(62 days)
The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.
The Empi Action Patch Iontophoresis System is a disposable single-use iontophoresis device with a self-contained battery and electrical circuitry. A single adhesive patch unifies both the battery-powered iontophoresis device and the active and return electrodes. The Empi Action Patch is designed to deliver a calibrated and fixed dose of ionic solution (between 1 and 160 mAmp * min.) over a specified time. After delivery of the specified dose, an LED indicator light extinguishes indicating that that the Patch can be removed.
This 510(k) premarket notification for the Empi Action Patch Iontophoresis System does not contain the detailed study information regarding acceptance criteria and performance data that you've requested.
The document primarily focuses on establishing substantial equivalence to predicate devices. This means that instead of presenting new clinical performance studies against defined acceptance criteria, the manufacturer is demonstrating that their new device is as safe and effective as devices already on the market.
Therefore, for your specific request, I can only provide the following based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not define specific quantitative "acceptance criteria" and "reported device performance" in the way one would expect from a clinical trial or performance study aiming to prove efficacy against a predefined standard. The evaluation of this device is based on its substantial equivalence to predicate devices, focusing on:
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (as claimed for Substantial Equivalence) |
|---|---|
| Intended Use Equivalence | "The Empi Action Patch has the same intended use as the above identified predicate devices... it is intended to be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections." |
| Technological Characteristics Equivalence | "Like the Birch Point IontoPatch, the Empi Action Patch is a disposable, self-contained, single use iontophoresis device in a unified patch form. In terms of outward appearance and intended use, it is substantially equivalent to the IontoPatch." "Both incorporate a battery to supply current to the electrodes and a means of electronically controlling a fixed dose (current * time)." Output voltage: Action Patch produces 10.5 volts (vs. IontoPatch 1 volt, Dupel 60 volts). This is presented as an "intrinsic safety factor." "The Empi Action Patch uses an immobilized buffer system to control pH... This buffering system is identical to the Dupel B.L.U.E. iontophoresis electrode in terms of mechanism of action, materials, and function." |
| Materials of Construction Equivalence | "The Empi Action Patch uses the identical adhesive foam backing as that used in the Empi Buffered Iontophoresis Electrodes." |
| Mode of Operation Equivalence | "[The Empi Action Patch] operates to deliver a calibrated and fixed dose of ionic solution... After delivery of the specified dose, an LED indicator light extinguishes indicating that that the Patch can be removed." This mode of operation is described as similar to predicate devices, particularly the Birch Point IontoPatch (discrete current * time dose delivery) and Empi Dupel systems (buffering mechanism). |
The following information cannot be provided from the given document, as it pertains to clinical performance studies, which are typically not required for 510(k) submissions based on substantial equivalence to predicate devices for this type of medical device.
- 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. This document does not describe a test set or associated data provenance from a performance study.
- 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/provided. No test set or ground truth establishment by experts is described.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/provided. No test set or adjudication method is described.
- 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
- Not applicable/provided. This device is an iontophoresis system, not an AI-assisted diagnostic tool. An MRMC study is irrelevant in this context.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/provided. This is not an algorithm-based device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/provided. No clinical studies requiring ground truth are described. The "ground truth" for 510(k) equivalence is generally the established safety and efficacy of the predicate devices.
- 8. The sample size for the training set
- Not applicable/provided. No training set for an algorithm is relevant to this device submission.
- 9. How the ground truth for the training set was established
- Not applicable/provided. No training set for an algorithm is relevant to this device submission.
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Section E
APR 0 8 2003
510(k) Summary
- A. General Provisions
| Submitter's Name: | Empi Corp. |
|---|---|
| Submitter's Address: | 599 Cardigan RoadSt. Paul, Minnesota 55126-3965 |
| Contact Person: | Suzan Onel and Donald R. Stone(202) 778-9000 (ph); (202) 778-9100 (fax) |
| Classification Name: | Iontophoresis Device21 CFR 890.5525 |
| Proprietary Name: | Empi Action Patch Iontophoresis System (alsoknown as the “Action Patch”) |
| Common Name: | Iontophoresis Device |
- B. Date of preparation of this Summary: January 31, 2003
- C. Name of Predicate Devices to which equivalence is claimed:
The Empi Action Patch is substantially equivalent to the identified Empi Dupel iontophoresis devices in intended use, materials of construction, and mode of operation. The Empi Action Patch is substantially equivalent to the Birch Point IontoPatch in terms of intended use and self contained design. The Action Patch uses the identical adhesive foam backing as that used in the Empi Buffered Iontophoresis Electrodes.
- D. Device Description
The Empi Action Patch Iontophoresis System is a disposable single-use iontophoresis device with a self-contained battery and electrical circuitry. A single adhesive patch unifies both the battery-powered iontophoresis device and the active and return electrodes. The Empi Action Patch is designed to deliver a calibrated and fixed dose of ionic solution (between 1 and 160 mAmp * min.) over a specified time. After delivery of the specified dose, an LED indicator light extinguishes indicating that that the Patch can be removed.
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-
Statement of Intended Use Compared to Predicate Device(s) E.
The Empi Action Patch has the same intended use as the above identified predicate devices and other iontophoresis devices, i.e., it is intended to be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections. -
F. Discussion of Technological Characteristics:
Like the Birch Point IontoPatch, the Empi Action Patch is a disposable, selfcontained, single use iontophoresis device in a unified patch form. In terms of outward appearance and intended use, it is substantially equivalent to the IontoPatch. In terms of design, both incorporate a battery to supply current to the electrodes and a means of electronically controlling a fixed dose (current * time). Both devices extend the duration of an iontophoresis session beyond that typical for multiple component systems, such as the Empi Dupel iontophoresis system designed to be used during a clinic visit. Since the duration is longer, both unified patch devices require a maximal output voltage that is less than predicate multicomponent systems such as the Dupel. The IontoPatch outputs 1 volt, and the Action Patch produces 10.5 volts: both significantly less than the maximal voltage of the Dupel system of 60 volts. This adds an intrinsic safety factor to both unified patch devices in that the maximal current density is also less than that of the predicate multicomponent devices designed for shorter iontophoresis sessions.
The Empi Action Patch uses an immobilized buffer system to control pH, a major determinant of chemical safety during iontophoresis. This buffering system is identical to the Dupel B.L.U.E. iontophoresis electrode in terms of mechanism of action, materials, and function.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Empi Corporation c/o Ms. Suzan Onel Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, NW Suite 200 Washington, DC 20036-1221
APR 0 8 2003
Re: K030395
Trade/Device Name: EMPI Action Patch Iontophoresis System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: February 5, 2003 Received: February 5, 2003
Dear Ms. Onel:
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 - Ms. Suzan Onel
forth in the quality systems (QS) 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 drugs for use with your device. Therefore, you may neither label nor promote your device for use with 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.
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
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Page 3 - Ms. Suzan Onel
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,
Mark A. Millheiser
Celia 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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Appendix A1
510(k) Number (if known):
Device Name: Empi Action Patch Iontophoresis System
Indications for Use:
The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Mark N. Milkus
(Division Sign-Off) Division of General, Restorative and Neurological Device
510(k) Number
K030395mnm
K030395mnm
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use
(Per 21 CFR 801.109)
§ 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.