HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR

{0}------------------------------------------------ Medic-Aid Limited Heath Place, Bognor Regis, West Sussex, UK PO22 9SL Telephone (01243) 840888 Fax (01243) 846100 K991685 Image /page/0/Picture/2 description: The image shows the logo for MEDIC-AID. The logo consists of two black triangles that are next to each other, forming a mountain-like shape. Below the triangles is the text "MEDIC-AID" in black, sans-serif font, with a registered trademark symbol next to the word "AID". ### Non-Confidential Summary of Safety and Effectiveness page 1 of 3 May 14, 1999 Medic-Aid Ltd. Heath Place Bognor Regis, West Sussex PO22 9SL United Kingdom | Tel - 011-44-1243-840888 | Fax - 011-44-1243-846100 | |----------------------------|----------------------------------------------------| | Official Contact: | Ed Walters, Quality Manager | | Proprietary or Trade Name: | HaloLite ™ AAD with Dedicated Compressor System | | Common/Usual Name: | Nebulizer | | Classification Name: | Nebulizer, Direct Patient Interface | | Predicate Devices: | Medic-Aid HaloLite ADD System - K981772 | | | Invacare - Medi-Pump Mobilaire (50 psi Compressor) | | | K950867 | #### Device Description: The Medic-Aid HaloLite AAD system with dedicated compressor is a single patient use, prescribed portable nebulizer designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a hand-piece containing a pressure transducer, a microprocessor control system, a medication chamber, and dedicated compressor to provide a compressed air source. Other compressed air sources can be -Invacare Mobilaire (50 psi compressor) and regulate wall compressed air. The HaloLite system analyses the patient's breathing pattern to determine the aerosol pulse time. The system then pulses aerosol during inspiration only. Each pulse of aerosol is matched according to the inspiratory time. HaloLite continues to monitor the breathing pattern in order to adapt to changes in breathing throughout the treatment. When the preset dose has been delivered, the system indicates that the treatment is complete. AUG 13 1099 Page 2 - 2 {1}------------------------------------------------ ### Non-Confidential Summary of Safety and Effectiveness page 2 of 3 May 14, 1999 | 1. Intended use - | Aerosolization of commonly prescribed liquid drug (except Pentamidine) for inhalation by the patient. | |-------------------------|-------------------------------------------------------------------------------------------------------| | 2. Environment of Use - | Single patient / multi-use for Home, Hospitals and Nursing Homes | | 3. Patient Population - | Patients requiring nebulized drug delivery via a mouthpiece. | ### Comparison to Other Legally Marketed Predicate Devices The following comparison table details the primary attributes of the intended device and legally marketed predicate devices. The most significant attributes have been listed. | | 20<br>2000 | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--| | アイディース (comment) starter (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c) (c)<br>Callery | | | | A STATE A STATE A BREAK A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEATH A BEACH AND A BEACH AND A BEACH AND A | | | | All Children<br>Carl September 200<br>AND STORES OF COLLECTION<br>LOLA STATUS COLLECTION COLLEGION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONTRACTOR COLLECTION CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTO | | | | RECORD OR COLORICOLOGY OOR JULINER<br>2.5 ALDESS 3.0 SMAN | | | | And State of Status and | | | | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | And Comment | | | Albert of the Children | | | | And Court of Street of Street, Inc.<br>And Control Concession Come of Children Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comme<br>11/2019-11-20 | 1999 | | | in th<br>Company of the program and the comments of the county of<br>Same of the consisted on the consisted on the contraction of the contribution of the comments of | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ<br>Company of the country of the county of the county of<br>STATE OF CONSULT OF CONSULTION OF | | | | Control Concession Company Construction of Children | | | | Contract<br>The first of the country of the county of<br>DOCK CARD FOR COLL | | | | And Control Controller | | | | 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 | Age | | | 177507 741<br>and the contraction of the production of the contribution of the county of the county | | | | The first 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 the first and<br>CONSULTION COLLECTION | | | ## Use | | Intended to nebulize drugs | Yes | Yes | Yes | |--------------------------------------------------------|-----|-----|-----| | Synchronized Delivery of<br>Nebulized drug | Yes | Yes | Yes | | Drug Delivery on demand | Yes | Yes | Yes | | Used in hospitals, home care,<br>nursing home settings | Yes | Yes | Yes | | Single Patient / Multi-use | Yes | Yes | Yes | - Design July 2017 11:40 11 - | Dynamic Pressure at<br>Nebulizer Jet | 1.75 bar | 1.75 bar | 1.75 bar | |--------------------------------------|----------------|----------------|----------------| | Gas Source - Compressed Air | Yes | Yes | Yes | | Software Driven | Microprocessor | Microprocessor | Microprocessor | {2}------------------------------------------------ # Non-Confidential Summary of Safety and Effectiveness page 3 of 3 May 14, 1999 | Attribute | HaloLite AAD<br>Compressor<br>System | HaloLite AAD<br>System<br>K981772<br>+ Wall supply<br>driving gas | HaloLite AAD<br>System<br>K981772<br>+ Medi-Pump<br>K950867 | |----------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------| | Design | | | | | Drug delivery triggered by | Patient<br>Inhalation<br>Airway<br>Pressure<br>Signal | Patient<br>Inhalation<br>Airway<br>Pressure<br>Signal | Patient<br>Inhalation<br>Airway<br>Pressure<br>Signal | | Used with Mouthpiece | Yes | Yes | Yes | | Materials | | | | | No significant changes | | | | | Packaging | | | | | Provided clean, non-sterile | Yes | Yes | Yes | | Performance Standards / Specifications | | | | | None applicable under Section 514 | Yes | Yes | Yes | # Differences Between Other Legally Marketed Predicate Devices of Children There are no differences in performance, safety, or efficacy between the new dedicated compressor and the Invacare compressor or regulated wall gas. {3}------------------------------------------------ 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 representation of a human figure with three flowing lines forming the body and head. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 3 1999 Mr. Paul E. Dryden Medic-Aid, Inc. c/o ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055-9501 Re: K991685 HaloLite ADD System with Compressor Regulatory Class: II (two) Product Code: 73 CAF Dated: May 14, 1999 Received: May 17, 1999 Dear Mr. Dryden: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {4}------------------------------------------------ Page 2 - Mr. Paul E. Dryden This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### INDICATIONS FOR USE Page 1 of 1 Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request. | 510(k) Number: | K991685 (To be assigned) | |----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | HaloLite AAD System with Compressor (modification) | | Intended Use : | A HaloLite Adaptive Aerosol Delivery, (AAD) system, a handheld nebulizer system including a dedicated compressor is designed to aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment. | | | The new dedicated compressor provides a compressed air source similar to the original predicate device compressed air sources, Invacare Mobilaire and regulated wall air. | Concurrence of CDRH, Office of Device Evaluation (ODE) Jacinta A. Weatherspoon (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number Prescription Use J (Per CFR 801.109) or Over-the-counter use ___