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K Number
K973532
Device Name
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
Manufacturer
DHD DIEMOLDING HEALTHCARE DIV.
Date Cleared
1998-03-19

(182 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

1 - Purpose: The DHD Steath Metered Dose Intraler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with then associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). 2 - Claims: 2.1 Use of the Stealth Spacer, without integral actuator, assists with the delivery of aerosolized medications from Metered Dose Inhaler (MDI) canisters. 2.2 Use of the Stealth Spacer reduces patient coordination and technique oriented problems associated with MDI drug delivery.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the "Stealth, Metered Dose Inhaler (MDI) Spacer without Integral Actuator." It grants permission to market the device based on its substantial equivalence to previously marketed devices. However, it does not contain the information required to describe the acceptance criteria and the study that proves the device meets them.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, or the number/qualifications of experts used for ground truth.
  • Information on adjudication methods.
  • Results from a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study.
  • The type of ground truth used.
  • Sample size or ground truth establishment methods for a training set.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.

§ 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).