(88 days)
Not Found
No
The summary describes a lead wire adapter for iontophoresis electrodes and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section states that "Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes," which describes a therapeutic function.
No.
The device description and intended use focus on drug delivery, stating it's for "local administration of ionic drug solutions into the body" and "can be used as an alternative to injections," which are therapeutic rather than diagnostic functions.
No
The device description explicitly states it is a "Lead Wire Adapter" and discusses "Electrodes," which are hardware components. The performance studies also focus on the physical connection and performance of these hardware elements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local administration of ionic drug solutions into the body for medical purposes." This describes a therapeutic or drug delivery function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is an "Empi Lead Wire Adapter" that allows the use of electrodes with iontophoresis devices. This is a component used in a drug delivery system, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for a therapeutic application (drug delivery) rather than a diagnostic one.
N/A
Intended Use / Indications for Use
Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
The Empi Lead Wire Adapter will allow the use of currently marketed Dupel Electrodes with other commercially available iontophoresis devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
the clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests: Qualification was performed to establish suitability of performance between Dupel electrodes and lead wire adapters with other commercially available iontophoresis devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K97049, K912015, K983484, K780310, K872040, K934335, K974855, K982668
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
SEP 1 0 1999
Image /page/0/Picture/1 description: The image shows the word "Empi" in a bold, sans-serif font. The letters are black against a white background. A small registered trademark symbol is located to the right of the "i".
Cost Effective Health Care Solutions
Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-4099 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
Dupel® Iontophoresis Lead Wire Adapter Date of Summary: June 11, 1999 Page 1 of 1
651-415-9000 FAX 651-415-7305
General Provisions A. Submitter's Name: Submitter's Address:
Contact Person:
Classification Name:
Proprietary Name: Common Name:
Empi, Inc. 599 Cardigan Road St. Paul. Minnesota 55126-3965 Kristy K. Mollner Regulatory Affairs Associate Iontophoresis Device 21 CFR 890.5525 Dupel® Iontophoresis Lead Wire Adapter Iontophoresis Lead Wire
B. Name of Predicate Devices
| • | Empi Dupel II Iontophoresis Electrodes | K97049 |
|---|---|---|
| • | Empi Iontophoresis Buffered Electrodes | K912015 |
| • | Dupel B.L.U.E. Electrodes | K983484 |
C. Device Description
The Empi Lead Wire Adapter will allow the use of currently marketed Dupel Electrodes with other commercially available iontophoresis devices.
D. Intended Use
The electrode is intended to be used in the clinic. Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
E. Non-Clinical and Clinical Test Summary
Non-Clinical Tests
Qualification was performed to establish suitability of performance between Dupel electrodes and lead wire adapters with other commercially available iontophoresis devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human profiles, which are meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1999
Ms. Kristy K. Mollner Regulatory Affairs Associate EMPI, Inc 599 Cardigan Road St. Paul, Minnesota 55126-4099
K991991 Re:
Trade Name: Dupel Iontophoresis Lead Wire Adapter Regulatory Class: Class III Product Code: EGJ Dated: June 11, 1999 Received: June 14, 1999
Dear Ms. Mollner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 device 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 (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
2
Our substantially equivalent decision does not apply to the drugs that you will label or promote 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.
If you have any questions regarding this letter, you may contact:
Kevin Lee, M. D. Division of General and Restorative Device Office of Device Evaluation 9200 Corporate Boulevard Rockville, MD 20850 Tel (301) 594-1296
This letter immediately will allow you to begin marketing your devices as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and permits your devices to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659 . Additionally, for question on the promotion and advertising, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or
3
Page 3 - Ms. Kristy K. Mollner
(301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D. , M. D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
510(k) Number: (if known): Unknown at time of submission 516(K) Name: Dupel® Iontophoresis Lead Wire Adapter Indications for Use:
Iontophoresis drug delivery systems are indicated for the local administration of ionic loniophoresis drug denvery systems are mercure see many and 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)
ioderks
(Division Sign-Off)
Division of General Restorative Devices K99199/
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ OR