ORACLE ORAL MASK, MODEL HC451A

K033087 · Fisher & Paykel Healthcare, Ltd. · BZD · Jan 14, 2004 · Anesthesiology

Device Facts

• Record ID: K033087
• Device Name: ORACLE ORAL MASK, MODEL HC451A
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oracle Oral Mask is intended for adult patient use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel ventilator treatment. A CPAP or Bilevel ventilator is typically used to treat obstructive sleep apnea (OSA) and may be used in the home, hospital or laboratory. The positive air pressure supplied by the ventilator is delivered via the Oracle Oral Mask to the patient's mouth.

Device Story

Oracle Oral Mask provides oral interface for CPAP/Bilevel ventilation; delivers positive airway pressure to patient mouth. Device features mouthpiece retained in mouth during sleep via adjustable SnapFlap™ resting against cheeks. Optional accessory kit includes nasal plugs and non-rebreathing valve to mitigate oral dryness from nasal leaks. Used in home, hospital, or laboratory settings; operated by patient. Healthcare provider prescribes treatment; device facilitates sustained pressure delivery. Benefits include effective OSA treatment via oral route, improved compliance through optional accessories, and secure fit.

Clinical Evidence

Bench testing only. Performance evaluated for strength, durability, and biocompatibility. Comparison of pressure-flow characteristics, dead space CO2, and flow impedance against predicate device.

Technological Characteristics

Oral mask interface; silicone SnapFlap™ retention mechanism; materials compliant with ISO 10993-1. Includes optional nasal plugs and non-rebreathing valve. Reusable device; suitable for multi-patient reprocessing. No electronic components or software.

Indications for Use

Indicated for adult patients requiring CPAP or Bilevel ventilator treatment for Obstructive Sleep Apnea (OSA). Used as a patient-to-ventilator oral interface in home, hospital, or laboratory settings under physician supervision.

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

• Fisher & Paykel Healthcare, LTD., Oracle Oral Mask, Model 900HC451 (K023559)

Submission Summary (Full Text)

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JAN 1 4 2004

K033087

## September 22, 2003

### 510(k) Summary of Safety and Effectiveness Information

| Trade Name: | Fisher & Paykel Healthcare Oracle Oral Mask |
|----------------------|--------------------------------------------------------------------------------|
| Model: | HC451A |
| Classification Name: | Accessory to Noncontinuous ventilator (IPPB) - 73 BZD |
| | Anesthesiology Devices, 21 CFR §868.5905 (Class II) |
| Predicate Device: | Fisher & Paykel Healthcare, LTD., Oracle Oral Mask, Model<br>900HC451, K023559 |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92:

### (a)(1) - (a)(3) Refer to information above and concluding this summary.

### (a)(4) Description of the Device

The Oracle Oral Mask provides a patient to ventilator oral interface in a noncontinuous ventilator system. The mouthpiece is positioned in the patient's mouth during CPAP or Bileyel treatment. Features of the mouthpiece ensure the desired positive airway pressure is delivered to the patient with minimal leakage and that the mouthpiece is retained in the mouth while asleep.

The Oracle Oral Mask is supplied with an accessory kit for optional use, consisting of nasal plugs and a non-rebreathing valve, which may be used to reduce oral dryness as a result of nasal leak.

## (a){5) Statement of the Intended Use

The Oracle Oral Mask is intended for adult patient use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel ventilator treatment. A CPAP or Bilevel ventilator is typically used to treat obstructive sleep apnea (OSA) and may be used in the home, hospital or laboratory. The positive air pressure supplied by the ventilator is delivered via the Oracle Oral Mask to the patient's mouth.

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# 510(k) Summary of Safety and Effectiveness Information (continued)

#### (a)(6) Technological Characteristics Summary and Comparison to Predicate

The Oracle Oral Mask in this submission is substantially equivalent to the predicate Oracle Oral Mask. Both masks have the same intended use, operating principle and technological characteristics.

The "Oracle" Oral Mask mouthpiece is designed to assure unobstructed access to the patient's airway and to create an air-seal around the patient's mouth to facilitate sustained delivery of positive airway pressure. The Oral Mask mouthpiece is retained inside the mouth during sleep by action of the SnapFlap™ which rests against the patient's cheeks. The position of the SnapFlap™ can be adjusted by the patient to any one of three positions to further improve the fit can adjust the position of the SnapFlap™.

The Oral Mask is manufactured from materials that have either been previously cleared for the same intended use, or are compliant with the requirements of ISO 10993-1.

The Oracle Oral Mask outlined in this submission is equivalent to the predicate mask with respect to pressure-flow characteristics, dead space CO2, and flow impedance.

- The SnapFlap™ material used in the Oracle in this submission continues to be a . silicone but is an alternative to that that used in the predicate.
- The "Oracle" is now packaged with an accessory package consisting of nasal . plugs and a non-rebreathing valve which may optionally be used to increase compliance in instances where the user experiences dryness from nasal leak.

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# 510(k) Summary of Safety and Effectiveness Information (continued)

# (b)(1) and b(2) Discussion of Non-Clinical and Clinical Tests

Tests, relevant to the modifications, were performed on the Oracle Oral Mask to demonstrate substantial equivalence to the predicate device. These demonstrated effective performance in terms of strength, durability and biocompatibility.

# (b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance

- The "Oracle" Oral Mask as outlined in this submission is substantially equivalent to the . predicate Oral Mask. When used as intended, the Oracle Oral Mask has been shown to be as safe and effective as the predicate device.
signed:

J.T.
James Thompson

date:

James Thompson Regulatory Affairs Engineer - OSA Fisher & Paykel Healthcare Ltd

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2004

Mr. James Thompson Regulatory Affairs Engineer Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place, East Tamaki PO Box 14-348, Panmure Auckland, New Zealand

Re: K033087

Trade Name: Oracle Oral Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 5, 2003 Received: December 16, 2003

Dear Mr. Thompson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revealed 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 for use stated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce provide to thay 20, 1977, and with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Ace, rece the device, subject to the general controls provisions of the Act. The I ou thay, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified too works. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Cour acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least oc advised that I Dris issuaires or our device complies with other requirements of the Act that I DA has Intace a abon regulations administered by other Federal agencies. You must or any I coclar statutes and regaranents, including, but not limited to: registration and listing (21

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Page 2 - Mr. James Thompson

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/dsma/dsmamain.html.

Sincerely yours,

Chiu 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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# INDICATIONS FOR USE

[510(k)] Number: K033087

Device Name: "Oracle" Oral Mask HC451A

Indications For Use:

The Fisher & Paykel Healthcare Oracle Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) as per BZD, 21 CFR §868.5905.

The Oral Mask is indicated for use by adults requiring CPAP or Bilevel ventilator treatment in The Oral Mask is Indicator for ass by analitts for the treatment of Obstructive Sleep Apnea mome, nospitar and fubblatory of wentilator interface in a non-continuous ventilator system. (Ook). The onlinisters positive airway pressure orally. The Oral Mask is a reusable device The device administers positive alitation of a suitably qualified physician. The Oral Mask may be reprocessed for multi-patient use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use_ (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: C033087