(408 days)
No
The description focuses on the mechanical and humidification aspects of a breathing circuit kit and does not mention any computational or learning capabilities.
Yes
The device is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients who require breathing support due to conditions associated with prematurity or other conditions where CPAP is required or desired, which directly addresses a medical condition.
No
The device provides heated and humidified CPAP for breathing support to patients; it does not diagnose conditions.
No
The device description clearly states that the subject devices are "F&P 950 Bubble CPAP Breathing Circuit Kits" which are physical components (breathing circuits, nasal interface, Bubble CPAP generator) designed for use with a respiratory humidifier. The performance studies also detail testing of physical characteristics like resistance to flow, compliance, gas leak, and biocompatibility. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a breathing set accessory for a respiratory humidifier. It provides heated and humidified CPAP to patients. This is a life support/breathing support device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is to provide breathing support to spontaneously breathing neonates and infants, not to diagnose a condition.
The device's function and intended use fall under the category of respiratory support devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
950N60J - Bubble CPAP Dual Heated Circuit Kit
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
950N62J - Bubble CPAP Dual Heated Circuit Kit (for Hudson interface)
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The subject devices of this 510(k) are the F&P 950 Bubble CPAP Breathing Circuit Kits (950N60J and 950N62J).
The F&P 950 Bubble CPAP Breathing Circuit Kits are single patient use and designed for use with the F&P 950 Respiratory Humidifier.
The F&P 950 Bubble CPAP (continuous positive airway pressure) Breathing Circuit Kits provide breathing support to spontaneously breathing neonates and infants. The F&P 950 Bubble CPAP breathing circuit kits deliver heated and humidified respiratory gas through an inspiratory limb to the infant via a nasal interface. An expiratory limb connects to a Bubble CPAP generator to generate CPAP. The device is intended to be operated at input gas flows of 4 - 15 L/min with available CPAP levels of 3 - 10 cmH2O.
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
premature and full term neonates and infant patients (up to a weight of 10 kg)
Intended User / Care Setting
hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The F&P 950 Bubble CPAP Breathing Circuit Kits has been tested to the applicable requirements of the following standards:
ASTM F1980-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Test for in-vitro cytotoxicity
ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10: Test for skin sensitization
ISO 10993-11:2017 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-3:2014 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-18:2020 - Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 10993-23:2021 - Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 18562-1:2017 - Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications- Part 1: Evaluation and Testing Within a Risk Management Process
ISO 18562-2:2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3:2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
ISO 18562-4:2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests.
Standard 7351731 Rev. 2.00 2017-02-23 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
ISO 5367:2014 - Anaesthetic and respiratory equipment - Breathing sets and connectors
ISO 5356-1:2004 - Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets.
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (edition 3.1).
ISO 80601-2-74: 2017 - Medical Electrical Equipment- Part 2-74: Particular Requirements For Basic Safety and Essential Performance Of Respiratory Humidifying Equipment
IEC 60601-1-6:2013 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366-1:2015 + AMD:2020 - Medical devices - Part 1: Application of usability engineering to medical devices
ISTA 3A:2018 - Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
Biocompatibility Testing:
The biocompatibility evaluation for the F&P 950 Bubble CPAP breathing circuit kits was conducted in accordance with the International Standards 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 a risk management process" and associated standards as recognized by the FDA. Testing of the F&P 950 Bubble CPAP breathing circuit kits demonstrates an appropriate biocompatibility profile for the device.
Electrical Safety and Electromagnetic Compatibility (EMC):
Electrical safety and EMC testing were conducted on the F&P 950 Respiratory Humidifier and accessory breathing circuit kits. The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1 and AIM Standard 7351731 Rev. 2.00 2017-02-23. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.
Human Factors Testing:
A Human Factors and Usability Engineering validation study was conducted on the F&P 950 Bubble CPAP breathing circuit kits, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices". The validation study demonstrates that the device has been found to be safe and effective for the intended users, uses, and use environments.
Bench / Performance Testing:
Performance testing was conducted to demonstrate substantial equivalence including:
- Humidification output, thermal overshoot, surface temperature of applied parts in line with ISO 80601-2-74:2017
- Resistance to flow, compliance, and gas leak testing in line with ISO 5367:2014 .
- Comparative system level pneumatic performance testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 29, 2023
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager- North America 15 Maurice Paykel Place. East Tamaki Auckland, 2013 New Zealand
Re: K221436
Trade/Device Name: F&P 950 Bubble CPAP Breathing Circuit Kits Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: April 17, 2022 Received: May 17, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Rachana Visaria -S
Rachana Visaria, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K221436
Device Name
F&P 950 Bubble CPAP Breathing Circuit Kits
Indications for Use (Describe)
950N60J - Bubble CPAP Dual Heated Circuit Kit
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
950N62J - Bubble CPAP Dual Heated Circuit Kit (for Hudson interface)
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
As required by 21 CFR 807.92
SUBMITTER ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
| 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
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
| Date Prepared | 29 June 2023 |
DEVICE ll.
| Name of Device | F&P 950 Bubble CPAP Breathing Circuit Kits |
|---|---|
| Common/Usual Name | Bubble CPAP Breathing Circuit Kits |
| Classification Name | Ventilator, Non-Continuous, (Respirator) |
| Regulatory Class | Class II |
| Primary Classification Product Code | BZD (21 CFR §868.5905) |
PREDICATE DEVICE III.
- Predicate device:
| 510(k) Number | Device Name |
|---|---|
| K100011 | Bubble CPAP System (BC151/BC161) |
4
Reference Devices: .
| 510(k)
| Number | Device Name | Reason for Reference Device |
|---|---|---|
| K212031 | F&P 850 AirSpiral Adult NIV And | |
| NHF Circuit Kit (850A61) | Used to address the technological differences | |
| between the subject and predicate device and support | ||
| claims of safety and effectiveness with respect to | ||
| breathing circuit kit design - same AirSpiral™ | ||
| inspiratory tube technology contained within the | ||
| subject device. | ||
| K103767 | F&P Infant Evaqua 2 | |
| (RT265/266) | Used to address the technological differences | |
| between the subject and predicate device and support | ||
| claims of safety and effectiveness with respect to | ||
| breathing circuit kit design - identical component(s) | ||
| contained within the subject device. | ||
| K173770 | OJR215 Pressure Relief Manifold | Used to address the technological differences |
| between the subject and predicate device and support | ||
| claims of safety and effectiveness with respect to | ||
| breathing circuit kit design - identical component(s) | ||
| contained within the subject device. |
DEVICE DESCRIPTION IV.
The subject devices of this 510(k) are the F&P 950 Bubble CPAP Breathing Circuit Kits (950N60J and 950N62J).
The F&P 950 Bubble CPAP Breathing Circuit Kits are single patient use and designed for use with the F&P 950 Respiratory Humidifier.
The F&P 950 Bubble CPAP (continuous positive airway pressure) Breathing Circuit Kits provide breathing support to spontaneously breathing neonates and infants. The F&P 950 Bubble CPAP breathing circuit kits deliver heated and humidified respiratory gas through an inspiratory limb to the infant via a nasal interface. An expiratory limb connects to a Bubble CPAP generator to generate CPAP. The device is intended to be operated at input gas flows of 4 - 15 L/min with available CPAP levels of 3 - 10 cmH2O.
V. INDICATIONS FOR USE STATEMENT
950N60J – Bubble CPAP Dual Heated Circuit Kit
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
950N62J - Bubble CPAP Dual Heated Circuit Kit (for Hudson interface)
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Characteristic for comparison | Subject Device
950N60J | Predicate Device
F&P Bubble CPAP System BC161
Breathing Circuit Kit (K100011) | Comments |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Classification Product Code | BZD | BZD | Identical to Predicate |
| Intended Use | Deliver heated and humidified respiratory gases
to provide CPAP. | Deliver heated and humidified respiratory gases
to provide CPAP. | Identical to Predicate |
| Indications for Use | The breathing set is an accessory to the F&P
950 Respiratory Humidifier. It is intended to
provide heated and humidified CPAP to
spontaneously breathing premature and full-term
neonates and infant patients (up to a weight of
10 kg) who require breathing support, due to
conditions associated with prematurity (such as
Respiratory Distress Syndrome) or other
conditions where CPAP is required or desired. It
is intended for use within a hospital clinical
environment such as a NICU (Neonatal Intensive
Care Unit) and PICU (Pediatric Intensive Care
Unit), within the limits of its stated technical
specifications. | The Fisher & Paykel Healthcare Bubble
CPAP System is intended to provide CPAP
to spontaneously breathing neonates and
infants who require breathing support due to
conditions associated with prematurity (such
as Respiratory Distress Syndrome) or other
conditions where CPAP is required or
desired and is prescribed by a physician.
The Bubble CPAP System is for use in the
hospital clinical environment such as the
NICU (Neonatal Intensive Care Unit) and
PICU (Pediatric Intensive Care Unit). The
intended patient population is premature and
full term neonates up to a weight of 10 kg. | Equivalent to Predicate
The subject and predicate devices are both
intended to provide CPAP to patients. |
| Operating Principle | Breathing circuit kit contains a humidification
chamber, inspiratory limb, expiratory limb,
pressure relief manifold and Bubble CPAP
generator to allow for the generation and delivery
of Bubble CPAP. | Breathing circuit kit contains a humidification
chamber, inspiratory limb, expiratory limb,
pressure relief manifold and Bubble CPAP
generator to allow for the generation and
delivery of Bubble CPAP. | Identical to Predicate |
| Patient Population | Neonatal and infant patients weighing 30 davs) duration of contact. The biocompatibility evaluation for the F&P 950 Bubble CPAP breathing circuit kits was conducted in accordance with the International Standards 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 a risk management process" and associated standards as recognized by the FDA. Testing of the F&P 950 Bubble CPAP breathing circuit kits demonstrates an appropriate biocompatibility profile for the device.
Electrical Safety and Electromagnetic Compatibility (EMC):
Electrical safety and EMC testing were conducted on the F&P 950 Respiratory Humidifier and accessory breathing circuit kits. The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 + AMD1:2020 Ed 4.1 and AIM Standard 7351731 Rev. 2.00 2017-02-23. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.
Human Factors Testing:
A Human Factors and Usability Engineering validation study was conducted on the F&P 950 Bubble CPAP breathing circuit kits, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices". The validation study demonstrates that the device has been found to be safe and effective for the intended users, uses, and use environments.
Bench / Performance Testing:
Performance testing was conducted to demonstrate substantial equivalence including:
- Humidification output, thermal overshoot, surface temperature of applied parts in line ● with ISO 80601-2-74:2017
- Resistance to flow, compliance, and gas leak testing in line with ISO 5367:2014 .
- . Comparative system level pneumatic performance testing
VIII. CONCLUSION
The F&P 950 Bubble CPAP Breathing Circuit Kits are substantially equivalent to the predicate devices 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 devices are substantially equivalent to the legally marketed predicate devices.