(188 days)
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850.
The provided text describes a 510(k) premarket notification for a medical device called the "AirLife Infant Single Limb Heated Wire Circuit." It focuses on demonstrating substantial equivalence to a predicate device. The information required for outlining acceptance criteria and a study proving a device meets them is not fully contained within this document because it is a submission for substantial equivalence, not a detailed clinical study report for a novel device.
However, based on the provided text, I can infer and extract some relevant details pertaining to performance testing and general acceptance principles for this type of device.
Here's an attempt to answer your request using the available information, with clear indications of where information is directly stated versus inferred as typical for a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document lists performance characteristics and the relevant standards they were tested against. For a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implied to be meeting the requirements set forth in these standards. The "reported device performance" is a general statement of compliance, rather than specific numerical results.
| Performance Characteristic | Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 series for cytotoxicity, sensitization, irritation, muscle implantation, genotoxicity, and extractables/leachables. | Tested to ensure compliance; implied acceptable results. |
| Length | Compliance with ISO 5367:2000 (specific length tolerances would be defined within the standard, but not explicitly stated here). | Compliance with ISO 5367:2000 demonstrated. |
| Resistance to flow/Rated Flow | Compliance with ISO 5367:2000 (specific resistance limits would be defined within the standard). | Compliance with ISO 5367:2000 demonstrated. |
| Resistance to Flow @ 2.5 lpm | Compliance with ISO 5367:2014 (specific resistance limits would be defined within the standard). | Compliance with ISO 5367:2014 demonstrated. |
| Increase in Flow Resistance with Bending | Compliance with ISO 5367:2000, ISO 5367:2014. | Compliance with ISO 5367:2000, ISO 5367:2014 demonstrated. |
| Conical Connectors | Compliance with ISO 5367:2000, ISO 5356-1:2004, ISO 8185:2008 (ensuring proper fit and function). | Compliance with relevant ISO standards demonstrated. |
| Security of Attachment | Compliance with ISO 5367:2000 (ensuring connections remain secure). | Compliance with ISO 5367:2000 demonstrated. |
| Leakage | Compliance with ISO 5367:2000 (ensuring no unintended gas escape). | Compliance with ISO 5367:2000 demonstrated. |
| Compliance | Compliance with ISO 5367:2000, ISO 8185:2008 (regarding elasticity/flexibility requirements). | Compliance with relevant ISO standards demonstrated. |
| Humidity Output | Compliance with ISO 8185:2008 (ensuring adequate humidification levels are maintained). | Compliance with ISO 8185:2008 demonstrated. |
| Security of Engagement Temperature Sensor | Compliance with ISO 8185:2008 (ensuring temperature sensor is securely attached). | Compliance with ISO 8185:2008 demonstrated. |
| Leakage from Sensing Port | Compliance with ISO 8185:2008 (ensuring no leakage from the temperature sensing port). | Compliance with ISO 8185:2008 demonstrated. |
| Specific Enthalpy | Compliance with ISO 8185:2008 (related to humidification performance). | Compliance with ISO 8185:2008 demonstrated. |
| Surface Temperature | Compliance with ISO 8185:2008 (ensuring safe surface temperatures). | Compliance with ISO 8185:2008 demonstrated. |
| Steady State Noise | Compliance with ISO 8185:2008 (ensuring noise levels are within acceptable limits). | Compliance with ISO 8185:2008 demonstrated. |
| Electrical safety (Patient Leakage Current) | Compliance with IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) (ensuring electrical safety for patients). | Compliance with IEC 60601-1:2005 demonstrated. |
| Electrical safety (Dielectric Strength Means) | Compliance with IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) (ensuring electrical insulation integrity). | Compliance with IEC 60601-1:2005 demonstrated. |
Regarding the study proving the device meets acceptance criteria:
The document broadly states: "The following tests were performed for the proposed device to support the substantial equivalence decision," and "The test results demonstrate that the device is as safe and effective as the predicate and therefore substantially equivalent to the predicate device." This indicates that a series of performance bench tests were conducted to verify compliance with the listed international standards (ISO, IEC, AAMI). These are typically laboratory-based engineering and material tests, not clinical studies involving human subjects in an "AI" context.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document. For engineering/bench tests, sample sizes would typically be determined by the specific standard's requirements (e.g., n=3, n=5, n=10 per test), but these details are not present.
- Data Provenance: The tests were performed by the manufacturer, CareFusion Inc., in support of their 510(k) submission to the FDA. The country of origin of the data would be the location where CareFusion conducted these tests, which is not explicitly stated but can be inferred as the US based on the company's US address. The data is retrospective in the sense that the tests were completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device and study. The testing described involves physical and electrical performance verification against defined standards, not evaluation by human experts or clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed for image interpretation or diagnosis. Bench testing against standards does not typically involve such adjudication.
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
This is not applicable. This device is a heated breathing circuit, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device does not involve any algorithms or AI for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance testing is adherence to the technical specifications and safety requirements outlined in the referenced international standards (e.g., ISO, IEC, AAMI). For biocompatibility, it's the results of specific biological assays. For mechanical and electrical properties, it's measurement against defined limits.
8. The sample size for the training set
This is not applicable. The device is a physical medical device (breathing circuit), not a machine learning model. Therefore, there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable. As stated above, there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
CareFusion Inc. Erika Fernandez Regulatory Affairs Manager 75 N Fairway Drive Vernon Hills, Illinois 60061
Re: K151959
Trade/Device Name: AirLife Infant Single Limb Heated Wire Circuit Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: December 18. 2015 Received: December 23, 2015
Dear Erika Fernandez:
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 may, therefore, market the device, subject to the general controls provisions of the Act. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
AirLife Infant Single Limb Heated Wire Circuit
Indications for Use (Describe)
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.
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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Image /page/3/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, there is a smaller text that says "has joined BD".
Summary of Safety and Effectiveness
510k summary complying with 21 CFR 807.92
1. SUBMITTER
CareFusion 2200, Inc. 75 N Fairway Drive, Vernon Hill, IL 60061
Phone: 847 362-8097 Fax: 312 949-0731
Contact Person: Erika Fernandez
Date Prepared: January 19th, 2016
2. Device
| Product Name: | AirLife Infant Single Limb Heated Wire Circuit |
|---|---|
| Device Name: | Heated Breathing Circuit |
| Common Name: | Heater, breathing system w/wo controller (not humidifier or nebulizer) |
| Classification Name: | Breathing system heater (21 CFR 868.5270) |
| Regulatory Class: | II |
| Product Code: | BZE |
3. Predicate Device
This submission demonstrates substantial equivalence to the AirLife Heated Ventilator and Anesthesia Breathing Circuits, K000697 was cleared on March 30, 2000. This predicate device has not been subject to a design-related recall.
4. Device Description
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850.
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Image /page/4/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, in smaller font, it says "has joined BD".
5. Indication for use
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatric population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediatric subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians.
6. Comparison of technological characteristics with the predicate device
The fundamental scientific technology is the same for both proposed and predicate device. It is based on acting as an airway conduit between a breathing machine and the patient (typically attached to an endotracheal or tracheal tube previously insert into the patient's airway).
| Element of comparison | Proposed Device | Predicate Device |
|---|---|---|
| Intended Use | Intended to warm breathinggases before they enter apatient's airway | Intended to warm breathinggases before they enter apatient's airway |
| Principal of Operation | Resistance wires within thetubing generate heat tomaintain temperatures andhumidity | Resistance wires within thetubing generate heat tomaintain temperatures andhumidity |
| Single limb High Flow | Proposed Device | Predicate Device |
| Circuit Characteristics | ||
| Infant Inspiratory Limb withUnheated Extension | 5 ft | 2 - 6 ft |
| Dryline Length | 2 ft | 2 ft |
| Inspiratory Limb Length | 4 ft | 4 ft |
| Heated Wire | Present | Present |
| Intended Patient Use | Infant | Infant |
| Usage | Disposable | Disposable |
| Design | Single Limb | Single Limb |
| Tube Specifications | ||
| Nominal ID | 11-12 mm (0.45in-0.46in) | 10-22mm |
| Design | Corrugate and smooth bore | Corrugate and smooth bore |
| Wire Design Criteria | ||
| Maximum Power | 60W | 60W |
| Min circuit resistance | $7.5 \Omega$ | $7.5 \Omega$ |
| Typical Wattage/foot of wire | 2 | 1.8-2.5 |
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Image /page/5/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the word "CareFusion" in gray text. Below the word "CareFusion" is the phrase "has joined BD" in a smaller, lighter gray font.
| Element of comparison | Proposed Device | Predicate Device |
|---|---|---|
| Maximum Power/ft of wire | 3.2 W/ft | 3.2 W/ft |
| Slack in wire (length in relationto tubing length) | 6-9 in | 2-4in |
| Conductor | 304 Steel | Copper/Ni alloy |
| Compatible Humidifier | Fisher and Paykel MR850 | Fisher and Paykel MR850 |
7. Performance Data
The proposed device was tested to ensure compliance to the following standards:
Biocompatibility
Tests for an externally communicating, tissue by way of gas path and direct mucosal contact with prolonged contact (greater than 24 hours but less than 30 days): Cytotoxicity, Sensitization, Irritation, Muscle Implantation, Genotoxicity and Extractables/Leachables
Standards
| Performance Characteristic | Standard |
|---|---|
| Biological Evaluation of Medical Devices Part 1: Evaluation andTestingFDA Guidance: Use of International Standard ISO- 10993,"Biological Evaluation of Medical Devices Part 1: Evaluation andTesting" | ISO 10993-1:2009 |
| Biological Evaluation of Medical Devices Part 3: Tests forgenotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3:2014 |
| Biological Evaluation of Medical Devices Part 5: Tests for in vitrocytotoxicity | ISO 10993-5:2009 |
| Biological Evaluation of Medical Devices Part 6: Tests for localeffects after implantation | ISO 10993-6:2007 |
| Biological Evaluation of Medical Devices Part 10: Tests forirritation and skin sensitization | ISO 10993-10:2010 |
| Biological Evaluation of Medical Devices Part 17: Establishment ofallowable limits for leachable substances | ISO 10993-17:2002 |
| Biological Evaluation of Medical Devices Part 18: Chemicalcharacterization of materials | ISO 10993-18:2005 |
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Image /page/6/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside. The text "CareFusion" is written in gray to the right of the circle. Below the text, it says "has joined BD" in a smaller font.
Performance
The following tests were performed for the proposed device to support the substantial equivalence decision.
| Performance Characteristic | Relevant Standard |
|---|---|
| Length | ISO 5367:2000 |
| Resistance to flow/ Rated Flow | ISO 5367: 2000 |
| Resistance to Flow @ 2.5 lpm | ISO 5367:2014 |
| Increase in Flow Resistance with Bending | ISO 5367:2000ISO 5367:2014 |
| Conical Connectors | ISO 5367:2000ISO 5356-1:2004ISO 8185:2008 |
| Security of Attachment | ISO 5367:2000 |
| Leakage | ISO 5367:2000 |
| Compliance | ISO 5367:2000ISO 8185:2008 |
| Humidity Output | ISO 8185:2008 |
| Security of Engagement Temperature Sensor | ISO 8185:2008 |
| Leakage from Sensing Port | ISO 8185:2008 |
| Specific Enthalpy | ISO 8185:2008 |
| Surface Temperature | ISO 8185:2008 |
| Steady State Noise | ISO 8185:2008 |
| Electrical safetyPatient Leakage Current | IEC 60601-1:2005, 3rd Edition(Equivalent to AAMI ES60601-1:2005) |
| Electrical safetyDielectric Strength Means | IEC 60601-1:2005, 3rd Edition(Equivalent to AAMI ES60601-1:2005) |
8. Conclusion
The test results demonstrate that the device is as safe and effective as the predicate and therefore 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).