RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD

K062019 · Innomed Technologies, Inc./Respcare, Inc. · CBK · Aug 17, 2006 · Anesthesiology

Device Facts

• Record ID: K062019
• Device Name: RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
• Applicant: Innomed Technologies, Inc./Respcare, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hybrid NE Mask 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, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. (Applies to the standard version): For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.

Device Story

Hybrid NE Mask is a patient interface for non-invasive ventilation; delivers positive pressure to oral and nasal passages. Device connects to ventilators via standard 22 mm fitting; includes accessory ports for pressure monitoring or supplemental oxygen. Held in place by headgear. Used in homecare and institutional settings; operated by clinicians or patients. Designed for use with ventilators possessing active safety valves; lacks intentional exhalation features. Provides seal against face to facilitate ventilation; benefits patient by enabling non-invasive respiratory support.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Patient interface for non-invasive ventilation; 22 mm standard connector; includes accessory ports for oxygen/pressure monitoring. Available in disposable and multi-use configurations. Mechanical design; no software or electronic components.

Indications for Use

Indicated for adult patients (>30 kg) requiring noninvasive positive pressure ventilation. Suitable for use with ventilators equipped with active safety valves. Contraindications not specified.

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

• Hans Rudolph 7500 Vmask (K030515)
• Respironics Image3 SE (K023135)

Reference Devices

• RespCare Face Mask (K052227)

Submission Summary (Full Text)

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K062019

## 510(k) SUMMARY

| Submitter's Name: | RespCare Inc. |
|----------------------|----------------------------------------------------------------------|
| Submitter's Address: | 6601 Lyons Road, Suites B1-B4<br>Coconut Creek, FI 33073, USA |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Frank Pelc |
| Date: | July 14, 2006 |
| Proprietary Name: | RespCare Hybrid NE Mask |
| Common/Usual Name: | Face Mask |
| Classification: | Class II, CFR 868.5895, CBK |
| Classification Name: | Accessory to Continuous Ventilator |
| Predicate Devices: | K030515 – Hans Rudolph 7500 Vmask<br>K023135 - Respironics Image3 SE |

#### Device Description

A specialized interface for Non-Invasive Ventilation. It will be modeled after the RespCare Face Mask (K052227), with intentional exhalation features removed for use with ventilators equipped with an active safety valve.

#### Comparison to Predicate Devices

The RespCare Hybrid NE Mask is essentially similar to the legally marketed predicate interfaces listed above in function, intended use, materials, and features. The essential difference between the RespCare face mask and the predicate devices is the shape of the interface.

Both the proposed device and the predicates are intended to be used as a patient interface for non-invasive ventilation devices. Each are designed to be suitable for use with ventilators equipped with an active safety valve. Each deliver non-invasive ventilation to the patient's oral and nasal passages and provide a seal against the face as it is held in place with a headgear worn around the head. Each provide accessory ports for pressure monitoring or supplemental oxygen, and connect to the ventilator device via a standard 22 mm fitting.

#### Substantial Equivalence

The RespCare Hybrid NE Mask is equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design is also equivalent to the predicates, as described in the comparison above. Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices.

As such, it is RespCare's conclusion that the RespCare Hybrid NE Mask is substantially equivalent to the predicate devices.

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AUG 1 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Pelc Director, Regulatory Affairs and Quality Compliance Innomed Technologies, Incorporated /RespCare, Incorporated 6601 Lyons Road, Suites B1-B4 Coconut Creek, Florida 33073

Re: K062019

Trade/Device Name: Hybrid NE Mask Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 14, 2006 Received: July 17, 2006

Dear Mr. Pelc:

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 8010 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Pelc

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 regencies. 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 monufacturing prectice 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/cdrl/industry/support/index.html.

Sincerely vours.

Chia Lin, Ph.D.

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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# SECTION 7: INDICATIONS FOR USE

## 510(k) Number (if known): K062019

Device Name: Hybrid NE Mask

### Indications for Use:

The Hybrid NE Mask 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, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.

(Applies to the standard version):

For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.

(Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.

Prescription Use X (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)

Cilia Sndliom

: Humber

of Anesthesiology, General Hospital

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