(258 days)
No
The 510(k) summary describes a nasal cannula and associated kits, which are passive devices for delivering heated and humidified air. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The performance studies focus on physical and material properties, not algorithmic performance.
Yes
The device is described as a "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", indicating its direct role in delivering a medical therapy.
No
The device is a nasal cannula intended to deliver heated and humidified nasal high flow therapy. Its purpose is therapeutic (delivery of breathing support), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is a "single-use patient interface" and lists physical product codes, indicating it is a hardware device (nasal cannula). The performance studies also focus on physical characteristics and testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The F&P Optiflow Junior 2 / 2+ Nasal Cannula Interface Range is a patient interface used to deliver heated and humidified nasal high flow therapy. It is a respiratory support device.
- Intended Use: The intended use is to deliver therapy to spontaneously breathing patients, not to analyze biological samples.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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 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.
Product codes
BTT
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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
Intended User / Care Setting
This product is designed for use in hospital environments and must be prescribed by a physician.
This product is designed for use in long term care environments and must be prescribed by a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.
3
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
As required by 21 CFR 807.92
I. SUBMITTER
| Company Name and Address | Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland 2013, New Zealand
Telephone: +64 9 574 0100 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Nicholas Yap
Senior Regulatory Affairs Specialist |
| Contact Person | Reena Daken
Regulatory Affairs Manager – North America
Telephone: +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 Interface
Range |
|---------------------|--------------------------------------------------------------|
| Common/Usual Name | Nasal Cannula |
| Classification Name | Respiratory gas humidifier 21
CFR §868.5450 |
| Regulatory Class | II |
| Product Code | BTT |
lll. PREDICATE DEVICE
| Predicate Device | F&P Optiflow Junior Nasal Cannula | K162553 |
|---|---|---|
| ------------------ | ----------------------------------- | --------- |
5
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)
6
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 .
7
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Design/Technological
Characteristic | Subject device
F&P Optiflow Junior 2 / 2+ Nasal Cannula
Interface Range | Predicate device
F&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 deliver
heated and humidified nasal high flow therapy to
spontaneously breathing patients. | Use with a nasal high flow therapy system to
deliver heated and humidified nasal high
flow therapy to spontaneously breathing
patients. | Identical |
| 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 | Single use nasal cannula intended for use
with a nasal high flow therapy system to
deliver heated and humidified nasal high
flow therapy to spontaneously breathing
patients who require breathing support. | The Indications for Use statements for each of the
subject device models are equivalent when
compared to the predicate device. |
| Design/Technological
Characteristic | Subject device
F&P Optiflow Junior 2 / 2+ Nasal Cannula
Interface Range | Predicate device
F&P Optiflow Junior (K162553) | Comments |
| | 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 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 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 Cannulas:
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. | | |
| Design/Technological
Characteristic | Subject device
F&P Optiflow Junior 2 / 2+ Nasal Cannula
Interface Range | Predicate device
F&P Optiflow Junior (K162553) | Comments |
| Patient Population | 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:
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+:
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 for
use with pediatric populations. Both are intended for
the pediatric subgroups 'infants' and 'children'.
The subject device has additional sizes to
accommodate for neonates, and infants and
children. |
| 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 for
use in hospital environments.
F&P Optiflow Junior 2 HM and 2+ HM models are
designed for use in long-term care environments. | Intended for use in both hospital and home
environments. | The subject device is only intended for hospital and
long term care environments. |
| Reusability | Single use | Single use | Identical |
| Duration | Seven days | Seven days | Identical |
8
9
10
| Design/Technological
Characteristic | Subject device
F&P Optiflow Junior 2 / 2+ Nasal Cannula
Interface Range | Predicate device
F&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 operating
temperature | 18 – 26 °C | 18 – 26 °C | Identical | | | | | | | | | | | | | | | | | | |
| F&P AIRVO 2 system
specifications | When the Airvo 2 system is set to Junior mode | Junior mode | Only the L, XL and XXL sizes of the subject device
are indicated for use on the AIRVO 2 system
(K131895). | | | | | | | | | | | | | | | | | | |
| | Product Code Size Flow Rates (L/min) OJR416
OJR416HM L 2 – 20 OJR418
OJR418HM 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) OJR520
OJR520HM XXL 10 – 50 | | | | | | | | | | | | | | | | | | | | |
| F&P MR850 system
specifications | When the MR850 is set to Invasive mode* | | The subject device is available in a larger range of
sizes compared to the predicate.
The XS-XL sizes have flow rates which are
equivalent 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 | | | | | | | | | | | | | |
11
| Design/Technological
Characteristic | Subject device
F&P Optiflow Junior 2 / 2+ Nasal Cannula
Interface Range | | | Predicate device
F&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 prescribed
to pediatric patients expected to fit the XXL size.
*Setting the MR850 humidifier in invasive mode
ensures adequate levels of humidity is being
delivered. Setting the MR850 to invasive mode for
the delivery of nasal high flow therapy is identical
between 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.