SINGLE USE ORAL MASK, MODEL HC455A

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with a stylized ampersand between the two words. Underneath is a horizontal line, and then the word "HEALTHCARE" is on the bottom line. K023670 15 Maurice Paykel Place, East Tamaki P O Box 14 348. Panmure Auckland, New Zealand JUN 12 2003 Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com 7 April 2003 # 510(k) Summary of Safety and Effectiveness Information | Trade Name: | Fisher & Paykel Healthcare Single Use Oral Mask | |----------------------|--------------------------------------------------------------------------------------------------------------| | Model: | HC455A | | Classification Name: | Accessory to Noncontinuous ventilator (IPPB) - 73 BZD<br>Anesthesiology Devices, 21 CFR §868.5905 (Class II) | | Predicate Device: | Oracle Oral Mask, Model 900HC451, K003894 | 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 Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) according to 21 CFR §868.5905. It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The Oral Mask consists of a mouthpiece and flexible breathing tube. The flexible breathing tube is connected to the output breathing tube of the ventilator. The ventilator supplies air at CPAP or Bilevel pressures, typically in the range 3 - 20 cm H2O, which are available at the Oral Mask mouthpiece. The mouthpiece is positioned in the patient's mouth during CPAP or Bilevel 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 flexible breathing tube provides a transition between the more rigid output tube of the ventilator and the mouthpiece, facilitating freedom of movement while maintaining circuit integrity. An exhaust port adjacent to the mouthpiece provides a means to purge exhaled gases from the breathing circuit. {1}------------------------------------------------ ### 510(k) Summary of Safety and Effectiveness Information (continued) #### (a)(5) Statement of the Intended Use The Oral Mask is for use by adults requiring CPAP or Bilevel ventilator treatment in home, hospital and laboratory environments. It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is for single patient use, for up to 30 days, on the prescription of a physician. ### (a)(6) Technological Characteristics Summary The technological characteristics of the Oral Mask are equivalent to the predicate device. The only differences consist of a change to new materials, a provision for mask adjustment and revised user labeling. The 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 SnapFlap™'s flexibility allows the mouthpiece to accommodate a wide range of face shapes and sizes. Additionally, the tightness of the SnapFlap™ maybe easily adjusted by the patient. The mouthpiece is connected to the elbow of a flexible breathing tube. The elbow incorporates a pattern of vent holes which constitute the exhaust port for bias airflow. The exhaust port allows the purging of exhaled gases. Product labeling states that the Oral Mask must not be used unless connected to a ventilator supplying the minimum specified ventilation pressure at which sufficient bias airflow is available to quarantee minimal re-breathing. Additional warnings state that the mask should only be used with CPAP systems recommended by the patient's physician or respiratory therapist, and that the vent holes in the exhaust port should never be blocked. The flexible breathing tube allows the patient freedom of movement by way of the elbow and swivel joint rotation and flexure of the tubing itself. The swivel joint at the end of the flexible breathing tube is a press fit to industry standard breathing tubes (ISO 5356-1, ASTM F1054: 22mm conical fitting). This allows effective connection to a wide range of CPAP and Bilevel ventilators. An adaptor, incorporating two ports, may be connected to the swivel joint at the ventilator end of the flexible breathing tube. This adaptor may be used optionally to gain access to the breathing tube gas flow. For example, oxygen may be added through one port while the other port accommodates a pressure transducer. Typically, this type of operation is performed by a sleep laboratory during patient diagnosis and titration. When not in use, the swivel adaptor ports may be blocked off by the port caps. The swivel adaptor is provided with the mask as an accessory. The Oral Mask is manufactured from materials that meet appropriate requirements of ISO 10993-1. {2}------------------------------------------------ ## 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 new Oral Mask to demonstrate substantial equivalence to the predicate device. These demonstrated effective performance in terms of strength, durability, and biocompatibility. Clinical evaluations have shown the mask to be safe and effective in delivering positive airway pressure to patients. #### (b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance When used as intended, the Oral Mask has been shown to be as safe and effective as the predicate device. Specifically: - . The Oral Mask is a safe 'patient to ventilator' interface when used as an accessory to a Noncontinuous ventilator. - The Oral Mask is an effective means of delivering positive airway pressure to . adults requiring CPAP or Bilevel ventilator treatment in the home, hospital and laboratory environments - . The Oral Mask is a reliable device when used and maintained as specified in the Instructions for Use. This information verifies that the Oral Mask is substantially equivalent to the predicate device in terms of safety, effectiveness and performance. signed: Robert te: 7 April 2003 Robert Petrv Fisher & Paykel Healthcare Ltd {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol of three human profiles facing to the right, with the profiles overlapping each other. JUN 12 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Robert Petry Regulatory Affairs Engineer Fisher & Paykel Healthcare, Limited 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland, New Zealand Re: K023670 Trade/Device Name: Single Use Oral Mask, Model HC455A Regulation Number: 21 CFR 868.5905 Regulation Name: Accessory to Non-Continuous Ventilator Regulatory Class: II Product Code: 73 BZD Dated: April 7, 2003 Received: April 14, 2003 Dear Mr. Petry: 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. {4}------------------------------------------------ #### Page 2 - Mr. Petry 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. 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 (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, Susan Raver Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold font on the top line. Below that, the word "HEALTHCARE" is in a smaller, bold font with a line above it. Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand > Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com 7 April, 2003 [510(k)] Number: K023670 # Fisher & Paykel Healthcare - Single Use Oral Mask # PREMARKET NOTIFICATION 510(k) INDICATIONS FOR USE STATEMENT The Fisher & Paykel Healthcare Single Use Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) as per 73 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 environments. It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is for single patient use, for up to 30 days, on the prescription of a physician. Concurrence of CDRH, Office of Device Evaluation (ODE) S.A. Wurtzben (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: Prescription Use (Per 21 CFR §801.109) ✓ डारर