(196 days)
Not Found
No
The device description and intended use focus on mechanical ventilation and a color-comparison CO2 detector, with no mention of AI or ML.
Yes
The device is intended for manual ventilatory support and pulmonary resuscitation, which are therapeutic interventions.
Yes
The device mentions an "integrated CO2 detector" which can be used to "assist the verification of tube placement during endotracheal or nasotracheal intubation" by detecting "approximate ranges of CO2 by color comparison." This function involves identifying a specific physiological parameter (CO2 levels) to inform a medical decision (verification of tube placement), which is a diagnostic purpose.
No
The device description clearly outlines physical components like a resuscitator bag, valves, connectors, and an oxygen accumulator, indicating it is a hardware device with an integrated CO2 detection feature.
Based on the provided text, 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: The DMR2 Plus™ is a manual resuscitator used for providing ventilatory support to patients. While it has an integrated CO2 detector, this detector is used to assist in verifying tube placement during intubation by detecting CO2 in exhaled breath. This is a direct measurement of a physiological process (respiration) and not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "manual ventilatory support" and the CO2 detector is for "assisting the verification of tube placement." Neither of these fall under the definition of an in vitro diagnostic test.
The CO2 detection feature, while involving a chemical reaction (color comparison), is integrated into a device primarily used for mechanical ventilation and is used for real-time monitoring of a physiological process, not for analyzing a biological sample in vitro.
N/A
Intended Use / Indications for Use
The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
The DMR2 Plus™ is available in three sizes and is for use on the following patient populations:
- Adult is indicated for use on adults >40 kg.
- Child is indicated for use on children 10 40 kg.
- Infant is indicated for use on infants 5 10 kg
The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.
Product codes
73BTM
Device Description
The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support.
The DMR2 Plus™ is available in three sizes: adult, child and infant. It may be used by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated; such as, hospital, transport, mobile and home.
The DMR2 Plus™ consists of a compressible resuscitator bag that is available in either processed natural rubber or PVC. The swivel, patient connection and CO2 detector cartridge are connected to the nonrebreathing Valve (NRV) housing - all housings are K-resin. The oxygen accumulator assembly enables the use of three different styles of oxygen accumulators: large bore, small bore or flat bag.
During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
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
Adults >40 kg, Children 10 40 kg, Infants 5 10 kg.
Intended User / Care Setting
Qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.
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
The safety and effectiveness of the DMR2 Plus™ has been demonstrated by design and testing. Testing was conducted in accordance with the requirements of ISO 8382: Resuscitators Intended for Use With Humans; ISO 5356-1: Anaesthetic and respiratory equipment - Conical connectors; and ASTM F 920-93: Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans.
In addition, environmental testing was conducted as recommended by applicable sections of the Draft Reviewer's Guidance for Premarket Notification Submissions, November 1993.
Test results demonstrate and/or labeling indicates how all applicable requirements have been addressed.
Key Metrics
Not Found
Predicate Device(s)
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
| Nellcor Puritan Bennett DMR 2 Plus ™ Disposable Manual Resuscitator | |
|---|---|
| with integrated CO2 detection | |
| 510(k) Summary | |
| December 18, 1997 | |
| Page 1 of 3 | MAR 25 1998 |
1. Company Information
Establishment:
Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588 (510) 463-4177
DMR2 Plus™ Disposable Manual
Resuscitator with integrated CO2
Disposable Manual Resuscitator
with integrated CO2 detection
- Shervil A. Mathews Official Correspondent: Regulatory Affairs Assistant
2. Device Name
Proprietary:
Common/Usual:
Classification:
73BTM
detection
3. Equivalent Device
-
- CAPNO-FLO™ End-Tidal CO2 Detector/Monitor Kirk Specialty Systems - K933626
-
- Nellcor Puritan Bennett DMR/CO2 Combo Kit K960468
Device Description 4.
The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support.
The DMR2 Plus™ is available in three sizes: adult, child and infant. It may be used by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated; such as, hospital, transport, mobile and home.
1
Nellcor Puritan Bennett DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection 510(k) Summary December 18, 1997 Page 2 of 3
The DMR2 Plus™ consists of a compressible resuscitator bag that is available in either processed natural rubber or PVC. The swivel, patient connection and CO2 detector cartridge are connected to the nonrebreathing Valve (NRV) housing - all housings are K-resin. The oxygen accumulator assembly enables the use of three different styles of oxygen accumulators: large bore, small bore or flat bag.
During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
5. Intended Use
The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
The DMR2 Plus™ is available in three sizes and are intended for use on the following patient populations:
- · Adult is indicated for use on adults >40 kg.
- · Child is indicated for use on children 10 40 kg.
- · Infant is indicated for use on infants 5 10 kg
The DMR2 Plus™ is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.
2
Nellcor Puritan Bennett DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection 510(k) Summary December 18, 1997 Page 3 of 3
6. Technological Characteristics
The method of operation and the CO2 detector technology of the DMR2 Plus™ are equivalent to the CAPNO-FLO and the Nellcor Puritan Bennett DMR/CO2 Combo Kit. A comparison of the devices' design features, methods of operation and labeling support technical equivalency.
The safety and effectiveness of the DMR2 Plus™ has been demonstrated by design and testing. Testing was conducted in accordance with the requirements of ISO 8382: Resuscitators Intended for Use With Humans; ISO 5356-1: Anaesthetic and respiratory equipment - Conical connectors; and ASTM F 920-93: Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans.
In addition, environmental testing was conducted as recommended by applicable sections of the Draft Reviewer's Guidance for Premarket Notification Submissions, November 1993.
Test results demonstrate and/or labeling indicates how all applicable requirements have been addressed.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a bird or eagle, with three curved lines forming the body and wings.
MAR 25 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sherry Mathews Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588-2719
Re: K973419 DMR2 Plus Disposable Manual Resuscitator Regulatory Class: II (two) Product Code: 73 BTM January 7, 1998 Dated: Received: January 9, 1998
Dear Ms. Mathews:
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 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 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. Sherry Mathews
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/dsmamain.html".
Sincerely yours,
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
5
Page _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known):
Unknown Ka73419
Device Name: DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection
Indications For Use:
The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
The DMR2 Plus™ is available in three sizes and is for use on the following patient populations:
- Adult is indicated for use on adults >40 kg. .
- Child is indicated for use on children 10 40 kg. .
- · Infant is indicated for use on infants 5 10 kg
The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3/24/98 C. Avery for Superstar, Branch, teling Chief
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number.
OR
Over-The-Counter Use __
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)