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510(k) Data Aggregation
(140 days)
ELITechGroup Inc.
The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis.
The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.
The Macroduct Advanced Sweat Collection System consists of the Macroduct Advanced Model 3710, which is a microprocessor-controlled device powered from a rechargeable lithium-ion battery, battery charging power supply and cord for charging the battery, electrode cable assembly, and a kit of single-use supplies (Pilogel discs, collectors, and straps). The system safely and efficiently accomplishes the stimulation of human sweat through pilocarpine iontophoresis using the Macroduct Advanced Model 3710. The Macroduct Advanced Sweat Collector collects a sample of the stimulated sweat. Markings on the collection tube of the collector indicate if a sufficient sweat rate is achieved during the collection of sweat. The sample can then be analyzed for indications of cystic fibrosis with the Sweat-Chek™ Sweat Conductivity Analyzer using the principle of total electrolyte concentration in the sweat sample; or with the ChloroChek® Chloridometer® using the principle of coulometric titration.
The provided document is an FDA 510(k) Premarket Notification for the Macroduct Advanced Model 3710 Sweat Collection System. This device is an iontophoresis device intended for the stimulation and collection of sweat for the diagnosis of cystic fibrosis.
The document focuses on demonstrating substantial equivalence to a predicate device (Macroduct Model 3700-SYS) rather than presenting a study proving a specific performance claim against established acceptance criteria using a novel algorithm or AI. Therefore, many of the requested elements for an AI/algorithm-based study (like MRMC studies, training/test set sample sizes, ground truth establishment for AI, etc.) are not applicable to this type of submission.
The "acceptance criteria" in this context refer to the device meeting the requirements for substantial equivalence, primarily by demonstrating that modifications do not introduce new safety or effectiveness concerns and that the device performs like the predicate.
Here's a breakdown of what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
For a substantial equivalence submission like this, "acceptance criteria" are typically related to maintaining the same fundamental function, safety, and effectiveness as the predicate device. The performance is demonstrated by showing that the modifications do not negatively impact these aspects.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use: Must be the same as the predicate device. | Same: "The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis." |
| Fundamental Scientific Technology: Must utilize the same core technology. | Same: Pilocarpine iontophoresis for sweat stimulation and collection. Iontophoresis current and time (Ramp 0-1.5mA, hold 1.5mA for 5 min, ramp down). Pilocarpine transferred per test (up to 1 mg). Current safety limit controlled by software/hardware to 1.5mA, limited by hardware alone to |
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