(106 days)
Not Found
No
The summary describes a standard air compressor nebulizer and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is intended to produce a fine aerosol mist of medication for respiratory therapy to treat respiratory disorders, which is a therapeutic purpose.
No
Explanation: The device is a nebulizer, which is used to deliver medication to the respiratory system. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device description explicitly lists hardware components: nebulizer main unit, air compressor, air filters, and nebulizer kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide compressed air for a nebulizer to deliver medication for respiratory therapy. This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the mechanical process of atomizing medication for inhalation. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is a key characteristic of IVDs.
- Lack of IVD-related terms: The document does not contain any terms related to in vitro diagnostics, such as "assay," "reagent," "analyte," "sample," "diagnosis," or "testing biological specimens."
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This nebulizer system does not perform any such analysis.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
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.
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
children and adults
Intended User / Care Setting
home health care
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)
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.
Standard Guidance: IEC 60601-1, Issue Date: 1998, Title: Medical Electrical Equipment - Part 1: General Requirements for Safety
Standard Guidance: IEC 60601-1-2, Issue Date: 2001, Title: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard; Electromagnetic Compatibility – Requirements and Tests (General)
Standard Guidance: FDA Document Number 784, Issue Date: 1993, Title: Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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.
Intended Use:
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.
510(k) Summary
1
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
il
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.
2
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.
| Standard
| Guidance | 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 - Collateral | ||
| Standard; Electromagnetic Compatibility – | ||
| Requirements and Tests (General) | ||
| FDA Document | ||
| Number 784 | 1993 | Reviewer Guidance for Nebulizers, Metered |
| Dose 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
3
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.
4
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
5
INDICATIONS FOR USE
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Deluxe Nebulizer™, Nebulizer
Indications for use:
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.
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