MULTI-STRAP FULL FACE MASK

{0}------------------------------------------------ # DEC = 1 2003 #### 2.1 510(k) Summary of Safety and Effectiveness ## Engineered Medical Systems, Inc. 2055 Executive Dr. Indianapolis, IN 46241 K023683 ## Non-Confidential Summary of Safety and Effectiveness Page 1 of 2 October 31, 2002 | Engineered Medical Systems | Tel (317) 246-5500 | |----------------------------|--------------------| | 2055 Executive Dr. | Fax (317) 246-5501 | | Indianapolis, IN 46241 | | | Official Contact: | Bonnie A. Holly - Quality Manager | |----------------------------|----------------------------------------------------| | Proprietary or Trade Name: | Multi-strap Full Face Mask | | Common/Usual Name: | Full Face CPAP Mask | | Classification Name: | Non-continuous ventilator (IPPB) accessory | | Predicate Devices: | Caradyne - Whisperflow mask - K982283 | | | Respironics - Spectrum Full Face Mask - K961915 | | | ResMed -- Sullivan Mirage Full Face Mask - K982530 | #### Device Description: The EMS Multi-strap Full Face mask covers both the nose and mouth and includes a nonrebreathing / anti-asphyxia valve, which is activated under flow / pressure from a CPAP or bilevel ventilator. It is open to ambient air when the ventilator is not ON allowing the patient to breath ambient air. It has a quick release mask harness system. It is single patient, multi-use. ### Intended Use: | Indicated Use -- | A patient interface accessory for use with CPAP<br>and bi-level systems used in the treatment of adult<br>OSA and / or ventilatory support. | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | | A minimum pressure of $\geq$ 3.0 cm H2O at the mask is<br>required. | | Environment of Use -- | Hospital, Sub-acute Institutions, Home | {1}------------------------------------------------ #### Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 October 31, 2002 #### General Technical Characteristics | Attribute | EMS – Proposed device | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of > 3.0 cm H₂O at the mask is required. | | Single patient, multi-use | Yes | | Prescription | Yes | | Intended population | Any patient | | Intended Environment of Use | Hospital, Sub-acute Institutions, Home | | Design | | | Mask covers nose and mouth | Yes | | Quick release mask harness | Yes | | Non-rebreathing / anti-asphyxia valve | Yes | | Must be used with exhalation valve in circuit | Yes | | Open to ambient when ventilator off | Yes | | Valve opens at > 3 cm H2O | Yes | | Can be cleaned | Yes | | Materials | | | Mask cone and Elbow - PC | Yes | | Mask cushion - PVC | Yes | | Flap valve - Silicone | Yes | | Performance Standards | | | None under Section 514 | Yes | # Differences between Other Legally Marketed Predicate Devices The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially cquivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the three branches of government. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 1 2003 Engineered Medical Systems, Inc. C/O Mr. Paul Dryden Regulatory Consultant Promedic, Inc. 6329 West Waterview Court McCordsville, Indiana 46055-9501 Re: K023683 Trade/Device Name: Multi-Strap Full Face Mask Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator Regulatory Class: II Product Code: BZD Dated: October 8, 2003 Received: October 9, 2003 Dear Mr. Dryden: 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 cither 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. {3}------------------------------------------------ Page 2 - Mr. Dryden 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, Susa Ruine 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 {4}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ and the control of the control of the control of the contribution of the first of the first of the first of the first of the first of the first of the first of the first of t ___ ..._______________________________________________________________________________________________________________________________________________________________________ # 2.3 Indications for Use Page 1 of 1 | 510(k) Number: | K023683 (To be assigned) | |----------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Multi-strap Full Face Mask | | Intended Use: | A patient interface accessory for use with CPAP<br>and bi-level systems used in the treatment of adult<br>OSA and / or ventilatory support. | | | A minimum pressure of > 3.0 cm H₂O at the mask is<br>required. | | | Single patient, multi-use | Concurrencc of CDRH, Office of Device Evaluation (ODE) Fisther (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K823683 Prescription Use (Per CFR 801.109) or Over-the-counter use _