(140 days)
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Not Found
No
The description clearly states the device is a "mechanical stop" and there is no mention of AI, ML, or any related technologies.
No
Explanation: The device is described as an accessory to prevent accidental actuation of a metered dose inhaler, not to treat a medical condition itself. It serves a protective, mechanical function rather than a therapeutic one.
No
The device is described as an accessory to a metered dose inhaler to prevent accidental actuation, serving as a mechanical stop. It does not collect, analyze, or interpret data from the body to aid in diagnosis.
No
The device is described as a "mechanical stop" and an "accessory to a metered dose inhaler," indicating it is a physical component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the MDI Trigger Guard clearly states it's a mechanical stop for a metered dose inhaler to prevent accidental actuation. It interacts with the inhaler itself, not with any biological samples from a patient.
- The intended use is purely mechanical. The device's function is to physically block the trigger of the inhaler. This is a mechanical action, not a diagnostic test performed on a specimen.
The description focuses on the device's interaction with the inhaler and its purpose in preventing accidental drug delivery, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation. Intended for use by entire patient population for which metered dose inhalers are approved, excluding children under the age of 8. Device is not reusable. Device is to be used for the life of the metered dose inhaler, then discarded.
Product codes
CAF
Device Description
MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation.
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
entire patient population for which metered dose inhalers are approved, excluding children under the age of 8.
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 2004
Mr. Richard Lanzillotto North American Technical Services Corporation 30 Northport Road Sound Beach, New York 11789-1734
Re: K040439
Trade/Device Name: MDI Trigger Guard Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: April 30, 2004 Received: May 14, 2004
Dear Mr. Lanzillotto:
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.
1
Page 2 - Mr. Lanzillotto
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 vour 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) 594-4646. 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,
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
2
MDI Trigger Guard K040439
INDICATIONS FOR USE
| 510(k) Number (if known): | K040439 |
|---|---|
| Device Name: | MDI Trigger Guard |
| Indications for Use: | The MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation.Intended for use by entire patient population for which metered dose inhalers are approved, excluding children under the age of 8.Device is not reusable. Device is to be used for the life of the |
metered dose inhaler, then discarded.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use イ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quey Suliom
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
NATS