HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR

K991685 · Medic-Aid , Ltd. · CAF · Aug 13, 1999 · Anesthesiology

Device Facts

• Record ID: K991685
• Device Name: HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
• Applicant: Medic-Aid , Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

HaloLite AAD system is a portable, single-patient-use nebulizer; delivers aerosolized liquid medication. System comprises hand-piece with pressure transducer, microprocessor control, medication chamber, and dedicated compressor. Device analyzes patient breathing patterns to determine aerosol pulse time; pulses aerosol during inspiration only; monitors breathing to adapt to changes throughout treatment. System indicates treatment completion when preset dose delivered. Used in home, hospital, or nursing home settings; operated by patient or clinician. Output is aerosolized medication; helps healthcare providers ensure precise, reproducible drug delivery; benefits patient through optimized inhalation therapy.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and performance specifications against predicate devices.

Technological Characteristics

Handheld nebulizer system; microprocessor-controlled; breath-actuated. Components: hand-piece, pressure transducer, medication chamber, dedicated compressor. Dynamic pressure at nebulizer jet: 1.75 bar. Gas source: compressed air. Single-patient, multi-use. Provided clean, non-sterile. No applicable performance standards under Section 514.

Indications for Use

Indicated for patients requiring nebulized drug delivery via a mouthpiece in home, hospital, or nursing home settings. Contraindicated for use with Pentamidine.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• Medic-Aid HaloLite ADD System (K981772)
• Invacare - Medi-Pump Mobilaire (50 psi Compressor) (K950867)

Submission Summary (Full Text)

{0}------------------------------------------------

Medic-Aid Limited Heath Place, Bognor Regis, West Sussex, UK PO22 9SL Telephone [phone] Fax [phone]

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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 ___