(85 days)
Not Found
No
The device description and intended use focus on mechanical and colorimetric detection methods, with no mention of AI or ML technologies.
Yes.
The Disposable Manual Resuscitator (DMR) component is described as a "bag-valve-mask device with the capability of delivering supplemental oxygen" and is used for "artificial ventilation," which is a therapeutic intervention.
Yes
Explanation: The "Easy Cap detector" and "Pedi-Cap detector" components of the kit are explicitly described as detecting approximate ranges of end-tidal CO2 by color comparison to assist verification of tube placement and to measure CO2 levels, which are diagnostic functions.
No
The device description clearly outlines physical hardware components: a bag-valve-mask device (Disposable Manual Resuscitator) and color-comparison detectors (Easy Cap and Pedi-Cap). There is no mention of software as a component or the primary function of the device.
Based on the provided information, the DMR/CO2 Combo Kit is NOT an In Vitro Diagnostic (IVD) device.
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 obtain information for diagnostic or monitoring purposes.
- Device Function: The devices in this kit (Manual Resuscitator and CO2 detectors) are used directly on the patient to assist with ventilation and verify tube placement by detecting CO2 in exhaled breath. They do not analyze specimens taken from the body.
- Intended Use: The intended uses described are related to providing artificial ventilation and verifying the placement of breathing tubes, which are clinical procedures performed on the patient.
Therefore, the DMR/CO2 Combo Kit falls under the category of medical devices used for patient care and monitoring, but not as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The inclusion of the following components in the DMR/CO2 Combo Kit does not alter the intended use of the individual components in any way.
The Disposable Manual Resuscitator (DMR) is a bag-valve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by extending the oxygen accumulator and connecting supply tubing to a metered oxygen source.
The Easy Cap detector, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CQ2 by color comparison in patients weighing more than 15 kg (33 lbs.). The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to two hours. The Easy Cap detector assists verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.
The Pedi-Cap detector detects approximate ranges of end-tidal CO2 by color comparison. It is intended for use during endotracheal or nasotracheal intubation to assist verification of tube placement. It is also intended for use on intubated patients where measuring approximate ranges of end-tidal CO2 may be clinically significant and other more precise methods are not feasible or available, i.e., during cardiac arrest or respiratory insufficiency. The Pedi-Cap detector connects to an endotracheal tube and a breathing device.
Product codes
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Device Description
The DMR/CO2 Combo Kit is comprised of the following devices:
Nellcor Puntan Bennett Disposable Manual Resuscitator (DMR) is a bagvalve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by extending the oxygen accumulator and connecting supply tubing to a metered oxygen source. It is a non-sterile, single-patient use device.
Nellcor Puntan Bennett Easy Cap Detector, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CO2 by color comparison in patients weighing more than 15 kg (33 lbs.). The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to two hours. The Easy Cap detector assists verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.
Nellcor Puntan Bennett Pedi-Cap Pediatric End-Tidal CO2 Detector detects approximate ranges of end-tidal CO2 by color comparison in patients weighing 1 to 15 kg (2.2 to 33 lbs.). It is intended for use during endotracheal or nasotracheal intubation to assist verification of tube placement. It is also intended for use on intubated patients where measuring approximate ranges of end-tidal CO2 may be clinically significant and other more precise methods are not feasible or available, i.e., during cardiac arrest or respiratory insufficiency. The Pedi-Cap detector connects to an endotracheal tube and a breathing device. It may be used during patient transport or in any location where intubations are performed. It is a nonsterile, disposable, single use end-tidal CO2 detector which may be used for up to two hours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
The Easy Cap detector is for patients weighing more than 15 kg (33 lbs.).
The Pedi-Cap detector is for patients weighing 1 to 15 kg (2.2 to 33 lbs.).
Intended User / Care Setting
Detector may be used during patient transport or in any location where intubations are performed.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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
16. 510(k) SUMMARY
January 31, 1996
APR 2 6 1996
- COMPANY INFORMATION Establishment: Puritan-Bennett Corp. 9728 Pflumm Road Lenexa, KS 66285-5915 Official Correspondent: C. Marshall Smith Project Manager, Regulatory Affairs
-
- KIT NAME
Proprietary:
- Common/Usual: Disposable Manual Resuscitator and CO2 Detector
DMR/CO2 Combo Kit
Classification: Kit unclassified
ന് EQUIVALENT DEVICE
The DMR/CO2 Combo Kit is comprised of the following devices:
- . Nellcor Puritan Bennett Disposable Manual Resuscitator (DMR) K943617; and either
- . Nellcor Puntan Bennett Easy Cap End-Tidal CO2 Detector K894053, or
- . Nellcor Puntan Bennett Pedi-Cap Pediatric End-Tidal CO2 Detector - K94400
These devices have been found to be substantially equivalent through the premarket notification process.
4. DEVICE DESCRIPTION
The DMR/CO2 Combo Kit is comprised of the following devices:
Nellcor Puntan Bennett Disposable Manual Resuscitator (DMR) is a bagvalve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by extending the oxygen accumulator and connecting supply tubing to a metered oxygen source. It is a non-sterile, single-patient use device.
DMR/CO2 Combo Kit
1
Nellcor Puritan Bennett DMR/02 Combo Kit 510(k) Summary Page 2
Nellcor Puntan Bennett Easy Cap Detector, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CO2 by color comparison in patients weighing more than 15 kg (33 lbs.). The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to two hours. The Easy Cap detector assists verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.
Nellcor Puntan Bennett Pedi-Cap Pediatric End-Tidal CO2 Detector detects approximate ranges of end-tidal CO2 by color comparison in patients weighing 1 to 15 kg (2.2 to 33 lbs.). It is intended for use during endotracheal or nasotracheal intubation to assist verification of tube placement. It is also intended for use on intubated patients where measuring approximate ranges of end-tidal CO2 may be clinically significant and other more precise methods are not feasible or available, i.e., during cardiac arrest or respiratory insufficiency. The Pedi-Cap detector connects to an endotracheal tube and a breathing device. It may be used during patient transport or in any location where intubations are performed. It is a nonsterile, disposable, single use end-tidal CO2 detector which may be used for up to two hours.
ട്. INTENDED USE
The inclusion of the following components in the DMR/CO2 Combo Kit does not alter the intended use of the individual components in any way.
The Disposable Manual Resuscitator (DMR) is a bag-valve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by extending the oxygen accumulator and connecting supply tubing to a metered oxygen source.
The Easy Cap detector, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CQ2 by color comparison in patients weighing more than 15 kg (33 lbs.). The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to two hours. The Easy Cap detector assists verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.
The Pedi-Cap detector detects approximate ranges of end-tidal CO2 by color comparison. It is intended for use during endotracheal or nasotracheal intubation to assist verification of tube placement. It is also intended for use on intubated patients where measuring approximate ranges of end-tidal CO2 may be clinically significant and other more precise methods are not feasible or available, i.e., during cardiac arrest or respiratory insufficiency. The Pedi-Cap detector connects to an endotracheal tube and a breathing device.