(241 days)
The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient's airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. 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. The AirLife Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.
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.
The provided document is a 510(k) premarket notification for a medical device called the "AirLife Adult Heated Wire Circuit." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's performance against clinical acceptance criteria in the same way a novel device might.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and performance tests against recognized standards for breathing circuits and humidifiers, not clinical performance measures like sensitivity, specificity, or reader agreement for an AI diagnostic device.
Here's the breakdown of the information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance statistics in a pass/fail format typical for a clinical study of an AI device. Instead, it lists the performance characteristics tested and the standards they comply with, implying that meeting these standards constitutes the acceptance criteria. The "reported device performance" is implicitly that the device did meet these standards, as stated in the conclusion.
| Performance Characteristic | Standard (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Length | BS EN ISO 5367: 2014 | Compliant |
| Resistance to Flow | BS EN ISO 5367: 2014 | Compliant |
| Resistance to Flow with Bending | BS EN ISO 5367: 2014 | Compliant |
| Conical Connectors | BS EN ISO 5367: 2014 | Compliant |
| Conical Connectors | BS EN ISO 8185: 2009 | Compliant |
| Security of Attachment | ISO 5356-1 | Compliant |
| Security of Attachment | BS EN ISO 5367: 2014 | Compliant |
| Leakage | BS EN ISO 5367: 2014 | Compliant |
| Compliance | BS EN ISO 5367: 2014 | Compliant |
| Resistance to Melt | BS EN ISO 8185: 2009 | Compliant |
| Security of Engagement Temperature Sensor | BS EN ISO 8185: 2009 | Compliant |
| Leakage from Sensing Port | BS EN ISO 8185: 2009 | Compliant |
| Specific Enthalpy | BS EN ISO 8185: 2009 | Compliant |
| Surface Temperature | BS EN ISO 8185: 2009 | Compliant |
| Humidity Output Invasive | BS EN ISO 8185: 2009 | Compliant |
| Humidity Output Non-Invasive | BS EN ISO 8185: 2009 | Compliant |
| Electrical Safety | IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012 | Compliant |
| Electromagnetic Compatibility | 60601-1-2 Edition 3: 2007-03 | Compliant |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Muscle Implantation, Genotoxicity and Extractables/Leachables) | ISO 10993-1, -3, -5, -6, -10, -17, -18 | Compliant |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not specify a "test set" in the context of clinical data for AI benchmarking. The tests performed are engineering and performance evaluations of the device itself (e.g., length, resistance, leakage). The document does not provide details on the sample size (number of devices tested), the provenance of the data (country of origin), or whether the testing was retrospective or prospective. These are typically internal validation tests by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is not an AI diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" here is defined by the technical specifications outlined in the referenced ISO and IEC standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human adjudication process involved as this is a technical device performance evaluation against standards.
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
Not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (heated wire circuit), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by the technical specifications and test methodologies outlined in the referenced international standards (e.g., ISO 5367, ISO 8185, IEC 60601-1, ISO 10993 series). The device's performance is measured against these quantitative and qualitative criteria defined by the standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2016
CareFusion, Inc. Erika Fernandez Regulatory Affairs Manager 75 N Fairway Drive Vernon Hills, Illinois 60061
Re: K153234
Trade/Device Name: AirLife Adult Heated Wire Circuit Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE Dated: May 27, 2016 Received: May 31, 2016
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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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Indications for Use
Form Approved OMB No 0910-0120 Expiration Date January 31, 2017 See PRA Statement below
510(k) Number (if known)
Device Name AirLife Adult Heated Wire Circuit
Indications for Use (Describe)
The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient's airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. The product is single use device, non-sterile and used in professional healthcare environments and intra-hosport environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
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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 black. 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 847-362-8097 Phone: Fax: 312 949-0731
Contact Person: Erika Fernandez
Date Prepared: July 6, 2016
2. Device
| Product Name: | AirLife Adult Heated Wire Circuit |
|---|---|
| Device Name: | Heated Breathing Circuit |
| Common Name: | Heater, breathing system w/wo controller (not humidifier ornebulizer) |
| 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.
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Image /page/4/Picture/0 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, in smaller gray font, it says "has joined BD".
5. Indication for use
The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient's airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. 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. The AirLife Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.
Comparison of technological characteristics with the predicate device 6.
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). The AirLife Adult Heated Wire Circuit is substantially equivalent to the predicate device AirLife Heated Wire Breathing Circuits regarding safety, effectiveness, design (technology), materials and intended use. The proposed AirLife Adult Heated Wire Circuit is designed to operate at the same minimum flow rate of 3 LPM as the predicate device. Successful test results (specific enthalpy, humidity output and surface temperature) ensured that the flow rate of the proposed device does not raise any different question of safety and effectiveness
| 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 |
| Circuit Characteristics | ||
| Limb Length (Inspiratoryand Expiratory) | 5 ft | 5 ft |
| Dryline Length | 1.7 ft | 1.7 ft |
| Intended Patient Use | Adult | Adult |
| Usage | Disposable | Disposable |
| Design | Dual and Single Limb | Dual and Single Limb |
| Tube Specifications | ||
| Nominal Inside Diameter | 21 mm | 21 mm |
| Design | Corrugated Breathing Tube with22mm Adapters | Corrugated Breathing Tubewith 22mm Adapters |
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| Element of comparison | Proposed Device | Predicate Device |
|---|---|---|
| Circuit Specifications | ||
| Circuit Design | Dual or Single | Dual or Single |
| Maximum Power | 60W | 60W |
| Min circuit resistance perLimb | 16.15 Ω | 16.24 - 17.75 Ω |
| Maximum Power/foot ofLimb | 6.0 | 6.0 |
| Conductor | Copper/Ni alloy | Copper/Ni alloy |
| Compatible Humidifiers | 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: Evaluationand TestingFDA Guidance: Use of International Standard ISO- 10993,"Biological Evaluation of Medical Devices Part 1: Evaluationand Testing" | 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 invitro cytotoxicity | ISO 10993-5:2009 |
| Biological Evaluation of Medical Devices Part 6: Tests forlocal effects 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 of allowable limits for leachable substances | ISO 10993-17:2002 |
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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, and the word "CareFusion" in gray text. Below the word "CareFusion" is the phrase "has joined BD" in a smaller font.
| Performance Characteristic | Standard |
|---|---|
| Biological Evaluation of Medical Devices Part 18: Chemicalcharacterization of materials | ISO 10993-18:2005 |
Performance
The following tests were performed for the proposed device to support the substantial equivalence decision.
| Performance Characteristic | Standard |
|---|---|
| Length | BS EN ISO 5367: 2014 |
| Resistance to Flow | BS EN ISO 5367: 2014 |
| Resistance to Flow with Bending | BS EN ISO 5367: 2014 |
| Conical Connectors | BS EN ISO 5367: 2014 |
| Conical Connectors | BS EN ISO 8185: 2009 |
| Security of Attachment | ISO 5356-1 |
| Security of Attachment | BS EN ISO 5367: 2014 |
| Leakage | BS EN ISO 5367: 2014 |
| Compliance | BS EN ISO 5367: 2014 |
| Resistance to Melt | BS EN ISO 8185: 2009 |
| Security of Engagement Temperature Sensor | BS EN ISO 8185: 2009 |
| Leakage from Sensing Port | BS EN ISO 8185: 2009 |
| Specific Enthalpy | BS EN ISO 8185: 2009 |
| Surface Temperature | BS EN ISO 8185: 2009 |
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Image /page/7/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".
| Performance Characteristic | Standard |
|---|---|
| Humidity Output Invasive | BS EN ISO 8185: 2009 |
| Humidity Output Non-Invasive | BS EN ISO 8185: 2009 |
| Electrical Safety | IEC 60601-1:2005 (Third Edition) + CORR.1:2006 + CORR. 2:2007 + A1:2012 (or IEC60601-1: 2012 reprint) |
| Electromagnetic Compatibility | 60601-1-2 Edition 3: 2007-03 |
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).