TWILIGHT FULL FACE MASK

K070321 · Invacare Corp. · BZD · Apr 30, 2007 · Anesthesiology

Device Facts

• Record ID: K070321
• Device Name: TWILIGHT FULL FACE MASK
• Applicant: Invacare Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.

Device Story

Twilight Full Face Mask serves as patient interface for positive airway pressure (PAP) therapy; delivers air from CPAP/Bi-Level devices to patient nose and mouth. Components include molded silicone cushion, rigid polycarbonate frame, headgear, exhalation ports, and anti-asphyxia valve. Anti-asphyxia valve ensures ambient air access if PAP unit fails. Integrated port allows pressure measurement. Used in clinical or home settings; operated by patient or clinician. Device facilitates therapy delivery; improves patient compliance/treatment efficacy for obstructive sleep apnea.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 17510-2:2003 (masks/accessories) and ISO 5356-1:2004 (conical connectors). Testing confirmed pressure drop, exhaust flow, and dead space parameters are substantially equivalent to predicate devices.

Technological Characteristics

Materials: Polycarbonate frame, silicone cushion. Sensing/Actuation: Passive interface; includes anti-asphyxia valve and exhalation ports. Dimensions: Compatible with standard 22mm hose. Connectivity: None. Sterilization: Reusable (multi-patient). Standards: ISO 17510-2, ISO 5356-1, ISO 13485, ISO 14971.

Indications for Use

Indicated for adult patients (>30 kg) with obstructive sleep apnea requiring positive airway pressure (CPAP or Bi-Level) therapy (4-20 cmH2O).

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

• ResMed Mirage Full Face Mask Series 2 (K023244)
• Respironics Spectrum 2 Reusable Full Face Mask, Model 1004884 (K002465)

Submission Summary (Full Text)

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APR 3 0 2007

# 510(K) SUMMARY FOR INVACARE'S TWILIGHT FULL FACE MASK

This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

The assigned 510(k) number is < 070321

Date: February 1, 2007

Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190

Telephone: [phone] Fax: [phone]

Contact Person: Mr. Carroll Martin

Trade Name: Twilight Full Face Mask

Common Name: Mask

Classification Name: Ventilator, non-continuous (respirator) per 21 CFR 868.5905

Legally Marketed Predicate Device(s): ResMed Mirage Full Face Mask Series 2: K023244 November 27, 2002 Respironics Spectrum 2 Reusable Full Face Mask, Model 1004884; K002465, September 8, 2000

Device Description: The Twilight full Face Mask consists of a mask that fits over the nose and mouth of a patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose and mouth. The cushion mounts to a rigid clear plastic frame. The frame has built in exhalation ports, a full swivel for locating the pressure device hose, a tubing swivel to allow for twisting of the hose, and a built in anti-asphyxia valve to allow the inner volume of the mask to be open to the outer atmosphere when there is no pressure being supplied by the flow generator device. Mounted to the frame is an adjustable forehead support for resting against the patient's forehead. The headgear has quick release clips and loop adjustment on the straps.

Intended Use: The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.

#### INVACARE CORPORATION

One Invacare Way P.O. Box 4028 Elvria, OH 440 440-329-6000 Fax: [phone] www.inva

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Image /page/1/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, sans-serif letters. The word is enclosed in a black oval shape with a white outline. The logo is simple and modern.

# Substantial Equivalence:

| Specification | Twilight Full Face Mask | ResMed Mirage Full<br>Face Mask Series 2 | Respironics Spectrum 2<br>Reusable Full Face Mask, Model<br>1004884 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K023244 | K002465 |
| Date Cleared | TBD | November 27, 2002 | September 8, 2000 |
| Intended Use | The Invacare Twilight Full Face Mask<br>is intended to be used with positive<br>airway pressure (PAP) devices, such as<br>CPAP and Bi-Level, which provide 4-<br>20 cmH2O for the treatment of adult<br>obstructive sleep apnea. There is a<br>port on the mask to allow for pressure<br>measurement. The mask is to be used<br>on adult patients (>30 kg) for whom<br>positive airway pressure therapy has<br>been prescribed. The mask is intended<br>for single or multiple patient re-use. | The Ultra Mirage Full Face Mask is<br>intended for multi-patient use for adult<br>patients (>30 kg) prescribed continuous<br>positive airway pressure (CPAP) or bi-<br>level therapy in hospital, clinic, and/or<br>home environments. | The ComfortFull 2 Reusable Full<br>face Mask and Headgear are<br>intended for use by adults as an<br>interface with Respironics CPAP<br>or bi-level devices. The mask<br>covers the nose and mouth. An<br>exhalation port is built into the<br>ComfortFull 2 mask so that a<br>separate exhalation port is not<br>required. Before using this mask,<br>the home care provider should<br>verify device pressure(s). This<br>mask is not suitable for providing<br>life support ventilation. |
| Patient Use | Adults >30Kg | Adults >30Kg | Adults |
| Single/Multiple<br>Patient Use | Multiple-patient | Multiple-patient | Multiple-patient |
| Input Device<br>Range | 4-20 cmH2O | 4-20 cmH2O | 3-40 cmH2O |
| Mask Frame<br>Material | Polycarbonate | Polycarbonate | Polycarbonate |
| Nasal Cushion<br>Material | Silicone | Silicone | Silicone |
| Anti-asphyxia<br>Valve | Yes - silicone | Yes - silicone | Yes - silicone |
| Hose Connection<br>Input | For Ø22mm hose | For Ø22mm hose | For Ø22mm hose |
| Exhalation Ports | 5 | 6 | 44 |
| Swivel<br>Connections | 360° Rotation | 360° Rotation | 360° Rotation |
| Ports | 1 port | 2 ports | 1 port |
| Exhaust Flow | 23 LPM @ 4 cmH2O<br>53 LPM @ 20 cmH2O | 22 LPM @ 4 cmH2O<br>54 LPM @ 20 cmH2O | Below 5 cmH2O, unknown<br>~ 43 LPM @ 20 cmH2O |
| Pressure Drop at<br>patient<br>connection | < 0.3 cmH2O @ 50 LPM<br>< 1.0 cmH2O @ 100 LPM | Unknown | Unknown |
| Internal volume<br>(Dead space) | Dead space varies according to<br>cushion sizes but is less than 303ml | Dead space varies according to cushion<br>sizes but is less than 258mL | Dead space varies according to<br>cushion sizes and is between<br>274ml and 428ml |

As the chart above shows, the Invacare Full Face Mask incorporates features from both predicate devices. All of the above devices have the same intended use for the same patient population, are made of similar materials, have exhalation ports to prevent re-breathing of exhaled gases, have an anti-

#### INVACARE CORPORATION

One Invacare Way P.O. Box 4028 Elyria, OH 44 440-329-6000 Fax: [phone] www.inv.

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Image /page/2/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, white letters against a black oval background. The oval is outlined by two white lines, one above and one below the word "INVACARE".

asphyxia valve to guard against possible suffocation if the PAP unit shuts down while the patient is wearing the mask and ports in the mask frame to allow for pressure measurement devices.

Performance Testing: The Invacare Twilght Full Face Mask has been tested in accordance with the following:

| ISO 17510-2:2003: | Sleep apnoea breathing therapy - Part 2: Masks and application accessories |
|-------------------------------------|-------------------------------------------------------------------------------------------|
| ISO 5356-1:2004: | Anaesthethic and respiratory equipment - Conical connectors - Part1: Cones<br>and sockets |
| ISO 13485:2003: | Medical devices - Quality management systems -- Requirements for regulatory<br>purposes |
| ISO 14971:2000:<br>(Amendment 2003) | Medical devices -- Application of risk management to Medical Devices |
| EN 980:2003: | Graphical symbols for use in the labeling of medical devices |
| EN 1041:1998: | Information supplied by the manufacturer with medical devices |

Performance Data: The performance data found in this submission shows that the Invacare Full Face Mask performs as intended and in a manner that is substantially equivalent to the predicate devices.

Conclusion: The data presented in this submission shows that the Invacare Twilight Full Face Mask performs as intended and in a manner that is substantially equivalent to the predicate devices.

One Invacare Way P.O. Box 4028 Elyria, OH 4 440-329-6000 Fax: [phone] www.inv

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carroll Martin Regulatory Specialist Invacare Corporation One Invacare Way Elyria, Ohio 44035-4190

APR 3 0 2007

Re: K070321

Trade/Device Name: Twilight Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 1. 2007 Received: February 5, 2007

Dear Mr. Martin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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## Page 2 - Mr. Martin

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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# Indications for Use

# 510(k) Number (if known): |くんつじろく

### Device Name: Twilight Full Face Mask

Indications for Use: The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.

Prescription Use (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)

Chilton

( E-Mon of Ancolnoon Dental Devices

C(k) Number:

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