(30 days)
K912203B, K924610A, K973419
No
The description focuses on a manual resuscitator with a color-based CO2 detection feature, which is a simple chemical reaction, not AI/ML. There are no mentions of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes.
The device provides ventilatory support and CO2 detection, which are therapeutic interventions.
Yes
The device "assists in verification of the endotracheal tube placing... by color comparison," which indicates it provides information to diagnose correct tube placement. While its primary function is ventilation, the CO2 detection component serves a diagnostic purpose.
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 is also described as a physical component located on the expiratory port.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is a manual resuscitator with a CO2 detector. Its primary function is to provide ventilatory support and assist in verifying endotracheal tube placement by detecting CO2 in exhaled breath.
- Nature of the Test: The CO2 detection is performed on exhaled breath, which is a gas expelled from the body, not a sample taken from the body for analysis in a laboratory setting. The detection is a direct measurement of a physiological process (respiration) rather than an analysis of a biological sample.
Therefore, while the device performs a diagnostic function (verifying tube placement), it does so through a method that falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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
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.
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): 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.
K912203B and K924610A, K973419
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.
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
§ 868.5915 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
1953
| EMS Engineered Medical Systems | | Attribute | EMS DMR
with CO₂
(Modification) | EMS DMR
K912203B
K924610A | NPB DMR
Plus with CO₂
K973419 |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------|---------------------------------|-------------------------------------|
| 2055 EXECUTIVE DRIVE • INDIANAPOLIS, IN 46241 • (317) 246-5500 • FAX (317) 246-5501 | | Use | | | |
| Non-Confidential Summary of Safety and Effectiveness | | Intended to provide manual
ventilatory support | Yes | Yes | Yes |
| page 1 of 3 | | Intended to assist in verification of
tube placement by expired CO₂ detection | Yes | -- | Yes |
| May 28, 1999 | | Used in hospitals, home, transport
mobile settings | Yes | Yes | Yes |
| Engineered Medical Systems, Inc.
2055 Executive Dr.
Indianapolis, IN 46241 | Tel - (317) 246-5500 | Single Patient Use | Yes | Yes | Yes |
| | Fax - (317) 246-5501 | Design | | | |
| Official Contact: | Bonnie Holly - Quality Manager | CO₂ detector placed on expiratory
port of manual resuscitator | Yes | -- | Yes |
| Proprietary or Trade Name: | EMS Disposable Manual Resuscitator with CO2 Detection | CO₂ detection by color comparison | Yes | -- | Yes |
| Common/Usual Name: | Disposable Manual Resuscitator with CO₂ Detection | CO₂ detector good for up to 2 hours | Yes | -- | Yes |
| Classification Name: | Emergency Manual Ventilator Resuscitator | Can be replaced if needed | Yes | -- | Yes |
| Device: | EMS Disposable Manual Resuscitator with CO₂ Detection | Materials | | | |
| Predicate Devices: | EMS Disposable Manual Resuscitator with CO₂ Detection -
K912203B and K924610A | Materials in CO₂ detection media the
exactly the same as predicate | Yes | -- | Yes |
| | Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO2
Detection - K973419 | All other materials exactly the
same as predicate | Yes | Yes | -- |
| | Nellcor Puritan Bennett - EasyCap CO₂ Detector - K894053 and
K944400 | Packaging | | | |
| Provided clean, non-sterile | Yes | Yes | Yes | | |
| Performance Standards / Specifications | | | | | |
| None applicable under Section 514 | Yes | Yes | Yes | | |
Device Description - Research - Comments - Research - Research - Mar - Mar - Mar -
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 of the may be the state of the county of the county of the first of the first
Intended for use where pulmonary support resuscitation is indicated and Indicated Use -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:
2
Non-Confidential Summary of Safety and Effectiveness
page 3 of 3 May 28, 1999
Differences Between Other Legally Marketed Predicate Devices | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 the department's symbol, which consists of three stylized human figures intertwined, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Ms. Bonnie Holly Engineered Medical Systems 2055 Executive Drive Indianapolis, IN 46241
Re: K991953 Disposable Manual Resuscitator with CO2 Detection Requlatory Class: II (two) Product Code: 73 BTM Dated: May 28, 1999 June 1, 1999 Received:
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 reqistration, 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 Requlations, 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.
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. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ATIONS 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)
Atl. A. Cirlouski.
(Division Sign-Off) Division of Cardiovascu and Neurological Devic 510(k) Number ..
Prescription Use
(Per CFR 801.109)
or
Over-the-counter use