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 home-use environment.

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 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 hook-and-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.

AI/ML Overview

The Lakeview Sleep Center, Nasal Comfort Freedom device underwent several non-clinical tests to establish substantial equivalence to predicate devices. These tests assessed device characteristics related to airflow, pressure, gas exhaustion, patient attachment, and material biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Nasal Comfort Freedom are implicitly set by matching or demonstrating comparable performance to the predicate devices, ResMed Swift FX (K090244) and Respironics GoLife Nasal Mask (K102502). The table below summarizes key performance attributes and how the Nasal Comfort Freedom's performance compares to these predicates.

Attribute	Predicate Device (ResMed Swift FX) Reported Performance	Predicate Device (Respironics GoLife) Reported Performance	Lakeview Sleep Center Nasal Comfort Freedom Reported Performance	Acceptance Criteria (Implicit from Predicate Comparison)	Device Performance Meets Criteria?
A. Intended Use
A.1 Indications for Use Statement	Adult patients (> 66 lb/30 kg) and single-patient re-use in home, multi-patient re-use in hospital/institutional.	Adult patients (> 66 lb/30 kg) and single-patient reuse in home, multi-patient multi-use in hospital/institutional.	Adult patients (>66 lb/30kg), single-patient re-use, clinical or home-use environment.	Comparable target population and usage environment.	Yes (more restrictive, thus safer)
A.2 Labeling	Equivalent in content	Label not available	Equivalent in content	Equivalent in content compared to Swift FX.	Yes
A.3 Target Population	Adult patients (>66 lbs)	Adult patients (>66 lbs)	Adult patients (>66 lbs)	Adult patients (>66 lbs).	Yes
B. Technology
B.1 Patient contacting materials	Unknown	Hytrel, Silicone, Ethylene octane copolymer, Polycarbonate, Urethane	Silicone, Polycarbonate, Polyolefin, Polyethylene, Nylon, 3M 7331 adhesive	Biocompatible materials, comparable to predicates where known.	Yes (assumed through biocompatibility testing)
B.2 Design	Nasal pillow style mask with chamber, rotating elbow, tubing, nasal pillows, strap headgear.	Nasal pillow style mask with chamber, rotating elbow, tubing, nasal pillows, strap headgear.	Nasal pillow style mask with chamber, rotating elbow, tubing, nasal pillows, and straps for connection to patient's nose.	Similar design structure.	Yes
B.3 Length of connector tubing	12 inches	Unknown	12 inches	Comparable to Swift FX (12 inches).	Yes
B.4 Diameter	Connector tubing ID = 15mm; Min airway diameter 6mm	Connector tubing ID = 15mm	Connector tubing ID = 15mm; Min airway diameter 7mm	Connector tubing ID = 15mm; Min airway diameter at least 6mm.	Yes
B.5 Exhaust	Passive, 38 holes, 0.027" diameter ~ 0.022 sq in exhaust area.	Passive, dimensions unknown.	Passive, 36 holes, 0.031" +/- 0.003" diameter ~ min 0.022 sq in exhaust area.	Passive exhaust with comparable exhaust area.	Yes
B.6 Dead Space	103 mL (per IFU)	< 27mL (per IFU)	90 mL	Comparable to predicate (within acceptable range or less).	Yes (less than Swift FX)
B.7 Operating Pressure	4 - 20 cm H2O	Unknown	5-20 cm H2O	Comparable operating pressure range to Swift FX.	Yes
B.6 Sterilization	None	None	None	Non-sterile.	Yes
C. Performance
C.1 Resistance to Flow	0.45 cmH2O at 50 L/min (as measured)	0.5 cm H2O at 50 L/min (per IFU)	0.46 cmH2O at 50 L/min (as measured)	≤ 0.5 cmH2O at 50 L/min (or comparable to predicates).	Yes
C.2 Exhaust Flow	Range for XS & L sizes (e.g., 2.8-53.8 L/min at 3-40cm H2O for XS; 11.3-90.6 L/min for L)	Unknown	5.1-82.7 L/min at 3-40cm H2O	Comparable range for effective CO2 washout.	Yes (within range of Swift FX)
C.3 Inspiratory and Expiratory Resistance	8.90 cmH2O	Unknown	4.72 cmH2O	Lower or comparable to predicate.	Yes (lower than Swift FX)
C.4 CO2 Rebreathing	Normal Conditions: 38.42% at 5cmH2O, 30.53% at 10cmH2O	Unknown	Normal Conditions: 8.86% at 5cmH2O, 7.34% at 10cmH2O	Lower or comparable to predicate, within acceptable safety limits.	Yes (significantly lower)
C.5 Patient Disengagement	Superior Peel Max Load = 3.8N; Lateral Shear Max Load = 20.0N	Unknown	Superior Peel Max Load = 12.6N; Lateral Shear Max Load = 46.0 N	Comparable or superior to predicate's resistance to disengagement.	Yes (superior)
C.6 Conical Fittings	Meets ISO 5356-1:2004	Meets ISO 5356-1:2004	Meets ISO 5356-1:2004	Meets ISO 5356-1:2004.	Yes

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical tests summarized under "Summary of Testing" in the 510(k) submission. These tests include:

Conical Fitting Testing, ISO 5356-1:2004 (Drop Test, Engagement, Disengagement, Leakage)
Resistance to Flow
Exhaust Flow
Inspiratory and Expiratory Resistance
Dead Space Volume
CO2 Rebreathing
Patient Disengagement
Biocompatibility Testing, ISO 10993-1:2009

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."

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

The document does not explicitly state the sample size for individual tests (e.g., number of masks tested for resistance to flow). However, the testing appears to be conducted on the device itself and its components in a laboratory setting, rather than through human or animal trials. Therefore, "test set" in this context refers to the manufactured units of the Nasal Comfort Freedom device or its components subjected to the physical and chemical performance evaluations.

Data Provenance: The data is generated from non-clinical bench testing rather than from clinical studies involving human subjects. The country of origin of the data is not specified beyond the Lakeview Sleep Center being based in Chicago, IL, USA, implying the testing likely occurred in the USA or through US-based contract labs. The nature of the testing is prospective in the sense that the device was manufactured and then subjected to these specific tests to gather performance data.

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

Not Applicable. For non-clinical bench testing of a device's physical and performance characteristics, ground truth is established by objective measurements against established engineering standards (e.g., ISO, ASTM) or performance characteristics of legally marketed predicate devices, not by expert consensus or interpretation of images/clinical data. The "ground truth" is typically the measured value compared to a defined limit or a predicate's performance.

4. Adjudication Method for the Test Set:

Not Applicable. Since the "test set" involves physical device measurements against objective standards and predicate device performance, there is no need for an adjudication method in the context of expert review for ambiguous cases. The outcomes are quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not Applicable. This device is a medical device (nasal mask for CPAP) and not an AI/imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable. This device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for validating the device's performance is based on established engineering standards (e.g., ISO 5356-1:2004, ISO 10993-1:2009) and performance characteristics of legally marketed predicate devices. For example, for "Resistance to Flow," the ground truth is the measured value compared to known values for predicates. For "Conical Fittings," the ground truth is compliance with ISO 5356-1:2004.

8. The Sample Size for the Training Set:

Not Applicable. This is a physical medical device. There is no concept of a "training set" in the context of machine learning for this type of device. The device itself is manufactured to specifications.

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

Not Applicable. As there is no training set for this physical medical device, there is no ground truth to be established for it.

Summary

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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 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

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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

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.

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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.

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Attribute	ResMed Swift FX	Respironics GoLife	Lakeview Sleep Center NasalComfort Freedom
A. Intended Use
A.1 Indicationsfor UseStatement	The Swift FX channels airflownoninvasively to a patient from apositive airway pressure (PAP)device such as a continuous positiveairway pressure (CPAP) or bilevelsystem. The Swift FX is:* to be used by adult patients (>66 lb/30 kg) for whom positive airwaypressure has been prescribed* intended for single-patient re-usein the home environment andmultipatient re-use in the hospital /institutional environment.	The GoLife Nasal Mask is intendedto provide an interface forContinuous Positive AirwayPressure(CPAP) or bi-level therapy. Thismask is intended for single-patientreuse in the home and multi-patient.multi-use in the hospital/institutionalenvironment. This mask is to beused on patients greater than 66lbs / 30 kg.	The Nasal Comfort Freedomprovides a conduit such thatairflow from a positive pressuresource is directed to a patient'snose. The device is intended foradult patients (>66 lb/30kg) forwhom positive airway pressurehas been prescribed. The deviceis single-patient re-use, and isintended for use in a clinical orhome-use environment.
A.2 Labeling	Equivalent in content	Label not available	Equivalent in content
A.3 TargetPopulation	Adult patients (>66 lbs)	Adult patients (>66 lbs)	Adult patients (>66 lbs)
B. Technology
B.1 Patientcontactingmaterials	Unknown	Hytrel, Silicone, Ethylene octanecopolymer, Polycarbonate, Urethane	Silicone, Polycarbonate,Polyolefin, Polyethylene, Nylon,3M 7331 adhesive
B.2 Design	The ResMed Swift FX is a nasalpillow style mask featuring a chamber,rotating elbow, tubing with connectorsfor adaptation to CPAP machines,nasal pillows, and strap headgear.	The Respironics GoLife is a nasalpillow style mask featuring achamber, rotating elbow, tubing withconnectors for adaptation to CPAPmachines, nasal pillows, and strapheadgear.	The Nasal Comfort Freedom is anasal pillow style mask featuring achamber, rotating elbow, tubingwith connectors for adaptation toCPAP machines, nasal pillows,and straps for connection topatient's nose.
B.3 Length ofconnector tubing	12 inches	Unknown	12 inches
B.4 Diameter	Connector tubing ID = 15mmMinimum airway diameter 6mm as .measured	Connector tubing ID = 15mm	Connector tubing ID = 15mmMinimum airway diameter 7mm
B.5 Exhaust	Passive, 38 holes, 0.027" diameter ~0.022 sq in exhaust area	Passive, dimensions unknown	Passive, 36 holes, 0.031" +/-0.003" diameter ~ min 0.022 sq inexhaust area
B.6 Dead Space	103 mL (per IFU)	< 27mL (per IFU)	90 mL
B.7 OperatingPressure	4 - 20 cm H2O	Unknown	5-20 cm H2O
B.6 Sterilization	None	None	None
Attribute	ResMed Swift FX	Respironics GoLife	Lakeview Sleep CenterNasal Comfort Freedom
C.1 Resistanceto Flow	0.45 cmH2O at 50 L/min (asmeasured)	0.5 cm H2O at 50 L/min (per IFU)	0.46 cmH2O at 50 L/min (asmeasured)
C.2 ExhaustFlow	Size XS:2.8L/min at 3cm H₂O8.5L/min at 10cm H₂O28.3L/min at 20cm H₂O39.6L/min at 30cm H₂O53.8L/min at 40cm H2OSize L:11.3L/min at 3cm H₂O25.5L/min at 10cm H2O56.6L/min at 20cm H₂O73.6L/min at 30cm H2O90.6L/min at 40cm H₂O	Unknown	5.1L/min at 3cm H₂O21.0L/min at 10cm H₂O44.7L/min at 20cm H₂O63.4L/min at 30cm H₂O82.7L/min at 40cm H₂O
C.3 Inspiratoryand ExpiratoryResistance	Resistance to flow = 8.90cmH2O	Unknown	Resistance to flow = 4.72cmH2O
C.4 CO₂Rebreathing	Normal Conditions:38.42% at 5cmH2O30.53% at 10cmH2OSingle Fault Condition 1:30.92% at 5cmH2O32.68% at 10cmH2OSingle Fault Condition 2:46.58% at 5&10cmH2O	Unknown	Normal Conditions:8.86% at 5cmH2O7.34% at 10cmH2OSingle Fault Condition 1:11.95% at 5cmH2O16.86% at 10cmH2OSingle Fault Condition 2:23.91% at 5&10cmH2O
C.5 PatientDisengagement	Superior PeelMax Load = 3.8NDisplacement = 4.2mmLateral ShearMax Load = 20.0NDisplacement = 25.0mm	Unknown	Superior PeelMax Load = 12.6Displacement at Swift FX maxload= 4.1mmLateral ShearMax Load = 46.0 NDisplacement at Swift FX maxload= 2.5 mm
C.6 ConicalFittings	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

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510(k) Premarket Notification Section F.r.6

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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
1. Resistance to Flow
1. Exhaust Flow
1. Inspiratory and Expiratory Resistance
1. Dead Space Volume
1. CO2 Rebreathing
1. Patient Disengagement
1. 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.

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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.

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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

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Indications for Use

510(k) Number: K130686

Device Name: Nasal Comfort Freedom

Indications for Use:

Prescription Use	X (Part 21 CFR 801 Subpart D)	AND/OR	Over The-Counter Use	(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anya C. Harry

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

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).