(268 days)
Use to assist verification of tube placement during endotracheal intubation. Use on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.
The subject device, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CO2 by color comparison in patients. The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to 2 hours. The subject device is non sterile and is intended for single use.
The provided text describes the 510(k) summary for the Nellcor™ EASYCAP II Adult Colorimetric CO2 Detector and Nellcor™ PEDCICAP Pediatric Colorimetric CO2 Detector. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a full-fledged study as would typically be done for a novel device or AI/ML-based diagnostic.
Therefore, many of the requested elements (like a test set sample size, expert consensus for ground truth, MRMC study, effects size of human readers, training set details) are not applicable (N/A) because the submission relies on bench testing and biocompatibility testing to establish substantial equivalence by comparing the device's characteristics to a legally marketed predicate, rather than a clinical performance study with human subjects interpreting results.
Here's how the available information maps to your request:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" for the device's performance are primarily that its technological characteristics are comparable to a predicate device and that any differences do not raise new questions of safety or effectiveness. The reported "performance" is demonstrated through bench testing and biocompatibility.
| Criterion Type | Acceptance Criteria (Bench Test/Spec) | Reported Device Performance (as per comparison table and summary) |
|---|---|---|
| Intended Use | Similar to predicate: To detect approximate ranges of end-tidal CO2. | Same as predicate. |
| Indications for Use | Similar to predicate: Assist verification of tube placement during endotracheal/nasotracheal intubation; detect approximate ranges of end-tidal CO2 when clinically significant on intubated patients. | Similar to predicate. |
| Patient Population | Nellcor™ EASYCAP II: Patients > 15 kg (33 lb).Nellcor™ PEDCICAP: Patients 1-15 kg (2.2-33 lb). (Predicate: 1-15 kg). The adult device (EASYCAP II) has a different patient population than the predicate (Pedi-CAP pediatric). | Nellcor™ EASYCAP II: Different (Adult). Justification: Intended for adult patients.Nellcor™ PEDCICAP: Same as predicate. |
| Duration of Use | <2 hours | Same as predicate. |
| Sterilization | Non-sterile | Same as predicate. |
| Shelf Life | Validated for longer shelf life than predicate. | 26 Months (Predicate: 22 Months). Justification: Subject device validated for longer shelf life. |
| Standard Connections | 15 mm connections. | Same as predicate. |
| Dead Space (Volume) | Nellcor™ EASYCAP II: Different from predicate (larger volume for adults). Acceptable if safety/effectiveness not impacted.Nellcor™ PEDCICAP: Similar to predicate. | Nellcor™ EASYCAP II: 22cc (Predicate: 3cc). Justification: Intended for adult patient, difference does not impact safety/effectiveness.Nellcor™ PEDCICAP: Same as predicate. |
| Resistance to Flow | Nellcor™ EASYCAP II: Different from predicate (higher resistance for adult breathing patterns). Acceptable if safety/effectiveness not impacted.Nellcor™ PEDCICAP: Similar to predicate. | Nellcor™ EASYCAP II: 4.4 cm H2O ± 1.0 cm at 60 L/min (Predicate: 2.5 cm H2O ± 0.5 cm at 10L/min). Justification: Intended for adult patient, difference does not impact safety/effectiveness.Nellcor™ PEDCICAP: Same as predicate. |
| Detected % CO2 Ranges/Colors | A: 0.03 < 0.5 %; B: 0.05 < 2 %; C: 2 - 5 % | Same as predicate. |
| Biocompatibility | Compliance with ISO 10993-1 and ISO 18562 series (cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, volatile organic compounds, particulate matter). | Met all biocompatibility requirements for intended use. Material differences (Filter, Device Body) evaluated to ISO 10993-1 & ISO 18562-1 and found safe/effective. |
| Bench Testing | Designs meet performance specification and evaluation for: color change/duration of use, resistance to flow, internal volume (dead space), anti-fog, shelf-life, packaging stability. | Performed, and designs demonstrated to meet performance specifications and evaluation (implied conformance as substantial equivalence was granted based on these tests). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of clinical data for performance assessment. The "testing" mentioned is bench testing (e.g., measuring resistance to flow, dead space, shelf life, color change properties in a controlled environment). The specific number of units tested during bench validation is not detailed in this summary.
- Data Provenance: N/A. This is not a study using patient data; it relies on engineering and material testing.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- N/A. Ground truth in the context of a diagnostic performance study (e.g., for AI/ML) is not relevant here. The device's function (colorimetric CO2 detection) is evaluated through its physical and chemical properties in bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable for a device cleared via substantial equivalence based on bench testing.
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
- N/A. This is not an AI/ML-based device. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a hardware device (colorimetric detector). No algorithm or standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. For this type of device, "ground truth" would correspond to established engineering specifications and physical/chemical standards (e.g., a known CO2 concentration for color change, standard measurements for dead space, flow resistance). The summary indicates these were evaluated against those specifications.
8. The sample size for the training set
- N/A. This device does not involve a "training set" as it is not an AI/ML product.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set.
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Covidien Ashley Johnston Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, Colorado 80301
Re: K203762
Trade/Device Name: Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: August 19, 2021 Received: August 20, 2021
Dear Ashley Johnston:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203762
Device Name
Nellcor™ EASYCAP II Adult Colorimetric CO2 Detector
Nellcor™ PEDICAP Pediatric Colorimetric CO2 Detector
Indications for Use (Describe)
Use to assist verification of tube placement during endotracheal intubation. Use on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K203762
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a 510(k) Summary for the Nellcor™ EASYCAP II Colorimetric CO2 Detector and Nellcor™ Pediatric Colorimetric CO2 Detector.
Covidien LLC
I. SUBMITTER
Submitted By:
| 6135 Gunbarrel AvenueBoulder, CO 80301 | |
|---|---|
| Date: | 21 December 2020 |
| Contact Person: | Ashley JohnstonRegulatory Affairs Manager720-440-1057 |
DEVICE II.
III.
| DEVICE | |
|---|---|
| Proprietary Name: | Nellcor™ EASYCAP II Adult Colorimetric CO2 DetectorNellcor™ PEDCICAP Pediatric Colorimetric CO₂ Detector |
| Common Name: | Carbon dioxide gas analyzer |
| Device Classification Regulation: | 21 CFR 868.1400 |
| Device Product Code & Panel: | CCK / Anesthesiology (73) |
| Class: | II |
| Predicate Device | |
| Predicate Devices: | Pedi-CAP™ Pediatric End-Tidal CO₂ Detector |
(K944400)
IV. Device Description
The subject device, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CO2 by color comparison in patients. The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to 2 hours.
The subject device is non sterile and is intended for single use.
The EASYCAP II is used in adult patients weighing more than 15 kg (33 lb), and the PEDICAP is used in pediatric patients weighing 1 - 15 kg (2.2 - 33 lb).
V. Indications for Use/Intended Use
Use to assist verification of tube placement during endotracheal intubation. Use on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.
COVIDIEN LLC 15 HAMPSHIRE STREET MANSFIELD, MA 02048
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VI. Technological Characteristics Comparison
The subject device has similar indications for use, design and functionality to the predicate device. A comparison table is provided below.
| Device Comparison Table: Subject Device, Predicate Device | |||
|---|---|---|---|
| Predicate Device | Subject Device Comparison | ||
|---|---|---|---|
| Features | Nellcor Pedi-CAP™ Pediatric End-Tidal CO2 Detector (K944400) | Nellcor™ EASYCAP II ColorimetricCO2 Detector | Nellcor™ PEDICAP ColorimetricCO2 Detector |
| Intended Use | To detect approximate ranges of end-tidal CO2 | Same as predicate | Same as predicate |
| Indications forUse | Intended for use duringendotracheal or nasotrachealintubation to assist verification oftube placement.It is also intended for use onintubated patients where measuringapproximate ranges of end-tidalCO2 may be clinically significantand other more precise methods arenot feasible or available. | SimilarUse to assist verification of tubeplacement during endotrachealor nasotracheal intubation.Use on intubated patients to detectapproximate ranges of end-tidal CO2when clinically significant. | SimilarUse to assist verification oftube placement duringendotracheal or nasotrachealintubation.Use on intubated patients to detectapproximate ranges of end-tidal CO2when clinically significant. |
| PatientPopulation | Patients weighing 1–15 kg (2.2-33 lb). | DifferentPatients weighing more than 15 kg (33 lb).Justification for difference:The subject is used for adult patients. | Same as predicate |
| Use | Single patient | Same as predicate | Same as predicate |
| Features | Predicate Device | Subject Device Comparison | |
| Nellcor Pedi-CAP™ Pediatric End-Tidal CO2 Detector (K944400) | Nellcor™ EASYCAP II ColorimetricCO2 Detector | Nellcor™ PEDICAP ColorimetricCO2 Detector | |
| Duration of Use | <2 hours | Same as predicate | Same as predicate |
| Features, Specification and Performance | |||
| Sterilization | Non-sterile | Same as predicate | Same as predicate |
| Shelf Life | 22 Months | Different | Different |
| 26 Months | 26 Months | ||
| Justification for difference:The subject device was validated forlonger shelf life. | Justification for difference:The subject device was validated forlonger shelf life. | ||
| Standard 15 mmconnections | Yes | Same as predicate | Same as predicate |
| Dead Space(Volume) | 3cc | Different22ccJustification for difference:The subject device is intended for adultpatient, therefore has different deadspace in comparison to the predicatedevice.The difference in the dead space(volume) does not impact the safety andeffectiveness of the device. | Same as predicate |
| Features | Predicate Device | Subject Device Comparison | |
| Nellcor Pedi-CAPTM Pediatric End-Tidal CO2 Detector (K944400) | NellcorTM EASYCAP II ColorimetricCO2 Detector | NellcorTM PEDICAP ColorimetricCO2 Detector | |
| Resistance to Flow | $2.5 cm H_2O \pm 0.5 cm$ at 10L/min | Different$4.4 cm H_2O \pm 1.0 cm$ at 60 L/minJustification for difference:The subject device is intended for adultpatient, therefore has differentresistance to flow in comparison to thepredicate device. The difference in theresistance to flow does not impact thesafety and effectiveness of the device. | Same as predicate |
| Detected % CO2Ranges andColors | A: 0.03 < 0.5 %B: 0.05 < 2 %C: 2 - 5 % | Same as predicate | Same as predicate |
| Materials | |||
| Device Cover | Acrylic copolymer | Same as predicate | Same as predicate |
| pH IndicatorPaper | pH-sensitive indicator paper | Same as predicate | Same as predicate |
| Device Support | Polypropylene | Same as predicate | Same as predicate |
| Features | Predicate Device | Subject Device Comparison | |
| Nellcor Pedi-CAP™ Pediatric End-Tidal CO2 Detector (K944400) | Nellcor™ EASYCAP II ColorimetricCO2 Detector | Nellcor™ PEDICAP ColorimetricCO2 Detector | |
| Filter | Polypropylene | DifferentPolypropylene and acrylicJustification fordifference:The material has been evaluated to ISO10993-1 & ISO 18562-1 and found tobe safe and effective. | DifferentPolypropylene and acrylic Justification fordifference:The material has been evaluated to ISO10993-1 & ISO 18562-1and found tobe safe and effective. |
| Device Body | Acrylic copolymer | SimilarAcrylic polymerJustification fordifference:This material has been evaluated toISO 10993-1& ISO 18562-1 andfound to be safe and effective. | Same as predicate |
COVIDIEN LLC 15 HAMPSHIRE STREET MANSFIELD, MA 02048
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Device Comparison Table: Subject Device, Predicate Device
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Device Comparison Table: Subiect Device, Predicate Device
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Device Comparison Table: Subject Device, Predicate Device
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Substantial Equivalence - Summary of Performance Testing
The following performance testing were performed in support of the substantial equivalence determination:
Biocompatibility testing
The biocompatibility evaluation was conducted in accordance with FDA Guidance "Use of International Standard ISO-10993, 'Bibogical Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" June 16, 2016, ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process' and ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process".
The biocompatibility tests for external communicating with tissue/bone/dentin with limited (less than 24 hours) include: cytotoxicity, sensitization, acute systemic toxicity, and material-mediated pvrogenicity, as well as an assessment to demonstrate compliance to the ISO 18562 standard series, including volatile organic compounds and particulate matter testing. The subject device met all biocompatibility requirements for its intended use.
Bench Testing
Performance bench testing including color change/duration of use, resistance to flow, internal volume(dead space), anti-fog, shelf-life, packaging stability and biocompatibility were performed on the subject devices to verify the designs meet performance specification and evaluation.
Substantial Equivalence - Clinical Evidence
N/A - Clinical evidence was not necessary to show substantial equivalence.
Substantial Equivalence - Conclusions
The subject device and the predicate device have the same intended use and the differences in technological features do not raise different questions of safety and effectiveness. From the evidence presented in the Premarket Notification, the subject device can be considered substantially equivalent.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).