(408 days)
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 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.
This document outlines the acceptance criteria and supporting studies for the F&P 950 Bubble CPAP Breathing Circuit Kits.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the F&P 950 Bubble CPAP Breathing Circuit Kits are primarily established through compliance with recognized medical device standards and comparison to a predicate device. The performance data section summarizes various tests conducted to demonstrate this compliance.
Since the document does not present specific quantitative acceptance criteria with corresponding performance metrics in a direct table format, I will reconstruct a table based on the information provided, inferring acceptance as "compliance" or "demonstrated safety/effectiveness" where specific numerical targets are not explicitly stated for the "acceptance criteria" column. The "reported device performance" will refer to the conclusion of the tests.
| Acceptance Criteria Category | Regulatory/Standard-Based Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | To deliver heated and humidified respiratory gases to provide CPAP to spontaneously breathing premature and full-term neonates and infants up to 10kg, in a hospital clinical environment (NICU/PICU). | Equivalent to Predicate: Subject and predicate devices are both intended to provide CPAP to patients. |
| Patient Population Equivalence | Neonatal and infant patients weighing <10 kg. | Identical to Predicate: Neonatal and infant patients weighing <10 kg. |
| Operating Principle Equivalence | Breathing circuit kit contains a humidification chamber, inspiratory limb, expiratory limb, pressure relief manifold, and Bubble CPAP generator. (For 950N62J, includes Hudson extensions). | Identical to Predicate: The subject device's operating principle is described as identical to the predicate (with the addition of Hudson extensions for 950N62J). |
| CPAP Range | 3 – 10 cmH2O | Identical to Predicate: 3 – 10 cmH2O. |
| Specified Flow Range | 4 – 15 L/min | Identical to Predicate: 4 – 15 L/min. |
| Over-pressure protection for patient safety | Yes – 17 cmH2O | Identical to Predicate: Yes – 17 cmH2O. |
| Ambient operating conditions | 20°C – 26°C | Identical to Predicate: 20°C – 26°C. |
| Reusability | Single Use | Identical to Predicate: Single Use. |
| Duration of Use | 14 Days (for subject device) | Different to Predicate (but accepted): The subject device has been tested to a 14-day duration, which is longer than the predicate's 7 days, indicating demonstrated capability for extended use. |
| Shelf Life | 3 years | Identical to Predicate: 3 years. |
| Storage conditions | -10°C – 50°C | Identical to Predicate: -10°C – 50°C. |
| Biocompatibility | Compliance with ISO 10993-1:2018, ISO 18562 (Parts 1, 2, 3, 4), and related standards for external communicating gas pathway (dry and humidified), permanent contact (> 30 days). | Compliant: Testing demonstrated an appropriate biocompatibility profile for the device, confirming compliance with specified ISO standards. |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliance 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. | Compliant: Testing demonstrated appropriate electrical safety and electromagnetic compatibility profile, confirming compliance with specified standards. |
| Human Factors & Usability | Conducted in accordance with FDA's "Applying Human Factors and Usability Engineering to Medical Devices" guidance. | Safe and Effective: Validation study demonstrated the device to be safe and effective for intended users, uses, and environments according to applicable guidance. |
| Humidification Output, Thermal Overshoot, Surface Temp. | Compliance with ISO 80601-2-74:2017. | Compliant: Performance testing for these parameters was conducted in line with ISO 80601-2-74:2017 to demonstrate substantial equivalence. (Implies compliance, though specific figures are not provided in this summary). |
| Resistance to Flow, Compliance, Gas Leak | Compliance with ISO 5367:2014. | Compliant: Performance testing for these parameters was conducted in line with ISO 5367:2014 to demonstrate substantial equivalence. (Implies compliance). |
| Comparative System Level Pneumatic Performance | Demonstrated equivalence. | Demonstrated: Testing conducted to demonstrate substantial equivalence. (Implied successful demonstration). |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes (number of devices or tests performed per device type) for the non-clinical tests (biocompatibility, electrical safety, human factors, bench/performance testing). It generally refers to "testing" or "studies" in the plural.
The data provenance is from non-clinical tests performed by the manufacturer, Fisher & Paykel Healthcare Limited, to evaluate the device against specified international standards and to demonstrate equivalence to a predicate device. This is prospective testing of the manufactured device components and systems. No country of origin for the data is explicitly mentioned beyond the manufacturer's location in New Zealand, but the tests are conducted against universally recognized international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies listed are primarily non-clinical engineering and performance tests, not clinical studies requiring expert ground truth for diagnostic or clinical outcomes. For the Human Factors testing, "intended users" would have been involved, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set
Not applicable. The tests described are objective, standard-based compliance evaluations or measurements, not clinical studies requiring expert adjudication of subjective outcomes.
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
Not applicable. This device is a mechanical breathing circuit kit, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical breathing circuit kit; there is no algorithm involved.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the requirements and methodologies outlined in the referenced international standards (e.g., ISO, ASTM, ANSI, IEC). For example, a successful biocompatibility test means the materials met the specified criteria of the ISO 10993 series. A successful electrical safety test means the device operated within the limits defined by IEC 60601-1-2.
8. The sample size for the training set
Not applicable. This device is a mechanical medical device, not an AI/machine learning product that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize AI and therefore has no training set or associated ground truth.
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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. 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
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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
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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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510(k) Summary
As required by 21 CFR 807.92
SUBMITTER ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
| 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 ManagerTelephone: +64 9 574 0100Email: 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) |
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Reference Devices: .
| 510(k)Number | Device Name | Reason for Reference Device |
|---|---|---|
| K212031 | F&P 850 AirSpiral Adult NIV AndNHF Circuit Kit (850A61) | Used to address the technological differencesbetween the subject and predicate device and supportclaims of safety and effectiveness with respect tobreathing circuit kit design - same AirSpiral™inspiratory tube technology contained within thesubject device. |
| K103767 | F&P Infant Evaqua 2(RT265/266) | Used to address the technological differencesbetween the subject and predicate device and supportclaims of safety and effectiveness with respect tobreathing circuit kit design - identical component(s)contained within the subject device. |
| K173770 | OJR215 Pressure Relief Manifold | Used to address the technological differencesbetween the subject and predicate device and supportclaims of safety and effectiveness with respect tobreathing 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.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Characteristic for comparison | Subject Device950N60J | Predicate DeviceF&P Bubble CPAP System BC161Breathing Circuit Kit (K100011) | Comments |
|---|---|---|---|
| Classification Product Code | BZD | BZD | Identical to Predicate |
| Intended Use | Deliver heated and humidified respiratory gasesto provide CPAP. | Deliver heated and humidified respiratory gasesto provide CPAP. | Identical to Predicate |
| Indications for Use | The breathing set is an accessory to the F&P950 Respiratory Humidifier. It is intended toprovide heated and humidified CPAP tospontaneously breathing premature and full-termneonates and infant patients (up to a weight of10 kg) who require breathing support, due toconditions associated with prematurity (such asRespiratory Distress Syndrome) or otherconditions where CPAP is required or desired. Itis intended for use within a hospital clinicalenvironment such as a NICU (Neonatal IntensiveCare Unit) and PICU (Pediatric Intensive CareUnit), within the limits of its stated technicalspecifications. | The Fisher & Paykel Healthcare BubbleCPAP System is intended to provide CPAPto spontaneously breathing neonates andinfants who require breathing support due toconditions associated with prematurity (suchas Respiratory Distress Syndrome) or otherconditions where CPAP is required ordesired and is prescribed by a physician.The Bubble CPAP System is for use in thehospital clinical environment such as theNICU (Neonatal Intensive Care Unit) andPICU (Pediatric Intensive Care Unit). Theintended patient population is premature andfull term neonates up to a weight of 10 kg. | Equivalent to PredicateThe subject and predicate devices are bothintended to provide CPAP to patients. |
| Operating Principle | Breathing circuit kit contains a humidificationchamber, inspiratory limb, expiratory limb,pressure relief manifold and Bubble CPAPgenerator to allow for the generation and deliveryof Bubble CPAP. | Breathing circuit kit contains a humidificationchamber, inspiratory limb, expiratory limb,pressure relief manifold and Bubble CPAPgenerator to allow for the generation anddelivery of Bubble CPAP. | Identical to Predicate |
| Patient Population | Neonatal and infant patients weighing <10 kg. | Neonatal and infant patients up to a weightof 10kg. | Identical to Predicate |
| Intended use environment | Hospital clinical environment such as a NICU(Neonatal Intensive Care Unit) and PICU(Pediatric Intensive Care Unit). | Hospital clinical environment such as a NICU(Neonatal Intensive Care Unit) and PICU(Pediatric Intensive Care Unit). | Identical to Predicate |
| Intended interface | Midline or lateral nasal CPAP interface with nasalprongs or a nasal mask | Midline or lateral nasal CPAP interface withnasal prongs or a nasal mask | Identical to Predicate |
| Characteristic forcomparison | Subject Device950N60J | Predicate DeviceF&P Bubble CPAP System BC161Breathing Circuit Kit (K100011) | Comments |
| Interface Connections | ISO 5356-1 Conical Connectors | ISO 5356-1 Conical Connectors | Identical to Predicate |
| CPAP Range | 3 – 10 cmH2O | 3 – 10 cmH2O | Identical to Predicate |
| Specified Flow Range | 4 – 15 L/min | 4 – 15 L/min | Identical to Predicate |
| Over pressure protection forpatient safety | Yes – 17 cmH2O | Yes – 17 cmH2O | Identical to Predicate |
| Ambient operating conditions | 20°C – 26°C | 20°C – 26°C | Identical to Predicate |
| Reusability | Single Use | Single Use | Identical to Predicate |
| Duration of Use | 14 Days | 7 days | Different to PredicateThe subject device has been tested to 14 dayduration of use. |
| Shelf Life | 3 years | 3 years | Identical to Predicate |
| Storage conditions | -10°C – 50°C | -10°C – 50°C | Identical to Predicate |
| Bubble CPAP Generator | F&P 950 Bubble CPAP Generator | BC100 CPAP Generator | Equivalent to PredicateThe same Bubble CPAP generator is included inboth the subject and the predicate device. |
Table 1: 950N60J – Bubble CPAP Circuit Kit to Predicate Comparison Table
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Table 2: 950N62J – Bubble CPAP Circuit Kit (for Hudson interface) to Predicate Comparison Table
| Characteristic forcomparison | Subject Device950N62J | Predicate DeviceF&P Bubble CPAP System BC151Breathing Circuit Kit (K100011) | Comments |
|---|---|---|---|
| Classification Product Code | BZD | BZD | Identical to Predicate |
| Intended Use | Deliver heated and humidified respiratory gases | Deliver heated and humidified respiratory gases | Identical to Predicate |
| Indications for Use | The breathing set is an accessory to the F&P950 Respiratory Humidifier. It is intended toprovide heated and humidified CPAP tospontaneously breathing premature and full-termneonates and infant patients (up to a weight of10 kg) who require breathing support, due toconditions associated with prematurity (such asRespiratory Distress Syndrome) or otherconditions where CPAP is required or desired. It | The Fisher & Paykel Healthcare BubbleCPAP System is intended to provide CPAPto spontaneously breathing neonates andinfants who require breathing support due toconditions associated with prematurity (suchas Respiratory Distress Syndrome) or otherconditions where CPAP is required ordesired and is prescribed by a physician. | Equivalent to PredicateThe subject and predicate devices are bothintended to provide CPAP to patients. |
| Characteristic forcomparison | Subject Device950N62J | Predicate DeviceF&P Bubble CPAP System BC151Breathing Circuit Kit (K100011) | Comments |
| is intended for use within a hospital clinicalenvironment such as a NICU (NeonatalIntensive Care Unit) and PICU (PediatricIntensive Care Unit), within the limits of its statedtechnical specifications. | The Bubble CPAP System is for use in thehospital clinical environment such as theNICU (Neonatal Intensive Care Unit) andPICU (Pediatric Intensive Care Unit). Theintended patient population is premature andfull term neonates up to a weight of 10 kg. | ||
| Operating Principle | Breathing circuit kit contains a humidificationchamber, inspiratory limb, expiratory limb,pressure relief manifold, Bubble CPAPgenerator, and Hudson extensions to allow forthe generation and delivery of Bubble CPAP. | Breathing circuit kit contains a humidificationchamber, inspiratory limb, expiratory limb,pressure relief manifold, Bubble CPAPgenerator, and unheated extension to allowfor the generation and delivery of BubbleCPAP. | Identical to Predicate |
| Patient Population | Neonatal and infant patients weighing <10 kg. | Neonatal and infant patients weighing <10kg. | Identical to Predicate |
| Intended use environment | Hospital clinical environment such as a NICU(Neonatal Intensive Care Unit) and PICU(Pediatric Intensive Care Unit). | Hospital clinical environment such as a NICU(Neonatal Intensive Care Unit) and PICU(Pediatric Intensive Care Unit). | Identical to Predicate |
| Intended interface | Nasal CPAP interface with nasal prongs with 8mm tapers | Nasal CPAP interface with nasal prongs with8 mm tapers | Identical to Predicate |
| Interface Connections | ISO 5356-1 Conical Connectors | ISO 5356-1 Conical Connectors | Identical to Predicate |
| CPAP Range | $3 - 10 cmH_2O$ | $3 - 10 cmH_2O$ | Identical to Predicate |
| Specified Flow Range | $4 - 15 L/min$ | $4 - 15 L/min$ | Identical to Predicate |
| Over pressure protection forpatient safety | $Yes - 17 cmH_2O$ | $Yes - 17 cmH_2O$ | Identical to Predicate |
| Ambient operating conditions | $20°C - 26°C$ | $20°C - 26°C$ | Identical to Predicate |
| Reusability | Single Use | Single Use | Identical to Predicate |
| Duration of Use | 14 Days | 7 days | Different to PredicateThe subject device has been tested to 14 dayduration of use. |
| Shelf Life | 3 years | 3 years | Identical to Predicate |
| Storage conditions | $-10°C - 50°C$ | $-10°C - 50°C$ | Identical to Predicate |
| Bubble CPAP Generator | F&P 950 Bubbler CPAP Generator | BC100 CPAP Generator | Equivalent to PredicateThe same Bubble CPAP generator is included inboth the subject and the predicate device. |
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VII. PERFORMANCE DATA
Summary of non-clinical tests
The F&P 950 Bubble CPAP Breathing Circuit Kits has been tested to the applicable requirements of the following standards:
| Standards | Title |
|---|---|
| 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. 2.002017-02-23 | 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 |
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Biocompatibility Testing:
The nature of body contact of materials used in the design of the F&P 950 Bubble CPAP breathing kits were classified as being external communicating gas pathway (both dry and humidified) with permanent (> 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.
§ 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).