(101 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the physical and electrical components for drug delivery, with no mention of data processing or algorithmic decision-making.
Yes.
The device is intended to introduce soluble salts and other drugs into the body for medical purposes, which is a therapeutic function.
No
The device is described as administering soluble salts and other drugs into the body, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like adhesive electrodes, leads (wires), and a drug/solution reservoir, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "introduce soluble salts and other drugs into the body as an alternative to hypodermic injection." This describes a therapeutic or drug delivery function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a device that applies an electrical current to the skin to facilitate drug delivery. This is a transdermal drug delivery system, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is entirely focused on delivering substances into the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
For body surface skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, medical clinics
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 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 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
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.
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
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)
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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.