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The Iomed, Inc. Phoresor II PM900 is indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, the strength of the electrical current being applied, electrode composition, duration of current flow, and numerous other factors.

ThePhoresor® II, Model PM900 iontophoretic device is a 9V battery-powered, solid state, microprocessorcontrolled device which controls current strength and duration, calculates total charge delivered, and monitors current flow and electrode/tissue impedance.

I am sorry, but the provided text from the K974855 submission does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) summary and the FDA's response letter for the Phoresor® II, Model PM900 iontophoresis device. It focuses on:

• Device Description and Intended Use: Explaining what the device is and its purpose (administration of soluble salts or other drugs into the body for medical purposes, specifically local dermal anesthesia using Iontocaine™).
• Predicate Device: Identifying the previous model (Phoresor® II, Model PM800) for substantial equivalence comparison.
• Regulatory Classification: Discussing the classification of iontophoresis devices (Class II or Class III) and the conditions under which the PM900 is considered substantially equivalent.
• FDA's Decision: Confirming the device's substantial equivalence to devices marketed prior to May 28, 1976, provided it complies with regulations, particularly regarding drug labeling and manufacturing practices. The approval specifically applies to the use with Iontocaine™.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or the nature of any study dataset.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and ground truth establishment as might be seen for novel high-risk medical devices or AI-powered diagnostics. In this case, the updated device (PM900) is being compared to its predecessor (PM800), and the focus is on its intended use for drug delivery, not diagnostic performance.

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