← Product Code [EGJ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/EGJ) · K232020 # Iontophoresis Electrodes (K232020) _Top-Rank Health Care Co., Ltd. · EGJ · Oct 16, 2023 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/EGJ/K232020 ## Device Facts - **Applicant:** Top-Rank Health Care Co., Ltd. - **Product Code:** [EGJ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/EGJ.md) - **Decision Date:** Oct 16, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5525 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. ## Device Story Iontophoresis Electrodes consist of adhesive anode and cathode electrodes applied to the skin surface. The device includes a drug/solution reservoir that end users saturate with the ionic solution to be delivered. Electrodes connect via leads to a separate iontophoresis controller to form a current loop. The controller drives the drug/solution transdermally into the patient. Used in hospitals and medical clinics by healthcare professionals. The Ag/AgCl film layer mitigates electrolytic water reactions to prevent pH-related skin corrosion. The device provides a non-invasive alternative to hypodermic injection for drug delivery. ## Clinical Evidence No clinical data. Bench testing only, including biocompatibility (cytotoxicity, sensitization, irritation) and electrical safety/EMC testing. ## Technological Characteristics Materials: Ag/AgCl film, PU conductive carbon film, polyethylene film, self-adhesive gel. Dimensions: 64x64mm to 88x98mm. Connectivity: Wired connection to external controller. Principle: Iontophoresis (transdermal drug delivery via electrical current). Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993-5/10/23 (biocompatibility). ## Regulatory 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. Additionally, 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. ## Special Controls *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. ## Predicate Devices - Iontophoresis Drug Delivery Electrodes ([K040495](/device/K040495.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 16, 2023 TOP-RANK Health Care Co., Ltd. % Heather Wang Consultant Microkn Medical Technology Service (Shanghai) Co., Ltd. Room 901, No. 889, Pinglu Road, Jing'an District, Shanghai (Shanghai Jing'an HUAFA Center) Shanghai, Shanghai 200435 China Re: K232020 Trade/Device Name: Iontophoresis Electrodes Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class II Product Code: EGJ Dated: August 18, 2023 Received: August 18, 2023 Dear Heather Wang: 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Tushar Bansal -S for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices {2}------------------------------------------------ OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K232020 Device Name Iontophoresis Electrodes Indications for Use (Describe) Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary # 1. Contact information ## 1.1. Applicant Applicant Name: Top-Rank Health Care Co., Ltd. Address: Mcshan Village, Dongguan Street, Shangyu District, Shaoxing City, Zhejiang Province, P.R. China. Contact Person: Yao fei jie Title: Product Manager Tel: +86-575-82912999 Email: yaofeijie@etop-rank.cn ## 1.2. Consultant Company: Microkn Medical Technology Service (Shanghai) Co., Ltd. Address: Room 901, No. 889, Pinglu Road, Jing'an District, Shanghai (Shanghai Jing'an HUAFA Center) Contact Person: Heather. Wang Telephone: +86 13166194697 Email: heather.wang@microkn.com # 2. Device information {5}------------------------------------------------ - Common Name: Iontophoresis Electrodes ● - Model(s): ION-T01, ION-T02, ION-T03, ION-T04, ION-T05 ● - Classification: II o - Product Code: EGJ 0 - Regulation Number: 21CFR 890.5525 o #### 3. Indications for Use Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. ## 4. Legally Marketed Predicate Device Product name: Iontophoresis Drug Delivery Electrodes 510(k) Number: K040495 Product Code: EGJ Manufacture: NAIMCO, INC. ## 5. Description of the device The proposed device is indicated for the administration of soluble salts or other drugs into the body for medical purposes. The Iontophoresis Electrodes utilize adhesive electrodes have both anode and cathode electrodes that adhere to the skin. The electrodes may either be connected by leads (wires) to a separate controller Forming a current loop. The portion of the active electrode that contacts the skin also has a drug/solution reservoir. End users saturate the {6}------------------------------------------------ reservoir with the ionic solution to be delivered. The reservoir contacts the electrode and the drug/solution is delivered to the patient transdermally. Five models (Small, Medium, Large, Butterfly and Return Electrode) are included in this series products, and they have the same intended purposes, working theories and specifications. {7}------------------------------------------------ The main components of proposed device shown in Table 1. | Component name | Description | Applie
d to | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Conductive button
(Upper) | It serves as a connecting component to the output terminal of
the controller, completing mechanical and electrical
connection functions | ALL
Models | | Conductive button
(Lower) | Conductive button (Lower) is used in conjunction with the
upper part and mechanically riveted to achieve a firm
connection between materials | ALL
Models | | POLY film layer | It is a thin film made of polyethylene material that is used to
support the surface of the product and achieve electrical
insulation functions with other internal components | ALL
Models | | Conductive carbon
film layer | It is a conductive film made of PU material and carbon
material, which realizes the transmission and uniform
distribution of current by connecting with metal buckle and
covering gel layer in a large area | ALL
Models | | Self-adhesive GEL
layer | It is used to adhere return electrode to the skin surface, and its
conductive properties can form a conductive circuit between
the controller and the body surface skin | ALL
Models | | GEL Protective
layer | It is used to store return electrode and has isolation and
protection effects on Self-adhesive GEL | ALL
Models | | Foma layer | It is used to adhere active drug delivery electrode to the skin
surface,at the same time, it ensures a firm fit and prevents the
outflow of drug/solution | ALL
Models | | AgAgCl film layer | AgAgCl is mainly used to alleviate the electrolytic reaction of
water, thereby preventing pH related corrosive skin reactions | ALL
Models | | drug/solution
reservoir layer | It is a medical porous material with good water absorption
and is used for temporary storage of drug/solution | ALL
Models | | Release paper layer | Used for long-term storage of active drug delivery electrodes
to ensure stable electrode performance | ALL
Models | #### Table 1 Main Components of Proposed Device {8}------------------------------------------------ #### 6. Non-Clinical Test conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - IEC 60601-1 Medical electrical device Part1: General requirements for o basic safety and essential performance - IEC 60601-1-2 Medical electrical equipment- Part 1-2: General ● requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests - ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests ● for In Vitro cytotoxicity - ISO 10993-10 Biological evaluation of medical devices Part 10: ● Tests for skin sensitization - ISO 10993-23 Biological evaluation of medical devices Part 23: ● Tests for irritation #### 7. Clinical Test Conclusion No clinical study is included in this submission. #### 8. Predicate Devices Product name: Iontophoresis Drug Delivery Electrodes 510(k) Number: K040495 Product Code: EGJ Manufacture: NAIMCO, INC. {9}------------------------------------------------ # 9. Substantially Equivalent (SE) Comparison The Iontophoresis Electrodes has been carefully compared to legally marketed devices with respect to intended use, configuration, principle of operation (Table 2), performance specifications (Table 3). | | Proposed Device | Predicate Device | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Item | Iontophoresis
Electrodes
(K232020) | Iontophoresis Drug
Delivery Electrodes
(K040495) | Remark | | Product Code | EGJ | EGJ | Same | | Regulation
Number | 21CFR 890.5525 | 21 CFR 890.5525 | Same | | Indications for
Use | Iontophoresis
Electrodes are intended
to be used to introduce
soluble salts and other
drugs into the body as
an alternative to
hypodermic injection. | Iontophoresis Drug
Delivery Electrodes are
intended to be used to
introduce soluble salts and
other drugs into the body
as an alternative to
hypodermic injection. | Same | | Patient
Population | With patients requiring
iontophoresis treatment | With patients requiring
iontophoresis treatment | Same | | Usage
environment | Hospitals, medical
clinics | Hospitals, medical clinics | Same | Table 2 General Comparison {10}------------------------------------------------ | | Proposed Device | | Predicate Device | | | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------| | Item | Iontophoresis | | Iontophoresis Drug | | Remark | | | Electrodes | | Delivery Electrodes | | | | Design
(Electrode
Size) | ION-T01( $69×69$ mm),
ION-T02( $82×82$ mm),
ION-T03( $88×88$ mm),
ION-T04( $84×94$ mm),
ION-T05( $64×64$ mm) | | Small( $2.75×2.75$ inch),
Medium( $3.25×3.25$ inch),
Large ( $3.5×3.5$ inch),
Butterfly( $3.35×3.75$ inch),
Return Electrode | | Same
(Note1) | | | | | ( $2.5×2.5$ inch) | | | | Main materials | Silver/Silver Chloride
(Ag/AgCI)
Buffering Agent;
PU Conductive carbon film | | Silver/Silver Chloride
(Ag/AgCI)
Buffering Agent;
PU Conductive carbon film | | Same | | Anatomical
sites | For body surface skin | | For body surface skin | | Same | | Working mode | Must be used as a complete
set
Consists of an active drug
delivery electrode
and
a
passive return electrode. | | Must be used as a complete
set
Consists of an active drug
delivery electrode and a
passive return electrode. | | Same | | Compatibility
with other | Designed for use with
iontophoresis devices only. | | Designed for use with
iontophoresis devices only. | | Same | # Table 3 Performance Comparison {11}------------------------------------------------ | | Proposed Device | Predicate Device | | |-------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------| | Item | Iontophoresis
Electrodes | Iontophoresis Drug
Delivery Electrodes | Remark | | devices | | | | | Impedance | $2MΩ~10MΩ$ | $2MΩ~10MΩ$ | Same | | System current | 4.0mA | 4.0mA | Same | | Maximum
Dosage | 80 mA-min | 80 mA-min | Same | | Fill Volume | 1.5cc (ION-T01),
2.5cc (ION-T02),
4.0cc (ION-T03),
2.0cc (ION-T04) | 1.5cc (201-400),
2.5cc (201-401),
4.0cc (201-402),
2.0cc (201-403) | Same | #### Note 1 The new device Iontophoresis Electrodes is substantial equivalence as the predicate device K040495. The differences in Dimensions, model are the differences in design requirements between different devices, which not affect the safety performance of the device, and the new device passed Safety testing, so these differences will not cause any safety and effectiveness issues. Considering the same intended use, Working mode and Product performance ect, they are substantial equivalence. Safety comparison has been done to validate the EMC, biocompatibility {12}------------------------------------------------ specification and safety of the device (Table 4). | Item | Proposed Device | Predicate Device | Remark | |------------------------|------------------------------|------------------------------|--------| | Biocompatibility | | | | | Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same | | Skin sensitization | No evidence of sensitization | No evidence of sensitization | Same | | Irritation | No evidence of irritation | No evidence of irritation | Same | | EMC, Electrical Safety | | | | | Electrical safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | Table 4 Safety Comparison # 10.Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/EGJ/K232020](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/EGJ/K232020) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com