(268 days)
No
The device description relies on color comparison for CO2 detection and does not mention any AI/ML terms or image processing.
No.
The device is used to assist verification of tube placement and detect CO2, which are diagnostic/monitoring functions, not therapeutic ones.
Yes
The device detects approximate ranges of end-tidal CO2 to assist verification of tube placement during endotracheal intubation, which is a diagnostic purpose.
No
The device description explicitly states it is a physical device that connects between an endotracheal tube and a breathing device and detects CO2 by color comparison. It also mentions biocompatibility and bench testing related to physical properties like resistance to flow and internal volume. This indicates it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist verification of tube placement during endotracheal intubation" and "detect approximate ranges of end-tidal CO2". This is a direct measurement of a physiological parameter (CO2 in exhaled breath) from the patient's body, not an analysis of a sample taken from the body (like blood, urine, tissue, etc.).
- Device Description: The device connects between the endotracheal tube and a breathing device and detects CO2 by color comparison. This is a real-time, in-line measurement.
- Lack of Sample Analysis: IVD devices typically involve the analysis of a biological sample in vitro (outside the body). This device is used in vivo (on the patient) to monitor a physiological process.
Therefore, this device falls under the category of a medical device used for monitoring a physiological parameter, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
CCK
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).
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
Adult patients weighing more than 15 kg (33 lb) for Nellcor EASYCAP II Adult Colorimetric CO2 Detector.
Pediatric patients weighing 1 - 15 kg (2.2 - 33 lb) for Nellcor PEDICAP Pediatric Colorimetric CO2 Detector.
Intended User / Care Setting
Not Found
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
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.
Clinical Evidence: N/A - Clinical evidence was not necessary to show substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Pedi-CAP™ Pediatric End-Tidal CO₂ Detector (K944400)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 Avenue
Boulder, CO 80301 |
|-----------------|---------------------------------------------------------------|
| Date: | 21 December 2020 |
| Contact Person: | Ashley Johnston
Regulatory Affairs Manager
720-440-1057 |
DEVICE II.
III.
| DEVICE | |
|---|---|
| Proprietary Name: | Nellcor™ EASYCAP II Adult Colorimetric CO2 Detector |
| Nellcor™ 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 Colorimetric | ||
| CO2 Detector | Nellcor™ PEDICAP Colorimetric | ||
| CO2 Detector | |||
| Intended Use | To detect approximate ranges of end- | ||
| tidal CO2 | Same as predicate | Same as predicate | |
| Indications for | |||
| Use | 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. | Similar | ||
| Use to assist verification of tube | |||
| placement during endotracheal | |||
| or nasotracheal intubation. | |||
| Use on intubated patients to detect | |||
| approximate ranges of end-tidal CO2 | |||
| when clinically significant. | Similar | ||
| Use to assist verification of | |||
| tube placement during | |||
| endotracheal or nasotracheal | |||
| intubation. | |||
| Use on intubated patients to detect | |||
| approximate ranges of end-tidal CO2 | |||
| when clinically significant. | |||
| Patient | |||
| Population | Patients weighing 1–15 kg (2.2-33 lb). | Different | |
| Patients 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 Colorimetric | ||
| CO2 Detector | Nellcor™ PEDICAP Colorimetric | ||
| CO2 Detector | |||
| Duration of Use |