(88 days)
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.
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.
This document is a 510(k) premarket notification for a nebulizer system, specifically the Medic-Aid HaloLite AAD with a dedicated compressor. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study with acceptance criteria and performance data for a new AI/software device.
Therefore, many of the requested sections (acceptance criteria, specific study details like sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance for an AI/software device) are not applicable and cannot be extracted from the provided text.
The document describes a medical device (nebulizer) and its functional characteristics, comparing them to existing predicate devices to show equivalence. It is not a study assessing the performance of software against clinical acceptance criteria.
Here's what can be extracted based on the provided text, with clarifications where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the context of specific acceptance criteria and performance metrics for the HaloLite AAD system as a new measurement or diagnostic device. The document focuses on demonstrating equivalence to predicate devices rather than meeting new, explicit performance targets.
Instead, the document implicitly demonstrates "acceptance" by showing that the new device operates similarly to existing, legally marketed devices.
| Attribute / Comparison Point | Predicate Devices (HaloLite AAD System K981772 + wall supply/Medi-Pump K950867) | New Device (HaloLite AAD Compressor System) | Statement of Equivalence/Acceptance |
|---|---|---|---|
| Intended Use | Aerosolization of commonly prescribed liquid drug (except Pentamidine) for inhalation by the patient. | Aerosolization of commonly prescribed liquid drug (except Pentamidine) for inhalation by the patient. | Yes (identical) |
| Environment of Use | Single patient / multi-use for Home, Hospitals and Nursing Homes | Single patient / multi-use for Home, Hospitals and Nursing Homes | Yes (identical) |
| Patient Population | Patients requiring nebulized drug delivery via a mouthpiece. | Patients requiring nebulized drug delivery via a mouthpiece. | Yes (identical) |
| Nebulizes Drugs | Yes | Yes | Yes (identical) |
| Synchronized Delivery | Yes (via patient inhalation airway pressure signal) | Yes (via patient inhalation airway pressure signal) | Yes (identical) |
| Drug Delivery on Demand | Yes | Yes | Yes (identical) |
| Dynamic Pressure at Nebulizer Jet | 1.75 bar | 1.75 bar | Yes (identical) |
| Gas Source | Compressed Air (wall supply or Medi-Pump) | Compressed Air (dedicated compressor) | Yes (similar function, different source but equivalent output pressure) |
| Software Driven | Microprocessor | Microprocessor | Yes (identical, implying similar control logic) |
| Materials/Packaging | No significant changes / Provided clean, non-sterile | No significant changes / Provided clean, non-sterile | Yes (identical) |
| Overall Performance, Safety, Efficacy | Not explicitly quantified for predicate | Not explicitly quantified for new device | "There are no differences in performance, safety, or efficacy between the new dedicated compressor and the Invacare compressor or regulated wall gas." (Statement of Equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- This document does not describe a "test set" in the context of evaluating a new device's performance against ground truth data. It is a 510(k) submission focused on substantial equivalence.
- Therefore, no sample size for a test set is provided.
- Data provenance is not applicable as there isn't a dataset being analyzed for performance. The comparison is based on device specifications and intended functionality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no "test set" requiring expert ground truth establishment for an AI/software device. The document is about a nebulizer's functional equivalence.
4. Adjudication Method for the Test Set
- Not applicable. No test set or expert ground truth requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This document is for a nebulizer, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Not applicable. This document is for a nebulizer, not an algorithm. The "software-driven" aspect refers to a microprocessor controlling the nebulizer's physical operation (pulsing aerosol during inspiration), not an interpretive algorithm.
7. The Type of Ground Truth Used
- Not applicable. The "ground truth" in this context is the functional behavior and specifications of the predicate devices. The new device is considered "equivalent" if its design and function match or perform similarly to the predicates.
8. The Sample Size for the Training Set
- Not applicable. This document is for a nebulizer and does not involve machine learning or a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set mentioned, this question is not relevant.
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Medic-Aid Limited Heath Place, Bognor Regis, West Sussex, UK PO22 9SL Telephone (01243) 840888 Fax (01243) 846100
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
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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.
| 202000 | ||
|---|---|---|
| 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)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 ChildrenCarl September 200AND STORES OF COLLECTIONLOLA STATUS COLLECTION COLLEGION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONTRACTOR COLLECTION CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTO | ||
| RECORD OR COLORICOLOGY OOR JULINER2.5 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.And Control Concession Come of Children Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comme11/2019-11-20 | 1999 | |
| in thCompany of the program and the comments of the county ofSame 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 ﺍﻟﻤﺴCompany of the country of the county of the county ofSTATE OF CONSULT OF CONSULTION OF | ||
| Control Concession Company Construction of Children | ||
| ContractThe first of the country of the county ofDOCK 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 741and 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 andCONSULTION COLLECTION |
Use |
| Intended to nebulize drugs | Yes | Yes | Yes |
|---|---|---|---|
| Synchronized Delivery ofNebulized drug | Yes | Yes | Yes |
| Drug Delivery on demand | Yes | Yes | Yes |
| Used in hospitals, home care,nursing home settings | Yes | Yes | Yes |
| Single Patient / Multi-use | Yes | Yes | Yes |
- Design July 2017 11:40 11 -
| Dynamic Pressure atNebulizer Jet | 1.75 bar | 1.75 bar | 1.75 bar |
|---|---|---|---|
| Gas Source - Compressed Air | Yes | Yes | Yes |
| Software Driven | Microprocessor | Microprocessor | Microprocessor |
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Non-Confidential Summary of Safety and Effectiveness
page 3 of 3 May 14, 1999
| Attribute | HaloLite AADCompressorSystem | HaloLite AADSystemK981772+ Wall supplydriving gas | HaloLite AADSystemK981772+ Medi-PumpK950867 |
|---|---|---|---|
| Design | |||
| Drug delivery triggered by | PatientInhalationAirwayPressureSignal | PatientInhalationAirwayPressureSignal | PatientInhalationAirwayPressureSignal |
| 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.
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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.
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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 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
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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 ___
§ 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).