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.

Device Description

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.

AI/ML Overview

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.

Summary

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K03/551

AUG 2 0 2003

Section E

5.0 510(k) Summary:

The following is a summary of the information contained in this traditional 510(k) application.

5.1 Submitter:

Vyteris Inc. 13-01 Pollitt Drive Fair Lawn, NJ 07410 Phone: 201-703-2299 Fax : 201-703-2295

5.2 Contact:

George M. Baskinger Manager, Quality Management and Regulatory Compliance

5.3 Device Name:

Name- Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)

Classification Name- Iontophoresis Device

Classification- Class II (special controls) pursuant to FR Doc.00-21251 filed 8-21-00 and 21CFR890.5525 paragraph a (revised April 1, 2002)

Predicate Device: ર .4

Iontophoresis Device Phoresor® II, Model PM900 K974855 & K982668

Manufactured by: IOMED, Inc. 3385 West 1820 South Salt Lake City, UT 84104

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ર : ર Description of Device:

It has been shown that the efficacious delivery of anesthetic levels of lidocaine hydrochloride can be made to local dermal areas through iontophoresis.

5.6 Intended Use of the Device:

Northstar System is indicated for use on patients 5 years of age and older.

5.7 Technical Characteristics:

The Northstar Controller-D uses a combination of discrete analog circuitry to control the delivery current and an embedded microprocessor to monitor the delivery.

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available, starts the delivery and two LED's (Light Emitting Diodes) on the controller indicate the delivery status to the user.

5.8 Predicate Device Comparison:

The Northstar Lidocaine Iontophoretic Drug Delivery System and the IOMED Numby® 900 Iontophoretic Drug Delivery System have substantially the same function, that is to provide local dermal anesthesia. They both use the same drugs, lidocaine and epinepherine, to accomplish the result.

The Controllers for these systems (Northstar Lidocaine Iontophoretic Controller and the predicate device Phoresor® II. Model PM900) are both constant current generators. Both devices have similar safety features for over and under current delivery detection.

The differences in controller output characteristic are the result of differences in the drug concentrations used in the delivery. The predicate device uses a drug preparation of slightly lower concentrations requiring an increased charge to achieve similar levels of anesthesia.

5.9 Performance Summary

The Northstar Lidocaine Iontophoretic Drug Delivery System is a combination product consisting of an iontophoretic patch (drug component) and a controller (device component). The performance of the Northstar Lidocaine Iontophoretic Drug Delivery System were evaluated as a system by the end user during Phase III clinical studies to provide safety and efficacy data in support of the indication of local dermal anesthesia on intact skin which has been submitted as a part of the Northstar Lidocaine Iontophoretic Drug Delivery System New Drug Application (NDA) - N21-504 to CDER at the FDA.

These 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.

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5.10 Conclusion

Overall, 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 and is suitable for its intended use.

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2003

Mr. George M. Baskinger Manager, Quality Management and Regulatory Compliance Vyteris, Inc. 13-01 Pollitt Drive Fair Lawn. New Jersey 07410

Re: K031551

Trade/Device Name: Northstar Lidocaine Iontophoretic Controller Northstar Controller D) Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: II Product Code: KTB Dated: May 16, 2003 Received: May 19, 2003

Dear Mr. Baskinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act), as long as you comply with all of the Act's requirements relating to drugs labeled or promoted with the devices as described below. You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. George M. Baskinger

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Our substantially equivalent decision does not apply to any specific drugs other than 10% Lidocaine and 1% Epinephrine packaged in a pre-filled patch submitted in NDA 21-504 for use with your device. Therefore, you may neither label nor promote your device for use with other specific drugs, nor package drugs with your device prior to FDA having approved the drugs for iontophoretic administration. For information on the requirements for marketing new drugs, you may contact:

Director Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland

As you are aware, iontophoresis devices that are 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, were classified into Class II. An iontophoresis device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes other than those specified for class II devices is classified into Class III (21 CFR 890.5525). We published our strategy for calling for premarket approval (PMA) applications in the enclosed Federal Register, dated May 6, 1994, and the enclosed memorandum, dated April 19, 1994, and the enclosed Federal Register, dated August 22, 2000.

If you have any questions regarding this letter, you may contact:

Kevin Lee. M.D. Food and Drug Administration Center for Devices and Radiological Health Division of General, Restorative and Neurological Devices 9200 Corporate Boulevard (HFZ-410) Rockville, Maryland 20850 (301) 594-1296

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 3 - Mr. George M. Baskinger

If you desire specific advice for your device on our labeling regulation, please contact the Office of Compliance at (301) 594- 4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

e Muh n Mullener

elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Section D

4.0 Statement of Indications for Use:

Northstar System is indicated for the administration of lidocaine hydrochloride to provide local dermal anesthesia on normal intact skin. This nyaloomoriae to provee to hypodermic injection or topical application of lidocaine hydrochloride.

Northstar System is indicated for use on patients 5 years of age and older.

Mark A Miller
(Division Sign Off)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K03155

Regulation Number and Section

§ 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.