The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is indicated to aerosolize medication approved for nebulization and prescribed by a physician. This Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System is intended for adult and pediatric patients consistent with the indications for delivery of aerosolized medication to/or through the patient's pulmonary system.

The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools, and long term care facilities.

Device Description

The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is a miniaturized nebulizer attached to a valved manifold. During patient inhalation, aerosol mist being generated from the nebulizer is substantially increased through Breath-Enhancement technology, and configuration is such that a filter can be added to the air exit port if so desired.

AI/ML Overview

The provided text does not contain a study with detailed acceptance criteria and performance results in the format typically used for AI/ML device evaluations. The document is a 510(k) summary for a medical device (nebulizer) that demonstrates substantial equivalence to a predicate device.

However, I can extract the "acceptance criteria" by interpreting the comparison table provided, where the new device's performance is compared against a predicate device. The "acceptance criteria" here implicitly refer to the performance of the predicate device, as the new device aims to be substantially equivalent.

Here's the information extracted and formatted to best fit your request, acknowledging the limitations of the provided document for AI/ML study details:

Acceptance Criteria and Device Performance (Interpreted from Substantial Equivalence Comparison)

Acceptance Criteria (Implied by Predicate Device Performance)

Feature or Specification	Acceptance Criteria (Predicate PARI LC-Star)	Reported Device Performance (Healthline MEDICATOR®/RediNeb®)
Particle Size (MMAD)	2.0 um	1.5 um
Aerosol Generation Rate (static)	0.26 ml/min.	0.23 ml/min.
Aerosol Generation Rate (enhanced)	0.38 ml/min.	0.42 ml/min.
Dead Volume	1.0 ml	0.72 ml
Drive Gas/Flow Rate	6-8 LPM (Air/Oxygen)	6-8 LPM (Air/Oxygen)
Intended Use	Same	Same

Study Details (Based on available information)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not describe a "test set" or clinical study in the context of AI/ML performance evaluation. The data presented is likely derived from laboratory testing of the nebulizer's physical and performance characteristics.
- No information on data provenance (country, retrospective/prospective) is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is not an AI/ML device that relies on expert interpretation for ground truth. The "ground truth" here would be objective measurements of physical properties (particle size, flow rate, etc.).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is a physical aerosol drug delivery system, not an AI/ML diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance characteristics listed (e.g., particle size, aerosol generation rate) would be established through objective laboratory measurements using established test methods for nebulizers.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of Testing Statement from the Document:

"All materials used in the fabrication of the Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System is currently in use in the manufacture of similar nebulizer devices and have FDA approval for this type application."

Interpretation: The "study" proving the device meets the acceptance criteria is a comparison of its performance specifications (Particle Size, Aerosol Generation Rate, Dead Volume, Drive Gas/Flow Rate, Intended Use) against a legally marketed predicate device (PARI LC Star Nebulizer). The implication is that if these key performance metrics are sufficiently similar or improved, the device is considered substantially equivalent and meets the necessary criteria for market entry. This is a common approach for 510(k) clearances of non-AI/ML medical devices.

Summary

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SECTION V.

K082541

page 1 of 1

510(k) SUMMARY Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System

Manufacturer:	Medi/Nuclear Corporation, Inc.4610 Littlejohn StreetBaldwin Park, CA 91706	NOV 26 2008
Regulatory Affairs Contact:	Jerry Schoen
Telephone:	(626) 960-9822
Date Summary Prepared:	August 22, 2008
Trade Name:	Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System
Classification:	Class II per 21CFR 868.5630
Predicate Device:	PARI LC Star Nebulizer K061381 and K963924
Description:	The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is aminiaturized nebulizer attached to a valved manifold. During patientinhalation, aerosol mist being generated from the nebulizer issubstantially increased through Breath-Enhancement technology, andconfiguration is such that a filter can be added to the air exit port if sodesired.
Intended Use:	The MEDICATOR®/RediNeb® Aerosol Drug Delivery System isindicated to aerosolize medication approved for nebulization andprescribed by a physician. This Healthline MEDICATOR®/RediNeb®Aerosol Drug Delivery System is intended for adult and pediatricpatients consistent with the indications for delivery of aerosolizedmedication to/or through the patient's pulmonary system.
	The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is forpatient use in all areas where the administration of medication byaerosol means is warranted. This includes hospital/institutionalsettings, home care use, schools, and long term care facilities.
Substantial Equivalence:	Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery Systemis substantially equivalent to the PARI LC Star nebulizer.
Summary of Testing:	All materials used in the fabrication of the HealthlineMEDICATOR®/RediNeb® Aerosol Drug Delivery System is currentlyin use in the manufacture of similar nebulizer devices and have FDAapproval for this type application. Note table below.

Feature or Specification	Predicate PARI LC-Star	Healthline MEDICATOR®/RediNeb®
Particle Size (MMAD)	2.0 um	1.5 um
Aerosol Generation Rate(static)	0.26 ml/min.	0.23 ml/min.
Aerosol Generation Rate(enhanced)	0.38 ml/min.	0.42 ml/min.
Dead Volume	1.0 ml	0.72 ml
Drive Gas/Flow Rate	6-8 LPM	6-8 LPM
	(Air/Oxygen)	(Air/Oxygen)
Intended Use	Same	Same

510(k) Premarket Notification

Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2008

Mr. Jerry Schoen, Chief Operating Officer Medi/Nuclear Corporation, Incorporated 4610 Littlejohn Street Baldwin Park, California 91706

Re: K082541

Trade/Devicc Name: MEDICATOR® / RediNeb® Regulation Number: 21 CFR 868.5630 Regulation Namc: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 28, 2008 Received: September 2, 2008

Dear Mr. Schoen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Schoen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Snute y. Mckee mas

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section IV.

Indications for Use Statement

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

Device Name: MEDICATOR® Aerosol Drug Delivery System is indicated to aerosolize medication approved for nebulization and prescribed by a physician. This Healthline medication nebulizer device is intended for adult and pediative by a "physical." This "Healthine medications for delivery of aerosolized medication to-or-through the patient's pulmonary system.

The MEDICATOR® /RediNeb® Nebulizer device is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools and long term care facilities.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: Korasy,

Concurrence of CDRH, Office of Device Evaluation (ODE):

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Co

Over-The-Counter Use ___________________

510(k) Premarket Notification Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System

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).