Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and function of a nasal mask for CPAP/bi-level therapy, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is a mask that provides an interface for therapy; it does not provide the therapy itself.

Diagnostic

No

A diagnostic device identifies medical conditions or diseases. This device is a mask for CPAP/bi-level therapy, which is a treatment, not a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a faceplate, gel cushion, seal, elbow, headgear, and connections for tubing, indicating it is a hardware device. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The ComfortGel Blue Nasal Mask is an interface used to deliver positive pressure therapy (CPAP or bi-level) to a patient's respiratory system. It does not perform any tests on bodily samples.
Intended Use: The intended use clearly states it's for applying CPAP or bi-level therapy, not for diagnostic testing.
Device Description: The description details the physical components and how it connects to a therapy device, not how it analyzes biological samples.

Therefore, the ComfortGel Blue Nasal Mask falls under the category of a respiratory therapy device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ComfortGel Blue Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Product codes (comma separated list FDA assigned to the subject device)

BZD

Device Description

The Respironics ComfortGel Blue Nasal Mask consists of a polycarbonate faceplate with a gel cushion encapsulated in a polyester seal for the face. The mask includes integrated exhalation features on the elbow. It is an accessory for use with CPAP and bi-level devices in the home (single patient use) and hospital/institution (multi-patient use).

The ComfortGel Blue Nasal mask covers the patient's nose only. It is strapped to the patient's face using headgear which connects to the mask via slots in the forehead bracket at the top, and via ball clip headgear attachments, which fit into sockets in the mask faceplate at the bottom. The mask is connected to the CPAP or bi-level flow generator via standard 22mm patient tubing. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nose

Indicated Patient Age Range

Patients (>66lbs/30kg) or adult patients (>30kg)

Intended User / Care Setting

single patient use in the home or multi-patient use in the hospital/institutional 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)

Extensive performance testing, to include intentional leak, pressure drop, CO2 rebreathing, deadspace testing and swivel torque was completed on both untreated and treated samples. Testing was performed pre and post home/clinical cleaning and disinfection treatments. Additionally, efficacy testing was performed to ensure that the mask could be high level disinfected to assure a minimum of a 6 log reductions for this mask as tested in accordance with AAM TIR No. 12-2004, AAMI TIR 30-2003, ANSI/AAMI/ISO 14937-2000, and the "content and format of Premarket notification submissions for liquid chemical sterilants/high level disinfectants" - FDA CDRH, January 3, 2000. Results from this testing concluded that the verification testing raises no new issues of safety or effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

Respironics ComfortGel Full Face Mask (K073600), Respironics Reusable Contour II Nasal Mask (K991648)

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

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).

Summary

0

1

TAB 3

K092835
page 1 of 7

510(K) SUMMARY OF SAFETY & EFFECTIVENESS

Original Date of Submission	14 September 2009	FEB 1 2 2010
Device Trade Name	ComfortGel Blue Nasal Mask
Common/Usual Name	Ventilator, non-continuous (respirator)
Establishment Registration #	2518422
Address of Mfr. Facility	Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
(724) 387-4120
Classification	Class II device
Classification Panel	Anesthesiology Devices
Classification Reference	21 CFR 868.5905
Product Code	BZD - Ventilator, non-continuous (respirator)
Predicate Device(s)	Respironics ComfortGel Full Face Mask (K073600)
	Respironics Reusable Contour II Nasal Mask (K991648)
Labeling	Draft Labeling can be found in Tab 5.
Intended Use	The ComfortGel Blue Nasal Mask is intended to provide an interface
for application of CPAP or bi-level therapy to patients. The mask is for
single patient use in the home or multi-patient use in the
hospital/institutional environment. The mask is to be used by patients
(>66lbs/30kg) for whom CPAP or bi-level therapy has been
prescribed.
Reason for Submission	Modify the ComfortGel Full Face Mask to provide a nasal mask
offering with a gel cushion.

1

Intended Use

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The ComfortGel Blue Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Device Description

The Respironics ComfortGel Blue Nasal Mask consists of a polycarbonate faceplate with a gel cushion encapsulated in a polyester seal for the face. The mask includes integrated exhalation features on the elbow. It is an accessory for use with CPAP and bi-level devices in the home (single patient use) and hospital/institution (multi-patient use).

The ComfortGel Blue Nasal mask covers the patient's nose only. It is strapped to the patient's face using headgear which connects to the mask via slots in the forehead bracket at the top, and via ball clip headgear attachments, which fit into sockets in the mask faceplate at the bottom. The mask is connected to the CPAP or bi-level flow generator via standard 22mm patient tubing. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

Substantial Equivalence

The ComfortGel Blue Nasal Mask has the following similarities to the previously cleared predicate devices:

D Same intended use.
D Same operating principle.
O Same technology.
O Same manufacturing process.

There is no change to the intended use, operating principle, technology or manufacturing process for the ComfortGel Blue nasal mask. Design modifications were made to the previously cleared ComfortGel Full Face Mask (K073600) to provide a nasal mask offering, similar to the Reusable Contour II Nasal Mask, with a gel cushion. The following changes have been made:

1. Modification to the mask materials
Removal of pressure pick-off port. 2.
Modification to match mask dimensions to that of a nasal mask 3.

2

1. Modification to the mask elbow to remove entrainment valve, similar to the Reusable Contour II Nasal Mask (K991648).
1. Modification to add additional sizes of the mask.
1. Modification to the mask deadspace.

Table 1 provides a detailed technology and performance comparison for the ComfortGel Blue Nasal Mask to the cited device predicates Reusable Contour II Nasal Mask (K991648) and ComfortGel Full Face Mask (K073600). Differences from the predicate devices are noted by the shaded areas.

3

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·

:

	Subject Device:	Predicate Device:	Subject Device:
	Device:	Device:	Device:
	Respironics ComfortGel
Full Face Mask	Respironics
Reusable Contour II
Nasal Mask	Respironics ComfortGel
Nasal Mask
	Manufacturer:	Manufacturer:	Manufacturer:
	Respironics, Inc.	Respironics, Inc.	Respironics, Inc.
	510(k) Number:	510(k) Number:	510(k) Number:
	K073600	K991648	To be determined
Intended Use	The ComfortGel Full
Face Mask is intended to
provide an interface for
application of CPAP or
bi-level therapy to
patients. The mask is for
multi-patient use in the
home or
hospital/institutional
environment. The mask
is intended to be used on
patients (>66 lbs/30kg)
for whom CPAP or bi-
level therapy has been
prescribed using a CPAP
or bi-level system.	The Respironics
Reusable Contour II
Nasal Mask is
intended to provide
an interface for
application of
Respironics bi-level
or CPAP therapy to
patients. For single
patient use in the
home or
hospital/institutional
environment. The
mask is to be used
on adult patients
(>30kg) for who bi-
level or CPAP
therapy has been
prescribed using a
Respironics bi-level
or CPAP system.	The ComfortGel Nasal
Mask is intended to
provide an interface for
application of CPAP or bi-
level therapy to patients.
The mask is for single
patient use in the home or
multi-patient use in the
hospital/institutional
environment. The mask is
intended to be used on
patients (>66lbs/30kg) for
whom CPAP or bi-level
therapy has been
prescribed using a CPAP
or bi-level system.
Patient
Population	Patients > 66 lbs/30 kg	Patients >30kg	Unchanged from
K073600/K991648
Environment of
Use	Home or
Hospital/institutional
Environment	Home or
Hospital/Institutional
Environment	Unchanged from
K073600/K991648
Product Code	BZD	BZD	Unchanged from
K073600/K991648
Provided Sterile
or Non-Sterile	Provided clean, not
sterile	Provided clean, not
sterile	Unchanged from
K073600/K991648
Patient Usage
Type	Multi-patient Use	Single patient use	Single Patient Use in the
home or multi-patient use
in the hospital/institutional
environment.
Design	Face Interface and
headgear	Nasal interface and
headgear	Unchanged from K991648
Materials	Faceplate: Polycarbonate
Face Seal: gel cushion	Faceplate:
Polycarbonate	Faceplate: Polycarbonate
Face seal: Gel cushion
	with urethane overlay .
Cushion flap: Silicone
Exhalation Port:
Polycarbonate
Entrainment Valve:
Polycarbonate with
Silicone Flapper
Headgear: UBL,
Urethane foam and lycra	Face Seal: Silicone
Cushion
Exhalation Elbow:
Polycarbonate
Headgear:
Velstretch/Lycra
laminated foam	with polyester overlay
Cushion Flap: Silicone
Exhalation Elbow:
Polycarbonate
Exhalation Port: Delrin
Forehead Pad: Silicone
Headgear: UBL, Urethane
Foam, and Lycra
Number of
Pressure Pickoff
ports	One	One	None
Shape and size
of faceplate	The shape of the
faceplate follows the
contours of the face
allowing clearance of
facial features, covering
the nose and mouth for
therapy. The faceplate
attaches to a silicone
sealing flap via a
retaining ring.	Profile of the
faceplate is
streamlined for a
slightly flatter,
rounder and more
complete shape to
help reduce mask
volume.	The shape of the
faceplate follows the
contours of the face
allowing clearance of
facial features, covering
the nose only for therapy.
The faceplate attaches to
a silicone sealing flap via
a retaining ring.
Shape and size
of cushion	Gel cushion to allow for a
more comfortable fit and
improved mask
performance (less leak).	Cushion varies in
thickness for better
seal and easier fit.
The cushion material
is thinnest where the
cushion contacts the
user's nose. Thin
cushion material
allows three basic
mask sizes to fit a
broad range of facial
features.	Gel cushion to allow for a
more comfortable fit and
improved mask
performance (less leak).
Dimensions modified to fit
nasal mask.
Safety Valve	The safety valve is
integral to the mask.	N/A- nasal mask	Unchanged from K991648
Exhalation
device	No accessory exhalation
device is required.
Exhalation ports are
integrated	No accessory
exhalation device is
required. Exhalation
ports are integrated	No accessory exhalation
device is required. 54 pin
hole exhalation ports are
integrated
Anatomical Sites	Nose & mouth	Nose	Unchanged from K991648
Patient Circuit
Connection	22 mm entrainment valve
elbow	22 mm exhalation
elbow	Unchanged from K991648
Pressure Range	4 to 30 cmH2O	4 to 30 cmH2O	Unchanged from
K073600/K991648
Number of Mask
Sizes	Three - small, medium
and large	Three - small,
medium and large	Four- petite, small,
medium, and large
Mask Deadspace	Small - 210 cc	Small: ~95 cc	Petite: 76 cc
	Medium - 260 cc	Medium: ~123 cc	Small: 97 cc
	Large - 300 cc	Large: ~123 cc	Medium: 99 cc
			Large: 118 cc
Intentional Leak	> 9.5 SLPM @ 2.5 cm	≥ 7.5 SLPM @ 1.5
cm H2O	Unchanged from K073600
	H2O

15 SLPM @ 5 cm H2O
66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Prescription Use X AND/OR (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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: