(13 days)
No
The device description explicitly states it is "totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply". There is no mention of AI, ML, or any computational elements.
Yes
The device is intended for pulmonary resuscitation and short-term ventilatory support for non-breathing patients, which are therapeutic interventions.
No
The device is described as an automatic/manually triggered resuscitator for pulmonary resuscitation and ventilatory support, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it is a "single handpiece design" and is "totally pneumatic in its function," requiring a compressed gas supply. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for pulmonary resuscitation and ventilatory support, which are direct interventions on a patient's respiratory system. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status.
- Device Description: The description details a pneumatic device that provides respiratory support. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related terms: There is no mention of analyzing specimens, diagnostic testing, or any other activities typically associated with IVDs.
The device is clearly a therapeutic device used for direct patient care, not a diagnostic device used for analyzing samples.
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
BTL
Device Description
The Genesis® 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® " 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.
This device is similar in terms of features to the Genesis® II product -510K # K932170 except in the removal of the demand breathing and auto shut off functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary
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 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.
The testing undertaken verified that the Genesis®II BLS device, 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)
Reference Device(s)
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
OCT 29 1998
SAFETY AND EFFECTIVNESS STATEMENT.
Genesis® BLS Resuscitator TRADE NAME:
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 Genesis® 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® " 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 removal of the demand breathing and auto shut off functions.
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 Genesis®II BLS device, 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
Doc. #: SER/BLS/Oct 98
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1998
Mr. Kevin Bowden O-Two Systems International Inc. 7575 Kimbel Street Mississauga, Ontario Canada L5S 1C8
Re: K983643 Genesis® BLS Requlatory Class: II (two) Product Code: BTL October 15, 1998 Dated: Received: October 16, 1998
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 requlations affecting your device 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 Druq 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 obliqation 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.
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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 qeneral 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. Callahon
Thomas J. Vallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__1__of__1__
510K Number (if known):
Device Name: GENESIS® BLS RESUSCITATOR
Indications for Use:
- Pulmonary resuscitation during respiratory and/or cardiac arrest. ្រ
- 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) |
|---|
| -------------------------------------------------------- |
| Mark Krame | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular, Respiratory, | ||
| and Neurological Devices | ||
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| 510(k) Number | K983643 |
(Optional Format 1-2-96)