MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR

• K Number: K111570
• Device Name: MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
• Manufacturer: THAYER MEDICAL CORPORATION
• Date Cleared: 2011-09-29 ( 115 days)
• Product Code: CAF
• Regulation Number: 868.5630
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The MINISPACER® 1024A, 1025A and 1543A adapters are single patient, disposable devices for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner.

The MINISPACER® 1024A, 1025A and 1543A adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments.

Device Description

Not Found

AI/ML Overview

My deepest apologies, but the provided text does not contain specific acceptance criteria or the details of a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the MiniSpacer® 1024A, 1025A, and 1543A MDI Adapters.

This type of document is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices. It confirms that the FDA has reviewed the manufacturer's submission and found it acceptable for market, but it does not typically include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Specifics about the type of ground truth used or the size and establishment of ground truth for a training set.

These details would normally be found in the V&V (Verification and Validation) reports or clinical study summaries submitted by the manufacturer to the FDA as part of their 510(k) application, but they are not typically included in the public-facing clearance letter itself.

Therefore, I cannot fulfill your request for this specific document. If you have a different document that details performance studies, I would be happy to analyze it.

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).