(214 days)
The Phoresor Iontophoretic Drug Delivery System is indicated for the administration of soluble salts and other drugs into the body for medical purposes as an alternative to hypodermic injections when it is advisable to avoid the pain that may accompany needle insertion and drug injection; when it is advisable to minimize the infiltration of carrier fluids; to avoid the damage caused by needle insertion when tissue is traumatized. It is also indicated for production of local dermal anesthesia using Iontocaine™, brand of Lidocaine HCI 2% and Epinephrine 1:100,000.
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.
The Phoresor® 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.
The provided text describes a 510(k) summary for the IOMED Phoresor® II, Model PM900 iontophoresis device, which is seeking substantial equivalence to the predicate device, the IOMED Phoresor® II, Model PM800. The focus is on the functional equivalence of the new device to the predicate.
Here's an analysis of the acceptance criteria and the study based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable form often seen for AI/ML devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The output(s) of the Phoresor® II, Model PM900 are functionally identical to the predicate device, the IOMED Phoresor® II, Model PM800. | "Testing data confirms that the output(s) of the Phoresor® II, Model PM900 are functionally identical to the predicate device, the IOMED Phoresor® II, Model PM800." |
| Device technical characteristics are substantially equivalent to the predicate, with modifications related to user input (pushbuttons vs. rotary knobs) and software redesign for GMP. | "The Phoresor® II, Model PM900 iontophoretic device and the presently marketed Phoresor® II, Model PM800 have the same technical characteristics except that the dose (total charge) is preset and the current levels are entered via pushbutton instead of rotary knobs. In both units, after the initial setup, there is an automatic delay and repeat of ramp up after a resistance limit occurs, and a current holdback in lieu of a voltage reject. In addition to the software modifications that were required to implement the functions, the software, as a whole, was re-designed into logical modules as required by Good Manufacturing Practices." |
| The device demonstrates safety and effectiveness comparable to the predicate for its intended use. | "Through non-clinical testing, design review, analysis and validation, and failure mode and effects analysis, the IOMED Phoresor® II, Model PM900 is found to be substantially equivalent to the IOMED Phoresor® II, Model PM800." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "testing data" and "non-clinical testing" but does not provide details on the number of units tested or and cases/scenarios/patients involved in these tests.
- Data Provenance: Not specified. It's likely that the testing was performed internally by the manufacturer (IOMED, Inc. in Salt Lake City, UT) as part of their design verification and validation process, which is typical for device modifications aiming for substantial equivalence. The data is retrospective in the sense that it's based on internal testing and comparison to an existing device, rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Given that this is a non-clinical performance summary for an iontophoresis device (which focuses on electrical and functional outputs), the "ground truth" would likely be established by engineering specifications, calibration standards, and direct measurement against the predicate device's known performance, rather than expert clinical judgment in the way it would be for an AI diagnostic tool.
4. Adjudication method for the test set:
Not applicable or not specified. Given the nature of the device (electrical output and control), the "adjudication method" would involve comparing measured outputs against expected values or the predicate device's outputs, which is a direct technical comparison rather than a consensus-based human adjudication process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an iontophoresis device, not an AI/ML diagnostic or assistive tool where human readers/interpreters would be involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of an "algorithm only" performance as understood for AI/ML. The device itself is a standalone medical device that performs a function. The "performance" described is the device's functional output, which is assessed inherently in a "standalone" manner (i.e., the device's outputs are measured independently). However, this is not an AI algorithm.
7. The type of ground truth used:
The ground truth, in this context, is the functional output and technical characteristics of the predicate device (IOMED Phoresor® II, Model PM800) and established engineering specifications/standards. The PM900's output and characteristics were compared against these known values to determine functional identity and substantial equivalence.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a "training set." The software redesign mentioned is for control functions and Good Manufacturing Practices adherence, not for learning from data to perform a task.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 890.5525 Iontophoresis device.
(a)
Iontophoresis device intended for certain specified uses —(1)Identification. 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 and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. An iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.(2)
Classification. Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted:
(A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended;
(B) Testing of the ability of the device to maintain a safe pH level; and
(C) If used in the ear, testing of the device to demonstrate mechanical safety.
(ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following:
(A) A description and/or graphical representation of the electrical output;
(B) A description of the electrode materials and pH buffer;
(C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and
(D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning:
Warning: Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile.
(vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.