(2 days)
K913039/B
Not Found
No
The description focuses on automatic time-cycled ventilation and comparison to a predicate device based on performance specifications, with no mention of AI or ML.
Yes
The device is described as a resuscitator designed to provide respiratory support for patients in respiratory or cardiac arrest, which are conditions requiring therapeutic intervention.
No
The device is described as an automatic time-cycled resuscitator designed to provide respiratory support, and its intended use is for pulmonary resuscitation and ventilatory support, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is an "automatic time cycled resuscitator" and describes physical components like a "control module with separate hose and patient valve," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients." This describes a device used to support a physiological function (breathing) in a patient.
- Device Description: The description details an "automatic time cycled resuscitator designed to provide respiratory support." This further reinforces its role as a life-support device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such activity. There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory tests.
Therefore, the Autovent 1500, as described, is a therapeutic medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
73 BTL
Device Description
The Autovent 1500 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.
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, preset 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. Also provided is a separate switch to select manual or automatic cycling which, in the predicate device, is integrated into the frequency/flow 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 airwav 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.
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
Not Found
Intended User / Care Setting
Not Found
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 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.
The testing undertaken verified that the Autovent 1500, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.
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.
K913039/B
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
NOV 4 1998
SAFETY AND EFFECTIVNESS STATEMENT.
TRADE NAME: Autovent 1500
COMMON NAME: AUTOMATIC RESUSCITATOR
REGULATORY CLASS: II
TO BE SUPPLIED 2983857 510K # :
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:
GENESIS® II Adult/Child -
DESCRIPTION OF THE DEVICE:
The Autovent 1500 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 Flynn® Genesis® product - 510K # K913039/B except in the range of automatic settings of the device which have been extended and chosen to provide the output requirements of the latest AHA recommendations.
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, preset automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control.
1
A manual button is provided to enable the operator to control the patient's breathing parameters. Also provided is a separate switch to select manual or automatic cycling which, in the predicate device, is integrated into the frequency/flow 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 airwav 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 Autovent 1500, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.
| CONTACT PERSON: | KEVIN BOWDEN,
DIRECTOR OF PRODUCT TECHNOLOGY
O-TWO SYSTEMS INTERNATIONAL INC.
7575 KIMBEL STREET
MISSISSAUGA
ONTARIO
CANADA
L5S 1C8
TEL: 905 677 9410
FAX:905 67 2035 |
| ----------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
E-MAIL: kevinb@otwo.com
Doc. #:SER/ATV1500/OCT1998
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are connected by a flowing ribbon-like shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 4 1998
Mr. Kevin Bowden O-Two Systems International Inc. 7575 Kimbel Street Mississauga, Ontario Canada L5S 1C8
Re: K983857 Autovent 1500 Regulatory Class: II (two) Product Code: 73 BTL October 30, 1998 Dated: November 2, 1998 Received:
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, Drug, 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 bligation 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.
3
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requlation 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
.ﺗﺎﺳﻪ
Enclosure
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Page 1 of of 1
510K Number (if known):
Device Name: AUTOVENT 1500 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) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | ✓ |
| OR | Over-The-Counter Use |
| (Division Sign-Off) | Marle Kramer (Optional Format 1-2-96) |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K983857 |