IMAGE3 SE DISPOSABLE FULL FACE MASK

K023135 · Respironics, Inc. · CBK · Jan 3, 2003 · Anesthesiology

Device Facts

• Record ID: K023135
• Device Name: IMAGE3 SE DISPOSABLE FULL FACE MASK
• Applicant: Respironics, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Image3 SE Disposable Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which 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, respiratory insufficiency, or obstructive sleep apnea. The mask is disposable and for single patient use. It is intended for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

Device Story

Full face mask covering nose and mouth; provides seal for positive pressure ventilation; connects to ventilator circuit via 22 mm elbow; includes pressure pickoff/oxygen enrichment port; features headgear with quick-release clips for rapid removal. Used in hospital/institutional environments by clinicians. Acts as patient interface for CPAP or positive pressure ventilation; directs airflow to patient; enables monitoring via pressure port. Benefits patient by facilitating noninvasive respiratory support.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Full face mask consisting of faceplate, cushion, elbow, and headgear. Includes integrated pressure pickoff/oxygen enrichment port. Disposable, single-patient use. No electronic components or software.

Indications for Use

Indicated for adult patients (> 30 kg) requiring noninvasive ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea in hospital/institutional 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

• Spectrum 2 Full Face Mask (K002465)

Submission Summary (Full Text)

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K023135

Image /page/0/Picture/3 description: The image shows the title "TAB I" followed by "510(K) SUMMARY OF SAFETY & EFFECTIVENESS / EXECUTIVE SUMMARY". The text is in bold and is centered on the page. The background of the image is a light gray color.

JAN 0 3 2003

Image /page/0/Picture/5 description: The image shows the logo for Respironics Inc. The logo consists of a triangle with a stylized figure inside, followed by the company name in bold letters. Below the name is the address "1001 Murry Ridge Lane, Murrysville, PA 15668".

| Date of Submission | September 13, 2002 |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Official Contact/ Address<br>Of Manufacturing Facility | Zita A. Yurko<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Respironics Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
| Establishment Registration<br>Number | 2518422 |
| Proprietary Name | Image3 SE Disposable Full Face Mask |
| Common/Usual Name | Face Mask |
| Classification Reference | 21 CFR 868.5895 |
| Class | Class II |
| Classification Panel | Anesthesiology Devices |
| Product Code | CBK - Ventilator, Continuous |
| Predicate Device | Spectrum 2 Full Face Mask (K002465) |
| Reason for submission | Modified design |

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The Image3 SE Disposable Full Face Mask is available in three sizes: small, medium, and large, and is only indicated for use on adult patients.

A typical patient circuit consists of tubing and possibly a humidifier, and/or bacteria filter.

Image /page/1/Figure/4 description: This image shows a diagram of a face mask and its components. The diagram labels the different parts of the mask, including the faceplate, 22 mm elbow, middle strap, slot, pressure pickoff port, lower side straps, quick-release clips, quick-release buttons, and cushion. Arrows point to each of these parts, indicating their location on the mask.

Figure 1-1: Image3 SE Disposable Full Face Mask

(End of Section.)

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## Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate device, the Spectrum 2 Full Face Mask (K002465):

- O Same operating principle
- O Same technology
- Q Same manufacturing process

Design verification tests were performed on the Respironics Image3 SE Disposable Full Face Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate device.

## Indications for Use

The Image3 SE Disposable Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which 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, respiratory insufficiency, or obstructive sleep apnea.

The mask is disposable and for single patient use. It is intended for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

# Device Description

The Image3 SE Disposable Full Face Mask is an externally placed mask covering the nose and mouth (full face) of a patient. It is intended to provide a seal so that positive pressure from a positive pressure source is directed to the patient's nose and mouth. The device consists of a faceplate, standard elbow, cushion, and headgear. The faceplate has one pressure pick off/oxygen enrichment port with port cap, a slot at the top of the faceplate to attach a headgear strap, and two integrated headgear quick release clips (one each side of the faceplate) for fast and easy removal of the mask.

Please refer to Figure 1-1 for an illustration of the mask.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design that resembles a bird or a stylized human figure, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**JAN 03 2003**

Ms. Zita A. Yurko Manager, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550

Re: K023135

Trade/Device Name: Image3 SE Disposable Face Mask Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 23, 2002 Received: December 24, 2002

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.

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.

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.

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Page 2 - Ms. Yurko

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

510(k) Number (if known):

Device Name: Image3 SE Disposable Full Face Mask

Indications for Use:

The Image3 SE Disposable Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which 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, respiratory insufficiency or obstructive sleep apnea.

The mask is disposable and for single patient use. It is intended for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

fo AWindoher

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

510(k) Number

(Optional Format 3-10-98)