Who is the manufacturer of COMFORTGEL NASAL MASK?

Respironics Inc., Sleep & Home Respiratory Group filed the 510(k) submission for COMFORTGEL NASAL MASK (K092835).

What is the FDA product code for COMFORTGEL NASAL MASK?

BZD. It is classified under 21 CFR 868.5905 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for COMFORTGEL NASAL MASK?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like COMFORTGEL NASAL MASK?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COMFORTGEL NASAL MASK

Q: What are the predicate devices for COMFORTGEL NASAL MASK?

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

K092835 · Respironics Inc., Sleep & Home Respiratory Group · BZD · Feb 12, 2010 · Anesthesiology

Device Facts

Record ID	K092835
Device Name	COMFORTGEL NASAL MASK
Applicant	Respironics Inc., Sleep & Home Respiratory Group
Product Code	BZD · Anesthesiology
Decision Date	Feb 12, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5905
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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.

Device Story

ComfortGel Blue Nasal Mask is a non-invasive patient interface for CPAP or bi-level therapy. Device consists of a polycarbonate faceplate, gel cushion with polyester seal, and integrated exhalation ports on the elbow. It covers the nose only and secures via headgear with ball clip attachments. Connects to flow generators via standard 22mm tubing. Used in home (single-patient) or hospital (multi-patient) settings by patients >66lbs/30kg. Healthcare providers or patients attach the mask to deliver positive pressure ventilation to the lungs. The gel cushion design aims to improve fit and reduce air leaks compared to traditional masks. The device facilitates therapy delivery, potentially improving patient compliance and treatment efficacy for respiratory conditions.

Clinical Evidence

Bench testing only. Performance testing included intentional leak, pressure drop, CO2 rebreathing, deadspace, and swivel torque on both untreated and treated samples. Disinfection efficacy testing was performed to ensure a minimum 6-log reduction in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, and ANSI/AAMI/ISO 14937-2000.

Technological Characteristics

Materials: Polycarbonate faceplate, gel cushion with polyester overlay, silicone cushion flap, Delrin exhalation port, UBL/urethane foam/lycra headgear. Sensing/Actuation: Passive interface for positive pressure delivery. Connectivity: Standard 22mm tubing. Sterilization: Provided clean, non-sterile; validated for high-level disinfection. Form factor: Nasal mask with integrated exhalation ports.

Indications for Use

Indicated for patients >66lbs/30kg requiring CPAP or bi-level therapy. Used as an interface for non-invasive positive pressure ventilation in home or hospital settings.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

{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}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ - 4. Modification to the mask elbow to remove entrainment valve, similar to the Reusable Contour II Nasal Mask (K991648). - 5. Modification to add additional sizes of the mask. - 6. 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}------------------------------------------------ · ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . · : ---- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | 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 < 64 SLPM @ 40 cm H2O | H2O ≥ 10 SLPM @ 2.5 cm ≥ 16 SLPM @ 5.0 cm ≤ 67 SLPM @ 40 cm H2O | | | Unintentional Leak | ≤17 SLPM @20 cm H2O ≤ 28 SLPM @ 35 cm H2O | ≤17 SLPM @20 cm ≤ 28 SLPM @ 35 cm H2O | Unchanged from K073600/K991648 | | Pressure Drop | Closed to Atmosphere: ≤ 1 cm H2O at flows ≤ 50 SLPM ≤ 4 cm H2O at flows ≤ 100 SLPM Open to Atmosphere: ≤ 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 (Elbow without entrainment valve comparable to Elbow with entrainment valve, closed to atmosphere.) | | Valve Open to Atmosphere | PAP Pressure ≥ 1cm H2O (0.40 in H2O) and ≤ 3 cm H2O (1.2 in H2O) | N/A- nasal mask | Unchanged from K99164 | | Valve Close to Atmosphere | PAP Pressure ≥ - 1 cm H2O (-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 information available | Petite: ~4.83 oz. Small: ~ 5.39 oz. Medium:~ 5.28 oz. Large: ~ 5.45 oz. | | Cushion Height, Length and Width | Small: 4.01" x 3.51" x 1.73" Medium: 4.34" x 3.84" x 1.72" Large: 4.78" x 3.84" x 1.74" | No information available | Petite: 2.26" x 2.45" x 1.47" Small: 2.76" x 2.78" x 1.47" Medium: 2.76" x 2.78" x 1.49" Large: 3.16" x 2.84" x 1.47" | | Faceplate | Small: 4.82" x 4.00" x 1.09" | No information available | Petite: 3.25" x 3.25" x 0.97" | | | 1.09" | | 3.38" x 0.97" | | | Large: 5.47" x 4.32" x 1.09" | | Large: 3.90" x 3.52" x 0.97" | | Occluded End Tidal CO2 | Small = 7.6% Medium = 6.9% Large = 6.7% | No information available | Large = 7.9% | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ .............................................................................................................................................................................. . .-- .-- .--------- {4}------------------------------------------------ · · ----- -------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ---- {5}------------------------------------------------ - ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {6}------------------------------------------------ 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. {7}------------------------------------------------ #### 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. {8}------------------------------------------------ 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 {9}------------------------------------------------ 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:

COMFORTGEL NASAL MASK

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COMFORTGEL NASAL MASK

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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