K Number

Device Name

HALOLITE AAD SYSTEM

Manufacturer

MEDIC-AID LTD.

Date Cleared

1998-11-03

(168 days)

Product Code

CAF

Regulation Number

868.5630

Intended Use

A Nebulizer system designed to aerosolize commonly prescribed liquid medication ( except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment.

Device Description

The Medic-Aid HaloLite AAD system 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, and a medication chamber, based on the Medic-Aid -Ventstream Nebulizer, K933535, and mouthpiece. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K935693, K933535

Reference Devices

K935693,K933535

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a "microprocessor control system" that "analyses the patient's breathing pattern" and "adapts to changes in breathing". While this involves processing and adaptation, the language used ("analyses," "adapts") is typical of rule-based or algorithmic control systems, not explicitly indicative of AI/ML which would usually involve terms like "learning," "training," "model," or specific AI/ML techniques. The absence of mentions of AI, DNN, ML, training sets, or test sets further supports this conclusion.

Therapeutic

Yes.
The device is a nebulizer system designed to aerosolize liquid medication for inhalation, which is a therapeutic treatment.

Diagnostic

No
The device is described as a nebulizer system designed to deliver medication, not to diagnose a condition. While it analyzes a patient's breathing pattern, this is to optimize drug delivery, not for diagnostic purposes.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of a hand-piece containing hardware components like a pressure transducer, microprocessor control system, and medication chamber.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to aerosolize liquid medication for inhalation by a patient. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
Device Description: The device is described as a nebulizer system that delivers medication based on the patient's breathing pattern. It does not perform any analysis of biological samples.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.

The device is clearly designed for the delivery of medication to a patient, which falls under the category of a therapeutic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A Nebulizer system designed to aerosolize commonly prescribed liquid medication ( except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment.

Product codes

73 CAF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home, Hospitals and Nursing Homes

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K935693, K933535

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

Medic-Aid Limited Heath Place, Bognor Regis, West Sussex, UK PO22 9SL Telephone (01243) 840888 Fax (01243) 846100

3 1998
K98 1772

NOV

Image /page/0/Picture/2 description: The image shows the logo for Medic-Aid. The logo consists of three black triangles arranged to look like a mountain range. Below the mountain range is the name of the company, "MEDIC-AID", in black, sans-serif font. There is a registered trademark symbol to the right of the name.

Non-Confidential Summary of Safety and Effectiveness

page 1 of 4 May 18, 1998

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
Common/Usual Name:	Nebulizer
Classification Name:	Nebulizer, Direct Patient Interface
Predicate Devices:	Vortran - AutoNeb K935693
Medic-Aid - Ventstream - K933535

Device Description: -- 1000

Aerosolization of commonly prescribed liquid drug (except Pentamidine) 1. Intended use for inhalation by the patient.
05/17/98

Page 2-2

Image /page/0/Picture/13 description: The image contains two logos. The logo on the left is a circular seal with the text "QUALITY ASSURED FIRM" around the top half of the circle and "ISO 9001" in the center, with a checkmark below it and the letters "SGS" at the bottom. The logo on the right features a crown at the top, a large checkmark below it, and the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES" below the checkmark.

Non-Confidential Summary of Safety and Effectiveness

page 2 of 4 May 18, 1998

Single patient / multi-use for Home, Hospitals and Nursing Homes 2. Environment of Use -
Patients requiring nebulized drug delivery via a 3. Patient Population 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.

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Use
Intended to nebulize drugs	Yes	Yes	Yes
Sidestream Jet System	Yes	Yes	No
Synchronized Delivery of
Nebulized drug	Yes	No	Yes
Drug Delivery on demand	Yes	No	Yes
Used in hospitals, home care,
nursing home settings	Yes	Yes	Yes
Single Patient / Multi-use	Yes	Yes	N/A

Design

Flow Rates	6 LPM	6-8 LPM	1.5-16LPM
Gas Source - Compressed Air	Yes	Yes	Yes
Software Driven	Microprocessor	No	No
Mode of Operation	Turn on
During
Patient
Inhalation	Breath
Enhanced
Continuous
System	Turn on
During
Patient
Inhalation

Non-Confidential Summary of Safety and Effectiveness

page 3 of 4

May 18, 1998

Attribute	HaloLite AAD System	Medic-Aid Ventstream K933535	Vortran AutoNeb K935693
Drug delivery triggered by	Patient Inhalation Airway Pressure Signal	None	Patient Inhalation Airway Pressure Signal
Used with Mouthpiece	Yes	Yes	Yes

Materials

Materials in Contact with Patient Polypropylene	Mouthpiece	Mouthpiece	Mouthpiece
-------------------------------------------------	------------	------------	------------

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

The differences between the intended device, HaloLite, and the predicates are -

1. The HaloLite system provides a hand-held, user-friendly device compared with the bench-mounted Vortran - AutoNeb which requires tubes to interconnect between the AutoNeb and a standard nebulizer.
1. The HaloLite is micro-processor controlled device. This permits the HaloLite device to operate across a wide range of patient ages and breathing patterns, without requiring any calibration or adjustment to sensitivity settings as required by the AutoNeb. The system can also adapt to any changes in the breathing pattern and adjust to the aerosol pulse time throughout the treatment. Each aerosol pulse is

Non-Confidential Summary of Safety and Effectiveness

page 4 of 4 May 18, 1998

summed to provide an accurate method of dose measurement so that a pre-set dose can be delivered. The HaloLite operates over a pulse range of 0.15 to 2.0 seconds compared to the Vortran AutoNeb 0.5 to 5.0 seconds. This range has been selected as being the most appropriate to match the patient's inhalation.

1. The Vortran AutoNeb can also be used to deliver a pre-set dose. This requires setting the controls for each patient's breathing pattern, and counting the number of pulses delivered to the patient. This is achieved automatically with the HaloLite, the press of a button initiates treatment and when the pre-set dose has been delivered the device signals that the treatment has been completed. This system provides ease of use for both the physician and the patient. The Vortran - AutoNeb is operated from 115 volt mains supply, and the HaloLite is powered by an internal replaceable 9 volt battery.
  There is no other differences between the intended device and the predicate devices which would be significant to patient safety or effectiveness.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

Mr. Paul E. Dryden Medic-Aid, Ltd. c/o ProMedic, Inc. 6329 W. Waterview Court 46055-9501 McCordsville, IN

Re: K981772 HaloLite AAD System Regulatory Class: II (two) Product Code: 73 CAF Dated: September 8, 1998 Received: September 9, 1998

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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.

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 requlation (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 qeneral 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 Radioloqical Health

Enclosure

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:	K981772 (To be assigned)
Device Name:	HaloLite AAD System
Intended Use :	A Nebulizer system designed to aerosolize commonly prescribed liquid medication ( except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Water

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number

Prescription Use
1
(Per CFR 801.109)
or

ﺔ ﺑ

Over-the-counter use