SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE

K961915 · Respironics, Inc. · BZD · Aug 15, 1996 · Anesthesiology

Device Facts

• Record ID: K961915
• Device Name: SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Patient interface accessory for Respironics CPAP and BiPAP® Systems

Device Story

Spectrum Reusable Full Face Mask is an externally placed interface covering nose and mouth; provides seal for positive pressure delivery from CPAP/BiPAP systems. Features include integrated entrainment valve (opens when positive pressure ceases to allow ambient air), quick-release mechanism, and adjustable headgear. Optional 'Comfort Flap' accessory improves seal/comfort. Device is reusable, intended for cleaning with soap and water. Used in hospital or home settings by patients. Output is physical delivery of pressurized air to patient airway; facilitates therapy for OSA.

Clinical Evidence

Bench testing only. Qualification tests included initial performance, environmental simulation (shipping, storage, usage, cleaning), performance at extreme conditions, and repeated disassembly/reassembly of the entrainment valve. Results confirmed device meets all functional and design requirements.

Technological Characteristics

Full face mask with entrainment valve and adjustable headgear. Materials support cleaning with soap and water. Entrainment valve activation pressure ≥ 3.0 cm H₂O. Non-sterile. Reusable design.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea (OSA) requiring positive pressure therapy (≥ 3.0 cm H₂O) via CPAP or BiPAP systems in hospital or home environments.

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 Spectrum Disposable Full Face Mask (K936047)
• Vacumed Comfo-Seal Reusable Full Face Mask (K# unknown)

Submission Summary (Full Text)

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K961915

RESPIRONICS INC.

AUG 15 1996

# Non-Confidential Summary of Safety and Effectiveness

page 1 of 4

May 13, 1996

Respironics, Inc.
1001 Murry Ridge Drive
Murrysville, PA
Tel - [phone]
Fax - [phone]

Official Contact: Francis X. Dobscha, Manager, Regulatory Affairs
Proprietary or Trade Name: Spectrum Reusable Full Face Mask
Common/Usual Name: Face Mask
Classification Name: Noncontinuous Ventilator (IPPB) Accessory
Device: Respironics Spectrum Reusable Full Face Mask
Predicate Devices: Respironics Spectrum Disposable Full Face Mask - K936047
Vacumed Comfo-Seal Reusable Full Face Mask - K# unknown

## Device Description:

The Spectrum Reusable 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. It connects to a patient circuit that contains an exhalation valve, tubing, and perhaps a humidifier and/or bacteria filter. It incorporates an Entrainment Valve which permits entrainment of ambient air when positive pressure to the patient ceases. The entrainment valve opens and closes based upon positive pressure being delivered to the patient. In addition, the mask incorporates a quick-release mechanism allowing the patient to quickly and easily remove the mask if desired. It is held in place with an adjustable headgear system. It is intended to be cleaned with soap and water. The cleaning process requires limited disassembly.

The Spectrum Reusable Full Face Mask may be used with an optional thin, pliable flap which may be used to improve the comfort and sealing of the basic unit. This accessory is referred to as the Comfort Flap. It is available either with the mask or sold separately as a replacement part.

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1001 Murry Ridge Drive, Murrysville, PA 15668-8550
412/733-0200 Fax: [phone]

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May 13, 1996

# Non-Confidential Summary of Safety and Effectiveness (continued)

## Intended Use:

**Indicated Use --** Patient interface accessory for Respironics CPAP and BiPAP® Systems

**Targeted Population --** Adult

**Environment of Use --** Hospital and Home

## Comparison to Predicate Devices:

| Attribute | Respironics Reusable Spectrum Full Face Mask | Respironics Disposable Full Face Mask | Vacumed Comfo-Seal Reusable Full Face Mask |
| --- | --- | --- | --- |
| **Use** | | | |
| Intended Use -- Adult Obstructive Sleep Apnea (OSA) | Yes | Yes | Yes |
| Intended to be used with devices such as Respironics CPAP Systems and BiPAP Systems producing positive pressures ≥ 3.0 cm H₂O at the mask. | Yes | Yes | Yes |
| Intended Environment - Hospital: Adult OSA | Yes | Yes | Yes |
| Intended Environment - Home: Adult OSA | Yes | Yes | Yes |

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page 3 of 4
May 13, 1996

# Non-Confidential Summary of Safety and Effectiveness (continued)

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May 13, 1996

## Comparison to Predicate Devices: (continued)

| Attribute | Respironics Reusable Spectrum Full Face Mask | Respironics Disposable Full Face Mask | Vacumed Comfo-Seal Reusable Full Face Mask |
| --- | --- | --- | --- |
| Design | | | |
| Offered in various sizes | Yes | Yes | Yes |
| Intended for single patient multi-use | Yes | No | Yes |
| Made to be cleaned with soap and water | Yes | No | Yes |
| Provided non-sterile | Yes | Yes | Yes |
| Incorporates an Entrainment Valve | Yes | Yes | No |
| Adapts to headgear | Yes | Yes | Yes |
| Performance Standards/Specifications | | | |
| Entrainment valve activation pressure of 3.0 cm H₂O minimum | Yes | Yes | Not Available |
| Meets design requirements after cleaning | Yes | Yes | Yes |

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# Non-Confidential Summary of Safety and Effectiveness (continued)

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May 13, 1996

## Performance Features:

Qualification tests were performed with samples of the intended device covering the following basic areas:

- Initial performance characteristics of the device and components
- Environmental performance simulating shipping, storage and usage, including cleaning
- Performance after environmental simulations of the device and components
- Performance at extreme user conditions
- Performance of repeated disassembly / reassembly of the Entrainment Valve

Test results show that the Spectrum Reusable Full Face Mask meets all functional and key requirements as defined in the product design specifications.

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