(140 days)
Not Found
No
The device description and performance studies focus on pneumatic operation and mechanical testing, with no mention of AI or ML algorithms.
Yes.
The device provides Constant Positive Airway Pressure (CPAP) for respiratory support to spontaneously breathing patients, which is a therapeutic intervention.
No
Explanation: The device is described as a CPAP system designed to provide respiratory support by delivering constant positive airway pressure. Its intended use is therapeutic, aimed at treating spontaneously breathing patients, not diagnosing their conditions.
No
The device description explicitly states it is a "pneumatically powered device" and mentions physical components like a "face mask" and "Airway Pressure Manometer," indicating it is a hardware device with mechanical and potentially electronic components, not solely software.
Based on the provided information, the CAREvent Handheld CPAP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide CPAP to spontaneously breathing patients. This is a direct medical intervention on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a pneumatically powered device that provides positive airway pressure to a patient via a face mask. This is a respiratory support device, not a device used for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is clearly a therapeutic medical device used for respiratory support.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
BTL, BYE
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Spontaneous breathing adult and pediatric patients
Intended User / Care Setting
qualified medical personnel under the direction of a physician.
hospital and pre-hospital (EMS) environments.
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)
The essential performance of the CAREvent Handheld CPAP System has been comprehensively tested as per requirements of ISO 10651-5:2006. All tests resulted in "Comply".
Summary of Bench Testing:
- Safety & Essential Performance: ISO10651-5:2006 Product Specifications, O-Two Medical, Comply, ISO10651-5:2005 checklist.
- Patient Valve function after contamination: ISO10651-5:2006 Clause 6.1.1, O-Two Medical, Comply, Functional Test of CARevent CPAP after Contamination with Vomits.
- Function Test after Reassembly: ISO10651-5:2006 Clause 6.1.3, O-Two Medical, Comply, Function Test After Reassembly.
- Mechanical Shock: ISO10651-5:2006 Clause 6.3.1, 6.3.3, O-Two Medical, Comply, Drop Test/ Immersion in Water of CAREvent CPAP.
- Splash-proof Test: ISO10651-5:2006 Clause 6.3.2, O-Two Medical, Comply.
- Delivered oxygen concentration: ISO10651-5:2006 Clause 7.1.1, O-Two Medical, Comply, Delivered Oxygen Concentration of CAREvent CPAP.
- Inadvertent PEEP & Continuing Expiratory Pressur: ISO10651-5:2006 Clause 7.1.3, 7.1.4, O-Two Medical, Comply, Inadvertent PEEP & Inadvertent Continuing Expiratory Pressure of CAREvent CPAP.
- Dead Space: ISO10651-5:2006 Clause 7.1.5, O-Two Medical, Comply, Dead Space of CAREvent CPAP.
- Pressure limitation: ISO10651-5:2006 Clause 7.2.4, 7.2.5, O-Two Medical, Comply, Pressure Limitation of CAREvent CPAP.
- Demand Valve: ISO10651-5:2006 Clause 7.2.9, O-Two Medical, Comply, Demand Valve Function of CAREvent CPAP.
- Durability of Markings: ISO10651-5:2006 Clause 8.2.2, O-Two Medical, Comply, Durability of Markings.
- Inspiratory & Expiratory Resistance: ISO10651-5:2006 Clause 7.1.2, O-Two Medical, Comply, Resistance of CARevent CPAP to Spontaneous Breathing.
- Expiratory flow characteristics: Adequatly to reduce carbon dioxide rebreathing, O-Two Medical, Comply, Expiratory Characteristics Test.
- Static pressure testing: +/- 10%, O-Two Medical, Comply, Static Pressure of CAREvent CPAP.
- Accuracy of pressure gauge: +/- 4% of the full range, O-Two Medical, Comply, CAREvent CPAP Pressure Gauge Accuracy Test.
- Environmental: ISO10651-5:2006 Clause 6.2, BET Service Inc./ O-Two Medical, Comply, CPAP Unit Environmental test- Mar.25-26, 2010 Nov. 2009.
- Vibration/Shock - Sinusodial vibration: IEC60068-2-6 Test Fc, Exova, Comply, Vibration & Shock Testing on CAREvent handheld CPAP System.
- Vibration/Shock - Random vibration: IEC60068-2-36 Test Fdb, Exova, Comply, CPAP System Report # 10-03-C0058.
- Vibration/Shock - Bump: IEC60068-2-29 Test Eb, Exova, Comply.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
Characteristics | CAREvent
Handheld CPAP
System | CAREvent ATV+
Ventilator
(K051469) | MACS CPAP
System
(K080692) | PortO₂Vent CPAP
(K021520) |
|----------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | Provide CPAP for
spontaneous
breathing patients
require respiratory
support | Pulmonary resuscitation
during respiratory and/
or cardiac arrest. The
CPAP subsystem
provides CPAP for
spontaneous breathing
patients | Provide CPAP for
spontaneous
breathing patients
via mask or endo-
tracheal tube | Provide CPAP for
spontaneous
breathing patients
via mask |
| Environments
of use | Hospital, pre-hospital
(EMS) environments | Pre-hospital, intra-
hospital and inter-
hospital transport | Hospital, pre-
hospital (EMS) and
sub-acute/ alternate
site facility
environments | Hospital, pre-
hospital (EMS)
environments |
| Patient
population | Spontaneous
breathing adult and
pediatric patients | Non-breathing and
Spontaneous breathing
patients (body weight
above 5 kg) | Spontaneous
breathing adult and
pediatric patients | Spontaneous
breathing adult and
pediatric patients |
2
Premarket Notification 510(k) Section 5 – 510(k) Summary
CAREvent Handheld CPAP System
| Operating
principles | Pneumatic, demand
flow system | Pneumatic, demand flow system | Pneumatic, demand
flow system | Pneumatic, demand
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
expiratory valve,
manometer and
mask | Tubing with external
expiratory valve and
mask | Tubing with external
expiratory valve and
mask | Tubing with external
expiratory valve and
mask |
| Enclosure | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight |
| Displays | Manometer | Manometer | Manometer | Manometer |
| Safety features | Internal high
pressure release (at
40 cmH2O), anti-
suffocation valve on
patient valve port | Internal high pressure
release, anti-suffocation
valve | Internal high
pressure release (at
42 cmH2O), anti-
suffocation valve | Internal high
pressure release (at
35 cmH2O), anti-
suffocation valve |
| Patient support
modes | CPAP | IMV, CPAP | CPAP | CPAP |
| Peak Flow on
Demand
(L/min) | 120 | > 100 | 140 | 100 |
| CPAP levels
(cmH2O) | 0 - 20 | 0 - 20 | 0 - 20 | 0 - 20 |
| Internal oxygen
control | Pure oxygen only | 2 position, 100% or 60% | 2 position, 100% or
65% | Pure oxygen only |
| Materials in gas
pathway | Identical to
CAREvent ATV+
ventilator | Cleared in K052469 | Unknown | Unknown |
| Accessories | Disposable patient
circuit with mask,
head strap,
manometer, oxygen
hose | Disposable patient
circuit with mask, head
strap, oxygen hose | Disposable patient
circuit with mask,
head strap, oxygen
hose | Disposable patient
circuit with mask,
head strap, oxygen
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/
Acceptance criteria | Testing Org. | Test Result | Title of Test Report | |
|-----------------------------------|-------------------------------------------------------------|------------------------------------------------------|-------------------------------------|------------------------------|-----------------------------------------------------------------------------------------|
| Safety & Essential
Performance | ISO10651-5:2006
Product Specifications | O-Two Medical | Comply | ISO10651-5:2005
checklist | |
| | Premarket Notification 510(k)
Section 5 - 510(k) Summary | | | | |
| | Patient Valve
function after
contamination | ISO10651-5:2006
Clause 6.1.1 | O-Two Medical | Comply | Functional Test of
CARevent CPAP after
Contamination with
Vomits |
| | Function Test
after Reassembly | ISO10651-5:2006
Clause 6.1.3 | O-Two Medical | Comply | Function Test After
Reassembly |
| | Mechanical Shock | ISO10651-5:2006
Clause 6.3.1, 6.3.3 | O-Two Medical | Comply | Drop Test/ Immersion in
Water of CAREvent
CPAP |
| | | ISO10651-5:2006
Clause 6.3.2 | O-Two Medical | Comply | Splash-proof Test |
| | Delivered oxygen
concentration | ISO10651-5:2006
Clause 7.1.1 | O-Two Medical | Comply | Delivered Oxygen
Concentration of
CAREvent CPAP |
| | Inadvertent PEEP
& Continuing
Expiratory Pressur | ISO10651-5:2006
Clause 7.1.3, 7.1.4 | O-Two Medical | Comply | Inadvertent PEEP &
Inadvertent Continuing
Expiratory Pressure of
CAREvent CPAP |
| | Dead Space | ISO10651-5:2006
Clause 7.1.5 | O-Two Medical | Comply | Dead Space of
CAREvent CPAP |
| | Pressure limitation | ISO10651-5:2006
Clause 7.2.4, 7.2.5 | O-Two Medical | Comply | Pressure Limitation of
CAREvent CPAP |
| | Demand Valve | ISO10651-5:2006
Clause 7.2.9 | O-Two Medical | Comply | Demand Valve Function
of CAREvent CPAP |
| | Durability of
Markings | ISO10651-5:2006
Clause 8.2.2 | O-Two Medical | Comply | Durability of Markings |
| | Inspiratory &
Expiratory
Resistance | ISO10651-5:2006
Clause 7.1.2 | O-Two Medical | Comply | Resistance of CARevent
CPAP to Spontaneous
Breathing |
| | Expiratory flow
characteristics | Adequatly to reduce
carbon dioxide
rebreathing | O-Two Medical | Comply | Expiratory
Characteristics Test |
| | Static pressure
testing | +/- 10% | O-Two Medical | Comply | Static Pressure of
CAREvent CPAP |
| | Accuracy of
pressure gauge | +/- 4% of the full
range | O-Two Medical | Comply | CAREvent CPAP
Pressure Gauge Accuracy
Test |
| | Environmental | ISO10651-5:2006
Clause 6.2 | BET Service Inc.
/ O-Two Medical | Comply | CPAP Unit
Environmental test-
Mar.25-26, 2010
Nov. 2009 |
| Vibration/
Shock | Sinusodial
vibration | IEC60068-2-6 Test Fc | Exova | Comply | Vibration & Shock Testing
on CAREvent handheld
CPAP System |
| | Random vibration | IEC60068-2-36 Test
Fdb | | Comply | CPAP System
Report # 10-03-C0058 |
| | Bump | IEC60068-2-29 Test Eb | | Comply | |
3
Premarket Notification 510(k)
.
.
4
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.
5
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.
6
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
7
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: