Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector

Q: Who is the manufacturer of Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector?

Covidien filed the 510(k) submission for Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector (K203762).

Q: What is the FDA product code for Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector?

CCK. It is classified under 21 CFR 868.1400 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector?

Pedi-CAP™ Pediatric End-Tidal CO2 Detector (K944400).

Q: Who can help prepare an FDA 510(k) submission like Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K203762 · Covidien · CCK · Sep 17, 2021 · Anesthesiology

Device Facts

Record ID	K203762
Device Name	Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
Applicant	Covidien
Product Code	CCK · Anesthesiology
Decision Date	Sep 17, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

Colorimetric CO2 detector; connects between endotracheal tube and breathing circuit; utilizes pH-sensitive indicator paper to detect end-tidal CO2 ranges via color change; provides visual feedback to clinician; used during intubation or patient transport; single-use; non-sterile; duration <2 hours; assists in confirming correct tube placement and monitoring ventilation status; benefits patient by reducing risks associated with esophageal intubation or dislodged tubes.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including color change performance, resistance to flow, dead space volume, anti-fog, shelf-life, packaging stability, and biocompatibility (ISO 10993-1, ISO 18562-1).

Technological Characteristics

Colorimetric CO2 gas analyzer; acrylic copolymer body/cover; polypropylene support/filter; pH-sensitive indicator paper; 15 mm standard connections; non-sterile; single-use; shelf life 26 months; EASYCAP II (adult) dead space 22cc, resistance 4.4 cm H2O at 60 L/min; PEDICAP (pediatric) dead space 3cc, resistance 2.5 cm H2O at 10 L/min.

Indications for Use

Indicated for verification of endotracheal tube placement and monitoring of end-tidal CO2 ranges in intubated patients. EASYCAP II for adults >15 kg; PEDICAP for pediatric patients 1-15 kg.

Regulatory Classification

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.

Predicate Devices

Pedi-CAP™ Pediatric End-Tidal CO2 Detector (K944400)

Related Devices

K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 · Mercury Medical · Jul 30, 2003
K112840 — CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR · Seebreath AB · Jul 13, 2012
K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 · Mercury Medical · Nov 4, 2002
K050066 — C-CO2 COLORIMETRIC CO2 INDICATOR · Marquest Medical Products, Inc. · Mar 1, 2005
K072220 — PEDI CO2 EASY · Westmed, Inc. · Aug 23, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional. # 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a grid pattern in lighter shades of blue on the left, and the word "COVIDIEN" in blue, sans-serif font on the right. The logo is simple and modern, and the colors are calming and professional. # 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 | <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 for longer shelf life. | Justification for difference: The subject device was validated for longer shelf life. | | Standard 15 mm connections | Yes | Same as predicate | Same as predicate | | Dead Space (Volume) | 3cc | Different 22cc Justification for difference: The subject device is intended for adult patient, therefore has different dead space in comparison to the predicate device. The difference in the dead space (volume) does not impact the safety and effectiveness of the device. | Same as predicate | | Features | Predicate Device | Subject Device Comparison | | | | Nellcor Pedi-CAPTM Pediatric End- Tidal CO2 Detector (K944400) | NellcorTM EASYCAP II Colorimetric CO2 Detector | NellcorTM PEDICAP Colorimetric CO2 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/min Justification for difference: The subject device is intended for adult patient, therefore has different resistance to flow in comparison to the predicate device. The difference in the resistance to flow does not impact the safety and effectiveness of the device. | Same as predicate | | Detected % CO2 Ranges and Colors | 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 Indicator Paper | 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 Colorimetric CO2 Detector | Nellcor™ PEDICAP Colorimetric CO2 Detector | | Filter | Polypropylene | Different Polypropylene and acrylic Justification for difference: The material has been evaluated to ISO 10993-1 & ISO 18562-1 and found to be safe and effective. | Different Polypropylene and acrylic Justification for difference: The material has been evaluated to ISO 10993-1 & ISO 18562-1and found to be safe and effective. | | Device Body | Acrylic copolymer | Similar Acrylic polymer Justification for difference: This material has been evaluated to ISO 10993-1& ISO 18562-1 and found to be safe and effective. | Same as predicate | COVIDIEN LLC 15 HAMPSHIRE STREET MANSFIELD, MA 02048 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the word "COVIDIEN" in a bold, sans-serif font. To the left of the word is a blue square divided into smaller squares of varying shades of blue. The word "COVIDIEN" is also in blue, and the overall design appears to be a logo. ### Device Comparison Table: Subject Device, Predicate Device {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the word "COVIDIEN" in a bold, sans-serif font. To the left of the word is a blue square logo. The logo is made up of smaller squares of varying shades of blue. # Device Comparison Table: Subiect Device, Predicate Device {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a lighter blue horizontal stripe in the middle, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, with a focus on the company name. ## Device Comparison Table: Subject Device, Predicate Device {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square made up of smaller squares of varying shades of blue. To the right of the square is the word "COVIDIEN" in blue sans-serif font. # 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.