(217 days)
Not Found
No
The description focuses on the mechanical components and airflow characteristics of a nasal mask for positive airway pressure, with no mention of AI or ML.
Yes
The device is described as providing a conduit for positive airway pressure, which is a common therapeutic intervention for conditions like sleep apnea. Its function as a delivery system for prescribed positive airway pressure defines it as a therapeutic device.
No
The device is described as a conduit for delivering airflow from a positive pressure source to a patient's nose, intended for patients for whom positive airway pressure has been prescribed. Its function is to deliver therapy, not to acquire or analyze data for diagnosis.
No
The device description clearly details physical components such as nasal pillows, a breathing chamber, a rotating elbow, a rotating connector, tubing, and an adhesive strip. The performance studies also focus on physical characteristics like flow, resistance, and biocompatibility, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "provides a conduit such that airflow from a positive pressure source is directed to a patient's nose." This describes a device used to deliver therapy (positive airway pressure) directly to a patient.
- Device Description: The description details a physical device that interfaces with the patient's nose to deliver air. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) outside of the body.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the device related to airflow, pressure, and patient interface. They do not involve any diagnostic testing or analysis of biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 home-use environment.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's nose
Indicated Patient Age Range
adult patients (>66 lb/30kg)
Intended User / Care Setting
clinical or home-use environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
-
- Conical Fitting Testing, ISO 5356-1:2004, Anesthetic and Respiratory Equipment
- a. Drop Test
- b. Engagement
- c. Disengagement
- d. Leakage
-
- Resistance to Flow
-
- Exhaust Flow
-
- Inspiratory and Expiratory Resistance
-
- Dead Space Volume
-
- CO2 Rebreathing
-
- Patient Disengagement
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to flow = 0.46 cmH2O at 50 L/min (as measured)
Exhaust Flow:
5.1L/min at 3cm H₂O
21.0L/min at 10cm H₂O
44.7L/min at 20cm H₂O
63.4L/min at 30cm H₂O
82.7L/min at 40cm H₂O
Inspiratory and Expiratory Resistance = 4.72cmH2O
CO₂ Rebreathing - Normal Conditions: 8.86% at 5cmH2O, 7.34% at 10cmH2O
CO₂ Rebreathing - Single Fault Condition 1: 11.95% at 5cmH2O, 16.86% at 10cmH2O
CO₂ Rebreathing - Single Fault Condition 2: 23.91% at 5&10cmH2O
Patient Disengagement - Superior Peel: Max Load = 12.6, Displacement at Swift FX max load= 4.1mm
Patient Disengagement - Lateral Shear: Max Load = 46.0 N, Displacement at Swift FX max load= 2.5 mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
Comfort Freedom |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A. Intended Use | | | |
| A.1 Indications
for Use
Statement | The Swift FX channels airflow
noninvasively to a patient from a
positive airway pressure (PAP)
device such as a continuous positive
airway pressure (CPAP) or bilevel
system. The Swift FX is:
- to be used by adult patients (>
66 lb/30 kg) for whom positive airway
pressure has been prescribed - intended for single-patient re-use
in the home environment and
multipatient re-use in the hospital /
institutional environment. | The GoLife Nasal Mask is intended
to provide an interface for
Continuous Positive Airway
Pressure
(CPAP) or bi-level therapy. This
mask is intended for single-patient
reuse in the home and multi-
patient.
multi-use in the hospital/institutional
environment. This mask is to be
used on patients greater than 66
lbs / 30 kg. | 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. |
| A.2 Labeling | Equivalent in content | Label not available | Equivalent in content |
| A.3 Target
Population | Adult patients (>66 lbs) | Adult patients (>66 lbs) | Adult patients (>66 lbs) |
| B. Technology | | | |
| B.1 Patient
contacting
materials | Unknown | Hytrel, Silicone, Ethylene octane
copolymer, Polycarbonate, Urethane | Silicone, Polycarbonate,
Polyolefin, Polyethylene, Nylon,
3M 7331 adhesive |
| B.2 Design | The ResMed Swift FX is a nasal
pillow style mask featuring a chamber,
rotating elbow, tubing with connectors
for adaptation to CPAP machines,
nasal pillows, and strap headgear. | The Respironics GoLife is a nasal
pillow style mask featuring a
chamber, rotating elbow, tubing with
connectors for adaptation to CPAP
machines, nasal pillows, and strap
headgear. | The Nasal Comfort Freedom is a
nasal pillow style mask featuring a
chamber, rotating elbow, tubing
with connectors for adaptation to
CPAP machines, nasal pillows,
and straps for connection to
patient's nose. |
| B.3 Length of
connector tubing | 12 inches | Unknown | 12 inches |
| B.4 Diameter | Connector tubing ID = 15mm
Minimum airway diameter 6mm as .
measured | Connector tubing ID = 15mm | Connector tubing ID = 15mm
Minimum 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 in
exhaust area |
| B.6 Dead Space | 103 mL (per IFU) | 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