(21 days)
The TRANSDERM IONTO System MK 2 is a powered iontophoresis drug delivery system that is for medical purposes and can be used as an alternative to injections. For the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
The TRANSDERM IONTO System MK 2 consists of a probe, power supply/support, and a disposable drug delivery cap electrode. The TRANSDERM IONTO System MK 2 generates mechanical vibrations that are produced by an electric motor which has an unbalanced weight applied on the device shaft. The vibrations are transmitted by the motor body to a plastic plate that is held in contact with the skin through the disposable drug delivery cap electrode. Electrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System MK 2 requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector male mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated The urug delivery cap electrug delivery cap electrode is affixed to the while solution: "Oneo the artig changes": applicator head can be attached pation internal side of the drug delivery cap electrode.
The provided text is a 510(k) summary for the TRANSDERM IONTO System MK 2, and it describes the device's safety and effectiveness compared to a predicate device. However, it does not include the details of a study with specific acceptance criteria and reported device performance in the manner requested.
Here's a breakdown of why many of your requested points cannot be filled from the provided text:
- No specific acceptance criteria or performance metrics are listed. The document states that "Performance testing and the applicable IFC 60601-1 standards testing including 21 CFR 898 was performed." This refers to general electrical safety and good manufacturing practice standards, not specific clinical or technical performance metrics for drug delivery efficacy or patient perception.
- No detailed study results are present. The document concludes that the device is "substantially equivalent" to legally marketed iontophoretic devices. This is the outcome of the 510(k) process, but not the detailed study results that would typically include an acceptance criteria table.
- No information on sample sizes, ground truth establishment, or expert involvement for a clinical study is provided. The 510(k) summary focuses on comparing the new device's design and intended use to an existing predicate device (TRANSDERM IONTO System K032968), rather than presenting a novel clinical trial with detailed methodology. The "study" mentioned for patient perception is simply stated as "supports that the TRANSDERM IONTO System MK 2 decreases the patient's perception of the electrical currents," without any data, sample size, or methodology.
Therefore, I cannot populate most of the requested fields accurately based on the provided text.
However, I can extract what is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General Safety & Standards Compliance | Performance testing and applicable IFC 60601-1 standards testing including 21 CFR 898 was performed. |
| Substantial Equivalence | The TRANSDERM IONTO System MK 2 is substantially equivalent to legally marketed iontophoretic devices in intended use and performance. |
| Patient Perception of Electrical Currents | (Implicit) Decrease patient's perception of electrical currents. (Reported) "The Sponsor supports that the TRANSDERM IONTO System MK 2 decreases the patient's perception of the electrical currents." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The "ground truth" here is regulatory substantial equivalence, assessed by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This refers to the FDA's regulatory review process for substantial equivalence, not a clinical trial adjudication method.
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
- No, an MRMC study was not done. This device is an iontophoresis system, not an AI-powered diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a drug delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The primary "ground truth" for a 510(k) is the predicate device (TRANSDERM IONTO System, K032968). The new device is compared to this already legally marketed device to demonstrate substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness. No specific clinical ground truth (like pathology or outcomes) is detailed from a new study.
8. The sample size for the training set
- Not applicable. No "training set" is mentioned as this is a medical device, not a machine learning algorithm being trained.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.