CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS

K081743 · Draeger Medical AG & Co. KG · CBK · Sep 22, 2008 · Anesthesiology

Device Facts

• Record ID: K081743
• Device Name: CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
• Applicant: Draeger Medical AG & Co. KG
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ClassicStar™, NV, Full Face Mask, SE (with standard elbow), size S-L: The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) is intended to provide a patient interface for application of noninvasive ventilation. The mask is to he used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. It is intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment. The mask is disposable and for single patient use. NovaStar™, NV, Full Face Mask, SE (with standard elbow), size S-L: The mask NovaStar noninvasive ventilation (NV) with standard elbow (SE) is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure. The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Device Story

Full-face masks providing patient interface for noninvasive ventilation; covers mouth and nose. ClassicStar (disposable) and NovaStar (reusable up to 5 times) variants available with standard elbow (SE) or anti-asphyxia valve (AAV). SE models require ventilators with integrated alarm/safety systems; AAV models include exhalation ports and anti-asphyxia valve. Used in hospital, institutional, or home environments by clinicians or patients. Masks connect to positive pressure ventilation devices to treat respiratory failure/insufficiency. Output is delivered air/pressure to patient airway; facilitates respiratory support and patient benefit through noninvasive ventilation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Full-face mask interface; available in sizes S, M, L. Materials include headgear and mask components. SE models feature standard elbow; AAV models feature integrated anti-asphyxia valve and exhalation ports. Reusable models (NovaStar) validated for up to 5 uses. No electronic components, software, or energy sources.

Indications for Use

Indicated for adult patients (>30 kg/66 lbs) requiring noninvasive ventilation (CPAP or positive pressure) for respiratory failure or insufficiency. SE models require ventilators with adequate alarms/safety systems; AAV models require positive airway pressure devices operating at ≥3 mbar. Used in hospital, institutional, or home (AAV only) settings.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Image3 SE Disposable Full Face Mask (K023135)
• SleepNet MoJoTM -NV Full Face Mask nonvented (K063806)
• SleepNet MoJoTM Full Face Mask (K060273)

Submission Summary (Full Text)

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# 510(k) Summary

## Summary of Safety and Effectiveness

#### Applicants Name and Address:

Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany

Establishment Registration Number: 9611500

#### Contact Person:

Dr. Karin Luebbers Senior Manager Regulatory Affairs

Tel. No.: + 49 [phone] Fax No .: + 49 (451) 882-7-5367

#### Applicants US Contact Person

Ms. Jovce Kilrov VP Processes, Quality & Regulatory Affairs

Tel. No .: [phone] Fax No .: [phone]

#### Date submission was prepared:

2008-09-09

#### Device Name:

ClassicStar™, NV, Full Face Mask, SE Trade Name: Common Name: Full Face Mask, Noninvasive ventilation Trade Name: NovaStar™, NV, Full Face Mask, SE Common Name: Full Face Mask, Noninvasive ventilation NovaStar™, NV, Full Face Mask, AAV Trade Name: Common Name: Full Face Mask, Noninvasive ventilation

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### Noninvasive Ventilation Masks

#### Classification:

| Class II | | |
|----------------|--------------------------------------|--------------|
| Regulation No. | Device | Product Code |
| 868.5895 | Ventilator, continuous, facility use | 73CBK |

Legally Marketed Device to which Substantial Equivalence is claimed:

| 510(k) number | Trade name | Company |
|---------------|-------------------------------------------------|------------------|
| K023135 | Image3 SE Disposable Full Face Mask | Respironics Inc. |
| K063806 | SleepNet MoJoTM -NV Full Face Mask<br>nonvented | SleepNet Corp. |
| K060273 | SleepNet MoJoTM Full Face Mask | SleepNet Corp. |

### Device Description:

Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation.

The masks ClassicStar and NovaStar are Full-Face masks which cover the mouth and the nose and are available with a standard elbow (SE) or an anti-asphyxia valve (AAV). Masks with a standard elbow (SE) may only be used on ventilation devices, which incorporate adequate alarm and safety systems for ventilation failure.

A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow.

The ClassicStar Masks are disposable, while the NovaStar Masks are reusable up to 5 times for multiple patients. Further differences are the headgears, which are similar in materials but differ in means of connection to the mask. The headgears are generally provided with the masks, for the reusable masks further headgears are available as optional accessory.

All noninvasive ventilation masks are available in three different sizes (S, M, L),

#### Intended Use:

ClassicStar™, NV, Full Face Mask, SE (with standard elbow), size S-L:

The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) is intended to provide a patient interface for application of noninvasive ventilation. The mask is to he used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. It is intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment. The mask is disposable and for single patient use. NovaStar™, NV, Full Face Mask, SE (with standard elbow), size S-L:

The mask NovaStar noninvasive ventilation (NV) with standard elbow (SE) is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

SEP 2 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karin Lübbers Senior Manger Regulatory Affairs Draeger Medical AG & Co. KG 53/55 Moislinger Allee Luebeck GERMANY 23542

Re: K081743

Trade/Device Name: ClassicStar™, NV, Full Face Mask, SE NovaStar™, NV, Full Face Mask, SE NovaStarTM, NV, Full Face Mask, AAV Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 10, 2008 Received: September 15, 2008

Dear Ms. Lübbers:

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 - Ms. Lübbers

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

ThAnnuele Yendms foell

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): K

Device Name:

ClassicStar ™, NV, Full Face Mask, SE Star TM, NV, Full Face Mask, SE
NovaStar TM, NV, Full Face Mask, AAV

Indications for Use:

The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (N); with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment.

The mask ClassicStar NV, with standard elbow is disposable and for single patient use.

The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Prescription Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. The

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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Ko81743 510(k) Number: -