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.

AI/ML Overview

The provided text describes a 510(k) summary for the ComfortGel Blue Nasal Mask. This document focuses on demonstrating substantial equivalence to predicate devices for a medical device rather than presenting a performance study with acceptance criteria and results in the typical sense of an AI/ML device study.

Therefore, many of the requested categories for AI/ML performance studies are not applicable to the information contained within this 510(k) summary. I will answer the questions to the best of my ability based on the provided text, indicating where information is not available or not relevant for this type of submission.

Here's a breakdown based on your request:

1. A table of acceptance criteria and the reported device performance

The 510(k) summary does not explicitly list "acceptance criteria" and "reported device performance" in the context of a statistical study with metrics like sensitivity, specificity, accuracy, etc., as would be common for AI/ML devices. Instead, it compares the technical characteristics and performance of the subject device to predicate devices to demonstrate substantial equivalence. The "acceptance criteria" in this context would implicitly be that the subject device's performance characteristics (e.g., leak rates, pressure drop, dead space) are comparable to or within acceptable limits of the predicate devices and do not raise new safety or effectiveness concerns.

Performance Characteristic	Predicate Device (ComfortGel Full Face Mask - K073600)	Predicate Device (Reusable Contour II Nasal Mask - K991648)	Subject Device (ComfortGel Blue Nasal Mask)	Implied "Acceptance Criteria" (Substantial Equivalence)	Reported Performance (Post-testing)
Intended Use	Provides interface for CPAP/bi-level therapy; multi-patient use (home/hospital); patients >66lbs/30kg; full face	Provides interface for CPAP/bi-level therapy; single patient use (home/hospital); patients >30kg; nasal mask	Provides interface for CPAP/bi-level therapy; single patient use (home) / multi-patient use (hospital); patients >66lbs/30kg; nasal mask	Same intended use, patient population, environment of use.	Substantially equivalent to predicates.
Mask Deadspace	Small - 210 cc, Medium - 260 cc, Large - 300 cc	Small: ~95 cc, Medium: ~123 cc, Large: ~123 cc	Petite: 76 cc, Small: 97 cc, Medium: 99 cc, Large: 118 cc	Comparable to nasal mask predicate.	New sizes introduced, values provided.
Intentional Leak	> 9.5 SLPM @ 2.5 cm H2O, > 15 SLPM @ 5 cm H2O, < 64 SLPM @ 40 cm H2O	≥ 7.5 SLPM @ 1.5 cm H2O, ≥ 10 SLPM @ 2.5 cm H2O, ≥ 16 SLPM @ 5.0 cm H2O, ≤ 67 SLPM @ 40 cm H2O	Unchanged from K073600	Comparable to predicates, no new safety/effectiveness issues.	Testing performed; "verification testing raises no new issues of safety or effectiveness."
Unintentional Leak	≤17 SLPM @20 cm H2O, ≤ 28 SLPM @ 35 cm H2O	≤17 SLPM @20 cm H2O, ≤ 28 SLPM @ 35 cm H2O	Unchanged from K073600/K991648	Comparable to predicates, no new safety/effectiveness issues.	Testing performed; "verification testing raises no new issues of safety or effectiveness."
Pressure Drop	Closed to Atm: ≤ 1 cm H2O @ flows ≤ 50 SLPM, ≤ 4 cm H2O @ flows ≤ 100 SLPM; Open to Atm: ≤ 2 cm H2O @ flow up 60 lpm	Not known	< 1 cmH2O (.98 hPa) at flows ≤ 50 SLPM, < 4 cmH2O (3.9 hPa) at flows ≤ 100 SLPM	Comparable to predicate K073600 for closed to atmosphere.	Testing performed; "verification testing raises no new issues of safety or effectiveness."
Occluded End Tidal CO2	Small = 7.6%, Medium = 6.9%, Large = 6.7%	No information available	Large = 7.9%	Comparable to predicate K073600, no new safety/effectiveness issues.	Testing performed; "verification testing raises no new issues of safety or effectiveness."
Disinfection Efficacy	Not explicitly stated in comparison table, but predicate would have been disinfected.	Not explicitly stated in comparison table, but predicate would have been disinfected.	Tested to ensure minimum 6 log reduction	Must meet high-level disinfection standards.	Tested in accordance with AAM TIR No. 12-2004, AAMI TIR 30-2003, ANSI/AAMI/ISO 14937-2000, and FDA guidance. Results concluded satisfactory.
Swivel Torque	No information available	No information available	Performed	Not explicitly detailed but part of performance testing.	Testing performed; "verification testing raises no new issues of safety or effectiveness."
Pre/Post Cleaning/Disinfection	No information available	No information available	Performed	Device performance must be maintained after cleaning/disinfection.	Testing performed; "verification testing raises no new issues of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions "extensive performance testing" on "both untreated and treated samples" for characteristics like intentional leak, pressure drop, CO2 rebreathing, deadspace, swivel torque, and disinfection efficacy. However, it does not specify the number of masks or subjects included in these tests for the test set.
Data Provenance: Not specified. As the manufacturer is Respironics, Inc. (Murrysville, PA, USA), it's highly likely the testing was conducted in the USA, but this is not explicitly stated. The nature of the testing implies prospective, in-house laboratory testing of the device prototypes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. For a physical medical device like a nasal mask, "ground truth" as it relates to expert consensus for image interpretation or diagnosis is not relevant. The "ground truth" here is established through objective physical measurements (e.g., pressure, flow rates, CO2 concentration) and microbiological testing standards for disinfection.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in subjective assessments, typically with imaging data. The testing described for this device involves objective physical and microbiological 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 is a physical medical device (CPAP mask), not an AI/ML diagnostic tool, so MRMC studies, human readers, and AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance testing is based on:

Objective physical measurements: Flow rates, pressure, CO2 concentration, dead space volume, torque.
Established engineering and biomedical standards: Referenced standards for disinfection efficacy (AAM TIR No. 12-2004, AAMI TIR 30-2003, ANSI/AAMI/ISO 14937-2000, and FDA guidance).
Comparison to predicate devices: The established performance characteristics of legally marketed predicate devices serve as benchmarks for safety and effectiveness.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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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 LaneMurrysville, 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 interfacefor application of CPAP or bi-level therapy to patients. The mask is forsingle patient use in the home or multi-patient use in thehospital/institutional environment. The mask is to be used by patients(>66lbs/30kg) for whom CPAP or bi-level therapy has beenprescribed.
Reason for Submission	Modify the ComfortGel Full Face Mask to provide a nasal maskoffering with a gel cushion.

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Intended Use

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

Device Description

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.

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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.

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

	Subject Device:	Predicate Device:	Subject Device:
	Device:	Device:	Device:
	Respironics ComfortGelFull Face Mask	RespironicsReusable Contour IINasal Mask	Respironics ComfortGelNasal 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 FullFace Mask is intended toprovide an interface forapplication of CPAP orbi-level therapy topatients. The mask is formulti-patient use in thehome orhospital/institutionalenvironment. The maskis intended to be used onpatients (>66 lbs/30kg)for whom CPAP or bi-level therapy has beenprescribed using a CPAPor bi-level system.	The RespironicsReusable Contour IINasal Mask isintended to providean interface forapplication ofRespironics bi-levelor CPAP therapy topatients. For singlepatient use in thehome orhospital/institutionalenvironment. Themask is to be usedon adult patients(>30kg) for who bi-level or CPAPtherapy has beenprescribed using aRespironics bi-levelor CPAP system.	The ComfortGel NasalMask is intended toprovide an interface forapplication of CPAP or bi-level therapy to patients.The mask is for singlepatient use in the home ormulti-patient use in thehospital/institutionalenvironment. The mask isintended to be used onpatients (>66lbs/30kg) forwhom CPAP or bi-leveltherapy has beenprescribed using a CPAPor bi-level system.
PatientPopulation	Patients > 66 lbs/30 kg	Patients >30kg	Unchanged fromK073600/K991648
Environment ofUse	Home orHospital/institutionalEnvironment	Home orHospital/InstitutionalEnvironment	Unchanged fromK073600/K991648
Product Code	BZD	BZD	Unchanged fromK073600/K991648
Provided Sterileor Non-Sterile	Provided clean, notsterile	Provided clean, notsterile	Unchanged fromK073600/K991648
Patient UsageType	Multi-patient Use	Single patient use	Single Patient Use in thehome or multi-patient usein the hospital/institutionalenvironment.
Design	Face Interface andheadgear	Nasal interface andheadgear	Unchanged from K991648
Materials	Faceplate: PolycarbonateFace Seal: gel cushion	Faceplate:Polycarbonate	Faceplate: PolycarbonateFace seal: Gel cushion
	with urethane overlay .Cushion flap: SiliconeExhalation Port:PolycarbonateEntrainment Valve:Polycarbonate withSilicone FlapperHeadgear: UBL,Urethane foam and lycra	Face Seal: SiliconeCushionExhalation Elbow:PolycarbonateHeadgear:Velstretch/Lycralaminated foam	with polyester overlayCushion Flap: SiliconeExhalation Elbow:PolycarbonateExhalation Port: DelrinForehead Pad: SiliconeHeadgear: UBL, UrethaneFoam, and Lycra
Number ofPressure Pickoffports	One	One	None
Shape and sizeof faceplate	The shape of thefaceplate follows thecontours of the faceallowing clearance offacial features, coveringthe nose and mouth fortherapy. The faceplateattaches to a siliconesealing flap via aretaining ring.	Profile of thefaceplate isstreamlined for aslightly flatter,rounder and morecomplete shape tohelp reduce maskvolume.	The shape of thefaceplate follows thecontours of the faceallowing clearance offacial features, coveringthe nose only for therapy.The faceplate attaches toa silicone sealing flap viaa retaining ring.
Shape and sizeof cushion	Gel cushion to allow for amore comfortable fit andimproved maskperformance (less leak).	Cushion varies inthickness for betterseal and easier fit.The cushion materialis thinnest where thecushion contacts theuser's nose. Thincushion materialallows three basicmask sizes to fit abroad range of facialfeatures.	Gel cushion to allow for amore comfortable fit andimproved maskperformance (less leak).Dimensions modified to fitnasal mask.
Safety Valve	The safety valve isintegral to the mask.	N/A- nasal mask	Unchanged from K991648
Exhalationdevice	No accessory exhalationdevice is required.Exhalation ports areintegrated	No accessoryexhalation device isrequired. Exhalationports are integrated	No accessory exhalationdevice is required. 54 pinhole exhalation ports areintegrated
Anatomical Sites	Nose & mouth	Nose	Unchanged from K991648
Patient CircuitConnection	22 mm entrainment valveelbow	22 mm exhalationelbow	Unchanged from K991648
Pressure Range	4 to 30 cmH2O	4 to 30 cmH2O	Unchanged fromK073600/K991648
Number of MaskSizes	Three - small, mediumand 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 @ 1.5cm H2O	Unchanged from K073600
	H2O> 15 SLPM @ 5 cm H2O< 64 SLPM @ 40 cmH2O	H2O≥ 10 SLPM @ 2.5 cm≥ 16 SLPM @ 5.0 cm≤ 67 SLPM @ 40 cmH2O
UnintentionalLeak	≤17 SLPM @20 cm H2O≤ 28 SLPM @ 35 cmH2O	≤17 SLPM @20 cm≤ 28 SLPM @ 35 cmH2O	Unchanged fromK073600/K991648
Pressure Drop	Closed to Atmosphere:≤ 1 cm H2O at flows ≤ 50SLPM≤ 4 cm H2O at flows ≤100 SLPMOpen to Atmosphere:≤ 2 cm H2O @ flow up 60lpm	Not known	< 1 cmH2O (.98 hPa) atflows ≤ 50 SLPM< 4 cmH2O (3.9 hPa) atflows ≤ 100 SLPM (Elbowwithout entrainment valvecomparable to Elbow withentrainment valve, closedto atmosphere.)
Valve Open toAtmosphere	PAP Pressure ≥ 1cmH2O (0.40 in H2O) and ≤3 cm H2O (1.2 in H2O)	N/A- nasal mask	Unchanged from K99164
Valve Close toAtmosphere	PAP Pressure ≥ - 1 cmH2O (-0.40 in H2O)	N/A- nasal mask	Unchanged from K99164
Mask Weight	Small: 5.24 oz.Medium: 5.54 oz.Large: 5.86 oz.	No informationavailable	Petite: ~~4.83 oz.Small: ~ 5.39 oz.Medium:~~ 5.28 oz.Large: ~ 5.45 oz.
CushionHeight, Lengthand Width	Small: 4.01" x 3.51" x1.73"Medium: 4.34" x 3.84" x1.72"Large: 4.78" x 3.84" x1.74"	No informationavailable	Petite: 2.26" x 2.45" x1.47"Small: 2.76" x 2.78" x1.47"Medium: 2.76" x 2.78" x1.49"Large: 3.16" x 2.84" x1.47"
Faceplate	Small: 4.82" x 4.00" x1.09"	No informationavailable	Petite: 3.25" x 3.25" x0.97"
	1.09"		3.38" x 0.97"
	Large: 5.47" x 4.32" x1.09"		Large: 3.90" x 3.52" x0.97"
Occluded EndTidal CO2	Small = 7.6%Medium = 6.9%Large = 6.7%	No informationavailable	Large = 7.9%

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

. .-- .-- .---------

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To demonstrate performance and functionality of the ComfortGel Blue Nasal Mask was unaffected as a result of these changes, 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.

Respironics has followed the FDA's Guidance for Industry and FDA Staff document "pre-market assessment of pediatric medical devices" and applied the principle of FDA's Least Burdensome Approach to demonstrate the Substantial Equivalence of the ComfortGel Blue Nasal Mask. As a result we conclude that the existing indications for use can be safely and effectively applied to this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an emblem featuring a stylized depiction of an eagle or other bird with outstretched wings, symbolizing national strength and protection.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

FEB 1 2 2010

Respironics, Incorporated Ms. Zita A. Yurko Director, Regulatory Affairs 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K092835

Trade/Device Name: ComfortGel Blue Nasal Mask Regulation Number: 21CFR 868.5905 Regulation Name: Noncontinuous Ventilator IPPB Regulatory Class: II Product Code: BZD Dated: January 18, 2010 Received: February 2, 2010

Dear Ms. Yurko:

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.

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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 (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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh fo=

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 1 _ of _ 1

Indications for Use

510(k) Number (if known): ___

Device Name: ComfortGel Blue Nasal Mask

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 hospitallinstitutional environment. The mask is to be used by patients (>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:

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).