(45 days)
The Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.
Iontophoresis electrodes described in this application are single patient use, disposable, nonsterile devices. Fundamentally the iontophoresis electrodes consist of two skin contacting electrodes: a drug delivery electrode and a return electrode. When connected to the user's iontophoresis electronic device, the electrodes localize administration of ionic drug solutions into the body for medical purposes.
The electrodes provide the patient contact device. The electrodes are used under the supervision of a physician or other medical professional. The iontophoresis electrodes are intended for use only with approved drugs delivered by iontophoresis technology.
There are variations of sizes and shapes of the drug delivery electrode. The size of the return electrode is constant for all drug delivery electrode variations. The iontophoresis electrodes do not include lead wires. The electrode electrical contact is made by a snap on the electrode.
lontophoresis electrodes are used under the direct supervision of a physician or medical professional. The electrodes are placed in contact with the skin to support introduction of soluble salts and other dugs into the body.
The iontophoresis electrodes do not contain active electronics, software or firmware. The electrodes connect to the user's iontophoresis electronic device. The drug delivery electrode is a buffed gel covered carbon electrode. The return electrode is a buffered hydrogel material electrode. Electrode material biocompatibility is addressed in the submission.
This 510(k) summary (K060579) describes an Iontophoresis Drug Delivery System Electrodes by Pepin Manufacturing, Inc. However, it does not contain the specific information required to complete a comprehensive table of acceptance criteria and a detailed study report. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
Here's an analysis of what can be extracted and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance
This information is not present in the provided text. The document states: "Verification of performance and labeling are provided in the submission," but the actual acceptance criteria or performance data itself is not included in this 510(K) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided text. No specific studies with test sets, sample sizes, or data provenance are described.
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)
This information is not present in the provided text. As no specific test studies are detailed, there is no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text.
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
This information is not present in the provided text. The device is an iontophoresis electrode, not an AI or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided text. The device is an electrode and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided text.
8. The sample size for the training set
This information is not present in the provided text. This device is not an AI/ML algorithm that would typically have a "training set."
9. How the ground truth for the training set was established
This information is not present in the provided text.
Summary of available information regarding acceptance criteria and study:
The provided document (K060579) for the Pepin Manufacturing, Inc. Iontophoresis Drug Delivery System Electrodes is a 510(k) summary report. The general approach for this type of device (iontophoresis electrodes) to gain FDA clearance is through demonstrating substantial equivalence to already legally marketed predicate devices, rather than through extensive clinical trials with specific acceptance criteria and detailed study reports as might be required for novel or high-risk devices, especially those involving AI/ML.
The key acceptance criteria for this device, as implied by the submission, are:
- Technological Characteristics Equivalence: The electrodes must have equivalent technological characteristics to predicate iontophoresis electrodes, including performance specifications, materials, sizes, packaging, and labeling.
- Biocompatibility: The electrode materials must be biocompatible.
- Intended Use Equivalence: The intended use (introducing soluble salts and other drugs into the body) must be equivalent to predicate devices.
- Safety and Effectiveness: The device should not raise new questions of safety or effectiveness.
Study/Evidence presented in the document:
The "study" or evidence presented in this 510(k) is a comparison to predicate devices rather than a standalone performance study with detailed numerical results against acceptance criteria.
The document states:
- "The iontophoresis electrodes have the equivalent technological characteristics to predicate iontophoresis electrodes, including performance specifications, materials, sizes, packaging and labeling."
- "Verification of performance and labeling are provided in the submission." (However, the details are not in this summary.)
- "The Pepin Manufacturing, Inc. iontophoresis electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."
The predicate devices listed are:
- K031053, Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes
- K914264, K925800, K933620, Iomed, Inc. Iontophoresis Drug Delivery Electrodes
- K040495, North American Industrial Manufacturing Company, Naimco, Inc. Iontophoresis Drug Delivery Electrodes
In conclusion, this 510(k) summary demonstrates substantial equivalence by asserting that the device shares the same fundamental principles and characteristics as established predicate devices, and that detailed performance verification was provided in the full submission, but the specific metrics and study details are not publicly available in this summary.
§ 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.