(290 days)
This product delivers respiratory gases to adult patients. It is intended for use with an MR810 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after set-up.
This product is indicated for the delivery of Nasal High Flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical room. Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min.
This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist.
This product is not intended for apneic ventilation.
The Fisher & Paykel (F&P) Optiflow™ Oxygen Kit consists of a dry line, humidification chamber inspiratory tube, and tubing clips. The dryline transfers the respiratory gases from a flow source to the humidification chamber. The humidification chamber provides a reservoir filled to an indicated maximum level with sterile water. As the humiditier heats the water in the chamber, water vapor is formed, which heats and humidifies the respiratory gases delivered from the dryline. The respiratory gas is then transferred to the inspiratory tube. The inspiratory tube (also known as inspiratory limb) electrically heats the respiratory gas utilizing a heater wire to maintain the temperature of the gas. The inspiratory tube delivers the gas through an FDA-cleared filter and interface. The filter and the patient interface are not in the scope of this submission. The tubing clips are attached to the inspiratory tube. They are used to connect the tube to the hospital bed sheet or pillow.
The device delivers gas at flow rates between 5 and 70 L/min. The device is to be used by medical professionals on multiple patients over a 24-hour period.
Only the Optiflow™ Oxygen Kit is part of this 510(k) submission. The flow source, humidifier, filter and interface are not in the scope of this submission.
The document provided is a 510(k) Premarket Notification from the FDA for a medical device called the "Optiflow™ Oxygen Kit." This type of document focuses on demonstrating substantial equivalence to a predicate device rather than explicitly detailing acceptance criteria and performance data in the context of an AI/ML medical device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not available in the provided text.
The document describes the device itself, its intended use, comparison to a predicate device (AirSpiral Heated Breathing tube), and the non-clinical testing performed to demonstrate its safety and effectiveness for a respiratory gas delivery system.
Here's what can be extracted from the document, though it doesn't align with the specific AI/ML questions:
1. A table of acceptance criteria and the reported device performance:
The document does not present a table of acceptance criteria for an AI/ML model. Instead, it describes various performance tests for a respiratory device to ensure it meets safety and effectiveness requirements. These are primarily engineering and material performance criteria.
| Test Category | General Description / Purpose |
|---|---|
| Preconditioning | - Shelf-life testing: Performed using accelerated aging (ASTM F1980-16) to ensure product requirements are met after 12 months. - Transportation testing: Performed following transport and storage simulation (ISTA 2A:2011). - Mechanical strength testing: Performed following push, impact, drop, and mold stress relief conditioning (IEC 60601-1 15.3.2, 15.3.3, 15.3.4, and 15.3.5). - Cleaning and low-level disinfection: Validated as per indications for use. |
| Additional Performance Testing | - Permanent connections test - Removable connections test - Gas delivery test - Resistance to flow test |
| Standards Compliance | - ISO 80601-2-74:2017(E) (Respiratory humidifying equipment) - IEC 60601-1-2 4th 2014 (Electromagnetic disturbances) - IEC 62366-1:2015 (Usability engineering) - ISO 5356-1:2004 (Anesthetic and Respiratory Equipment- Conical Connectors) |
| Biocompatibility | - Evaluated according to ISO 10993-1:2018 and ISO 18562-1:2017. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the device is a physical respiratory kit, not an AI/ML model that processes data. The tests are physical and laboratory-based.
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)
This information is not applicable. Ground truth, in the context of an AI/ML model, refers to validated data labels. For a physical device, testing involves standard engineering and medical device compliance procedures by qualified personnel (e.g., engineers, lab technicians), not medical experts establishing a "ground truth" for interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for human interpretation of data, often used in labeling datasets for AI/ML validation. This is not a component of testing a physical respiratory device.
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 information is not applicable. MRMC studies are designed to assess the diagnostic performance of human readers, typically with and without AI assistance, for image-based or similar data. The Optiflow™ Oxygen Kit is a direct medical device for gas delivery, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question pertains to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. See point 3.
8. The sample size for the training set
This information is not applicable. This device does not use a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
This information is not applicable. This device does not have a "training set" or "ground truth" in the AI/ML sense.
In summary, the provided FDA 510(k) document concerns a traditional medical device (respiratory gas delivery kit) and its approval based on substantial equivalence and non-clinical performance testing. It does not contain any information relevant to the development, validation, or acceptance criteria for an AI/ML-based medical device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 28, 2022
Fisher &Paykel Healthcare Ltd. Reena Daken Regulatory Affairs Market Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K211096
Trade/Device Name: Optiflow Oxygen Kit Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: January 26, 2022 Received: January 28, 2022
Dear Reena Daken:
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. 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.
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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 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.
Brandon Blakely Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211096
Device Name OptiflowTM Oxygen Kit
Indications for Use (Describe)
This product delivers respiratory gases to adult patients. It is intended for use with an MR810 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after set-up.
This product is indicated for the delivery of Nasal High Flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical room. Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min.
This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist.
This product is not intended for apneic ventilation.
| 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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5 510(k) Summary
As Required by 21 CFR 807.92 SUBMITTER -
| Date prepared | 26 Jan 2022 |
|---|---|
| Company Name andAddress | Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100 |
| Prepared and Submittedby | Carolina ZatarainRegulatory Affairs Specialist |
| Contact Person | Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email: reena.daken@fphcare.co.nz |
II. DEVICE
| Name of Device | F&P Optiflow™ Oxygen Kit |
|---|---|
| Common/Usual Name | Inspiratory tube |
| Classification Name | Respiratory gas humidifier,21 CFR §868.5450 |
| Regulatory Class | II |
| Product Code | BTT |
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PREDICATE DEVICE lll.
Predicate Device: ●
- AirSpiral Heated Breathing tube (K162553) O
● Reference Device:
- RT380 and RT385 Adult Evaqua 2 Dual Heated Breathing Circuits (K122432) o
IV. DEVICE DESCRIPTION
The Fisher & Paykel (F&P) Optiflow™ Oxygen Kit consists of a dry line, humidification chamber inspiratory tube, and tubing clips. The figure below shows the Optiflow™ Oxygen Kit, as it would be legally marketed in the USA.
Image /page/4/Figure/8 description: The image shows a medical device with four labeled parts. The first part is a dry line, which is a blue, corrugated tube that arches upwards. The second part is a humidification chamber, which is a clear, round container. The third part is a heated inspiratory tube, which is a blue, corrugated tube that is coiled. The fourth part is tubing clips, which are used to hold the heated inspiratory tube in place.
Figure 5-1 Optiflow™ Oxygen Kit
The dryline (1) transfers the respiratory gases from a flow source to the humidification chamber. The humidification chamber (2) provides a reservoir filled to an indicated maximum level with sterile water. As the humiditier heats the water in the chamber, water vapor is formed, which heats and humidifies the respiratory gases delivered from the dryline. The respiratory gas is then transferred to the inspiratory tube. The inspiratory tube (3) (also known as inspiratory limb) electrically heats the respiratory gas utilizing a heater wire to maintain the temperature of the gas. The inspiratory tube delivers the gas through an FDA-cleared filter and interface. The filter and the patient interface are not in the scope of this submission. The tubing clips (4) are attached to the inspiratory tube. They are used to connect the tube to the hospital bed sheet or pillow.
The device delivers gas at flow rates between 5 and 70 L/min. The device is to be used by medical professionals on multiple patients over a 24-hour period.
Only the Optiflow™ Oxygen Kit is part of this 510(k) submission. The flow source, humidifier, filter and interface are not in the scope of this submission.
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INDICATIONS FOR USE V.
This product delivers respiratory gases to adult patients. It is intended for use with an MR810 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the patient interface for a maximum of 24 hours after set-up.
This product is indicated for the delivery of Nasal High Flow (NHF) by appropriately qualified heather the direction of a physician anesthesiologist in a medical room. Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min.
This product can be used for pre-oxygenation and short-term supplemental oxygenation in operating rooms under the direction of a physician anesthesiologist.
This product is not intended for apneic ventilation.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
Table 5-1 compares technological characteristics of the subject device compared to the predicate device.
| Design/technologicalcharacteristic forcomparison | Subject deviceOptiflow™ Oxygen Kit | Predicate deviceAirSpiral Heated Breathing tube(K162553) | Comments | |
|---|---|---|---|---|
| Indications for use | This product delivers respiratory gases toadult patients. It is intended for use with anMR810 humidifier at flows from 5 to 70 L/min.This product can be used onmultiple patients when used with ahydrophobic filter between the product andthe patient interface for a maximum of 24hours after set-up.This product is indicated for the delivery ofNasal High Flow (NHF) by appropriatelyqualified healthcare professionals underthe direction of a physiciananesthesiologist in a medical procedure orsurgical room. Qualitative carbon dioxidesampling can be used at nasal cannula flowrates from 5 to 50 L/min.This product can be used for pre-oxygenation and short-term supplementaloxygenation (up to 10 minutes) during | The 900PT561 inspiratory tube is forthe delivery of humidified respiratorygases. For use with AIRVO™ andAIRVO™ 2 Series humidifiers inhospitals and long-term carefacilities. For use at flows from 2 to 60L/min depending on the patientinterface. | EquivalentSubject and predicate devices havethe same intended use to deliverhumidified respiratory gases.The indications for the use of thesubject device include multi-patientuse when used with an FDA-clearedfilter and interface for each patient. | |
| Design/technologicalcharacteristic forcomparison | Subject deviceOptiflow™ Oxygen Kit | Predicate deviceAirSpiral Heated Breathing tube(K162553) | Comments | |
| intubation in operating rooms under thedirection of a physician anesthesiologist.This product is not intended for apneicventilation. | ||||
| Operation and safety features | ||||
| Reusability | Multi-patient use | Single patient use | Indications for use include multi-patient use. This difference wasaddressed using the FDA Guidancedocument, "Reprocessing MedicalDevices in Healthcare CareSettings: Validation Methods andLabeling." Cleaning andreprocessing instructions werevalidated. | |
| Testing per the guidance documentdemonstrates that this differencedoes not raise new questions ofsafety and effectiveness | ||||
| Use Duration | < 24 hours | < 14 days (hospital) | Subject device duration of use iswithin the duration of use of thepredicate device. | |
| Decreasing the duration of use doesnot raise new questions of safetyand effectiveness | ||||
| Availability | Prescription use | Prescription use | Identical | |
| Design/technologicalcharacteristic forcomparison | Subject deviceOptiflow™ Oxygen Kit | Predicate deviceAirSpiral Heated Breathing tube(K162553) | Comments | |
| (Part 21 CFR 301 Subpart D) | (Part 21 CFR 301 Subpart D) | |||
| Patient Population | Adult patients | Adult and Pediatric patients | Subject device patient population isa subset of the predicate devicepatient population. Limiting thepatient population just to adultsdoes not raise new questions ofsafety and effectiveness. | |
| Intended UseEnvironment | Hospitals | Hospitals and long-term carefacilities | EquivalentBoth the subject and predicatedevices are intended to be used inthe hospital. Subject device is notintended to be used in long-termcare facilities. | |
| Principle ofOperation | The Optiflow™ Oxygen Kit transportsrespiratory gases from a flow source via ahumidifier to the patient interface. | AirSpiral Heated Breathingtubetransport respiratory gases from aflow source via a humidifier to thepatient interface. | EquivalentBoth the subject and predicatedevices transport respiratory gasesfrom a flow source via a humidifierto the patient interface. | |
| Specifications | ||||
| Flow Range | $5 \text{ to } 70 \text{ L min}^{-1}$ | $2 \text{ to } 60 \text{ L min}^{-1}$ | EquivalentThe subject device is intended to beused with higher flow rates.Performance testing to demonstratethat the device performs as | |
| Design/technologicalcharacteristic forcomparison | Subject deviceOptiflow™ Oxygen Kit | Predicate deviceAirSpiral Heated Breathing tube(K162553) | Comments | |
| intended at the higher flow rate hasbeen provided. The increased flowrate does not raise new questions ofsafety and effectiveness. | ||||
| Sterility | Device not provided sterile | Device not provided sterile | Identical | |
| Shelf Life | 12 months | Five years shelf-life | Difference in shelf life does notraise new questions of safety andeffectiveness. | |
| StorageTemperature | -10°C to +50°C | -10°C to +50°C | Identical | |
| Disposal | Dispose of product safely in accordancewith standard hospital procedure. | None | Disposal instructions were notprovided for the predicate device.The addition of disposalinstructions for the subject devicedoes not raise new questions ofsafety and effectiveness. | |
| Biocompatibility and Materials | ||||
| Assessment | TestingperformedaccordingtoISO 10993-1: Fifth edition 2018-08 andISO 18562-1: First Edition 2017-03 | Testing performedaccordingtoISO 10993-1:2009 | EquivalentThe subject device complies withthe latest standards. | |
| Components and materials | ||||
| Inspiratory breathingtube | Included. | Included. | EquivalentSimilar design. | |
| Design/technologicalcharacteristic forcomparison | Subject deviceOptiflow™ Oxygen Kit | Predicate deviceAirSpiral Heated Breathing tube(K162553) | Comments | |
| Inspiratory breathingtube heater wire | Included. | Included. | EquivalentSimilar design. | |
| HumidificationChamber | Included. | Included. | EquivalentSimilar design. | |
| Clip | Included. | Included. | Identical | |
| Dryline | Included. | Not Included. | The addition of this component tothe Optiflow™ Oxygen Kit does notraise new questions of safety andeffectiveness. |
Table 5-1 Comparison of technological Characteristics with Predicate
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VII. PERFORMANCE DATA
● Summary of non-clinical tests
Performance testing of the Fisher & Paykel Optiflow™ Oxygen kit was completed to determine that the differences between the subject device and the predicate device do not raise new questions of safety and effectiveness. These tests demonstrate substantial equivalence of the Fisher & Paykel Optiflow™ Oxygen kit to the predicate device.
The following preconditioning was carried out as applicable for each test:
- Shelf-life testing was performed following accelerated aging conditioning as per ASTM . F1980-16 to demonstrate product requirements continue to be met after 12 months of storage.
- Transportation testing was performed following transport and storage simulation as per ISTA 2A:2011.
- . Mechanical strength testing was performed following push, impact, drop, and mold stress relief conditioning as per IEC 60601-1 15.3.2, 15.3.3, 15.3.4, and 15.3.5
- . Cleaning and low-level disinfection as per the indications for use.
The following additional performance testing has also been completed to confirm the safety and effectiveness of the Optiflow™ Oxygen Kit:
- Permanent connections test
- Removable connections test
- . Gas delivery test
- . Resistance to flow test
The Optiflow™ Oxygen Kit has been tested to applicable requirements of the following standards:
- ISO 80601-2-74:2017(E) "Medical electrical equipment, Part 2-74: Particular ● requirements for basic safety and essential performance of respiratory humidifying equipment".
- . IEC 60601-1-2 4th 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 62366-1:2015 Usability Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 5356-1:2004 "Anesthetic and Respiratory Equipment- Conical Connectors- Part 1: Cones and Sockets".
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. Summary of Biocompatibility testing.
The biocompatibility evaluation of the Fisher & Paykel Optiflow™ Oxygen Kit was conducted in accordance with the use of international standard ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; and ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within risk management process.
VIII. CONCLUSIONS
The Optiflow™ Oxygen kit device is substantially equivalent to the predicate based on patient population, intended use, comparison of the technological characteristics, and performance. In addition, the conclusions drawn from the nonclinical tests demonstrate that the differences between the predicate and subject devices do not raise new questions of safety and effectiveness, and the subject device is substantially equivalent to the legally marketed predicate device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).