NASAL COMFORT FREEDOM

{0}------------------------------------------------ # 510(k) Summary Lakeview Sleep Center, Nasal Comfort Freedom The assigned 510(k) number is: K130686 . . . . . . Lakeview Sleep Center 510(k) Owner: 840 West Irving Park Rd. Suite 301 Chicago, IL 60613 USA Phone: (773) 477-0200 Fax: (773) 477-0700 **OCT** 16 2013 Contact Person: Andy Black October 15, 2013 Date Prepared: # Device Name and Classification | Classification Name: | Accessory to Noncontinuous Ventilator (IPPB) | |------------------------|----------------------------------------------| | Common/Usual Name: | Vented Nasal Mask | | Proprietary Name: | Nasal Comfort Freedom | | Device Classification: | Class II | | Regulation Number | 21 CFR Ref. § 868.5905 | | Product Code: | BZD | #### Device Description The Nasal Comfort Freedom is a medical device that is capable of connection to a positive pressure source, and provides a conduit for delivery of an air flow to a patient's nose. The device is a single-patient re-use device supplied non-sterile by prescription. The Nasal Comfort Freedom interfaces with the patient by way of nasal pillows assembled into a breathing chamber. The nasal pillows and breathing chamber are soft and flexible to conform to the patient's nose. A rotating elbow is connected to the breathing chamber and incorporates a passive vent for exhaled gases to escape the device. The elbow is permanently connected at its distal end to a rotating connector. The Rotating Connector provides a means by which air supply may be connected and disconnected from the breathing mask via two {1}------------------------------------------------ clips incorporated into the Tubing Connector. The supplied tubing uses a standard conical fitting for connection to currently marketed 22mm fittings for use with CPAP ventilators and accessories. The Nasal Comfort Freedom is secured to the patient during use by way of a disposable adhesive strip that is fitted over the bridge of the patient's nose. The adhesive on the underside of the Nose Strip provides attachment to the patient's skin, while the outward facing layer of the strip features the loop side of a hookand-loop fabric. The Breathing Chamber of the mask incorporates two hook fabric strips to be mated with the loop fabric of the Nose Strip. The patient may fit the nasal pillows into the nostrils, and then secure the hook strips over the loop strip on the nose to provide a snug fit of the device. Following each use, the Nose Strip may be removed and discarded by the patient. ## Indications for Use The Nasal Comfort Freedom provides a conduit such that airflow from a positive pressure source is directed to a patient's nose. The device is intended for adult patients (>66 lb/30kg) for whom positive airway pressure has been prescribed. The device is single-patient re-use, and is intended for use in a clinical or homeuse environment. ## Substantial Equivalence Claim Based on comparison of device features, materials, intended use and performance, the Lakeview Sleep Center, Nasal Comfort Freedom is substantially equivalent to the commercially available predicate devices ResMed Swift FX approved by the FDA under 510k number K090244, and Respironics GoLife Nasal Mask approved by the FDA under 510k number K102502. Table 1 shows a summary of the technological characteristics of the Nasal Comfort Freedom compared to the predicate devices. Differences in the Indications For Use statement of the Nasal Comfort Freedom and its predicate devices do not affect the safety and effectiveness of the device when used as labeled. The Nasal Comfort Freedom is indicated as a conduit for airflow from a positive pressure source, where the positive pressure air source is a CPAP or bi-level system specified by the Indications For Use of the predicate devices. Also the Nasal Comfort Freedom is single patient-reuse in both hospital and home use environments, where the predicate devices are multi-patient use in the hospital setting; therefore, the indications of the Nasal Comfort Freedom are more restrictive, and do not introduce additional risk to the patient compared to the predicate devices. The technology incorporated into the Nasal Comfort Freedom is substantially equivalent to the technology for the predicate devices. All devices use a similar design structure that connects a positive air pressure source (CPAP machine) to a patient's nose by way of tubing, a breathing chamber with passive venting, and nasal pillows that insert into the patient's nostrils. All devices use equivalent or similar materials, with the prevalent air path materials consisting of Polycarbonate and Silicone. {2}------------------------------------------------ The sizes of the components of the Nasal Comfort Freedom are equivalent to those of the predicate devices. The devices feature a 15mm ID connection tube intended for connection to tubing compatible with a CPAP machine. The Nasal Comfort Freedom has equivalent venting design, equivalent nasal pillow diameters, and has slightly less dead space than does the Swift FX. The Nasal Comfort Freedom differs from the predicate devices in the method by which the device is fixed to the patient. The predicate devices use straps that are connected to the breathing chamber and fitted around the patient's head. The Nasal Comfort Freedom utilizes straps connected to the breathing chamber that are able to be attached to an adhesive strip applied to the patient's nose. The attachment method includes connection points to the chamber that are in an equivalent location as are those of the predicate devices, and comparative test data indicates that the Nasal Comfort Freedom has greater resistance to displacement from the patient than does the attachment mechanism of the predicate Swift FX. The adhesive strips are disposable, and may be available in various sizes for conformity to a variety of patient sizes. {3}------------------------------------------------ | Attribute | ResMed Swift FX | Respironics GoLife | Lakeview Sleep Center Nasal<br>Comfort Freedom | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | A. Intended Use | | | | | A.1 Indications<br>for Use<br>Statement | The Swift FX channels airflow<br>noninvasively to a patient from a<br>positive airway pressure (PAP)<br>device such as a continuous positive<br>airway pressure (CPAP) or bilevel<br>system. The Swift FX is:<br>* to be used by adult patients (><br>66 lb/30 kg) for whom positive airway<br>pressure has been prescribed<br>* intended for single-patient re-use<br>in the home environment and<br>multipatient re-use in the hospital /<br>institutional environment. | The GoLife Nasal Mask is intended<br>to provide an interface for<br>Continuous Positive Airway<br>Pressure<br>(CPAP) or bi-level therapy. This<br>mask is intended for single-patient<br>reuse in the home and multi-<br>patient.<br>multi-use in the hospital/institutional<br>environment. This mask is to be<br>used on patients greater than 66<br>lbs / 30 kg. | The Nasal Comfort Freedom<br>provides a conduit such that<br>airflow from a positive pressure<br>source is directed to a patient's<br>nose. The device is intended for<br>adult patients (>66 lb/30kg) for<br>whom positive airway pressure<br>has been prescribed. The device<br>is single-patient re-use, and is<br>intended for use in a clinical or<br>home-use environment. | | A.2 Labeling | Equivalent in content | Label not available | Equivalent in content | | A.3 Target<br>Population | Adult patients (>66 lbs) | Adult patients (>66 lbs) | Adult patients (>66 lbs) | | B. Technology | | | | | B.1 Patient<br>contacting<br>materials | Unknown | Hytrel, Silicone, Ethylene octane<br>copolymer, Polycarbonate, Urethane | Silicone, Polycarbonate,<br>Polyolefin, Polyethylene, Nylon,<br>3M 7331 adhesive | | B.2 Design | The ResMed Swift FX is a nasal<br>pillow style mask featuring a chamber,<br>rotating elbow, tubing with connectors<br>for adaptation to CPAP machines,<br>nasal pillows, and strap headgear. | The Respironics GoLife is a nasal<br>pillow style mask featuring a<br>chamber, rotating elbow, tubing with<br>connectors for adaptation to CPAP<br>machines, nasal pillows, and strap<br>headgear. | The Nasal Comfort Freedom is a<br>nasal pillow style mask featuring a<br>chamber, rotating elbow, tubing<br>with connectors for adaptation to<br>CPAP machines, nasal pillows,<br>and straps for connection to<br>patient's nose. | | B.3 Length of<br>connector tubing | 12 inches | Unknown | 12 inches | | B.4 Diameter | Connector tubing ID = 15mm<br>Minimum airway diameter 6mm as .<br>measured | Connector tubing ID = 15mm | Connector tubing ID = 15mm<br>Minimum airway diameter 7mm | | B.5 Exhaust | Passive, 38 holes, 0.027" diameter ~<br>0.022 sq in exhaust area | Passive, dimensions unknown | Passive, 36 holes, 0.031" +/-<br>0.003" diameter ~ min 0.022 sq in<br>exhaust area | | B.6 Dead Space | 103 mL (per IFU) | < 27mL (per IFU) | 90 mL | | B.7 Operating<br>Pressure | 4 - 20 cm H2O | Unknown | 5-20 cm H2O | | B.6 Sterilization | None | None | None | | Attribute | ResMed Swift FX | Respironics GoLife | Lakeview Sleep Center<br>Nasal Comfort Freedom | | C.1 Resistance<br>to Flow | 0.45 cmH2O at 50 L/min (as<br>measured) | 0.5 cm H2O at 50 L/min (per IFU) | 0.46 cmH2O at 50 L/min (as<br>measured) | | C.2 Exhaust<br>Flow | Size XS:<br>2.8L/min at 3cm H₂O<br>8.5L/min at 10cm H₂O<br>28.3L/min at 20cm H₂O<br>39.6L/min at 30cm H₂O<br>53.8L/min at 40cm H2O<br>Size L:<br>11.3L/min at 3cm H₂O<br>25.5L/min at 10cm H2O<br>56.6L/min at 20cm H₂O<br>73.6L/min at 30cm H2O<br>90.6L/min at 40cm H₂O | Unknown | 5.1L/min at 3cm H₂O<br>21.0L/min at 10cm H₂O<br>44.7L/min at 20cm H₂O<br>63.4L/min at 30cm H₂O<br>82.7L/min at 40cm H₂O | | C.3 Inspiratory<br>and Expiratory<br>Resistance | Resistance to flow = 8.90cmH2O | Unknown | Resistance to flow = 4.72cmH2O | | C.4 CO₂<br>Rebreathing | Normal Conditions:<br>38.42% at 5cmH2O<br>30.53% at 10cmH2O<br>Single Fault Condition 1:<br>30.92% at 5cmH2O<br>32.68% at 10cmH2O<br>Single Fault Condition 2:<br>46.58% at 5&10cmH2O | Unknown | Normal Conditions:<br>8.86% at 5cmH2O<br>7.34% at 10cmH2O<br>Single Fault Condition 1:<br>11.95% at 5cmH2O<br>16.86% at 10cmH2O<br>Single Fault Condition 2:<br>23.91% at 5&10cmH2O | | C.5 Patient<br>Disengagement | Superior Peel<br>Max Load = 3.8N<br>Displacement = 4.2mm<br>Lateral Shear<br>Max Load = 20.0N<br>Displacement = 25.0mm | Unknown | Superior Peel<br>Max Load = 12.6<br>Displacement at Swift FX max<br>load= 4.1mm<br>Lateral Shear<br>Max Load = 46.0 N<br>Displacement at Swift FX max<br>load= 2.5 mm | | C.6 Conical<br>Fittings | Meets ISO 5356-1:2004 | Meets ISO 5356-1:2004 | Meets ISO 5356-1:2004 | Table 1. Summary of technological characteristics compared to predicate devices {4}------------------------------------------------ # 510(k) Premarket Notification Section F.r.6 {5}------------------------------------------------ #### Summary of Testing The Nasal Comfort Freedom has been tested in accordance with applicable standards. A summary of non-clinical tests performed to support the claim of substantial equivalence is below. - 1. Conical Fitting Testing, ISO 5356-1:2004, Anesthetic and Respiratory Equipment - a. Drop Test - b. Engagement - c. Disengagement - d. Leakage - 2. Resistance to Flow - 3. Exhaust Flow - 4. Inspiratory and Expiratory Resistance - 5. Dead Space Volume - 6. CO2 Rebreathing - 7. Patient Disengagement - 8. Biocompatibility Testing, ISO 10993-1:2009, Biological Evaluation of Medical Devices The non-clinical tests performed were intended to assess the characteristics of airflow through the device, measured pressures within the device and at the patient interface, determine the ability of the device to exhaust exhaled gases from the patient, compare the ability of the device to remain affixed to the patient, and evaluate the materials from which the device is constructed. The results of performance testing of the Nasal Comfort Freedom demonstrate that it is substantially equivalent to the performance, safety, and effectiveness of the predicate device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### October 16, 2013 Lakeview Sleep Center C/O Mr. Andy Black Senior Engineer Medical Murray, Incorporated 400 North Rand Road NORTH BARRINGTON IL 60010 Re: K130686 Trade/Device Name: Nasal Comfort Freedom Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 3, 2013 Received: September 17, 2013 Dear Mr. Black: 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 murketed in interstate commerce prior to May 28. 1976. the enactment date of the Medical Device Amendments, or 10 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). and Oosmetic room of 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 mislcading. 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 may be subject to additions, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {7}------------------------------------------------ Page 2 - Mr. Black 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 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 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/Resourcesfor You/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/Industry/default.htm. Image /page/7/Picture/6 description: The image shows a signature and some text. The text includes "Sincerely yours," followed by the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." The acronym "DAGRID" is also present. Finally, the word "FOR" is at the bottom right. 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 {8}------------------------------------------------ #### Indications for Use 510(k) Number: K130686 Device Name: Nasal Comfort Freedom Indications for Use: The Nasal Comfort Freedom provides a conduit such that airflow from a positive pressure source is directed to a patient's nose. The device is intended for adult patients (>66 lb/30kg) for whom positive airway pressure has been prescribed. The device is single-patient re-use, and is intended for use in a clinical or homeuse environment. | Prescription Use | _X_ (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) Anya C. Harry S Digitally signed by Anya C. Harry -S 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 Date: 2013.10.11 17:59:00 -04'00' Lakeview Sleep Center, Nasal Comfort Freedom