(140 days)
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.
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.
I am sorry, but the provided text from the FDA 510(k) summary for the "MDI Trigger Guard" (K040439) does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, and an "Indications for Use" statement. It explicitly mentions that the FDA's determination of substantial equivalence does not mean the device complies with other requirements, including those related to performance studies.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance: This information is not present in the document.
- Sample size used for the test set and data provenance: Not available.
- Number of experts used to establish ground truth and their qualifications: Not available.
- Adjudication method for the test set: Not available.
- Multi-reader multi-case (MRMC) comparative effectiveness study details: Not available. The device is a mechanical accessory, not an AI or imaging device that would typically involve such studies.
- Standalone performance study details: Not available.
- Type of ground truth used: Not available.
- Sample size for the training set: This refers to AI algorithms, which is not applicable here.
- How ground truth for the training set was established: Not applicable.
The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria as you've described for AI/diagnostic devices.
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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.
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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
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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
§ 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).