Who is the manufacturer of F&P 950 Accessory Breathing Circuit Kits?

Fisher & Paykel Healthcare, Ltd. filed the 510(k) submission for F&P 950 Accessory Breathing Circuit Kits (K221436).

What is the FDA product code for F&P 950 Accessory Breathing Circuit Kits?

BZD. It is classified under 21 CFR 868.5905 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for F&P 950 Accessory Breathing Circuit Kits?

510(k) clearance (submission type: Traditional).

What are the predicate devices for F&P 950 Accessory Breathing Circuit Kits?

Bubble CPAP System (BC151/BC161) (K100011).

Who can help prepare an FDA 510(k) submission like F&P 950 Accessory Breathing Circuit Kits?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

F&P 950 Accessory Breathing Circuit Kits

K221436 · Fisher & Paykel Healthcare, Ltd. · BZD · Jun 29, 2023 · Anesthesiology

Device Facts

Record ID	K221436
Device Name	F&P 950 Accessory Breathing Circuit Kits
Applicant	Fisher & Paykel Healthcare, Ltd.
Product Code	BZD · Anesthesiology
Decision Date	Jun 29, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5905
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

F&P 950 Bubble CPAP Breathing Circuit Kits are single-patient-use accessories for the F&P 950 Respiratory Humidifier. The kit includes a humidification chamber, inspiratory/expiratory limbs, pressure relief manifold, and Bubble CPAP generator. It delivers heated, humidified gas to neonates/infants via nasal interface (prongs or mask). Operated in NICU/PICU settings by clinicians. Input gas flows of 4-15 L/min; CPAP levels of 3-10 cmH2O. The device provides respiratory support, potentially benefiting patients with prematurity-related conditions. Clinicians monitor the system and patient status to guide therapy.

Clinical Evidence

Bench testing only. Performance testing included humidification output, thermal overshoot, surface temperature (ISO 80601-2-74), resistance to flow, compliance, gas leak (ISO 5367), and comparative pneumatic performance. Biocompatibility (ISO 10993, ISO 18562), electrical safety/EMC (IEC 60601-1, IEC 60601-1-2), and human factors/usability validation were performed.

Technological Characteristics

Single-use breathing circuit kit for F&P 950 Respiratory Humidifier. Components: humidification chamber, inspiratory/expiratory limbs, pressure relief manifold, Bubble CPAP generator. Materials evaluated per ISO 10993 and ISO 18562. Connections: ISO 5356-1 conical. Over-pressure protection: 17 cmH2O. Operating conditions: 20-26°C. Shelf life: 3 years. Duration of use: 14 days.

Indications for Use

Indicated for spontaneously breathing premature and full-term neonates and infants up to 10 kg requiring CPAP for respiratory support due to conditions like Respiratory Distress Syndrome or other conditions requiring CPAP.

Regulatory Classification

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.

Predicate Devices

Bubble CPAP System (BC151/BC161) (K100011)

Reference Devices

F&P 850 AirSpiral Adult NIV And NHF Circuit Kit (850A61) (K212031)
F&P Infant Evaqua 2 (RT265/266) (K103767)
OJR215 Pressure Relief Manifold (K173770)

Related Devices

K040862 — GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM · Caradyne, Ltd. · Jun 30, 2004
K103410 — NEOPAP SYSTEM · Childrens Medical Ventures, LLC · Mar 30, 2011
K100011 — FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM · Fisher & Paykel Healthcare, Ltd. · Oct 8, 2010
K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) · Draegerwerk AG & CO Kgaa · Apr 4, 2025
K050994 — AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM · Cardinalhealth · Aug 3, 2005

Submission Summary (Full Text)

{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) | <div>Prescription Use (Part 21 CFR 801 Subpart D)</div> | |-------------------------------------------------------------------------------------------------------| | <div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 <10 kg. | Neonatal and infant patients up to a weight of 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 nasal prongs or a nasal mask | Midline or lateral nasal CPAP interface with nasal prongs or a nasal mask | Identical to Predicate | | Characteristic for comparison | Subject Device 950N60J | Predicate Device F&P Bubble CPAP System BC161 Breathing 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 for patient 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 Predicate The subject device has been tested to 14 day duration 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 Predicate The same Bubble CPAP generator is included in both the subject and the predicate device. | # Table 1: 950N60J – Bubble CPAP Circuit Kit to Predicate Comparison Table {6}------------------------------------------------ # Table 2: 950N62J – Bubble CPAP Circuit Kit (for Hudson interface) to Predicate Comparison Table | Characteristic for comparison | Subject Device 950N62J | Predicate Device F&P Bubble CPAP System BC151 Breathing 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&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 | 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. | Equivalent to Predicate The subject and predicate devices are both intended to provide CPAP to patients. | | Characteristic for comparison | Subject Device 950N62J | Predicate Device F&P Bubble CPAP System BC151 Breathing Circuit Kit (K100011) | Comments | | | 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 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. | | | Operating Principle | Breathing circuit kit contains a humidification chamber, inspiratory limb, expiratory limb, pressure relief manifold, Bubble CPAP generator, and Hudson extensions to allow for the generation and delivery of Bubble CPAP. | Breathing circuit kit contains a humidification chamber, inspiratory limb, expiratory limb, pressure relief manifold, Bubble CPAP generator, and unheated extension to allow for the generation and delivery of Bubble CPAP. | 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 8 mm tapers | Nasal CPAP interface with nasal prongs with 8 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 for patient 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 Predicate The subject device has been tested to 14 day duration 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 Predicate The same Bubble CPAP generator is included in both the subject and the predicate device. | {7}------------------------------------------------ {8}------------------------------------------------ # 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. 2.00 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 | {9}------------------------------------------------ ## 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.