(81 days)
Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).
An iontophoresis device 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 on the charge and molecular wcight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.
The IOMED, Inc. RH-950 iontophoresis electrode patch consists of an active delivery electrode and a passive return electrode. These electrodes are designed for a singlepatient, one-application use.
This electrode is powered by an on-board 1.5-volt button-cell battery. The maximum allowable electrical current is controlled by means of a fixed in-series resistor included in the device, while the treatment duration is pre-defined and controlled by a printed conductive ink limit switch.
The RH-950 iontophoresis electrode consists of dry, monolithic, impregnated polyester nonwoven fabric drug and clectrolyte containment pads designed to be hydrated with aqueous solutions of the drug and electrolyte immediately prior to use. It features a Silver-based metallic conductive current distribution component and a medical-grade pressure sensitive adhesive tape border for skin attachment. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.
The provided text describes the IOMED, Inc. RH-950 iontophoresis electrode. However, it does not contain specific acceptance criteria, performance metrics, or study details in the format requested. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance.
Therefore, many of the requested fields cannot be filled directly from the provided text. I will extract what is available and note what is missing.
Acceptance Criteria and Study Details for IOMED, Inc. RH-950 Iontophoresis Electrode
The provided document, a 510(k) summary for the IOMED, Inc. RH-950 iontophoresis electrode, primarily focuses on demonstrating substantial equivalence to predicate devices (IOMED RH-900 and Birch Point IontoPatch). It describes the device, its intended use, and comparative testing for drug delivery and biocompatibility. However, it does not define specific numerical acceptance criteria for performance or explicitly detail a "study that proves the device meets the acceptance criteria" in a typical clinical trial or rigorous performance study format. Instead, it presents comparative data against a predicate device.
Below is an attempt to structure the available information according to your request, with significant caveats about missing data.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state numerical "acceptance criteria" for performance. The "performance" is largely demonstrated through comparability to a predicate device.
| Aspect | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (IOMED RH-950) |
|---|---|---|
| Drug Delivery | Presumably, comparable transport of both negative and positive charged drugs to the predicate RH-900 electrode. Specific quantitative thresholds are not provided. | Iontophoretic transport of dexamethasone sodium phosphate (-) and lidocaine hydrochloride (+) was "comparably delivered" using the RH-950 compared to the Iomed's RH-900 electrode. This was assessed in vitro using hairless mouse skin. The document also states "The testing shows that these model drugs can be comparably delivered using the BH-d20" (likely a typo, meant RH-950). |
| Biocompatibility - Primary Dermal Irritation | Negligible irritation (e.g., scores of 0.0 to 0.4 on an 8-point scale) in accordance with ISO 10993-10:2002. Also, comparable to predicate device RH-900. | RH-950 (materials identical to RH-900): Not directly tested, but the RH-900 (materials of which are identical to RH-950) was rated: |
- 0.1 (negligible) when operated from negative polarity.
- 0.3 (negligible) when operated from positive polarity.
These scores are "comparable to the IOMED, Inc. RH-900 electrode" (which is self-referential but implies meeting the negligible category). Scores for the Birch Point predicate were not available for comparison. |
| Biocompatibility - Cytotoxicity | Meeting USP and ISO 10993-10 requirements, indicating 'mild' reactivity (e.g., Grade 2 on a 0-4 scale). | RH-950 (materials identical to RH-900): Not directly tested, but the RH-900 showed a cytotoxic grade of 2 (on a 0 to 4 scale), indicating 'mild' reactivity. This "meets USP and ISO 10993-10 requirements and shows that all the materials used in the RH-950 are safe to come in limited contact with intact patient skin." |
2. Sample Size Used for the Test Set and Data Provenance
- Drug Delivery Test Set: Not explicitly stated. The study involved "hairless mouse skin in vitro." The number of samples (e.g., number of skin pieces, number of repetitions) is not provided.
- Biocompatibility - Primary Dermal Irritation Test Set: "Rabbits." The specific number of animals is not provided.
- Biocompatibility - Cytotoxicity Test Set: Not explicitly stated, as direct testing was not done on RH-950. The RH-900 results are referenced. Specific sample size for RH-900 cytotoxicity is not provided.
- Data Provenance: The drug delivery study was in vitro. The dermal irritation study involved "rabbits." No country of origin is specified for these studies, but the regulatory submission is to the US FDA. The studies appear to be prospective in nature, conducted for the purpose of demonstrating equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable in the context of the provided information. "Ground truth" in this document refers to analytical measurements (drug transport) and standardized biological response assessments (irritation, cytotoxicity) rather than expert interpretation of images or clinical outcomes. The studies were conducted according to established scientific protocols (e.g., Petelenz et al., J Controlled Release 20 (1992), 55-56 for drug delivery; ISO 10993-10:2002 and GLP for biocompatibility).
4. Adjudication Method for the Test Set
- Not applicable. This is not a study relying on subjective adjudication of results. Measurements and observations were made according to scientific protocols.
- If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where multiple human readers assess cases with and without AI assistance. The RH-950 is an iontophoresis electrode, and its evaluation relies on drug delivery kinetics and biocompatibility, not reader performance.
- If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a passive electrode, not an algorithm. Its performance is evaluated intrinsically through its physical and chemical properties and interaction with biological systems, not as an "algorithm only" component.
- The Type of Ground Truth Used
- Drug Delivery: Quantitative measurements of drug transport (e.g., amount of drug delivered across the skin) in an in vitro model. This is an objective, measured outcome.
- Biocompatibility (Dermal Irritation): Standardized scoring of observed biological reactions in animal models (rabbits) according to ISO 10993-10:2002 guidelines. These scores are objective based on a predefined scale.
- Biocompatibility (Cytotoxicity): Standardized scoring of cellular reactions (grade 0-4) according to USP and ISO 10993-10 requirements. This is an objective, measured outcome.
- The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." The materials and design are based on established principles and manufacturing processes.
- 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.