(14 days)
- Pulmonary resuscitation during respiratory and/or cardiac arrest.
- Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
The CAREvent BLS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II BLS device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
The CAREvent ALS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® " Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
The CAREvent BLS* is an automatic time cvcled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic and Manual Ventilation into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1000 - 510K #: K983785 with the addition of the ability to select the manual flowrate equivalent to that selected on the tidal volume/frequency control. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, pre-set, automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control. The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO. which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.
The CAREvent ATV is an automatic time cycled ventilator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of independent minute volume and frequency controls. adjustable pressure relief, 60/100% air/oxygen mix and the ability to select the manual flowrate with a flowrate equivalent to that selected on the minute volume control. An additional alarm feature has also been added to warn of low input pressure. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, automatic frequency settings and 12 minute volume settings which are both adjusted by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the minute volume control. Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary. The patient's airway is protected by an over pressure alarm (adjustable from 20 to 60 cmH20), which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.
The CAREvent ALS is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of the ability to select the manual flowrate with a flowrate equivalent to that selected on the tidal volume/frequency control. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, pre-set automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control. Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary. The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO. which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.
The provided text describes several medical devices, all named "CAREvent" followed by different designations (BLS, ALS, ATV). The common theme across all descriptions is that performance data was assessed based on non-clinical testing against the international standard ISO 8382-1988. The conclusion for each device states that "The testing undertaken verified that the CAREvent [Device Name], when compared with the performance of the device to which substantial equivalence is claimed, performed within specification."
Given the nature of the provided text (a 510(k) submission summary), detailed acceptance criteria in the format of specific numerical thresholds and performance metrics are not explicitly presented. Instead, it relies on demonstrating equivalence to predicate devices and compliance with an international standard.
Here's an attempt to structure the information based on the provided text, acknowledging the limitations inherent in these types of documents:
Acceptance Criteria and Study Details for CAREvent Resuscitators/Ventilators
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from Text) | Reported Device Performance |
|---|---|---|
| Performance Standard | Compliance with ISO 8382-1988 (International Standard for Resuscitators) | Verified to perform "within specification" as per ISO 8382-1988. |
| Equivalence to Predicate | Performance comparable to legally marketed predicate devices | Verified to perform "within specification" compared to predicate devices. |
| Functional Features | Provide respiratory support; automatic/manual ventilation; pneumatic operation; regulated gas output (50-90 psi). | Device incorporates these features and functions. |
| Specific Features (where applicable to specific models) | Additional automatic settings; manual override for flowrate selection; tidal volume/frequency adjustment; over pressure alarm (e.g., 60 cmH2O or adjustable 20-60 cmH2O); demand breathing. | Device incorporates these features and functions as described. |
Note: The document focuses on demonstrating substantial equivalence to predicate devices and compliance with a standard, rather than presenting specific numerical acceptance limits for performance parameters (e.g., tidal volume accuracy, frequency accuracy, pressure relief settings).
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It broadly refers to "significant amount of non-clinical test data."
- Data Provenance: The testing was "non-clinical" and likely performed by or for the manufacturer (O-Two Systems International Inc. in Mississauga, Ontario, Canada). The data is retrospective in the sense that it's submitted after the testing was completed. The country of origin for the data is Canada (manufacturer's location) for the testing, referencing an international standard (ISO 8382-1988) which is not country-specific.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: The studies described are non-clinical, likely bench testing or engineering verification. There is no mention of expert-established ground truth in the context of human physiological data or interpretations. The "ground truth" here would be the specified performance parameters of the device and the requirements of the ISO standard.
4. Adjudication Method for the Test Set
- Not Applicable: Given the non-clinical nature of the testing, an adjudication method for a test set (e.g., clinical outcomes, image interpretation) is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No: The document does not mention any clinical studies involving human readers or comparative effectiveness studies with or without AI assistance. The testing is non-clinical.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes (Implied): The "assessment of performance data" is implicitly a standalone evaluation of the device's technical specifications and functionality against a standard and a predicate, without human-in-the-loop performance being a primary measure. The devices are pneumatic and mechanical, not algorithmic in the modern AI sense.
7. The Type of Ground Truth Used
- Engineering Specifications and International Standards: The ground truth for this device's performance is based on its engineering design specifications, the functional requirements outlined for resuscitators/ventilators, and the specific requirements of the international standard ISO 8382-1988. The performance of the legally marketed predicate devices also served as a reference point for equivalence.
8. The Sample Size for the Training Set
- Not Applicable: These are mechanical/pneumatic devices, not AI/machine learning algorithms. Therefore, there is no "training set" in the computational sense. The design and development process for such devices would involve iterative testing and refinement, but not a distinct "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this question is not relevant. The device design and manufacturing processes are validated against engineering principles and regulatory standards.
{0}------------------------------------------------
4/22/99
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '991195'. The numbers are written in a cursive style, and the overall appearance suggests that it was written quickly.
TRADE NAME: CAREvent BLS Resuscitator
COMMON NAME: AUTOMATIC RESUSCITATOR
REGULATORY CLASS: II
510K # : TO BE SUPPLIED
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:
GENESIS® BLS -510K #: K983643
DESCRIPTION OF THE DEVICE:
The CAREvent BLS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.
The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II BLS device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
This device is designed to meet the ever-changing needs of the emergency respiratory care market. This device is similar in terms of features to the GENESIS® BLS - 510K #: K983643 except in the addition of an extra automatic setting and the change of the manual ventilation mode to manual override of the automatic cycling, allowing the selection of a range of flowrates for manual ventilation in line with the size of patient being resuscitated.
ASSESSMENT OF PERFORMANCE DATA
The submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against both the current domestic and international standards for these devices.
In particular, references were made to ISO 8382-1988.
{1}------------------------------------------------
CONCLUSIONS BASED ON PERFORMANCE DATA
The testing undertaken verified that the CAREvent BLS device, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.
CONTACT PERSON: KEVIN BOWDEN, GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA 155 1C8
TEL: 905 677 9410 FAX: 905 677 2035 E-MAIL: kevinb@otwo.com
Doc. #: SER/BLS/Mar 99
{2}------------------------------------------------
TRADE NAME: CAREvent ALS Resuscitator
COMMON NAME: AUTOMATIC RESUSCITATOR
REGULATORY CLASS: II
510K # : TO BE SUPPLIED
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:
GENESIS® II A/C - - - -510K #: K932170
DESCRIPTION OF THE DEVICE:
The CAREvent ALS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.
The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® " Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
This device is designed to meet the ever-changing needs of the emergency respiratory care market. This device is similar in terms of features to the Genesis® II product -510K # K932170 except in the addition of an extra automatic setting and the change of the manual ventilation mode to manual override of the automatic cycling, allowing the selection of a range of flowrates for manual ventilation in line with the size of patient being resuscitated.
ASSESSMENT OF PERFORMANCE DATA
The submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against both the current domestic and international standards for these devices.
In particular, references were made to ISO 8382-1988.
{3}------------------------------------------------
CONCLUSIONS BASED ON PERFORMANCE DATA
The testing undertaken verified that the CAREvent ALS device, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.
CONTACT PERSON: KEVIN BOWDEN, GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA L5S 1C8
TEL: 905 677 9410 FAX: 905 677 2035 E-MAIL: kevinb@otwo.com
{4}------------------------------------------------
CAREvent BLS* TRADE NAME:
COMMON NAME: AUTOMATIC RESUSCITATOR
REGULATORY CLASS: II
TO BE SUPPLIED 510K # :
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:
510K #: K983785 Autovent 1000
DESCRIPTION OF THE DEVICE:
The CAREvent BLS* is an automatic time cvcled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.
The device incorporates the features of Automatic and Manual Ventilation into a control module with separate hose and patient valve
This device is identical in terms of features to the Autovent 1000 - 510K #: K983785 with the addition of the ability to select the manual flowrate equivalent to that selected on the tidal volume/frequency control.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
The device is a time-cycled ventilator with a range of 12, pre-set, automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control.
The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO. which gives an audible signal of over pressure and vents the remaining tidal volume
{5}------------------------------------------------
delivery for that breath to atmosphere.
ASSESSMENT OF PERFORMANCE DATA
The predicate device submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against international standard for these devices - ISO 8382-1988.
CONCLUSIONS BASED ON PERFORMANCE DATA
The testing undertaken verified that the CAREvent BLS* resuscitator, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.
CONTACT PERSON: KEVIN BOWDEN. GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA L5S 1C8
TEL: 905 677 9410 FAX: 905 677 2035 E-MAIL: kevinb@otwo.com
{6}------------------------------------------------
CAREvent ATV TRADE NAME:
COMMON NAME: AUTOMATIC TRANSPORT VENTILATOR
REGULATORY CLASS:
510K # : TO BE SUPPLIED
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:
Autovent 1500 -
DESCRIPTION OF THE DEVICE:
The CAREvent ATV is an automatic time cycled ventilator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.
The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve.
This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of independent minute volume and frequency controls. adjustable pressure relief, 60/100% air/oxygen mix and the ability to select the manual flowrate with a flowrate equivalent to that selected on the minute volume control. An additional alarm feature has also been added to warn of low input pressure.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
The device is a time-cycled ventilator with a range of 12, automatic frequency settings and 12 minute volume settings which are both adjusted by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the minute volume control.
{7}------------------------------------------------
Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary.
The patient's airway is protected by an over pressure alarm (adjustable from 20 to 60 cmH20), which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.
ASSESSMENT OF PERFORMANCE DATA
The predicate device submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against international standard for these devices - ISO 8382-1988.
CONCLUSIONS BASED ON PERFORMANCE DATA
The testing undertaken verified that the CAREvent ATV, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.
CONTACT PERSON: KEVIN BOWDEN, GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA L5S 1C8 TEL: 905 677 9410
FAX: 905 677 2035 E-MAIL: kevinb@otwo.com
Doc. #:SER/ATV/Mar 99
{8}------------------------------------------------
TRADE NAME: CAREvent ALS*
COMMON NAME: AUTOMATIC RESUSCITATOR
REGULATORY CLASS: II
510K # : TO BE SUPPLIED
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:
Autovent 1500 -
DESCRIPTION OF THE DEVICE:
The CAREvent ALS is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.
The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve.
This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of the ability to select the manual flowrate with a flowrate equivalent to that selected on the tidal volume/frequency control.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
The device is a time-cycled ventilator with a range of 12, pre-set automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control.
Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while
{9}------------------------------------------------
simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary.
The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO. which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.
ASSESSMENT OF PERFORMANCE DATA
The predicate device submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against international standard for these devices - ISO 8382-1988.
CONCLUSIONS BASED ON PERFORMANCE DATA
The testing undertaken verified that the CAREvent ALS*, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.
CONTACT PERSON: KEVIN BOWDEN, GENERAL MANAGER O-TWO SYSTEMS INTERNATIONAL INC. 7575 KIMBEL STREET MISSISSAUGA ONTARIO CANADA 155 1C8
TEL: 905 677 9410 FAX:905 67 2035 E-MAIL: kevinb@otwo.com
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles or a caduceus-like design with three intertwined lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 1999
Mr. Kevin Bowden O-Two Systems International, Inc. 7575 Kimbel Street Mississauga, Ontario Canada L5S 1C8
Re: K991195 CAREvent BLS, CAREvent BLS, CAREvent ALS, CAREvent ALS, and CAREvent ATV Regulatory Class: II (two) Product Code: 73 BTL Dated: April 6, 1999 Received: April 8, 1999
Dear Mr. Bowden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{11}------------------------------------------------
Page 2 - Mr. Kevin Bowden
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{12}------------------------------------------------
Page 1 of 1 -
510K Number (if known):
Device Name: CAREvent BLS RESUSCITATOR
Indications for Use:
- Pulmonary resuscitation during respiratory and/or cardiac arrest. []
- Short term ventilatory support for both inter and intra-hospital transport of [] non-breathing patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atl. A. Garchurst.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Nijm over-The-Counter Use
Prescription Use v (Per 21 CFR 801.109)
OR
{13}------------------------------------------------
510K Number (if known):
Device Name: CAREvent BLS* RESUSCITATOR
Indications for Use:
- [] Pulmonary resuscitation during respiratory and/or cardiac arrest.
- Short term ventilatory support for both inter and intra-hospital transport of [] non-breathing patients.
(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 Cardiovascular, Respiratory, - -- - Purological Devices to and Number . Prescription Use OR Over-The-Counter Use __ (Per 21 CFR 801.109) (Optional Format 1-2-96)
{14}------------------------------------------------
Page__1__of__1__
510K Number (if known):
Device Name: CAREvent ALS RESUSCITATOR
Indications for Use:
- Pulmonary resuscitation during respiratory and/or cardiac arrest. []
- Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
(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 Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use ------------
{15}------------------------------------------------
Page__________________________________________________________________________________________________________________________________________________________________________
510K Number (if known):
Device Name: CAREvent ALS* RESUSCITATOR
Indications for Use:
- Pulmonary resuscitation during respiratory and/or cardiac arrest. []
- Short term ventilatory support for both inter and intra-hospital transport of [] non-breathing patients.
(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 Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _
Prescription Use_/ (Per 21 CFR 801.109) OR
Over-The-Counter Use_
{16}------------------------------------------------
Page__1__of__1__
510K Number (if known):
Device Name: CAREvent ATV
Indications for Use:
- [] Pulmonary resuscitation during respiratory and/or cardiac arrest.
- [] Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
(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 Cardiovascular, Respiratory, and Neurological Devices ి 1 3(k) Number _____________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Prescription Use را (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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).