(14 days)
1 - Intended Use: The DHD TRUST is intended for use as a nebulizer.
- 2 Indications:
- The DHD TRUST provides additional hydration to help loosen secretions for patients whom extended therapy is required.
- The DHD TRUST delivers aerosolized medications and diagnostic formulations.
- 3 Target Patient Population
Patients with asthma, pneumonia, COPD, or any other condition in which appropriate medications would be nebulized.
The DHD TRUST is indicated for use as a single patient use nebulizer. TRUST is a small plastic device that threads onto a regulated flow meter supplying air or oxygen. A reservoir bottle threads to the bottom of TRUST to hold water and/or medication. Trust has a secondary port on the side of the device to allow for supplemental air, oxygen, or heliox.
The provided text describes a 510(k) premarket notification for the DHD Healthcare Corporation's "TRUST" nebulizer. It details the device's intended use, technological characteristics, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or software. The study mentioned relates to particle size delivery for a physical medical device (nebulizer) and aims to show equivalence to a predicate device, not performance benchmarks for an AI system.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for an AI/ML device, nor can I discuss sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.
The "Summary of Studies" section only states:
"Testing of particle size delivery was performed in accordance with the guidance document "REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS". The results of this testing shows particle size delivery to be equivalent between TRUST and the predicate."
This describes a physical performance test for a nebulizer, not an AI/ML model.
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February 5, 2004
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APR - 2 2004
510(k) Summary
Submitter:
SECTION 16
DHD Healthcare Corporation One Madison Street Wampsville, NY 13163
Contact: David Geary, Regulatory Affairs Manager Phone: 315-363-2330 x267 315-363-9462 Fax:
Device Name:
Product Code Name: Trade name: Common Name: Classification Name: TRUST To Be Determined Nebulizer Nebulizer - 868.5630
Predicate Devices:
Hope Nebulizer K980407 B&B Medical Technologies P.O. Box 1958 Loomis, CA 95650
Device Description:
The DHD TRUST is indicated for use as a single patient use nebulizer. TRUST is a small plastic device that threads onto a regulated flow meter supplying air or oxygen. A reservoir bottle threads to the bottom of TRUST to hold water and/or medication. Trust has a secondary port on the side of the device to allow for supplemental air, oxygen, or heliox.
Intended Use:
TRUST is intended for use as a nebulizer.
Technological Characteristics Compared to Predicate:
Hope and TRUST use identical technology.
Summary of Studies:
Testing of particle size delivery was performed in accordance with the guidance document "REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS". The results of this testing shows particle size delivery to be equivalent between TRUST and the predicate.
Conclusion Drawn from Studies
For the indications for use, the DHD TRUST nebulizer performs substantially equivalent to the predicate device, B&B Medical Technologies' Hope nebulizer. In
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the opinion of DHD, it is substantially equivalent to the predicate device and does not adversely affect safety and effectiveness compared to the predicate device.
PAGE 16-2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2004
DHD Healthcare Corporation C/O Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K040718
Trade/Device Name: Trust Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 18, 2004 Received: March 19, 2004
Dear Mr. Mosenkis:
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. Robert Mosenkis
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 (QS) 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 (301) 594-5613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Susan Burns
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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DHD HEALTHCARE
TRUST
Indications For Use
K040718 510(k) Number (if known):
Device Name: TRUST
1 - Intended Use: The DHD TRUST is intended for use as a nebulizer.
- 2 Indications:
- 트 The DHD TRUST provides additional hydration to help loosen secretions for patients whom extended therapy is required.
- The DHD TRUST delivers aerosolized medications and diagnostic formulations. ■
- 3 Target Patient Population
Patients with asthma, pneumonia, COPD, or any other condition in which appropriate medications would be nebulized.
- 4 Intended Environment For Use
To be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
H. Humbshin
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Numb
Page 1 of 1 Page 2-1
§ 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).