The F&P 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).

Device Description

The Fisher & Paykel Healthcare (F&P) Bubble CPAP (continuous positive airway pressure) System provides respiratory support to spontaneously breathing infants. The F&P Bubble CPAP System delivers heated and humidified respiratory gas through an inspiratory breathing circuit to the infant via a nasal interface. An expiratory circuit connects to a water column threshold resistor which pressurizes the circuit. The F&P Bubble CPAP System consists of an in-line pressure relief valve, a humidification chamber, a heated breathing circuit, patient nasal interface and CPAP generator (water column threshold resistor). The System is intended to be operated at input gas flows of 4 - 15 L/min with available CPAP levels of 3 - 10 cmH2O.

AI/ML Overview

The Fisher & Paykel Healthcare (F&P) Bubble CPAP System provides respiratory support to spontaneously breathing infants.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of numerical "acceptance criteria" for the device's main function (CPAP delivery) or a direct comparison to specific threshold values. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence in CPAP Delivery (Bench Test)	Bench tests show that the F&P Bubble CPAP System's water column threshold resistor and the predicate Dräger device's electronically regulated valve provide substantially equivalent CPAP. The CPAP level delivered to the patient by the F&P system is "very close to the intended pressure set at the CPAP generator."
Substantial Equivalence in Work of Breathing (Bench Test)	The work of breathing of the F&P Bubble CPAP System is "significantly less than the predicate device in all measurements." While not directly "equivalent," being better than the predicate device supports substantial equivalence in functionality.
Compliance with ISO 8185:2007 (E) (Respiratory Humidifiers)	The single heated breathing circuit meets requirements for Surface Temperature, Humidification System Output, and Protection Against Hazardous Output.
Compliance with ISO 5367:2000 (E) (Breathing Tubes)	The breathing circuit meets requirements for Occlusion Resistance.
Biocompatibility (ISO 10993-1)	Assessment and testing show that all materials contacting the patient directly or indirectly are suitable for patient contact.
Stability of CPAP over time	The auto-leveling mechanism of the CPAP generator compensates for accumulated condensate and allows the mean CPAP level to remain stable over time.
Pressure Oscillations Effect	Gas bubbling from the water threshold resistor creates pressure oscillations, but these "do not adversely affect the performance or safety of the device." This is confirmed by clinical evidence.
Clinical Efficacy and Safety	Eight peer-reviewed and published reports (including three randomized controlled trials) using the F&P Bubble CPAP System demonstrate it has been "widely and successfully used around the world." Comparisons with other forms of respiratory support have "positive outcomes towards the F&P Bubble CPAP System."

Study Details Proving Acceptance Criteria:

The submission outlines a combination of bench testing and a summary of existing clinical literature to establish substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Bench Tests: The specific sample sizes for the various bench tests are not explicitly stated in the provided summary.
Clinical Performance: "Eight peer reviewed and published reports using the F&P Bubble CPAP System, including three randomized controlled trials."
- Data Provenance: "Used around the world" and "compared with other forms of respiratory support in a variety of settings." These are retrospective studies (already published). The countries of origin are not specified beyond "around the world."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Bench Tests: The summary does not specify the number or qualifications of experts involved in establishing ground truth for the bench tests. Ground truth would likely be based on established engineering principles and measurement standards.
Clinical Performance: For the eight peer-reviewed and published reports, the "ground truth" (i.e., clinical outcomes, efficacy, safety) would have been established by the clinicians and researchers involved in those studies. The number and specific qualifications of these experts are not detailed in this 510(k) summary. These would be implicit in the peer-reviewed publications.

4. Adjudication Method for the Test Set

Bench Tests: No adjudication method is described. Bench tests typically rely on direct measurements against predefined standards.
Clinical Performance: For the summarized clinical reports, the adjudication method would have been specific to each individual study and subject to the peer-review process of the journal in which they were published. This summary does not detail these methods (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed or referenced. The device is a medical device (CPAP system), not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases. The comparison is between the F&P Bubble CPAP System and a predicate CPAP device, primarily through bench testing of physical performance and a review of existing clinical literature on the F&P system.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The F&P Bubble CPAP System is a medical device that delivers a therapy, not an algorithm in the sense of a software-only tool. Its "standalone performance" is understood through its function of generating and delivering CPAP. The bench tests described (CPAP level delivered, work of breathing, compliance with ISO standards) directly assess its standalone physical performance.
There isn't an "algorithm only" component in the context of typical AI/software medical devices. The device's operation is its standalone performance.

7. Type of Ground Truth Used

Bench Tests: Engineering measurements, adherence to ISO standards, and comparison to the predicate device's measured performance.
Clinical Performance: Clinical outcomes, safety data, and efficacy measures reported in peer-reviewed medical literature.

8. Sample Size for the Training Set

The F&P Bubble CPAP System is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of artificial intelligence or machine learning. The device's design is based on engineering principles and knowledge, validated through testing.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the device's development would be established engineering specifications, medical requirements for CPAP delivery, and safety standards, which are met through design and validation testing.

Summary

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K100011

Image /page/0/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with a large ampersand between the two words. Underneath the first line is a horizontal line, and then the word "HEALTHCARE" is on the second line.

510(k) Summary

510(k) Owner:	Fisher & Paykel Healthcare Ltd
Street Address:	15 Maurice Paykel PlaceEast TamakiAuckland 2013New Zealand.
Postal Address:	P.O. Box 14-348PanmureAuckland 1741New Zealand.
	DCT 8 2010
Establishment Registration Number:	9611451
Owner/Operator Number:	8040217
Contact Person:	Robert Petry,Regulatory Affairs Manager - Neonatal
Contact Numbers:	Telephone: +64-9 574 0100Facsimile: +64-9 574 0158
Summary Preparation Date:	23 December 2009
Trade Name:	Fisher & Paykel Healthcare Bubble CPAP System.
Common Name:	Bubble CPAP
Device Classification:	Device Name: Noncontinuous ventilator (IPPB)Product Code: 73 BZDRegulation: 21 CFR 868.5905Device Class: Class 2
Predicate Device:	Product Name: Babylog 8000 plus ventilator (CPAP mode)510(k) Number: K974176Manufacturer: Dräger MedicalProduct Code: 73 CBKDevice Class: Class 2

Device Description:

Indications for Use:

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Contra-indications:

Contra-indicated in non-spontaneously breathing infants, infants not requiring CPAP support, gas flows over 15 L/min and in non-hospital environments.

Patient Population:

The intended patient population is premature and full term neonates up to a weight of 10 kg.

Environment of Use: Hospital.

Comparison of Technological Characteristics:

The F&P Bubble CPAP System is substantially equivalent in indications for use, intended patient population and function of the predicate device. Both devices use an expiratory threshold resistor although the type of resistor differs. The F&P Bubble CPAP System uses a water column threshold resistor and the Dräger device uses an electronically requlated valve. Bench tests show that both expiratory resistors provide substantially equivalent CPAP. That is, the CPAP level delivered to the patient and the work of breathing associated with both devices are substantially equivalent.

Pre-clinical Testing:

The single heated breathing circuit of the F&P Bubble CPAP System has been designed and tested to work specifically with F&P Respiratory Humidifiers and the F&P Bubble CPAP System. The breathing circuit meets the requirements of ISO 8185:2007 (E) Respiratory tract humidifiers for medical use -Particular requirements for respiratory humidification systems (Sufface Temperature; Humidification System Output; Protection Against Hazardous Output) and ISO 5367:2000 (E) Breathing tubes intended for use with anaesthetic apparatus and ventilators (Occlusion Resistance).

The CPAP level delivered to the patient has been shown to be very close to the intended pressure set at the CPAP generator. In addition, the auto-leveling mechanism of the CPAP generator compensates for accumulated condensate from the expiratory limb and allows the mean CPAP level to remain stable over time.

The work of breathing of the F&P Bubble CPAP System and the predicate Dräger device has been compared. The results show that the work of breathing of the F&P Bubble CPAP System is significantly less than the predicate device in all measurements.

Biocompatibility assessment and testing of the F&P Bubble CPAP System as per ISO 10993-1, has been undertaken and shows that all materials that contact the directly or indirectly, are suitable for patient contact.

Clinical Performance:

Gas bubbling out of the water threshold resistor of the F&P Bubble CPAP System creates pressure oscillations about a mean CPAP level, in the expiratory breathing circuit. These pressure oscillations do not adversely affect the performance or safety of the device. Eight peer reviewed and published reports using the F&P Bubble CPAP System, including three randomized controlled trials, show that the device has been widely and successfully used around the world. The device has been compared with other forms of respiratory support in a variety of settings. The outcomes in all of these reports are positive towards the F&P Bubble CPAP System.

Conclusion:

The F&P Bubble CPAP System is intended to be used for spontaneously breathing infants requiring continuous positive airway pressure support and is substantially equivalent to the predicate device. The two devices have substantially equivalent indications for use, environment of use and intended patient population. Both devices use an expiratory threshold resistor and although the type of resistor differs, the performance is substantially equivalent. Pressure oscillations in the expiratory air path of the F&P Bubble CPAP System do not adversely affect performance or safety. The performance testing of the F&P Bubble CPAP System shows that it is safe and effective, and substantially equivalent to the predicate Dräger Babylog 8000 Plus device in CPAP mode.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert Petry Regulatory Affairs Manager-Neonatal Fisher & Pavkel Healthcare P.O Box 14-348 Panmure Auckland 1741 NEW ZEALAND

OCT 0 8 2011

Re: K100011

Trade/Device Name: Bubble CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: September 20, 2010 Received: September 23, 2010

Dear Mr. Petry:

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. 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.

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and · Radiological Health

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Indications for Use Statement

510(k) Number (if known): K100011

Device Name: Fisher & Paykel Healthcare Bubble CPAP System.

Indications For Use:

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.

All components of the Bubble CPAP System are single use only.

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

L. Schult

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

:10(k) Number: K100011

Regulation Number and Section

§ 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).