand Valve | ISO10651-5:2006Clause 7.2.9 | O-Two Medical | Comply | Demand Valve Functionof CAREvent CPAP | |
| Durability ofMarkings | ISO10651-5:2006Clause 8.2.2 | O-Two Medical | Comply | Durability of Markings | |
| Inspiratory &ExpiratoryResistance | ISO10651-5:2006Clause 7.1.2 | O-Two Medical | Comply | Resistance of CAReventCPAP to SpontaneousBreathing | |
| Expiratory flowcharacteristics | Adequatly to reducecarbon dioxiderebreathing | O-Two Medical | Comply | ExpiratoryCharacteristics Test | |
| Static pressuretesting | +/- 10% | O-Two Medical | Comply | Static Pressure ofCAREvent CPAP | |
| Accuracy ofpressure gauge | +/- 4% of the fullrange | O-Two Medical | Comply | CAREvent CPAPPressure Gauge AccuracyTest | |
| Environmental | ISO10651-5:2006Clause 6.2 | BET Service Inc./ O-Two Medical | Comply | CPAP UnitEnvironmental test-Mar.25-26, 2010Nov. 2009 | |
| Vibration/Shock | Sinusodialvibration | IEC60068-2-6 Test Fc | Exova | Comply | Vibration & Shock Testingon CAREvent handheldCPAP System |
| Random vibration | IEC60068-2-36 TestFdb | Comply | CPAP SystemReport # 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 (800) 638-2041 or (301) 796-7100 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:
§ 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).