(195 days)
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.
It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.
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 setup.
This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.
The Fisher & Paykel Healthcare (F&P) Optiflow™ Oxygen Kit is a multiple-patient use breathing tube kit. This F&P Optiflow™ Oxygen Kit is presented as the AA451J.
The kit consists of a dry line, water bag, humidification chamber, inspiratory limb, tubing clips and datechange stickers.
The flow source delivers gas through a dryline to a humidification chamber that sits on a humidifier. As the gas passes through the chamber, it is heated and humidified. The gas then flows through the inspiratory limb, through a hydrophobic filter and then through a patient interface into the patients' upper airway via the nose.
The AA451J kit delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDAcleared hydrophobic filter, the AA451J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup.
The scope of this 510(k) submission is limited to the AA451J, F&P Optiflow™ Oxygen Kit. The flow source, humidifier, hydrophobic filter and interface are not in the scope of this submission.
The provided text does not contain information about the acceptance criteria or a study proving that a software device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a physical medical device, the "F&P Optiflow Oxygen Kit (AA451J)," which is a breathing set accessory for a respiratory humidifier.
The sections titled "PERFORMANCE DATA" (Section VII) and "CONCLUSION" (Section VIII) discuss performance testing, but this refers to non-clinical tests for the physical device's safety and effectiveness, such as biological evaluation, electrical safety, and respiratory humidifying equipment standards (e.g., ISO 10993-1, ISO 80601-2-74, IEC 60601-1). These tests are typically laboratory-based and relate to the device's physical properties, material compatibility, and functional performance (e.g., flow rates, humidification).
Therefore, I cannot provide the requested information regarding acceptance criteria for a software device based on the given input, as the document pertains to a hardware medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 13, 2024
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland. 2013 New Zealand
Re: K233821
Trade/Device Name: F&P Optiflow Oxygen Kit (AA451J) Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: May 29, 2024 Received: May 29, 2024
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and
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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) K233821
Device Name F&P Optiflow Oxygen Kit (AA451J)
Indications for Use (Describe)
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.
It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.
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 setup.
This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.
| 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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510(k) Summary
As Required by 21 CFR 807.92
I. SUBMITTER
| Company Name andAddress | Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100 |
|---|---|
| Prepared and Submitted by | Danica Tung |
| Regulatory Affairs Market Manager | |
| Contact Person | Reena Daken |
| Regulatory Affairs Manager | |
| Telephone: +64 9 574 0100 | |
| Email: reena.daken@fphcare.co.nz | |
| Date Prepared | 13 June 2024 |
| II. DEVICE | |
| Name of Device | F&P Optiflow™ Oxygen Kit (AA451J) |
| Common/Usual Name | Inspiratory tube |
| Classification Name | Respiratory gas humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |
PREDICATE DEVICE lll.
- Primary Predicate Device: Optiflow™ Oxygen Kit, K211096 .
- Secondary Predicate: F&P 950 Respiratory Humidifier, K220703
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DEVICE DESCRIPTION IV.
The Fisher & Paykel Healthcare (F&P) Optiflow™ Oxygen Kit is a multiple-patient use breathing tube kit. This F&P Optiflow™ Oxygen Kit is presented as the AA451J.
The kit consists of a dry line, water bag, humidification chamber, inspiratory limb, tubing clips and datechange stickers.
The flow source delivers gas through a dryline to a humidification chamber that sits on a humidifier. As the gas passes through the chamber, it is heated and humidified. The gas then flows through the inspiratory limb, through a hydrophobic filter and then through a patient interface into the patients' upper airway via the nose.
The AA451J kit delivers humidified respiratory gases at flows from 5 to 70 L/min. When used with an FDAcleared hydrophobic filter, the AA451J kit can be used on multiple patients. The kit is reprocessed between each patient. The kit can be exposed to a maximum of 30 reprocessing cycles and used for a maximum of 24 hours after setup.
The scope of this 510(k) submission is limited to the AA451J, F&P Optiflow™ Oxygen Kit. The flow source, humidifier, hydrophobic filter and interface are not in the scope of this submission.
INDICATIONS FOR USE V.
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.
It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.
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 setup.
This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.
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COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VI.
| Design/TechnologicalCharacteristic | Subject Device(AA451J - K233821) | Primary Predicate Device(AA403 - K211096) | Secondary Predicate Device(AA451SU - K220703) | Similarity of subjectdevice toprimary/secondarypredicate device |
|---|---|---|---|---|
| Indications for use | This breathing set is an accessory to theF&P 950 Respiratory Humidifier to be usedwithin the limits of its stated technicalspecifications.It is intended for delivery of heated humidifiedhigh flow respiratory gases to adult patients ina hospital.This product can be used on multiple patientswhen used with a hydrophobic filter betweenthe product and the patient interface for amaximum of 24 hours after setup.This product is for use by appropriatelyqualified healthcare professionals who performanesthesia care and airway management. | This product delivers respiratory gases toadult patients. It is intended for use with anMR810 humidifier at flows from 5 to 70L/min.This product can be used on multiplepatients when used with a hydrophobic filterbetween the product and the patient interfacefor a maximum of 24 hours after set-up.This product is indicated for the delivery ofNasal High Flow (NHF) by appropriatelyqualified healthcare professionals under thedirection of a physician anesthesiologist in amedical procedure or surgical room.Qualitative carbon dioxide sampling can beused at nasal cannula flow rates from 5 to 50L/min.This product can be used for pre-oxygenation and short-term supplementaloxygenation (up to 10 minutes) duringintubation in operating rooms under thedirection of a physician anesthesiologist.This product is not intended for apneicventilation. | The breathing set is an accessory to theF&P 950 Respiratory Humidifier. It isintended for delivery of heated humidifiedrespiratory gases to adult, adolescent andchild patients, within the limits of its statedtechnical specifications. | Equivalent.The subject device andthe predicate devices areintended for use withhumidifiers.The primary predicate isintended for use with theMR810 humidifier,whereas the subjectdevice is intended for usewith the F&P 950humidifier.The subject device andsecondary predicate areboth intended for usewith the F&P 950humidifier. |
| Design/TechnologicalCharacteristic | Subject Device(AA451J - K233821) | Primary Predicate Device(AA403 - K211096) | Secondary Predicate Device(AA451SU - K220703) | Similarity of subjectdevice toprimary/secondarypredicate device |
| Operation and safety features | ||||
| Patient Population | Adult patients | Adult patients | Adult, adolescent and child patients | Identical to primarypredicate |
| Intended UseEnvironment | Hospitals | Hospitals | Hospital or long-term care facility | Identical to primarypredicate |
| Availability | Prescription use | Prescription Use | Prescription use | Identical |
| Operating Principle | Breathing circuit kit contains a dryline,humidification chamber, and inspiratory limbto create a single limb for the delivery of highflow therapy. | Breathing circuit kit contains a dryline,humidification chamber, and inspiratorylimb to create a single limb for the deliveryof high flow therapy. | Breathing circuit kit contains a dryline,humidification chamber, and inspiratorylimb to create a single limb for the deliveryof high flow therapy. | Identical |
| Reusability | Multi-patient use | Multi-patient use | Single Use | Identical to primarypredicate |
| Duration of Use | < 24 hours | < 24 hours | 14 Days | Identical to primarypredicate |
| Specifications | ||||
| Specified Flow Range | 5 - 70 L/min | 5 to 70 L/min | 5 - 70 L/min | Identical |
| Sterility | Device not provided sterile | Device not provided sterile | Device not provided sterile | Identical |
| Design/TechnologicalCharacteristic | Subject Device(AA451J - K233821) | Primary Predicate Device(AA403 - K211096) | Secondary Predicate Device(AA451SU - K220703) | Similarity of subjectdevice toprimary/secondarypredicate device |
| Shelf Life | 3 years | 12 months | 3 years | Identical to secondarypredicate |
| Storage conditions | -10°C - 50°C | -10°C - 50°C | -10°C – 50°C | Identical |
| Biocompatibility and Materials | ||||
| Assessment | Testing performed according to ISO 10993-1:Fifth edition 2018-08 and ISO 18562-1: FirstEdition 2017-03 | Testing performed according to ISO 10993-1: Fifth edition 2018-08 and ISO 18562-1:First Edition 2017-03 | Testing performed according to ISO 10993-1: Fifth edition 2018-08 and ISO 18562-1:First Edition 2017-03 | Identical |
| Components | ||||
| HumidificationChamber | Included | Included | Included | The humidificationchamber of the subjectdevice is identical to thesecondary predicate. |
| Inspiratory Limb | Included | Included | Included | The inspiratory limb ofthe subject device isidentical to thesecondary predicate. |
| Design/TechnologicalCharacteristic | Subject Device(AA451J - K233821) | Primary Predicate Device(AA403 - K211096) | Secondary Predicate Device(AA451SU - K220703) | Similarity of subjectdevice toprimary/secondarypredicate device |
| Dryline | Included | Included | Included | Identical |
| Circuit Clip | Included | Included | Included | Equivalent to primarypredicateThe tubing clip of thesubject device isidentical to thesecondary predicate. |
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VII. PERFORMANCE DATA
Summary of Non-Clinical Tests
Performance testing of the F&P Optiflow™ Oxygen Kit was completed and confirms the subject device does not raise new questions of safety and effectiveness. The testing provided demonstrates that the reusability characteristic and environment of use of the subject device is substantially equivalent to the predicates.
The F&P Optiflow™ Oxygen Kit has been tested to the applicable requirements to the following standards:
- ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 80601-2-74:2017 Part 2-74 Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- IEC 60601-1 Edition 3.2 (2020) Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- ISO 5367:2014
- AAMI TIR12:2010
- AAMI ST98:2022
VIII. CONCLUSION
The F&P Optiflow™ Oxygen Kit is substantially equivalent to the predicates based on patient population, intended uses, comparison of the technological characteristics, and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the 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).