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.

AI/ML Overview

The provided text is a 510(k) summary for the Medic-Aid HaloLite AAD system, a nebulizer. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and performance data in the format requested. Therefore, much of the requested information is not available in the provided document.

Here's an attempt to answer based on the available information, with clear indications where the information is "Not Provided":

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (HaloLite AAD)
Intended Use	Nebulize commonly prescribed liquid drugs (except Pentamidine) for inhalation by patient.	Meets; designed to "aerosolize commonly prescribed liquid drug (except Pentamidine) for inhalation by the patient."
Environment of Use	Home, Hospitals, and Nursing Homes.	Meets; "Single patient / multi-use for Home, Hospitals and Nursing Homes."
Patient Population	Patients requiring nebulized drug delivery via a mouthpiece.	Meets; "Patients requiring nebulized drug delivery via a mouthpiece."
Sidestream Jet System	Yes (based on predicate comparisons).	Yes
Synchronized Delivery of Nebulized Drug	Yes (based on Vortran AutoNeb).	Yes; "pulses aerosol during inspiration only. Each pulse of aerosol is matched according to the inspiratory time."
Drug Delivery on Demand	Yes (based on Vortran AutoNeb).	Yes; "pulses aerosol during inspiration only."
Flow Rates	Consistent with predicate devices (e.g., 6-8 LPM for Vortran, 1.5-16 LPM for Medic-Aid Ventstream).	6 LPM
Gas Source - Compressed Air	Yes	Yes
Software Driven	Microprocessor (differentiator from predicates).	Microprocessor
Mode of Operation	Turn on during patient inhalation.	Turn on during patient inhalation
Drug Delivery Triggered by	Patient Inhalation Airway Pressure Signal.	Patient Inhalation Airway Pressure Signal
Used with Mouthpiece	Yes	Yes
Materials in Contact with Patient	Polypropylene Mouthpiece	Polypropylene Mouthpiece
Provided Clean, Non-sterile	Yes	Yes
Dose Measurement Accuracy	Not explicitly stated an acceptance criterion, but the text mentions "summed to provide an accurate method of dose measurement so that a pre-set dose can be delivered."	"summed to provide an accurate method of dose measurement so that a pre-set dose can be delivered."
Pulse Range	Not explicitly stated as an acceptance criterion, but compared to AutoNeb.	0.15 to 2.0 seconds

2. Sample size used for the test set and the data provenance

Sample Size: Not Provided.
Data Provenance: Not Provided. The document describes the device and compares it to predicate devices, but does not detail a specific test study with a described sample set. It's likely that performance data was generated internally for technical verification, but the specifics are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not Provided.
Qualifications of Experts: Not Provided.

4. Adjudication method for the test set

Adjudication Method: Not Provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This device is a nebulizer, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is Not Applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a hardware nebulizer with a microprocessor, not a standalone algorithm. Therefore, a standalone algorithm-only performance study is Not Applicable and was not performed. The device's "standalone" performance would relate to its ability to accurately deliver aerosolized medication. While the document mentions "accurate method of dose measurement," specific study details are not provided here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not Provided in terms of a formal study assessing device performance. The "ground truth" for substantial equivalence is based on the features and performance of legally marketed predicate devices. The device's own performance would be verified against engineering specifications, likely through bench testing, but the methodology and "ground truth" for those tests are not detailed here.

8. The sample size for the training set

Sample Size: Not Applicable. This is a hardware medical device (nebulizer), not an AI/machine learning model that would require a training set.

9. How the ground truth for the training set was established

Ground Truth Establishment: Not Applicable. As this is not an AI/machine learning model, no training set or ground truth for a training set was established.

Summary

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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 K935693Medic-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.

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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 ofNebulized 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 onDuringPatientInhalation	BreathEnhancedContinuousSystem	Turn onDuringPatientInhalation

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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

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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.

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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.

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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

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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

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).