(85 days)
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.
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 Puritan 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.
Here's a breakdown of the acceptance criteria and study information for the Nellcor Puritan Bennett DMR/CO2 Combo Kit based on the provided text.
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way a clinical trial report would. Therefore, much of the requested information (like specific sample sizes, ground truth establishment for training, or MRMC studies) is not explicitly stated in this type of regulatory submission. The information below reflects what can be extracted or reasonably inferred from the text.
Acceptance Criteria and Device Performance for Nellcor Puritan Bennett DMR/CO2 Combo Kit
The document states that the DMR/CO2 Combo Kit is comprised of individual components (Disposable Manual Resuscitator (DMR) and either the Easy Cap End-Tidal CO2 Detector or the Pedi-Cap Pediatric End-Tidal CO2 Detector) that have already been found to be substantially equivalent through the premarket notification process. This means the acceptance criteria and performance data for the individual components were established during their respective 510(k) submissions (K943617 for DMR, K894053 for Easy Cap, and K94400 for Pedi-Cap). The current submission (K960468) for the combo kit primarily asserts that combining these previously cleared components does not alter their intended use or performance.
Therefore, the "acceptance criteria" for the combo kit itself are implicitly that the combination of these devices performs as expected based on their individual clearances, and that their intended uses are not altered.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from intended use of components) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|---|
| DMR (Disposable Manual Resuscitator) | Functionality: Capable of delivering supplemental oxygen during artificial ventilation. | "A bag-valve-mask device with the capability of delivering supplemental oxygen... can be operated from ambient air or provide oxygen-enriched air..." |
| Usability: Non-sterile, single-patient use. | "It is a non-sterile, single-patient use device." | |
| Easy Cap End-Tidal CO2 Detector | Functionality: Detects approximate ranges of end-tidal CO2 by color comparison. | "Detects approximate ranges of end-tidal CO2 by color comparison..." |
| Patient Weight Range: Patients > 15 kg (33 lbs). | "...in patients weighing more than 15 kg (33 lbs.)." | |
| Purpose: Assists verification of tube placement during intubation; detects clinically significant end-tidal CO2 in intubated patients. | "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." | |
| Duration of Use: Up to two hours. | "It may be used for up to two hours." | |
| Pedi-Cap Pediatric End-Tidal CO2 Detector | Functionality: Detects approximate ranges of end-tidal CO2 by color comparison. | "Detects approximate ranges of end-tidal CO2 by color comparison..." |
| Patient Weight Range: Patients 1 to 15 kg (2.2 to 33 lbs). | "...in patients weighing 1 to 15 kg (2.2 to 33 lbs.)." | |
| Purpose: Assists verification of tube placement during intubation; detects clinically significant end-tidal CO2 in intubated patients where precise methods are not feasible. | "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..." | |
| Duration of Use: Up to two hours. | "...may be used for up to two hours." | |
| Usability: Non-sterile, disposable, single use. | "It is a non-sterile, disposable, single use end-tidal CO2 detector..." | |
| Combo Kit Overall | No Alteration of Intended Use: The combination of components does not change their individual intended uses. | "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." |
Regarding a "study that proves the device meets the acceptance criteria":
The 510(k) for the combo kit does not describe a specific new study to demonstrate its performance. Instead, it relies on the previous clearances of its individual components. The "study" (or rather, the basis for clearance) is the determination of substantial equivalence for each component in their prior 510(k) submissions. For the combo kit itself, the "proof" is that combining these already cleared devices does not introduce new questions of safety or effectiveness, and their individual intended uses remain unchanged.
Specific Information Not Present in the 510(k) Summary (and likely not part of this specific submission):
The following points address elements typically found in detailed performance studies, which are generally not included in a 510(k) summary for a product combining already-cleared components:
2. Sample size used for the test set and the data provenance:
* Not specified in this document. The performance data for the individual components would have been provided in their respective 510(k)s (K943617, K894053, K94400). This document for the combo kit emphasizes substantial equivalence, not new clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified in this document. This level of detail would be in the individual component's 510(k) submissions if clinical performance was a primary focus. For a device like a manual resuscitator or a colorimetric CO2 detector, ground truth may be established by direct physiological measurements or established clinical protocols, rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not specified in this document. This applies more to subjective interpretations (e.g., imaging devices) than objective physiological indicators or physical device performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No, an MRMC study was not done for this device. This device is a manual resuscitator and a colorimetric CO2 detector, which are physical medical devices, not AI-powered diagnostic tools. Therefore, the concept of "human readers" or "AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not specified in detail for this document pertaining to the combo kit. For the CO2 detectors, ground truth would likely involve direct capnography measurements, blood gas analysis, or visual confirmation of tube placement in conjunction with physiological response, rather than expert consensus on images or pathology. For the resuscitator, ground truth would relate to oxygen delivery and ventilation effectiveness, typically measured by engineering tests and physiological parameters.
8. The sample size for the training set:
* Not applicable/Not specified in this document. This device does not involve machine learning or AI models that require training sets.
9. How the ground truth for the training set was established:
* Not applicable/Not specified in this document. As above, no training set for an AI model.
§ 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).