(93 days)
Northstar System is indicated for the administration of lidocaine hydrochloride to provide local dermal anesthesia on normal intact skin. This system is an alternative to hypodermic injection or topical application of lidocaine hydrochloride.
Northstar System is indicated for use on patients 5 years of age and older.
The Northstar Lidocaine Iontophoretic Drug Delivery System (Northstar System) is composed of the Controller and the pre-medicated Patch. The Controller is fitted with a unique interconnect device, mating only with the Northstar Patch.
The Northstar System delivers drugs through a process known as iontophoresis. It is based on the principle that a soluble salt or drug can be transported across the skin barrier as a part of an electric current induced in the skin.
The quantity and distribution of delivered drug(s) is dependent on; ion charge, molecular weight, the intensity of the electric current and the time the current is present. In most iontophoretic systems the delivery is measured in terms of milliampere-minutes (mA-min).
It has been shown that the efficacious delivery of anesthetic levels of lidocaine hydrochloride can be made to local dermal areas through iontophoresis.
The Northstar Controller-D uses a combination of discrete analog circuitry to control the delivery current and an embedded microprocessor to monitor the delivery.
The Northstar System utilizes a solid-state electronic controller and a pre-medicated drug delivery patch to form a simplified iontophoretic drug delivery system. As a result of this product design coordination, the Northstar System requires no special patch preparation or delivery parameter selection in the controller. An ON button actuation turns on an LCD (Liquid Crystal Display) indicating the number of deliveries available, starts the delivery and two LED's (Light Emitting Diodes) on the controller indicate the delivery status to the user.
The Northstar System has been specifically designed for the delivery of a proprietary preparation containing 10.0% Lidocaine hydrochloride and 1.0% Epinepherine packaged in a pre-filled patch. The delivery is done over a 10 minute interval. The user simply applies the patch to the patient, connects the controller and patch then depresses the ON button to start the delivery.
The provided text describes the Northstar Lidocaine Iontophoretic Drug Delivery System (Northstar System), which gained 510(k) clearance. The focus of the provided document is on the device itself (the controller) and its substantial equivalence to a predicate device, rather than a detailed clinical study report with acceptance criteria and specific performance metrics.
Therefore, the following information is extracted and inferred from the given text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the device performance but rather focuses on its ability to deliver the electrical current required for the intended use and its safety and efficacy as a system.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Ability to deliver electrical current for local dermal anesthesia | The controller of the Northstar system performed as intended to deliver the electrical current required to provide local dermal anesthesia to intact skin when used with the Northstar patch. |
| Safety and efficacy in achieving local dermal anesthesia | Phase III clinical studies demonstrated the safety and efficacy of the Northstar Lidocaine Iontophoretic Drug Delivery System in achieving local dermal anesthesia on intact skin in both adults and pediatrics. |
| Substantial equivalence to predicate device (Phoresor® II, Model PM900) | The Northstar System has substantially the same function, uses the same drugs (lidocaine and epinepherine), and both controllers are constant current generators with similar safety features for over and under current delivery detection. The differences in controller output are due to drug concentration differences. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that Phase III clinical studies were conducted, but does not specify the sample size for these studies.
- Data Provenance: The studies were prospective Phase III clinical studies conducted to provide safety and efficacy data for a New Drug Application (NDA) (N21-504) to CDER at the FDA. The country of origin of the data is not specified in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information regarding the number of experts or their qualifications used to establish ground truth for the test set. Given that it's a drug delivery system for local anesthesia, ground truth would likely be based on objective measures of pain reduction or numbness, potentially reported by patients and assessed by clinicians.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The study described focuses on the efficacy of the device-drug system itself, not on human readers interpreting outputs or improving with AI assistance, as there is no AI component mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the described device is an iontophoretic drug delivery system, not an algorithm or AI system. The "performance" refers to the system delivering the drug and achieving local anesthesia in patients.
7. Type of Ground Truth Used
The ground truth for the clinical studies would be related to the patient's response to local dermal anesthesia, likely assessed through clinical observations, patient-reported pain scales, or objective measures of numbness. The document refers to "safety and efficacy data" from the Phase III clinical studies supporting the indication of local dermal anesthesia.
8. Sample Size for the Training Set
The document does not specify a training set in the context of an algorithm. The term "training set" is typically used in machine learning. For a medical device, there would be development and testing phases, but not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no mention of an algorithm training set. The clinical studies establish the safety and efficacy of the system as a whole.
§ 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.