SEATTLE - PAP

{0}------------------------------------------------ #### 510(k) Summary Page I of 5 | Date prepared: | 8-Oct-13 | |----------------------------------------------------------------------------|-----------------------------------------------------------------| | Seattle Children's Hospital<br>4800 Sand Point Way NE<br>Seattle, WA 98105 | Tel - 206-884-5138<br>Fax - 206-985-3134 | | Official Contact: | Erik Lausund<br>VP, Research Ops & Logistics | | Proprietary or Trade Name: | Seattle-PAP | | Common/Usual Name: | Bubble CPAP System | | Classification Name/Code: | BZD - Noncontinuous ventilator (IPPB)<br>CFR 868.5905, Class II | | Device: | Seattle-PAP | | Predicate Devices: | K100011 - Fisher & Paykel - Bubble CPAP System | #### 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. #### 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 {1}------------------------------------------------ #### 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 for<br>Use | The Seattle-PAP is intended to<br>provide continuous positive airway<br>pressure (CPAP) to spontaneously<br>breathing neonates and infants, up to<br>weights of 10 kg, requiring respiratory<br>support due to conditions associated<br>with prematurity, such as Respiratory<br>Distress Syndrome, or other<br>conditions where CPAP is required or<br>desired and prescribed by a physician.<br>It is for use only by trained medical<br>personnel in hospital clinical<br>environment, such as the Neonatal<br>Intensive Care Unit (NICU) and<br>Pediatric Intensive Care Unit (PICU). | Intended to provide continuous positive<br>airway pressure (CPAP) to spontaneously<br>breathing neonates and infants, up to<br>weights of 10 kg, requiring respiratory<br>support due to conditions associated with<br>prematurity, such as Respiratory Distress<br>Syndrome, or other conditions where<br>CPAP is required or desired and<br>prescribed by a physician. | {2}------------------------------------------------ # 510(k) Summary Page 3 of 5 8-Oct-13 | | Proposed device<br>Seattle-PAP | Predicate<br>K100011<br>Fisher & Paykel - Bubble CPAP | |-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Environment of<br>Use | Hospital clinical environment, NICU and<br>PICU | Hospital clinical environment, NICU and<br>PICU | | Patient<br>population | Neonates and infants, up to weights of<br>10 kg | Neonates and infants, up to weights of 10<br>kg | | Prescriptive | Yes, for use by trained medical<br>personnel | Yes, for use by trained medical personnel | | Principle of<br>Operation | Expiratory limb of a breathing circuit<br>connected to a column that is submerged<br>in water. The water column acts to<br>provide pressure when exhaling, CPAP.<br>The column is adjustable. | Expiratory limb of a breathing circuit<br>connected to a column that is submerged<br>in water. The water column acts to<br>provide pressure when exhaling, CPAP.<br>The column is adjustable. | | Pressure<br>Oscillations | Pressure oscillations are created as gas<br>exits the Bubble Tube. | Pressure oscillations are created as gas<br>exits the Bubble Tube. | | Placed in<br>expiratory limb<br>of breathing<br>circuit | Yes | Yes | | Single use,<br>disposable | Yes | Yes | | Pressure range | 4.5 to 10 cm H₂O | 3 to 10 cm H₂O | | Accuracy<br>As measured<br>during<br>comparative<br>testing | Specified as +/- 1 cm H₂O<br>Tested accuracy = - 0.21 to +0.17 H₂O | Not specified in available documentation.<br>Tested accuracy -0.09 to +0.52 H₂O | | Gas flow range | 4 to 12 Lpm | 4 to 15 Lpm | | Material<br>biocompatibility | All materials are out of direct or indirect<br>gas pathway | All materials are out of direct or indirect<br>gas pathway | | Non-clinical<br>Performance<br>Testing | Environmental conditions, storage,<br>operational, aging and endurance testing<br>Mechanical Drop test<br>Accuracy<br>Reproducibility of MAP<br>Repeatability of performance | Accuracy<br>Reproducibility 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. {3}------------------------------------------------ # 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 . {4}------------------------------------------------ # 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ # Indications for Use Statement Page I of I 510(k) Number: (To be assigned) Seattle-PAP Device Name: 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 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). Prescription Use XX (Part 21 CFR 801 Subpart D) or 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