The Access Point, LLC Deluxe Nebulizer is intended to provide a source of compressed air for medical purposes for use in home health care. The Deluxe Nebulizer is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

Device Description

The Deluxe Nebulizer, consist of four components. The nebulizer main unit, air compressor, air filters and nebulizer kit (hand held nebulizer with mouthpiece). The Nebulizer atomizes medicinal liquid into tiny fog droplets by compressing air. Patients inhale the compressed air for optimal internal medicinal delivery.

AI/ML Overview

This 510(k) summary for the Deluxe Nebulizer does not contain the acceptance criteria or results from a study proving it meets specific performance criteria designed for a diagnostic or AI-driven device.

This submission is for a medical device that provides compressed air for nebulizer therapy. Its performance is evaluated against recognized consensus standards for safety and electrical compatibility, rather than through clinical or diagnostic accuracy studies.

Here's why the requested information for an AI/diagnostic device is not present in this document:

Device Type: The Deluxe Nebulizer is a compressor for a nebulizer. It's a mechanical device, not an AI, diagnostic, or imaging device designed to provide a specific output value, classification, or prediction.
Performance Metrics: The "performance" of this device is related to its ability to safely and reliably produce compressed air according to engineering and safety standards, not to its diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Therefore, I cannot populate the table or answer many of the questions as they pertain to clinical performance studies for AI/diagnostic devices.

However, I can extract the available information related to the device's conformance to standards based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards for Conformance)	Reported Device Performance
IEC 60601-1 (1998): Medical Electrical Equipment - Part 1: General Requirements for Safety	Designed to conform to applicable sections of this standard. (Specific results not detailed, but conformance is implied by submission)
IEC 60601-1-2 (2001): Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard; Electromagnetic Compatibility – Requirements and Tests (General)	Designed to conform to applicable sections of this standard. (Specific results not detailed, but conformance is implied by submission)
FDA Document Number 784 (1993): Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators	Designed to conform to applicable sections of this guidance. (Specific results not detailed, but conformance is implied by submission)

2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI or diagnostic device that uses a "test set" of data for performance evaluation in the way a diagnostic algorithm would. Testing would involve engineering verification and validation against the specified standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device. Conformance to engineering and safety standards is verified.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "truth" here is compliance with established engineering and safety standards.

8. The sample size for the training set: Not applicable. This is not an AI device that requires a "training set."

9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance as Stated:

The document explicitly states: "The Deluxe Nebulizer was designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards and the published specifications."

The Conclusion reinforces this by stating: "The Deluxe Nebulizer is as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the devices." This implies that the testing performed demonstrated compliance with these standards, establishing its safety and effectiveness. The "study" for this device revolves around engineering and safety verification and validation, rather than clinical efficacy trials or diagnostic accuracy trials.

Summary

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K063449

510(k) Summary of Safety and Effectiveness

Submitter Information:

Access Point Medical, LLC 3 CityPlace Drive, Suite 750 St. Louis, MO 63141 USA

MAR J 1 2007

USA Contact:

Rick Davis Access Point Medical, LLC 3 CityPlace Drive, Suite 750 St. Louis, MO 63141- USA

Phone: (314) 255-2700 Fax: (541) 255-2738

Device Name:

Trade Name: Deluxe Nebulizer Common Name: Nebulizer (Direct Patient Interface) Classification Name: Anesthesia Conduction Kit (Reference, 21CFR, 868.5630, April 1, 2005)

Predicate Devices:

The Deluxe Nebulizer is substantially equivalent to the Medical Depot Power Neb 2 ™ nebulizer cleared for market under 510(k) K003344. The indication for use for the Deluxe Nebulizer is identical to the Power Neb 2 TM

Device Description:

Intended Use:

510(k) Summary

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Technology Characteristics:

414 - 1

The Deluxe Nebulizer operation is based upon a non-oil lubricating, single-cylinder piston pump for air pressure. It is compact, simple to operate and convenient to carry. As shown in Figure 1 below, air flows through the air filter into the nebulizer's air compressor unit, out the jet outlet and then through the nebulizer.

Image /page/1/Figure/2 description: The image shows a diagram of a compressor. The diagram includes labels for the air filter, inlet, jet outlet, outlet, and compressor. The air filter is connected to the inlet, and the jet outlet is connected to the outlet.

FIGURE 1 - WORKING PRINCIPLE

The Nebulizer (Figure 4) atomizes medicinal liquid into tiny fog droplets by compressing air. Patients inhale the compressed air for optimal internal medicinal delivery.

Image /page/1/Figure/5 description: This image shows a diagram of a nebulizer, labeled as "FIGURE 4 - NEBULIZER". The diagram shows the different parts of the nebulizer, including the mouthpiece, T-piece, rinse tube, air hose, cup, and baffle. The diagram shows how the different parts of the nebulizer are connected.

510(k) Summary

Image /page/1/Figure/7 description: The image shows the text "Page 2 of 3". This indicates that the image is part of a document with multiple pages. The current page being displayed is page 2, and the total number of pages in the document is 3.

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Summary of Performance Testing

The Deluxe Nebulizer was designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards and the published specifications.

StandardGuidance	Issue Date	Title
IEC 60601-1	1998	Medical Electrical Equipment - Part 1:General Requirements for Safety
IEC 60601-1-2	2001	Medical Electrical Equipment - Part 1-2:General Requirements for Safety - CollateralStandard; Electromagnetic Compatibility –Requirements and Tests (General)
FDA DocumentNumber 784	1993	Reviewer Guidance for Nebulizers, MeteredDose Inhalers, Spacers and Actuators

Conclusion:

The Deluxe Nebulizer is as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the devices.

510(k) Summary

Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 】 2007

Access Point Medical, L.L.C C/O Ms. Casey Conroy Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville. New York 11747

Re: K063449

Trade/Device Name: Deluxe Nebulizer™, Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 6, 2007 Received: February 9, 2007

Dear Ms. Conroy:

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 - Ms. Conroy

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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,

Suresh Kumar

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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INDICATIONS FOR USE

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Deluxe Nebulizer™, Nebulizer

Indications for use:

X OR Over-The-Counter___________________________________________________________________________________________________________________________________________________________ Prescription Use_ (Per 21 CFR 801.109)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Wh Wh

K063419

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).