(101 days)
Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
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 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.
The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the Iontophoresis Electrodes (K232020).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison to a predicate device (Iontophoresis Drug Delivery Electrodes, K040495) to demonstrate substantial equivalence, rather than setting explicit numerical acceptance criteria for a new device's performance. The "acceptance criteria" are implied by the predicate device's specifications and the non-clinical test conclusions.
| Acceptance Criteria (Implied by Predicate & Standards Compliance) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|
| Product Code: EGJ | EGJ | Same |
| Regulation Number: 21 CFR 890.5525 | 21 CFR 890.5525 | Same |
| Indications for Use: Introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. | Introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. | Same |
| Patient Population: Patients requiring iontophoresis treatment | Patients requiring iontophoresis treatment | Same |
| Usage Environment: Hospitals, medical clinics | Hospitals, medical clinics | Same |
| Design (Electrode Size): Comparable to predicate sizes (e.g., Small, Medium, Large, Butterfly, Return Electrode) | ION-T01 (69x69 mm), ION-T02 (82x82 mm), ION-T03 (88x88 mm), ION-T04 (84x94 mm), ION-T05 (64x64 mm) | Same (Note 1 - differences in design requirements, not affecting safety/performance) |
| Main Materials: Silver/Silver Chloride (Ag/AgCl), Buffering Agent, PU Conductive carbon film | Silver/Silver Chloride (Ag/AgCl), 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, consisting of an active drug delivery electrode and a passive return electrode. | Must be used as a complete set, consisting of an active drug delivery electrode and a passive return electrode. | Same |
| Compatibility with other devices: Designed for use with iontophoresis devices only. | Designed for use with iontophoresis devices only. | Same |
| Impedance: 2MΩ ~ 10MΩ | 2MΩ ~ 10MΩ | Same |
| System current: 4.0mA | 4.0mA | Same |
| Maximum Dosage: 80 mA-min | 80 mA-min | Same |
| Fill Volume: Comparable to predicate fill volumes (e.g., 1.5cc, 2.5cc, 4.0cc, 2.0cc for specific models) | 1.5cc (ION-T01), 2.5cc (ION-T02), 4.0cc (ION-T03), 2.0cc (ION-T04) | Same |
| Biocompatibility (Cytotoxicity): No Cytotoxicity | No Cytotoxicity | Same |
| Biocompatibility (Skin sensitization): No evidence of sensitization | No evidence of sensitization | Same |
| Biocompatibility (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, Electrical Safety (EMC): Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no sample size for a clinical test set or information on its provenance. The testing was non-clinical.
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, as no clinical study was conducted that would require expert ground truth. The evaluation focused on non-clinical performance and safety based on recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was conducted.
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. This device is an Iontophoresis Electrode, which is a physical device for drug delivery, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study was conducted. The "ground truth" for the non-clinical tests was established by compliance with international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 10993-23) and comparison to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not a machine learning model.
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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.
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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
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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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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)
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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
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- 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
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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.
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The main components of proposed device shown in Table 1.
| Component name | Description | Applied to |
|---|---|---|
| Conductive button(Upper) | It serves as a connecting component to the output terminal ofthe controller, completing mechanical and electricalconnection functions | ALLModels |
| Conductive button(Lower) | Conductive button (Lower) is used in conjunction with theupper part and mechanically riveted to achieve a firmconnection between materials | ALLModels |
| POLY film layer | It is a thin film made of polyethylene material that is used tosupport the surface of the product and achieve electricalinsulation functions with other internal components | ALLModels |
| Conductive carbonfilm layer | It is a conductive film made of PU material and carbonmaterial, which realizes the transmission and uniformdistribution of current by connecting with metal buckle andcovering gel layer in a large area | ALLModels |
| Self-adhesive GELlayer | It is used to adhere return electrode to the skin surface, and itsconductive properties can form a conductive circuit betweenthe controller and the body surface skin | ALLModels |
| GEL Protectivelayer | It is used to store return electrode and has isolation andprotection effects on Self-adhesive GEL | ALLModels |
| Foma layer | It is used to adhere active drug delivery electrode to the skinsurface,at the same time, it ensures a firm fit and prevents theoutflow of drug/solution | ALLModels |
| AgAgCl film layer | AgAgCl is mainly used to alleviate the electrolytic reaction ofwater, thereby preventing pH related corrosive skin reactions | ALLModels |
| drug/solutionreservoir layer | It is a medical porous material with good water absorptionand is used for temporary storage of drug/solution | ALLModels |
| Release paper layer | Used for long-term storage of active drug delivery electrodesto ensure stable electrode performance | ALLModels |
Table 1 Main Components of Proposed Device
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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.
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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 | IontophoresisElectrodes(K232020) | Iontophoresis DrugDelivery Electrodes(K040495) | Remark |
| Product Code | EGJ | EGJ | Same |
| RegulationNumber | 21CFR 890.5525 | 21 CFR 890.5525 | Same |
| Indications forUse | IontophoresisElectrodes are intendedto be used to introducesoluble salts and otherdrugs into the body asan alternative tohypodermic injection. | Iontophoresis DrugDelivery Electrodes areintended to be used tointroduce soluble salts andother drugs into the bodyas an alternative tohypodermic injection. | Same |
| PatientPopulation | With patients requiringiontophoresis treatment | With patients requiringiontophoresis treatment | Same |
| Usageenvironment | Hospitals, medicalclinics | Hospitals, medical clinics | Same |
Table 2 General Comparison
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| Proposed Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Item | Iontophoresis | Iontophoresis Drug | Remark | ||
| Electrodes | Delivery Electrodes | ||||
| Design(ElectrodeSize) | 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 | ||
| Anatomicalsites | For body surface skin | For body surface skin | Same | ||
| Working mode | Must be used as a completesetConsists of an active drugdelivery electrodeandapassive return electrode. | Must be used as a completesetConsists of an active drugdelivery electrode and apassive return electrode. | Same | ||
| Compatibilitywith other | Designed for use withiontophoresis devices only. | Designed for use withiontophoresis devices only. | Same |
Table 3 Performance Comparison
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| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Item | IontophoresisElectrodes | Iontophoresis DrugDelivery Electrodes | Remark |
| devices | |||
| Impedance | $2MΩ~10MΩ$ | $2MΩ~10MΩ$ | Same |
| System current | 4.0mA | 4.0mA | Same |
| MaximumDosage | 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
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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.
§ 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.