(290 days)
The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and include heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
These devices are made of corrugated tubing (10mm in diameter), which houses the heated wires and are kitted with various adaptors and connectors to aid the respiratory care clinician in system configuration. In general these heated wire circuits are connected to both a ventilator and a Hudson RCI Neptune Heated Humidifier. The single limb configuration is compatible with the CareFusion Infant Flow system.
All Neonatal ConchaSmart Breathing Circuits have a useful life of 21 days. Neonatal ConchaSmart Breathing Circuits are sold non-sterile.
The provided text describes a 510(k) premarket notification for a medical device, the "Neonatal ConchaSmart Breathing Circuits." The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The document details the device's indications for use, technological characteristics, and performance data from non-clinical testing.
However, the information provided focuses on the physical and functional performance of the breathing circuits themselves, rather than an AI/ML-driven device's performance measured against acceptance criteria in a clinical or image-based diagnostic setting. Specifically, it does not contain the following information typically found in an AI/ML device submission for establishing acceptance criteria and proving performance:
- A table of acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC) and reported device performance against these.
- Sample sizes for test sets in an AI/ML context (e.g., number of images, patient cases).
- Data provenance (country of origin, retrospective/prospective) for an AI/ML test set.
- Number of experts and their qualifications for establishing ground truth for an AI/ML test set.
- Adjudication methods for AI/ML ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness study details (effect size of human reader improvement with AI assistance).
- Standalone performance (algorithm only without human-in-the-loop) for an AI/ML device.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data) for an AI/ML device.
- Sample size for AI/ML training set.
- How ground truth for the AI/ML training set was established.
The document discusses engineering acceptance criteria related to standards for breathing circuits (e.g., resistance to flow, compliance, leakage, useful life, electrical safety, biocompatibility) and confirms that the device passed these tests. It indicates the device functions as intended with a specific humidifier.
Therefore, I cannot extract the requested information as the document describes a traditional medical device (breathing circuits) and not an AI/ML medical device where such acceptance criteria and study designs (related to AI model performance, human-in-the-loop studies, ground truth establishment for AI) would be relevant.
The acceptance criteria and study described in the document are limited to the physical and functional aspects of a non-AI/ML medical device.
The closest information provided related to "acceptance criteria" and "study proving it meets criteria" is:
Acceptance Criteria (Extrapolated from "Test Objective" and ISO Standards):
| Acceptance Criteria (related to breathing circuits) | Reported Device Performance |
|---|---|
| Useful Life: Maintain performance after 21 days of use post-1-year accelerated aging. | PASS |
| ISO 8185:2007 (Respiratory tract humidifiers for medical use): Perform as intended with Hudson RCI Neptune Heated Humidifier post-aging/useful life testing. | PASS |
| IEC 60601-1:1988 + A1:1991 + A2:1995 (Medical Electrical Equipment Safety): Perform as intended with Hudson RCI Neptune Heated Humidifier post-aging/useful life testing. | PASS |
| ISO 5367:2014 (Breathing sets and connectors): Perform as intended post-aging/useful life testing. | PASS |
| ISO 5356-1:2015 (Conical connectors): Perform as intended post-aging/useful life testing. | PASS |
| Additional Design Testing (incl. component break/slip): Perform as intended post-aging/useful life testing. | PASS |
| Biocompatibility (ISO 10993 series): Cytotoxicity, sensitization, irritation, extractable/leachable testing. | PASS |
| Leakage: Less than 30 ml/min at 60 cmH2O (per ISO 5367:2014) | Less than 30 ml/min @ 60 cmH2O (Implication of PASS) |
| Resistance to Flow (inspiratory/expiratory limb): Less than 1.89 cmH2O @ 2.5LPM (per ISO 5367:2014) | Less than 1.89 cmH2O @ 2.5LPM (Implication of PASS) |
| Compliance: Less than 1.5 ml/cmH2O @ 60 cmH2O (per ISO 5367:2014) | Less than 1.5 ml/cmH2O @ 60 cmH2O (Implication of PASS) |
Study Proving Device Meets Acceptance Criteria:
The study involved a series of non-clinical, laboratory-based tests.
- Sample Size Used for Test Set and Data Provenance: The document does not specify a "sample size" in terms of number of patient cases or images, as it is not an AI/ML study. It refers to testing "the proposed devices," implying physical units of the Neonatal ConchaSmart Breathing Circuits. The tests were performed in a lab setting, not using human data/patients, so "provenance" in the sense of country of origin or retrospective/prospective is not applicable.
- Number of Experts and Qualifications for Ground Truth: Not applicable for this type of device where laboratory measurements against international standards establish "truth."
- Adjudication Method: Not applicable. Lab testing against defined physical and electrical parameters.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for AI/ML devices involving human readers.
- Standalone Performance: Not applicable in the context of an AI/ML algorithm. The device performance itself is evaluated (e.g., its resistance to flow, electrical safety, etc.).
- Type of Ground Truth Used: The "ground truth" here is adherence to specified parameters and performance limits defined by international standards (e.g., ISO 5367, IEC 60601-1, ISO 8185, ISO 5356-1, ISO 10993) and the manufacturer's design verification testing for compatibility and durability.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/ML device relying on a "training set" of data.
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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 in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
August 2, 2018
Teleflex Medical, Inc Brian Gall Senior Regulatory Affairs Specialist, Respiratory Division 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K173280
Trade/Device Name: Neonatal ConchaSmart Breathing Circuits Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: June 29, 2018 Received: July 2, 2018
Dear Brian Gall:
We have reviewed your 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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173280
Device Name
Neonatal ConchaSmart Breathing Circuit
Indications for Use (Describe)
The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and include heated wire(s) for use with the Hudson RCI Neptune Heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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510(k) SUMMARY
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-228-4350
B. Contact Person
Brian Gall Regulatory Affairs Group Lead, Respiratory Division
C. Date Prepared
31 July 2018
D. Device Name
| Trade Name: | Neonatal ConchaSmart Breathing Circuits |
|---|---|
| Common Name: | Breathing system heater |
| Product Code: | BZE |
| Regulation Number: | 868.5270 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
E. Predicate Device
The Neonatal ConchaSmart Breathing Circuits are substantially equivalent to the following devices:
- K103767 RT265 and RT266 Dual Heated Infant Breathing Circuits .
In addition, the following devices are used as reference devices as described:
K140556 has been added as a reference 510(k). The primary reason for referencing K140556 is that this is the adult version of the proposed device. The adult breathing circuits were added as a reference for the following primary reasons:
- . Different technological characteristics (single vs. dual limb) do not raise different questions of safety and effectiveness from the predicate device since the adult circuit is available in both configurations.
- . The materials used in the proposed neonatal breathing circuit and the reference are similar and well understood.
- . The useful life testing strategy of the reference device was accepted. It is an equivalent test method to the proposed device.
- . The heated wires used in the reference device are similar to the proposed device. The intent of using the adult circuits as a reference was to show that Teleflex has market knowledge of the interaction of this type of heated wire being used with similar materials with the Hudson RCI Neptune Heated Humidifier system.
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K151959 has been added as a reference 510(k). The primary reason for referencing K151959 the following:
- . It is a single limb breathing circuit cleared to be used with a heated humidifier for neonatal and infant patient populations.
- . The testing related to the single limb configuration was similar (biocompatibility to ISO 10993; circuit construction and performance to ISO 5356-1, ISO 5367, and ISO 8185; and electrical testing to IEC 60601-1).
F. Device Description
The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
These devices are made of corrugated tubing (10mm in diameter), which houses the heated wires and are kitted with various adaptors and connectors to aid the respiratory care clinician in system configuration. In general these heated wire circuits are connected to both a ventilator and a Hudson RCI Neptune Heated Humidifier. The single limb configuration is compatible with the CareFusion Infant Flow system.
All Neonatal ConchaSmart Breathing Circuits have a useful life of 21 days. Neonatal ConchaSmart Breathing Circuits are sold non-sterile.
G. Indications for Use
The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and include heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
H. Technological Characteristics - Comparison to the Predicate
The proposed Heated Wire Breathing Circuits are substantially equivalent to the predicate device as the intended use, fundamental scientific technology, and operating principles are the same. The circuits differ with regards to limb configurations, tubing dimensions, and materials, however through testing and the introduction of reference predicates, the proposed devices are substantially equivalent to the predicate as indicated below:
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| ComparativeCharacteristics | RT265 and RT266 Dual HeatedInfant Breathing CircuitsPredicate (K103767) | Neonatal ConchaSmart BreathingCircuitsProposed | |
|---|---|---|---|
| Indications forUse | The dual-heated breathing circuitsare intended as conduits ofbreathing gas for ventilation of infantpatients, and to maintain thetemperature of humidified inspiredgas. The RT265 is used for flowrates greater than 4LPM, and theRT266 is for flow rates between0.3LPM and 4LPM. | The Neonatal ConchaSmartBreathing Circuits are intended forneonatal and infant patients inprofessional healthcareenvironments as a conduit forrespiratory gas between a patientand a ventilator or Infant FlowGenerator (for single limbconfiguration) and include heatedwire(s) for use with the Hudson RCINeptune Heated Humidifier. Theheated wires are intended to aid inmaintaining the set patienttemperature and minimizecondensation in the ventilatortubing. | |
| Intended Use | The RT265 and RT266 infantbreathing circuits are intended todeliver humidified breathing gasesfor administration to an infantpatient. Gases available for medicaluse do not contain sufficientmoisture and may damage or irritatethe respiratory tract, or desiccatesecretions of patients whosesupraglottic airways have beenbypassed. Thus humidified gasesvia heated breathing circuit may beindicated for patients requiringmechanical ventilation, positivepressure breathing assistance, orgeneral medical gases. Thesegases may be delivered byfacemask or through bypassingupper airways, for example use ofan endotracheal tube. | The proposed NeonatalConchaSmart breathing circuits areintended to deliver humidifiedbreathing gases for administrationto an infant/neonate patient. Gasesavailable for medical use do notcontain sufficient moisture and maydamage or irritate the respiratorytract, or desiccate secretions ofpatients whose supraglottic airwayshave been bypassed. Thushumidified gases via heatedbreathing circuit may be indicatedfor patients requiring mechanicalventilation, positive pressurebreathing assistance, or generalmedical gases. These gases maybe delivered by nasal prongs usingthe CareFusion Infant Flow systemand the single limb circuit, orthrough bypassing upper airways,for example through the use of anendotracheal tube with the duallimb configuration. | |
| Environment ofUse | Professional HealthcareEnvironment | Professional HealthcareEnvironment | |
| PatientPopulation | Infant | Neonate/Infant | |
| CompatibleHumidifiers | MR850 Heated Humidifier | Hudson RCI Neptune HeatedHumidifier | |
| ComparativeCharacteristics | RT265 and RT266 Dual HeatedInfant Breathing Circuits | Neonatal ConchaSmart BreathingCircuits | |
| Predicate (K103767) | Proposed | ||
| CircuitConfigurations | Dual Limb Heated Wire Circuit | Dual Limb Heated Wire CircuitSingle Limb Heated Wire Circuit | |
| Flow Range | RT265 - flow rates greater than4LPMRT266 - 0.3LPM and 4LPM" | 1-15 LPM | |
| Kit components | Remote temperature port tubingWater feed tubeTubing adaptor set15 mm adaptorsLuer tee connectorStep down adaptorHumidifier limb | ConchaSmart Column, Non-sterileAirway adaptors and connectorsHumidifier Limb tubing withconnectorsRemote Temp Port tubing withconnectorsPressure Line tubing withconnectors | |
| Disposable vs.Reusable | Disposable | Disposable | |
| Circuit TubingDiameter | 11mm | 10mm | |
| Design | Corrugated | Corrugated | |
| Wire MaximumPower | Unknown | Single Limb: 21 WattsDual Limb: 21 to 30 Watts | |
| Min CircuitResistance | Unknown | Single Limb: 3 OhmsDual Limb: 0.8 to 4.7 Ohms | |
| Wire Material | Unknown | Single Limb: Nickel Chromium IronDual Limb: Nickel Chromium Ironand Nickel Chromium | |
| Wire Length | Unknown | Single Limb: 116 inchesDual Limb: 94 to 141 inches | |
| Heated WireSpecification | Unknown | Maximum of 2.5W per linear foot | |
| Circuit Length | 1.5 meters | Single Limb: 1.8 metersDual Limib: 1.5 meters to 1.8meters | |
| Resistance toFlow(inspiratorylimb) | 2 cmH2O @ 13LPM | Less than 1.89 cmH2O @ 2.5LPM(per ISO 5367:2014) | |
| Resistance toFlow (expiratorylimb) | 2 cmH2O @ 13LPM | Less than 1.89 cmH₂O @ 2.5LPM(per ISO 5367:2014) | |
| Compliance | 0.81 ml/cmH20 | Less than 1.5 ml/cmH₂O @ 60cmH2O(per ISO 5367:2014) | |
| Leakage | Maximum Circuit Gas Leakage:75ml/min @ 60 cmH2O | Less than 30 ml/min @ 60 cmH2O(per ISO 5367:2014) | |
| Useful Life | 7 days | 21 days | |
| ComparativeCharacteristics | RT265 and RT266 Dual HeatedInfant Breathing CircuitsPredicate (K103767) | Neonatal ConchaSmart BreathingCircuitsProposed | |
| Standards | Interface Connection: ISO 5356-1(no other standards cited in 510(k) summary or on labeling) | Interface Connection: ISO 5356-1:2015Compliant to ISO 5367:2014Tested per ISO 10993 andGuidance for Industry and FoodandDrug Administration Staff: Use ofInternational Standard ISO10993-1, "Biological evaluation ofmedical devices - Part 1: Evaluationand testing within a riskmanagement process" | |
| Heated WireBreathingCircuit Materials | Not disclosed in 510(k) Summary |
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Similarities
The proposed device and predicate are similar in that they have the same intended use and same indications for use. They are used for the same patient population in the dual limb configuration and were subjected to and passed testing to the same performance (ISO 5367, ISO 8185, ISO 5356-1), biological (ISO 10993), and electrical (IEC 60601-1 and IEC 60601-1-2) standards.
Differences
The main differences are the limb configuration of single limb, the flow rates, and the use of the device with the Neptune Heated Humidifier. With respect to the limb configurations, a reference predicate was introduced that is a single limb configuration cleared for the neonatal / infant population for use with a heated humidifier. The physical and electrical characteristics of the proposed device were testing according to IEC 60601-1 and IEC 60601-1-2 and were appropriate for the indicated Heated Humidifier (Hudson RCI Neptune). For the tubing dimensions, testing to ISO 5367 showed that the proposed device and the predicate were substantially equivalent.
I. Performance Data
The following testing was performed on the proposed devices.
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995, applicable sections
- ISO 8185:2007 - Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems, applicable sections
- . ISO 5356-1:2015 - Anaesthetic and respiratory equipment -- Conical connectors --Part 1: Cones and sockets, applicable sections
- ISO 5367:2014 Anaesthetic and respiratory equipment -- Breathing sets and . connectors, applicable sections
- Biocompatibility .
- o ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- o ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5:
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- Tests for in vitro cytotoxicity o
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: o Tests for irritation and skin sensitization
- ISO 10993-17:2002 Biological evaluation of medical devices -- Part 17: o Establishment of allowable limits for leachable substances
- o ISO 10993-18:2002 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
- Shelf Life (accelerated aging) ●
- . Useful life
The proposed devices were tested to the neonatal requirements of ISO 5367:2014. In addition, testing was performed to ensure compatibility with the Hudson RCI Neptune Heated Humidifier and a useful life of 21 days. Cytotoxicity, sensitization, irritation, and Extractable and Leachable testing were performed to demonstrate biocompatibility of the patient contacting materials.
| Test Description | Test Objective | Results |
|---|---|---|
| Shelf Life testing | The proposed Neonatal ConchaSmart BreathingCircuits were aged according to ASTM F1980:Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices for theequivalent of one year. | N/A(for test setuponly) |
| Useful Life testing | The proposed Neonatal ConchaSmart BreathingCircuits were tested for a 21 day useful life afteraccelerated aging equivalent to one year using worstcase use scenarios. During and after the useful lifetesting, the circuits were tested for applicable sectionsof ISO 5367 | PASS |
| All testing below was conducted on the proposed devices after the one year accelerated shelflife and 21 day useful life testing. This was considered the worst case. | ||
| Design Verificationtesting:ISO 8185:2007 Testing | The proposed Neonatal ConchaSmart BreathingCircuit, when used with the Hudson RCI NeptuneHeated Humidifier, must perform as intended postaccelerated aging and useful life testing when subjectto the test methods from applicable sections of ISO8185:2007 Respiratory tract humidifiers for medicaluse -- Particular requirements for respiratoryhumidification systems | PASS |
| Design Verificationtesting:IEC 60601-1:1988 +A1:1991 + A2:1995Testing | The proposed Neonatal ConchaSmart BreathingCircuit, when used with the Hudson RCI NeptuneHeated Humidifier, must perform as intended postaccelerated aging and useful life testing when subjectto the test methods from applicable sections of IEC60601-1 Medical electrical equipment - Part 1:General requirements for safety: | PASS |
J. Summary on Non-Clinical Testing
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| Test Description | Test Objective | Results |
|---|---|---|
| Design Verificationtesting:ISO 5367:2014 Testing | The proposed Neonatal ConchaSmart BreathingCircuit, when used with the Hudson RCI NeptuneHeated Humidifier, must perform as intended postaccelerated aging and useful life testing when subjectto the test methods from applicable sections of ISO5367:2014 - Anaesthetic and respiratory equipment --Breathing sets and connectors | PASS |
| Design Verificationtesting:ISO 5356-1:2015Testing | The proposed Neonatal ConchaSmart BreathingCircuit must perform as intended post acceleratedaging and useful life testing when subject to the testmethods from the following applicable sections of ISO5356-1:2015 – Anaesthetic and respiratory equipment-- Conical connectors -- Part 1: Cones and sockets: | PASS |
| Design Verificationtesting:Additional DesignTesting | The proposed Neonatal ConchaSmart BreathingCircuit must perform as intended post acceleratedaging and useful life testing when subject to the testmethods from additional design testing includingcomponent break and slip testing. | PASS |
K. Conclusion
As with the predicate, all of the acceptance criteria required through the use of the harmonized standards (including performance, biocompatibility, and electrical as discussed above) were met for the proposed device. In addition, the circuit was found to function as intended when used with the Neptune Heated Humidifier, for which it is intended to use. The device data and test results demonstrate that the devices meet the applicable standards for breathing circuits and are substantially equivalent to the predicate device.
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).