(107 days)
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 home, hospital and laboratory for the treatment of Obstructive Sleep Apnea (OSA). The Oral Mask is a ventilator interface in a non-continuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is a reusable device for use under the direct supervision of a suitably qualified physician. The Oral Mask may be reprocessed for multi-patient use.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fisher & Paykel Healthcare Oracle Oral Mask (K033087):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K033087) does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria Category | Acceptance Criteria (as implied/inferred from the document) | Reported Device Performance and Evidence in Study (from the document) |
|---|---|---|
| Intended Use | Must align with the predicate device's intended use. | "Both masks have the same intended use..." (Section 1a(6)). The Oracle Oral Mask is intended for adult patient use by individuals diagnosed with requiring CPAP or Bilevel ventilator treatment, typically for Obstructive Sleep Apnea (OSA), for use in home, hospital, or laboratory settings. |
| Operating Principle | Must align with the predicate device's operating principle. | "Both masks have the same... operating principle..." (Section 1a(6)). The mouthpiece is positioned in the patient’s mouth to deliver positive airway pressure for CPAP or Bilevel treatment, minimizing leakage, and ensuring retention during sleep. |
| Technological Characteristics | Must demonstrate similar technological characteristics to the predicate device, especially in pressure-flow, dead space CO2, and flow impedance. | "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." (Section 1a(6)). Minor modifications (alternative silicone for SnapFlap™, inclusion of accessory kit) are noted but not considered to alter fundamental equivalence. |
| Biocompatibility | Materials must be biocompatible and suitable for intended use. | "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." (Section 1a(6)). Tests performed demonstrated biocompatibility (Section 1b(1)). |
| Strength and Durability | Must withstand normal use and reprocessing procedures, demonstrating effective performance in terms of strength and durability. | "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..." (Section 1b(1)). The device is reusable and may be reprocessed for multi-patient use. |
| Safety and Effectiveness | Must be as safe and effective as the predicate device when used as intended. | "When used as intended, the Oracle Oral Mask has been shown to be as safe and effective as the predicate device." (Section 1b(3)). This is a general conclusion based on the equivalence demonstrated through various tests and comparisons. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any clinical or non-clinical tests. It refers generally to "tests pertinent to the modifications" (Section 1b(1)). Similarly, there is no information on data provenance (e.g., country of origin, retrospective/prospective). The studies are non-clinical, focusing on material and design characteristics rather than patient outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not mentioned in the provided document. The studies described are non-clinical and focus on engineering and material properties, not clinical ground truth established by medical experts.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not mentioned. The document describes non-clinical engineering and material tests, not clinical evaluations requiring adjudication of subjective expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. The submission is for a medical device (oral mask), not an AI-powered diagnostic tool, so this type of study is not relevant or included.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical mask, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Engineering specifications/standards: For strength, durability, pressure-flow characteristics, dead space CO2, and flow impedance.
- ISO 10993-1 standards: For biocompatibility.
- Material specifications: For the silicone used in the SnapFlap™.
No "expert consensus," "pathology," or "outcomes data" in the medical sense of establishing ground truth for a diagnostic algorithm is mentioned or required here.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical oral mask, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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JAN 1 4 2004
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, Model900HC451, 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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)
fothillstehension
vision Sign-Off) wision of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: C033087
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).