The Seattle-PAP is intended to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required or desired and prescribed by a physician. It is for use only by trained medical personnel in hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).

Device Description

Seattle-PAP is a bubble continuous positive airway pressure (CPAP) device. Seattle-PAP is installed at the end of an expiratory limb, distal to the patient, in a continuous gas flow breathing system. Seattle-PAP is intended to assist spontaneous breathing in neonates and infants, up to weights of 10 kg. Seattle-PAP is comprised of two key elements; a water container and a tube inserted into the water. The Water Reservoir contains the water and has a Lid permanently attached to help prevent splashing and spillages. The Lid has an integrated Water Level Adjustment Port, so a clinician can adjust the water level in the Reservoir, if necessary, without disconnecting the breathing circuit. The tube is comprised of a Funnel-Swivel that is permanently attached to Bubble Tube. The Funnel-Swivel helps prevent spillages when filling the Water Reservoir initially and can rotate to help reduce tension that may build up in the expiratory limb of the breathing circuit. The expiratory end of the patient's breathing circuit, distal to the patient, is inserted into the center of the Funnel-Swivel. A Bubble Tube Lock mechanism is used to ensure the depth of the tube in the water does not change unintentionally. The gas bubbling out of the end of the Tube creates air pressure oscillations in the breathing circuit. These pressure oscillations do not adversely affect the performance of the Seattle-PAP device, i.e. the ability to deliver the desired CPAP pressure accurately.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Seattle-PAP device:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria	Reported Device Performance
Pressure Range	Not explicitly stated as acceptance criteria, but predicate's is 3 to 10 cm H₂O.	4.5 to 10 cm H₂O
Accuracy (CPAP Pressure)	Specified as +/- 1 cm H₂O	Tested accuracy = -0.21 to +0.17 cm H₂O
Gas Flow Range	Not explicitly stated as acceptance criteria, but predicate's is 4 to 15 Lpm.	4 to 12 Lpm

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical performance testing. The testing summary lists various tests performed but does not delve into the specifics of how many devices were tested or under what conditions beyond the environmental parameters.

3. Number of Experts Used and Qualifications:

The document does not mention using experts to establish ground truth for a test set, expert qualifications, or any process involving expert review for determining device performance. The testing described is non-clinical performance testing of the device itself.

4. Adjudication Method:

Since there's no mention of expert involvement or ground truth establishment based on human review, there is no adjudication method described.

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

The document does not describe an MRMC comparative effectiveness study. The "Comparison of MAP control Seattle-PAP vs. Predicate Fisher & Paykel (K100011)" is a non-clinical, device-to-device comparison based on physical measurements, not human reader performance.

6. Standalone (Algorithm Only) Performance:

The Seattle-PAP is a physical bubble CPAP device, not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The testing described is for the physical device's performance characteristics.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical performance testing of the Seattle-PAP device is based on instrumental measurements and engineering specifications. For example, pressure accuracy is measured against a known standard, and flow rates are controlled and measured. It's not based on expert consensus, pathology, or outcomes data, as this is a physical medical device.

8. Sample Size for the Training Set:

The Seattle-PAP is a physical medical device and does not have a "training set" in the context of an AI/ML algorithm. Therefore, this information is not applicable and not provided in the document.

9. How the Ground Truth for the Training Set was Established:

As the device is not an AI/ML algorithm, the concept of a "training set" and establishing "ground truth for the training set" is not applicable. The device's design and operation are based on established physiological principles and engineering.

Summary

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510(k) Summary Page I of 5

Date prepared:	8-Oct-13
Seattle Children's Hospital4800 Sand Point Way NESeattle, WA 98105	Tel - 206-884-5138Fax - 206-985-3134
Official Contact:	Erik LausundVP, Research Ops & Logistics
Proprietary or Trade Name:	Seattle-PAP
Common/Usual Name:	Bubble CPAP System
Classification Name/Code:	BZD - Noncontinuous ventilator (IPPB)CFR 868.5905, Class II
Device:	Seattle-PAP
Predicate Devices:	K100011 - Fisher & Paykel - Bubble CPAP System

Device Description:

Seattle-PAP is comprised of two key elements; a water container and a tube inserted into the water. The Water Reservoir contains the water and has a Lid permanently attached to help prevent splashing and spillages. The Lid has an integrated Water Level Adjustment Port, so a clinician can adjust the water level in the Reservoir, if necessary, without disconnecting the breathing circuit.

The tube is comprised of a Funnel-Swivel that is permanently attached to Bubble Tube. The Funnel-Swivel helps prevent spillages when filling the Water Reservoir initially and can rotate to help reduce tension that may build up in the expiratory limb of the breathing circuit. The expiratory end of the patient's breathing circuit, distal to the patient, is inserted into the center of the Funnel-Swivel. A Bubble Tube Lock mechanism is used to ensure the depth of the tube in the water does not change unintentionally.

The gas bubbling out of the end of the Tube creates air pressure oscillations in the breathing circuit. These pressure oscillations do not adversely affect the performance of the Seattle-PAP device, i.e. the ability to deliver the desired CPAP pressure accurately.

Indications for Use:

The Seattle-PAP is intended to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory

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510(k) Summary Page 2 of 5 8-Oct-13

support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required or desired and prescribed by a physician.

It is for use only by trained medical personnel in hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).

Patient Population:

Neonates and infants up to weights of 10 kg

Environment of Use:

Hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).

Contraindications

. Non-spontaneous breathing patient
Congenital abnormalities or malfunctions where positive pressure therapies are . contraindicaated (e.g., diaphragmatic hernia and tracheo-oesophageal fistula)

Predicate Device Comparison:

Table 1 - Comparison to Predicates with Similar Technology and Indications for Use

	Proposed device	Predicate
510(k)		K100011
Manufacturer		Fisher & Paykel
Device Name	Seattle-PAP	Bubble CPAP
Product Code	BZD	BZD
CFR	868.5905	868.5905
Indications forUse	The Seattle-PAP is intended toprovide continuous positive airwaypressure (CPAP) to spontaneouslybreathing neonates and infants, up toweights of 10 kg, requiring respiratorysupport due to conditions associatedwith prematurity, such as RespiratoryDistress Syndrome, or otherconditions where CPAP is required ordesired and prescribed by a physician.It is for use only by trained medicalpersonnel in hospital clinicalenvironment, such as the NeonatalIntensive Care Unit (NICU) andPediatric Intensive Care Unit (PICU).	Intended to provide continuous positiveairway pressure (CPAP) to spontaneouslybreathing neonates and infants, up toweights of 10 kg, requiring respiratorysupport due to conditions associated withprematurity, such as Respiratory DistressSyndrome, or other conditions whereCPAP is required or desired andprescribed by a physician.

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510(k) Summary Page 3 of 5 8-Oct-13

	Proposed deviceSeattle-PAP	PredicateK100011Fisher & Paykel - Bubble CPAP
Environment ofUse	Hospital clinical environment, NICU andPICU	Hospital clinical environment, NICU andPICU
Patientpopulation	Neonates and infants, up to weights of10 kg	Neonates and infants, up to weights of 10kg
Prescriptive	Yes, for use by trained medicalpersonnel	Yes, for use by trained medical personnel
Principle ofOperation	Expiratory limb of a breathing circuitconnected to a column that is submergedin water. The water column acts toprovide pressure when exhaling, CPAP.The column is adjustable.	Expiratory limb of a breathing circuitconnected to a column that is submergedin water. The water column acts toprovide pressure when exhaling, CPAP.The column is adjustable.
PressureOscillations	Pressure oscillations are created as gasexits the Bubble Tube.	Pressure oscillations are created as gasexits the Bubble Tube.
Placed inexpiratory limbof breathingcircuit	Yes	Yes
Single use,disposable	Yes	Yes
Pressure range	4.5 to 10 cm H₂O	3 to 10 cm H₂O
AccuracyAs measuredduringcomparativetesting	Specified as +/- 1 cm H₂OTested accuracy = - 0.21 to +0.17 H₂O	Not specified in available documentation.Tested accuracy -0.09 to +0.52 H₂O
Gas flow range	4 to 12 Lpm	4 to 15 Lpm
Materialbiocompatibility	All materials are out of direct or indirectgas pathway	All materials are out of direct or indirectgas pathway
Non-clinicalPerformanceTesting	Environmental conditions, storage,operational, aging and endurance testingMechanical Drop testAccuracyReproducibility of MAPRepeatability of performance	AccuracyReproducibility of MAP
Standards	None under section 514	None under section 514

Based upon the above comparative table it is our view that there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

The data presented in the comparative table above indicate no significant differences between the intended device and the predicate device that affect the safety or effectiveness of the respective devices.

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510(k) Summary Page 4 of 5

8-Oct-13

The Seattle Children's Hospital Seattle-PAP is viewed as substantially equivalent to the predicate devices because:

Indications -

. The intended use to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required or desired and prescribed by a physician is identical to the predicate.
. Discussion - The indications for use are identical to the predicate Fisher & Paykel -Bubble CPAP (K 100011)

Technology and Mode of Operation -

The concept of a tube / column submerged in water to create CPAP is identical to the � predicate Fisher & Paykel - Bubble CPAP (K 100011)
. The ability to adjust the pressure by changing the column depth in water is identical to the predicate.
. Creates pressure oscillations in the expiratory limb of the breathing circuit from the gas bubbling out the end of the tube under water.
. The performance specifications are almost identical to the predicate.
. Discussion - The technology and mode operation are identical to the predicate Fisher & Paykel - Bubble CPAP (K100011)

Environment of Use -

Identical to predicate Fisher & Paykel Bubble CPAP (K100011) .
. Discussion - The environments of use are identical to the predicate's.

Differences -

No differences between the proposed device would raise any new safety or risk concerns, thus the two devices can be found to be substantially equivalent.

Non-clinical Testing Summary -

We have performed a number of tests appropriate for the proposed device. These tests include:

Repeatability and Accuracy of Mean Airway Pressure (MAP)
Reproducibility of Mean Airway Pressure (MAP) .
Accuracy to control MAP .
Comparison of MAP control Seattle-PAP vs. Predicate Fisher & Paykel (K100011) .
. Adjustability of device from 4.5 to 10 cm H3O
. Measured MAP at various flow rates 4 -12 Lpm
Endurance testing for 180 hours and performance
. Storage - high temperature
. Operational - high temperature
Storage low temperature .
Operational low temperature .

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510(k) Summary Page 5 of 5

8-Oct-13

High Humidity operational / storage .
. Age testing
Vibration sinusoidal .
. Vibration - random
. Shock
. Discussion - The performance testing, post-conditioning and comparative testing all demonstrated that the Seattle-PAP met its performance specifications and was substantially equivalent to the predicate K 100011.

Biocompatibility of Materials -

Materials are typical of the predicate .
- The device is downstream of the patient, on the expiratory limb. The device is o not in the direct or indirect gas pathway.
Discussion No ISO 10993 testing is required. ●

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent to the predicate.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

October 11, 2013

Seattle Children's Hospital C/O Mr. Paul Dryden Regulatory Consultant 1900 Ninth Avenue SEATTLE WA 98101

Re: K131502

Trade/Device Name: Seattle-PAP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 9, 2013 Received: September 11, 2013

Dear Mr. Dryden:

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 vour 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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/Industrv/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology. General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page I of I

510(k) Number:

(To be assigned)

Seattle-PAP Device Name:

Indications for Use:

It is for use only by trained medical personnel in hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

K131502

Image /page/7/Picture/14 description: The image shows the name "Anya C. Harry -S" in large, bold font. To the right of the name, there is some smaller text that reads "DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anya C. Harry -S, 0.9.2342,19200300.100.1.1=0011315590". The text appears to be a digital signature or certificate information associated with the name.

Digitally signed by Anya C. Harry -S DN: c=US, o=U.S. Government, ou=HHS, 0.9.2342.19200300.100.1.1=0011315590 Date: 2013.10.11 13:21:16 -04'00

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).