(258 days)
F&P Optiflow Junior 2: The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes: Neonates, birth up to 1 month of age, Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.
F&P Optiflow Junior 2+: The Fisher & Paykel Healthcare Optiflow Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and high flow therapy to spontanously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes: Infants. 1 month up to 2 years of age, Children, 2 years up to 12 years of age.
F&P Optiflow Junior 2 HM Cannula: The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and high flow therapy to spontaneously breathing patients. This product is designed for use in long term care environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes: Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.
F&P Optiflow Junior 2+ HM Cannula: The Fisher & Paykel Healthcare Optiflow™ Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow (NHF) therapy system to deliver heated and high flow therapy to spontanously breathing patients. This product is designed for use in long term care environments and must be prescribed by a physician. The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes: Infants, 1 month up to 2 years of age, Children, 2 years up to 12 years of age.
The F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range are single-use patient interfaces that are intended to deliver heated and humidified Nasal High Flow therapy to spontaneously breathing neonates, infants and children. It is intended to be prescription-only and provided in a non-sterile state.
The F&P Optiflow Junior 2 Product Codes are OJR410 (XS), OJR414 (M), OJR416 (L) OJR416HM (L), OJR418 (XL), and OJR418HM (XL).
The F&P Optiflow Junior 2+ Product Codes are OJR520 (XXL) and OJR520HM (XXL).
Optional Kits:
Ventilator Transition Kits: The F&P Optiflow Junior 2 and 2+ Ventilator Transition Kits allow the use of the F&P Optiflow Junior 2 and F&P Optiflow Junior 2+ cannula with approved Fisher & Paykel Healthcare breathing circuits when connected to a ventilator to deliver heated and humidified nasal high flow (NHF) therapy. This kit contains the F&P Optiflow Junior 2 and 2+ cannula (subject device) and a 12F/15M Adaptor.
Blender Transition Kits: The F&P Optiflow Junior 2 and 2+ Blender Transition Kits allow the use of F&P Optifilow Junior 2 and 2+ cannula with approved Fisher & Paykel Healthcare breathing circuits when connected to a blender heated and humidified nasal high flow (NHF) therapy to spontaneously breathing patients who require breathing support. This kit contains F&P Optiflow Junior 2 and 2+ cannula (subject device), a 12F/15M Adaptor and a Pressure Relief Manifold (cleared in K173770).
Here's a breakdown of the acceptance criteria and the study information based on the provided document.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results for novel devices. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or specific effect sizes for human improvement with AI assistance are not applicable here as this is a medical device (nasal cannula) and not an AI/ML powered device.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly define "acceptance criteria" against numerical targets in the way an AI/ML device would. Instead, substantial equivalence is demonstrated through a comparison of the subject device's (F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range) characteristics and performance against a predicate device (F&P Optiflow Junior Nasal Cannula, K162553). The "acceptance" is that the device has similar technological characteristics, intended use, and performs safely and effectively as demonstrated through non-clinical testing.
Here's a table summarizing the comparison, with "Reported Device Performance" reflecting how the subject device aligns with or deviates from the predicate, implying acceptability.
| Acceptance Criteria (based on predicate) | Reported Device Performance (F&P Optiflow Junior 2 / 2+ Nasal Cannula) | Comment / Justification |
|---|---|---|
| Classification | Identical: Matches predicate | |
| Manufacturer | Fisher & Paykel Healthcare Ltd. | Identical |
| Device Regulation | Class II, 21 CFR 868.5450 | Identical |
| Product Code | BTT | Identical |
| Classification Panel | Anesthesiology | Identical |
| Intended Use | Identical: Use with a nasal high flow therapy system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. | |
| Indications for Use | Equivalent: Indications for Use statements for each subject device model are equivalent when compared to the predicate device. | |
| Patient Population | Expanded: Intended for pediatric populations (infants, children). Subject device has additional sizes to accommodate neonates, which expands the age range compared to the predicate (which was 1 month to 12 years). | |
| Patient Acuity | Spontaneously breathing patients | Identical |
| Patient Monitoring | Appropriate patient monitoring | Identical |
| Operating Environment | Different: Subject device is for hospital and long-term care environments. Predicate was for hospital and home environments. (This difference is noted but not presented as an impediment to substantial equivalence). | |
| Reusability | Single use | Identical |
| Duration | Seven days | Identical |
| Range of Cannula Sizes | Expanded: Available in six sizes (XS, S, M, L, XL, XXL) compared to predicate's two sizes (L, XL). Additional sizes accommodate broader patient range including neonates. | |
| Specifications (Flow Rates) | Similar/Expanded Flow Rates: L and XL sizes have equivalent flow rates for AIRVO 2 system. XXL size has increased maximum flow rate for MR850 specific to the larger pediatric patients. Overall, a broader range of cannulas and associated flow rates. | |
| Ambient Operating Temperature | 18 – 26 °C | Identical |
| Shelf-Life | Three years | Identical |
| Sterility | Device not provided sterile | Identical |
| Storage Temperature | -10°C to +50°C | Identical |
| Performance Testing | Meets Applicable Standards: Tested to ISO 5356-1, ISO 10993-1, ISO 18562-1, ISTA 2A, ASTM F1980-16, IEC 62366-1. Additional performance tests (Leak Testing, Condensate Lavage, Retention System, Nasal Prong Stability, Tubing, Connector, Human Factors, Shelf Life, Transport, Accuracy of Delivered Flow). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical performance testing rather than a clinical study with a "test set" of patients. Therefore, specific sample sizes for patient data or data provenance (country of origin, retrospective/prospective) are not provided as it's not relevant to this type of submission. The "test set" would refer to the physical devices and materials tested in the various engineering and biocompatibility evaluations. These tests are conducted by the manufacturer, Fisher & Paykel Healthcare Ltd. (New Zealand).
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 is not applicable to a 510(k) submission for a non-AI medical device like a nasal cannula. "Ground truth" in this context would come from recognized standards, engineering specifications, and established biocompatibility principles, not from expert review of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies for interpretation of complex diagnostic results to establish a consensus ground truth, which is not relevant for the engineering and biocompatibility tests conducted for this 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 is not applicable. The device is a nasal cannula, not an AI-powered diagnostic or assistive tool. No human "readers" or AI assistance are involved in its primary function, and therefore, an MRMC study or effect size related to AI improvement is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" is established by:
- International and National Standards: e.g., ISO and ASTM standards for dimensions, materials, biocompatibility, packaging, and shelf life.
- Engineering Specifications: Internal design specifications and performance requirements for the cannula's physical properties, leak rates, flow rates, and connection integrity.
- Risk Management Processes: Identified hazards and associated mitigations based on expected device performance.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a non-AI medical device submission.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set."
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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, 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.
April 6, 2023
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager - North America 15 Maurice Paykel Place, East Tamaki Auckland. 2013 New Zealand
Re: K222197
Trade/Device Name: F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: July 22, 2022 Received: July 22, 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.
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
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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,
Ethan L. Nyberg -S
for James Lee Division 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) K222197
Device Name
Optiflow Junior 2 / 2+ Nasal Cannula Interface Range
Indications for Use (Describe)
F&P Optiflow Junior 2:
The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow
therapy to spontaneously breathing patients.
This product is designed for use in hospital environments and must be prescribed by a physician.
The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes:
- · Neonates, birth up to 1 month of age
- · Infants, 1 month up to 2 years of age
- · Children, 2 years up to 12 years of age
F&P Optiflow Junior 2+
The Fisher & Paykel Healthcare Optiflow Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and high flow therapy to spontanously breathing patients.
This product is designed for use in hospital environments and must be prescribed by a physician.
The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes:
· Infants. 1 month up to 2 years of age
· Children, 2 years up to 12 years of age
F&P Optiflow Junior 2 HM Cannula
The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and high flow therapy to spontaneously breathing patients.
This product is designed for use in long term care environments and must be prescribed by a physician.
The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes:
· Infants, 1 month up to 2 years of age
· Children, 2 years up to 12 years of age
F&P Optiflow Junior 2+ HM Cannula
The Fisher & Paykel Healthcare Optiflow™ Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow (NHF) therapy system to deliver heated and high flow therapy to spontanously breathing patients.
This product is designed for use in long term care environments and must be prescribed by a physician.
The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes:
· Infants, 1 month up to 2 years of age
· Children, 2 years up to 12 years of age.
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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 and Address | Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100 |
|---|---|
| Prepared and Submitted by | Nicholas YapSenior Regulatory Affairs Specialist |
| Contact Person | Reena DakenRegulatory Affairs Manager – North AmericaTelephone: +64 9 574 0100 |
| Email: reena.daken@fphcare.co.nz | |
| Date Prepared | 06 April 2023 |
II. DEVICE
| Name of Device | F&P Optiflow™ Junior 2 / 2+ Nasal Cannula InterfaceRange |
|---|---|
| Common/Usual Name | Nasal Cannula |
| Classification Name | Respiratory gas humidifier 21CFR §868.5450 |
| Regulatory Class | II |
| Product Code | BTT |
lll. PREDICATE DEVICE
| Predicate Device | F&P Optiflow Junior Nasal Cannula | K162553 |
|---|---|---|
| ------------------ | ----------------------------------- | --------- |
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IV. DEVICE DESCRIPTION
The F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range are single-use patient interfaces that are intended to deliver heated and humidified Nasal High Flow therapy to spontaneously breathing neonates, infants and children. It is intended to be prescription-only and provided in a non-sterile state.
The F&P Optiflow Junior 2 Product Codes are OJR410 (XS), OJR414 (M), OJR416 (L) OJR416HM (L), OJR418 (XL), and OJR418HM (XL).
The F&P Optiflow Junior 2+ Product Codes are OJR520 (XXL) and OJR520HM (XXL).
Optional Kits:
Ventilator Transition Kits
The F&P Optiflow Junior 2 and 2+ Ventilator Transition Kits allow the use of the F&P Optiflow Junior 2 and F&P Optiflow Junior 2+ cannula with approved Fisher & Paykel Healthcare breathing circuits when connected to a ventilator to deliver heated and humidified nasal high flow (NHF) therapy.
The intended population is identical to the F&P Optiflow Junior 2 and F&P Optiflow Junior 2+ models.
This kit contains the F&P Optiflow Junior 2 and 2+ cannula (subject device) and a 12F/15M Adaptor. The included 12F/15M Adaptor supplied allows for connection to approved Fisher & Paykel Healthcare infant breathing circuits.
The Ventilator Transition Kit Product Codes are OJR410VT (XS), OJR412VT (S), OJR416VT (M), OJR416VT (L), OJR418VT (XL) and OJR520VT (XXL).
Blender Transition Kits
The F&P Optiflow Junior 2 and 2+ Blender Transition Kits allow the use of F&P Optifilow Junior 2 and 2+ cannula with approved Fisher & Paykel Healthcare breathing circuits when connected to a blender heated and humidified nasal high flow (NHF) therapy to spontaneously breathing patients who require breathing support.
The intended patient population is identical to the F&P Optiflow Junior 2 and 2+ cannula models.
This kit contains F&P Optiflow Junior 2 and 2+ cannula (subject device), a 12F/15M Adaptor and a Pressure Relief Manifold (cleared in K173770). The included 12F/15M Adaptor supplied allows for connection to approved F&P infant breathing circuits. The included Pressure Relief Manifold allows for the relief of pressure in the event of occlusion downstream in the system.
The Blender Transition Kit Product Codes are OJR410B (XS), OJR414B (M), OJR414B (M), OJR416B (L), OJR418B (XL), and OJR520B (XXL)
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V. INDICATIONS FOR USE
F&P Optiflow Junior 2
The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients.
This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes:
- . Neonates, birth up to 1 month of age
- Infants, 1 month up to 2 years of age
- . Children, 2 years up to 12 years of age
F&P Optiflow Junior 2+
The Fisher & Paykel Healthcare Optiflow Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients.
This product is designed for use in hospital environments and must be prescribed by a physician.
The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes:
- . Infants. 1 month up to 2 vears of age
- . Children, 2 years up to 12 years of age
F&P Optiflow Junior 2 HM Cannula:
The Fisher & Paykel Healthcare Optiflow™ Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow (NHF) therapy system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients.
This product is designed for use in long term care environments and must be prescribed by a physician.
The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2 Nasal Cannula includes:
- Infants, 1 month up to 2 years of age ●
- . Children, 2 years up to 12 years of age
F&P Optiflow Junior 2+ HM Cannula:
The Fisher & Paykel Healthcare Optiflow™ Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow (NHF) therapy system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients.
This product is designed for use in long term care environments and must be prescribed by a physician.
The intended pediatric subpopulation targeted for use on the F&POptiflow Junior 2+ Nasal Cannula includes:
- Infants, 1 month up to 2 years of age ●
- Children, 2 years up to 12 years of age .
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Design/TechnologicalCharacteristic | Subject deviceF&P Optiflow Junior 2 / 2+ Nasal CannulaInterface Range | Predicate deviceF&P Optiflow Junior (K162553) | Comments |
|---|---|---|---|
| Classification | |||
| Manufacturer | Fisher & Paykel Healthcare Ltd. | Fisher & Paykel Healthcare Ltd. | Identical |
| Device Regulation | Class II, Regulation: 21 CFR 868.5450 | Class II, Regulation: 21 CFR 868.5450 | |
| Product Code | BTT | BTT | |
| Classification Panel | Anesthesiology | Anesthesiology | |
| Intended Use and Indications for Use | |||
| Intended Use | Use with a nasal high flow therapy system to deliverheated and humidified nasal high flow therapy tospontaneously breathing patients. | Use with a nasal high flow therapy system todeliver heated and humidified nasal highflow therapy to spontaneously breathingpatients. | Identical |
| Indications for Use | F&P Optiflow™ Junior 2:The Fisher & Paykel Healthcare Optiflow Junior 2nasal cannula is a single use nasal cannula intendedfor use with a nasal high flow therapy (NHF) systemto deliver heated and humidified nasal high flowtherapy to spontaneously breathing patients.This product is designed for use in hospitalenvironments and must be prescribed by a physician.The intended pediatric subpopulations targeted foruse of the F&P Optiflow Junior 2 Nasal Cannularange includes:• Neonates, birth up to 1 month of age• Infants, 1 month up to 2 years of age• Children, 2 years up to 12 years of ageF&P Optiflow™ Junior 2+:The Fisher & Paykel Healthcare Optiflow Junior 2+nasal cannula is a single use nasal cannula | Single use nasal cannula intended for usewith a nasal high flow therapy system todeliver heated and humidified nasal highflow therapy to spontaneously breathingpatients who require breathing support. | The Indications for Use statements for each of thesubject device models are equivalent whencompared to the predicate device. |
| Design/TechnologicalCharacteristic | Subject deviceF&P Optiflow Junior 2 / 2+ Nasal CannulaInterface Range | Predicate deviceF&P Optiflow Junior (K162553) | Comments |
| intended for use with a nasal high flow therapy(NHF) system to deliver heated and humidifiednasal high flow therapy to spontaneouslybreathing patients. | |||
| This product is designed for use in hospitalenvironments and must be prescribed by aphysician. | |||
| The intended pediatric subpopulation targeted foruse on the F&P Optiflow Junior 2+ NasalCannula includes:Infants, 1 month up to 2 years of age Children, 2 years up to 12 years of age | |||
| F&P Optiflow Junior 2 HM Cannulas:The Fisher & Paykel Healthcare Optiflow™ Junior 2nasal cannula is a single use nasal cannulaintended for use with a nasal high flow (NHF)therapy system to deliver heated and humidifiednasal high flow therapy to spontaneously breathingpatients.This product is designed for use in long term careenvironments and must be prescribed by aphysician.The intended pediatric subpopulation targeted foruse on the F&P Optiflow Junior 2 Nasal Cannulaincludes:Infants, 1 month up to 2 years of age Children, 2 years up to 12 years of age | |||
| F&P Optiflow Junior 2+ HM Cannulas:The Fisher & Paykel Healthcare Optiflow™ Junior2+ nasal cannula is a single use nasal cannulaintended for use with a nasal high flow (NHF)therapy system to deliver heated and humidifiednasal high flow therapy to spontaneously breathingpatients. | |||
| Design/TechnologicalCharacteristic | Subject deviceF&P Optiflow Junior 2 / 2+ Nasal CannulaInterface Range | Predicate deviceF&P Optiflow Junior (K162553) | Comments |
| Patient Population | This product is designed for use in long term careenvironments and must be prescribed by aphysician.The intended pediatric subpopulation targeted foruse on the F&P Optiflow Junior 2+ NasalCannula includes:Infants, 1 month up to 2 years of age Children, 2 years up to 12 years of ageF&P Optiflow Junior 2:Neonates, birth up to 1 month of age Infants, 1 month up to 2 years of age Children, 2 years up to 12 years of ageF&P Optiflow Junior 2+:Infants, 1 month up to 2 years of age Children, 2 years up to 12 years of age | Infants, 1 month up to 2 years of age Children, 2 years up to 12 years of age | Both subject and predicate devices are intended foruse with pediatric populations. Both are intended forthe pediatric subgroups 'infants' and 'children'.The subject device has additional sizes toaccommodate for neonates, and infants andchildren. |
| Patient Acuity | Spontaneously breathing patients | Spontaneously breathing patients | Identical |
| Patient Monitoring | Appropriate patient monitoring | Appropriate patient monitoring | Identical |
| Operating Environment | The F&P Optiflow Junior 2 and 2+ are designed foruse in hospital environments.F&P Optiflow Junior 2 HM and 2+ HM models aredesigned for use in long-term care environments. | Intended for use in both hospital and homeenvironments. | The subject device is only intended for hospital andlong term care environments. |
| Reusability | Single use | Single use | Identical |
| Duration | Seven days | Seven days | Identical |
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| Design/TechnologicalCharacteristic | Subject deviceF&P Optiflow Junior 2 / 2+ Nasal CannulaInterface Range | Predicate deviceF&P Optiflow Junior (K162553) | Comments | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Range of cannula sizes | Available in six different sizes which are indicated by color: | Available in two sizes which are indicated by color: | The subject device contains the following additional cannula sizes:• Extra Small (XS)• Small (S)• Medium (M)• Extra Extra Large (XXL) | ||||||||||||||||||
| Specifications | |||||||||||||||||||||
| Ambient operatingtemperature | 18 – 26 °C | 18 – 26 °C | Identical | ||||||||||||||||||
| F&P AIRVO 2 systemspecifications | When the Airvo 2 system is set to Junior mode | Junior mode | Only the L, XL and XXL sizes of the subject deviceare indicated for use on the AIRVO 2 system(K131895). | ||||||||||||||||||
| Product Code Size Flow Rates (L/min) OJR416OJR416HM L 2 – 20 OJR418OJR418HM XL 2 - 25 | Product Code Size Flow Rates (L/min) OPT316 L 2 – 20 OPT318 XL 2 - 25 | ||||||||||||||||||||
| When the Airvo 2 system is set to Default mode: | |||||||||||||||||||||
| Product Code Size Flow Rates (L/min) OJR520OJR520HM XXL 10 – 50 | |||||||||||||||||||||
| F&P MR850 systemspecifications | When the MR850 is set to Invasive mode* | The subject device is available in a larger range ofsizes compared to the predicate.The XS-XL sizes have flow rates which areequivalent to the predicate device. | |||||||||||||||||||
| Product Code Size Flow Rates (L/min) OJR410 XS 0.5 – 8 | Product Code Size Flow Rates (L/min) OPT316 L 0.5 - 20 |
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| Design/TechnologicalCharacteristic | Subject deviceF&P Optiflow Junior 2 / 2+ Nasal CannulaInterface Range | Predicate deviceF&P Optiflow Junior (K162553) | Comments | ||||
|---|---|---|---|---|---|---|---|
| OJR412 | S | $0.5 - 9$ | OPT318 | XL | $0.5 - 25$ | The XXL size has an increased maximum flow rate.This is due to higher flow rates commonly prescribedto pediatric patients expected to fit the XXL size.*Setting the MR850 humidifier in invasive modeensures adequate levels of humidity is beingdelivered. Setting the MR850 to invasive mode forthe delivery of nasal high flow therapy is identicalbetween the subject and predicate devices. | |
| OJR414 | M | $0.5 - 10$ | |||||
| OJR416 | L | $0.5 - 23$ | |||||
| OJR418 | XL | $0.5 - 25$ | |||||
| OJR520 | XXL | $1 - 36$ | |||||
| Shelf-Life | Three years | Three years | |||||
| Sterility | Device not provided sterile | Device not provided sterile | Identical | ||||
| Storage Temperature | -10°C to +50°C | -10°C to +50°C | Identical |
{12}------------------------------------------------
PERFORMANCE DATA VII.
Summary of non-clinical tests
The F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range has been tested to applicable requirements to the following standards:
- . ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
- . ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process
- . ISTA 2A International Safe Transit Association Guidelines - Procedure 2A: Packaged Products weighing 150 lb (68 kg) or less.
- . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- . IEC 62366-1:2015/AMD 1:2020 Medical devices – Part 1: Application of Usability Engineering to Medical Devices - Amendment 1
Additional performance testing has also been completed to confirm the safety and effectiveness of the Optiflow Junior 2 / 2+ Nasal Cannula Interface Range:
- Assembly Leak Testing ●
- Condensate Lavage Testing .
- Retention System Testing ●
- Nasal Prong Stability Testing .
- . Tubing Testing
- Connector Testing
- Human Factors Testing ●
- Shelf Life Testing .
- Transport Testing .
- Accuracy of Delivered Flow Testing
VIII. CONCLUSIONS
The Optiflow Junior 2 / 2+ Nasal Cannula Interface Range are substantially equivalent to the predicate 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).