The Dynatron® IBox™ is an iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.

The Dynatron® IBox™ is a battery powered, solid state, microprocessor-controlled unit that delivers measured, displayed direct current as defined by the user. Treatment duration is also measured and displayed.

The device connects to any number of existing electrodes cleared for marketing in the United States that have a common snap connection. Device output is functionally identical to predicate devices.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Dynatron® IBox™ Iontophoresis device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving comprehensive clinical effectiveness through studies with acceptance criteria in the manner typically seen for novel devices.

Therefore, the submission does not contain information about specific acceptance criteria for device performance or a study demonstrating the device meets such criteria. Instead, it asserts that the device is "functionally identical to predicate devices" and "substantially equivalent" to them.

Here's why the requested information cannot be fully provided from the given text:

Acceptance Criteria & Reported Performance: The document does not define specific performance metrics (like accuracy, sensitivity, specificity, etc.) for the Dynatron® IBox™ or report any test results against such criteria. The "performance standards" mentioned refer to 21 CFR section 1010, which states that iontophoresis devices are not designated under performance standards requirements.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These are all elements of studies designed to assess direct clinical or analytical performance. Since the 510(k) relies on substantial equivalence and states the device is "functionally identical to predicate devices," it does not include new clinical or analytical study data of this type for the Dynatron® IBox™.

Based on the provided text, here's what can be stated:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics (e.g., accuracy, precision) for this specific device in the submission. The submission relies on "substantial equivalence" to predicate devices and asserts functional identity.
- Reported Device Performance:
  - "Device output is functionally identical to predicate devices." (Claim)
  - The device "delivers measured, displayed direct current as defined by the user."
  - "Treatment duration is also measured and displayed."
Sample size used for the test set and the data provenance: Not applicable. No new clinical or analytical test set or data provenance is detailed for the Dynatron® IBox™ in this substantial equivalence submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new clinical or analytical test set requiring expert ground truth establishment is detailed.
Adjudication method for the test set: Not applicable.
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. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for direct current delivery, not an algorithm.
The type of ground truth used: Not applicable. The submission focuses on functional equivalence to predicate devices, not on proving clinical efficacy or diagnostic accuracy with a specific ground truth.
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or complex analytical models.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for a Class III Iontophoresis device seeking clearance based on substantial equivalence. It highlights the device's functional similarity to existing cleared devices rather than presenting new clinical study data with defined acceptance criteria.

Summary

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K043047

JAN - 7 2005

SUMMARY OF SAFETY AND EFFECTIVENESS

DYNATRONICS CORPORATION SUBMITTED BY: 7030 Park Centre Drive Salt Lake City UT 84121 Phone: (800) 874-6251; (801) 568-7000; Fax: (801) 568-7711

DEVICE NAME (Trade/common, and classification): Dynatron@ IBox™ Iontophoresis device.

1.	Regulation Name:	Iontophoresis device
	Classification:	Class III
	Regulation Nos.:	890.5525
	Product Codes:	EGJ

2. PREDICATE DEVICES:

Iontophor-II, model 6110B, manufactured by Life-Tech, Inc. cleared under K863166.

Dupel Iontophoresis Device, manufactured by Empi cleared under K915444

1. PERFORMANCE STANDARDS: 21 CFR section 1010 (Performance Standards for Electronic Products: General) does not designate iontophoresis devices under performance standards requirements.
1. DESCRIPTION: The Dynatron® IBox™ is an iontophoresis device that delivers direct current to a drug delivery clectrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.

The device connects to any number of existing electrodes cleared for marketing in the United States that have a common snap connection. Device output is functionally identical to predicate devices.

1. INTENDED USE/INDICATIONS FOR USE: 7 The Dynatron® IBox™ is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.
  The Intended Use/Indications For Use stated herein are consistent with the cleared indications for the predicate devices.

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Dynatronics 510(k)

The following information is provided in support of this pre-market notification.

1.0 DEVICE IDENTIFICATION

Dynatron® IBox™ 1.1. TRADE NAME:
1.2 COMMON NAME: Iontophoresis device
1.3 REGULATION NUMBER: 890.5525
1.4 PRODUCT CODE: EGJ
1.5 CLASSIFICATION: Class III
1.6 PANEL: Physical Medicine

2.0 MANUFACTURER/SPONSOR INFORMATION:

2.1 MANUFACTURER:
DYNATRONICS CORPORATION 7030 Park Centre Drive Salt Lake City, UT 84121 Phone: (800) 874-6251; (801) 568-7000 (801) 568-7711 Fax:

2.2 ESTABLISHMENT REGISTRATION NUMBER: 1719362

2.3 SUBMISSION CORRESPONDENT:
Ron Hatch VP Operations/Regulatory Affairs DYNATRONICS CORPORATION 7030 Park Centre Drive Salt Lake City, UT 84121

3.0 PERFORMANCE STANDARDS:

21 CFR scction 1010 (Performance Standards for Electronic Products: General) does not designate iontophoresis devices under performance standards requirements.

4.0 INTENDED USE/INDICATIONS FOR USE:

The Dynatron® IBox™ is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

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5.0 DEVICE DESCRIPTION:

The Dynatron® IBox™ is an electrophoresis device that delivers direct current to an clectrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.

The Dynatron® IBox™ is a battery powered, solid state, microprocessor-controlled unit that delivers measured, displayed direct current flow as defined by the user. Treatment duration is also measured and displayed.

The device connects to any number of existing drug delivery electrodes that have a common snap connection. Device output is functionally identical to predicate devices.

6.0 PROPOSED LABELING:

A label with statement "Caution. Federal law restricts this device to sale or by the order of a licensed practitioner" will appear on the device.

Copics of the Operator's Manual -- Instructions for Use are submitted as an attachment (Appendix II).

7.0 PREDICATE DEVICE INFORMATION:

The proposed Dynatron® IBox™ is substantially equivalent to fontophor-II model 6110, cleared under under K863166; and to Microphor, cleared under K913601; and to RH-900, cleared under K031115.

Fividence of Substantial Equivalence determination for the predicate devices is included in Appendix 1.

The above cleared 510/k)s deternined that these products, both hardware and software, were substantially equivalent (SE) to devices already in interstate commerce: hence, these products become the predicate devices for this submission.

No changes from the intended uses of the cleared predicate devices are claimed .

8.0 SUBSTANTIAL EQUIVALENCE:

The Dynatron® IBox™ is a variant of previously cleared iontophoresis devices, as follows:

Iontophor-II, model 6110, manufactured by Life-Tech, Inc. cleared under K863166.

Dupel Iontophoresis Device, manufactured by Empi cleared under K915444

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Mr. Ronald J. Hatch VP Operations/Regulatory Affairs Dynatronics Corporation 7030 Park Centre Drive Salt Lake City Utah 84121

Re: K043047

Trade/Device Name: Dynatron® IBox™ Iontophoresis Device Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: November 1, 2004 Received: November 4, 2004

Dear Mr. Hatch:

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 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.

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Page 2 -- Mr. Ronald J. Hatch

Our substantially equivalent decision does not apply to the drugs that you will label or promote Our substantally equiralized seefore, you may neither label nor promote your device for use with for use with your devices - a drugs with your device prior to FDA having approved the drugs for specific 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 r 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 iontophorosis are 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 approval (19. 1994) 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by

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Page 3 – Mr. Ronald J. Hatch

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, Information on your responsionnes ander install free number (800) 638-2041 or (301) 443-6597, International and Consumer Proclow. Ida.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Elen wittd

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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Indications for Use

510(k) Number (if known): ___

Device Name: Dynatron® IBox™

Indications for Use:

The Dynatron® IBox™ is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

X_________ ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.