(35 days)
Not Found
No
The device description and intended use focus on a manual resuscitator with a color-based CO2 detector, which is a passive chemical indicator, not an AI/ML technology. There are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is a manual resuscitator, which provides ventilatory support, directly treating a patient's pulmonary function.
No
The device is primarily a manual resuscitator, which is a therapeutic device for ventilatory support. While it has a CO2 detector that assists in verification of endotracheal tube placement, this function is a measurement or monitoring tool that supports a medical procedure rather than diagnosing a disease or condition itself.
No
The device description clearly states it is a "bag-valve-mask device" and a "disposable manual resuscitator," which are physical hardware components. The CO2 detector, while potentially a separate component, is also described as being "located on the expiratory port" and assisting in "verification of the endotracheal tube placing," indicating a physical interaction with the patient and the resuscitator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: This device is a manual resuscitator with a CO2 detector. Its primary function is to provide ventilatory support to patients and to assist in verifying the placement of an endotracheal tube by detecting CO2 in exhaled breath.
- Specimen Type: The CO2 detection is based on analyzing exhaled breath, which is a gas directly from the patient's respiratory system, not a specimen collected from the body for in vitro analysis.
- Intended Use: The intended use is for manual ventilatory support and verifying tube placement, not for diagnosing a disease or condition based on the analysis of a collected specimen.
The CO2 detector component, while analyzing a biological output (exhaled CO2), does so in real-time and directly from the patient's airway, not through the in vitro analysis of a collected sample.
N/A
Intended Use / Indications for Use
"Intended for use where pulmonary support resuscitation is indicated and exhaled CO₂ detection is desirable."
"Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings."
Product codes
73 BTM
Device Description
"The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection."
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
"Used in hospitals, home, transport mobile settings"
"qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings."
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K912203B, K924610A, K973419, K894053, K944400
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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
Engineered Medical Systems ISO 9001 Certified 2055 EXECUTIVE DRIVE • INDIANAPOLIS, IN 46241 • (317) 246-5500 • FAX (317) 246-5501 Non-Confidential Summary of Safety and Effectiveness
| page 1 of 3 | |
|---|---|
| May 28, 1999 | |
| Engineered Medical Systems, Inc. | |
| 2055 Executive Dr. | Tel - (317) 246-5500 |
| Indianapolis, IN 46241 | Fax - (317) 246-5501 |
| Official Contact: | Bonnie Holly - Quality Manager |
| Proprietary or Trade Name: | EMS Disposable Manual Resuscitator with CO₂ Detection |
| Common/Usual Name: | Disposable Manual Resuscitator with CO₂ Detection |
| Classification Name: | Emergency Manual Ventilator Resuscitator |
| Device: | EMS Disposable Manual Resuscitator with CO₂ Detection |
| Predicate Devices: | EMS Disposable Manual Resuscitator with CO₂ Detection - |
| K912203B and K924610A | |
| Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO₂ | |
| Detection - K973419 | |
| Nellcor Puritan Bennett - EasyCap CO₂ Detector - K894053 and | |
| K944400 |
Device Description | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 12 - 102
The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection.
Intended Use - - Real 11 - 30
| Indicated Use -- | Intended for use where pulmonary support resuscitation is indicated and
exhaled CO₂ detection is desirable. |
| ------------------ | ---------------------------------------------------------------------------------------------------------------- |
|---|
Environment of Use --Hospital, Transport, Mobile and Home settings
1
Non-Confidential Summary of Safety and Effectiveness
page 2 of 3
May 28, 1999
Comparison to Predicate Devices: 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
| Attribute | EMS DMR
with CO₂
(Modification) | EMS DMR
K912203B
K924610A | NPB DMR
Plus with
CO₂
K973419 |
|----------------------------------------------------------------------------------|---------------------------------------|---------------------------------|----------------------------------------|
| Use | | | |
| Intended to provide manual
ventilatory support | Yes | Yes | Yes |
| Intended to assist in verification of
tube placement by expired CO₂ detection | Yes | -- | Yes |
| Used in hospitals, home, transport
mobile settings | Yes | Yes | Yes |
| Single Patient Use | Yes | Yes | Yes |
| Design | | | |
| CO₂ detector placed on expiratory
port of manual resuscitator | Yes | -- | Yes |
| CO₂ detection by color comparison | Yes | -- | Yes |
| CO₂ detector good for up to 2 hours | Yes | -- | Yes |
| Can be replaced if needed | Yes | -- | Yes |
| Materials | | | |
| Materials in CO₂ detection media the
exactly the same as predicate | Yes | -- | Yes |
| All other materials exactly the
same as predicate | Yes | Yes | -- |
| Packaging | | | |
| Provided clean, non-sterile | Yes | Yes | Yes |
| Performance Standards / Specifications |
|---|
| ---------------------------------------- |
| None applicable under Section 514 | Yes | Yes | Yes |
|---|---|---|---|
| ----------------------------------- | ----- | ----- | ----- |
2
Non-Confidential Summary of Safety and Effectiveness
page 3 of 3 May 28, 1999
Differences Between Other Legally Marketed Predicate Devices - Predicate Device College Co
There are no differences between the proposed modification, that of adding CO2 detection capabilities to the exhalation port of the manual resuscitator, and the predicates.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 1999
Ms. Bonnie Holly Engineered Medical Systems 2055 Executive Drive Indianapolis, IN 46241
Re: K991955 Disposable Manual Resuscitator with CO2 Detection Requlatory Class: II (two) Product Code: 73 BTM Dated: May 28, 1999 Received: June 1, 1999
Dear Ms. Holly:
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 Requlation (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.
4
Page 2 - Ms. Bonnie Holly
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 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. 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
5
INDICATIONS FOR USE
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | (To be assigned) |
|---|---|
| Device Name: | EMS Disposable Resuscitator with CO2 Detector |
| Intended Use : | Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arle A. Ciarkowski.
Respiratory.
Prescription Use _ > (Per CFR 801.109)
or
Over-the-counter use _________________________________________________________________________________________________________________________________________________________