(104 days)
The Iontophoresis System with Headset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.
The Iontophoresis System with Headset (IPSHS) is a single-use device that employs electric current to transport drug solution, salts, or ions in the ear, including the tympanic membrane. IPSHS consists of four components: a Control Unit, a Headset, Ear Plugs, and a Return Electrode Patch. The accessories to IPSHS include a Syringe, a Fill Nozzle, and a set of Ear Plug Sizers.
The provided text describes a 510(k) submission for the Acclarent Tula™ Iontophoresis System. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria in the way an AI/ML device would.
Based on the provided text, the specific acceptance criteria and the detailed study proving the device meets these criteria (with specific metrics like sensitivity, specificity, or reader improvement) are not included. The document primarily states:
- "IPSHS met all performance testing acceptance criteria."
- "Summary of IPSHS is substantially equivalent to the predicate Device as confirmed through relevant performance tests."
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample size, data provenance, expert involvement, or MRMC studies, as this information is not present in the provided 510(k) summary.
A 510(k) submission for a non-AI/ML device typically involves engineering and functional performance testing (e.g., electrical safety, biocompatibility, mechanical integrity, current delivery accuracy for an iontophoresis system) to demonstrate that the new device performs as intended and is safe and effective when compared to a legally marketed predicate device. The summary provided here only states that these tests were met, not the specific criteria or results of those tests.
Summary of Information NOT Available in the Provided Text:
- A table of acceptance criteria and the reported device performance: Not provided. The text only states that the device "met all performance testing acceptance criteria."
- Sample sizes used for the test set and the data provenance: Not provided. This type of detail is typical for clinical studies, not generally for 510(k) summaries of non-AI/ML devices unless a specific clinical performance claim is being made that requires clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable/provided. This device is not an AI/ML diagnostic tool, so "ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here.
- Adjudication method for the test set: Not applicable/provided for the same reasons as above.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a non-AI/ML device for drug administration, not an AI/ML diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a hardware device; this concept is not applicable.
- The type of ground truth used: Not applicable. For a medical device like an iontophoresis system, performance is measured against engineering specifications (e.g., accurate current delivery) and safety standards, not against "ground truth" of a medical condition.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
What is available from the text:
- Device Name: Tula™ Iontophoresis System
- Purpose: Delivers electrical current to transport drug solution, salts, or ions into the ear.
- Regulatory Pathway: Traditional 510(k)
- Classification: Class III, Product Code EGJ
- Predicate Device: Iontophoresis System (K073276) manufactured by Acclarent.
- Performance Statement: "IPSHS met all performance testing acceptance criteria." and "IPSHS is substantially equivalent to the predicate Device as confirmed through relevant performance tests."
§ 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.