(107 days)
Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.
Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) consist of an active drug delivery electrode and a passive return electrodes are designed for one use on a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are four sizes and for the roundinen a releaser of roles to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes as the maximum delivery of 80 milliamp-minutes is the same regardless of size. Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and abeling.
This 510(k) premarket notification for the Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) does not describe a study to prove the device meets specific acceptance criteria based on its intrinsic performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer argues that their device is as safe and effective as devices already legally marketed.
Therefore, many of the requested sections below related to "acceptance criteria" and "study that proves the device meets acceptance criteria" are not directly applicable in the context of this 510(k) submission, as performance was demonstrated through comparison to known predicates, not independent testing against novel criteria.
Description of Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) submission based on substantial equivalence, there are no specific "acceptance criteria" in the traditional sense of performance metrics against a defined standard that the device itself had to meet in an independent study (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, the acceptance criteria are demonstrated through comparative equivalency to predicate devices. The "performance" is implicitly deemed equivalent if the device shares the same intended use, technological characteristics, and safety profile as the predicates.
The table below summarizes the similarities and equivalencies presented in the 510(k) to demonstrate that the proposed device performs identically to the predicate devices. The "acceptance criteria" here are effectively that the proposed device matches the established characteristics of the predicates.
| Feature / Criteria | Acceptance Criteria (Matched to Predicate) | Reported Device Performance (Comfort Iontophoresis Electrodes) |
|---|---|---|
| Intended Use | Administration of soluble salts or other drugs into the body for medical purposes, as an alternative to hypodermic injection. | Identical: "Iontophoresis is indicated for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection." |
| Target Population | Medical professionals with patients requiring iontophoresis treatment. | Identical: "Medical professionals with patients requiring iontophoresis treatment." |
| Design (Shapes) | Small Square, Butterfly, Medium Square, Large Square, Return Electrode. | Identical: "Shapes: Small Square, Butterfly, Medium Square, Large Square, Return Electrode." |
| Design (Electrode Size) | Small Square (2.75"x2.75"), Butterfly (3.75"x3.38"), Medium Square (3.25"x3.25"), Large Square (3.50"x3.50"), Return Electrode (2.20"x1.82"). | Identical: "Electrode Size - Small Square (2.75"x2.75"), Butterfly (3.75"x3.38"), Medium Square (3.25"x3.25"), Large Square (3.50"x3.50"), Return Electrode (2.20"x1.82")." |
| Design (Active Area) | Small Square (7.6 cm²), Butterfly (8.3 cm²), Medium Square (11.4 cm²), Large Square (18.1 cm²), Return Electrode (25.5 cm²). | Identical: "Active Area - Small Square (7.6 cm²), Butterfly (8.3 cm²), Medium Square (11.4 cm²), Large Square (18.1 cm²), Return Electrode (25.5 cm²)." |
| Materials | Buffering Agent – Silver/SilverChloride (Ag/AgCl), Conductive layer on polyester. Reservoir Layer - Cotton Blend. Non-irritating adhesive backing. | Identical: "Buffering Agent – Silver/SilverChloride (Ag/AgCl). Conductive layer on polyester. Reservoir Layer - Cotton Blend. Electrodes backed with non-irritating adhesive." |
| Chemical Safety | Electrodes backed with non-irritating adhesive. | Identical: "Electrodes backed with non-irritating adhesive." |
| Anatomical Sites | For epidermal use (various locations). | Identical: "For epidermal use (various locations)." |
| Energy Used/Delivered | Not to exceed 80mA-minutes total dosage. | Identical: "Not to exceed 80mA-minutes total dosage." |
| Maximum Current | 4 mA. | Identical: "4 mA." |
| Maximum Dosage | 80 mA-minutes. | Identical: "80 mA-minutes." |
| Compatibility | Designed for use with iontophoresis devices only. | Identical: "Designed for use with iontophoresis devices only." |
| Where Used | Hospitals, medical clinics. | Identical: "Hospitals, medical clinics." |
| Electrical Safety | Does not have electrode wires. | Identical: "Does not have electrode wires." |
| Electrode Fill Volume | Small Square (1.5 to 2.0cc), Butterfly (2.0 to 2.5cc), Medium Square (2.5 to 3.0cc), Large Square (4.0 to 4.5cc). | Identical: "Small Square (1.5 to 2.0cc), Butterfly (2.0 to 2.5cc), Medium Square (2.5 to 3.0cc), Large Square (4.0 to 4.5cc)." |
The key "study" proving the device met the "acceptance criteria" was the detailed comparison of technical and functional characteristics against two predicate devices (North Coast Medical Buffered Iontophoresis Electrodes (K052019) and Dynatron Ion (K060814)). The core argument is stated explicitly: "In comparing the Comfort Iontophoresis Electrodes... it must be noted that there are no product differences since Axelgaard Manufacturing Co., Ltd. manufactures both these electrodes." This implies that the proposed device is literally the same product as the predicates, just marketed under a different name.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not include an independent "test set" or clinical study with a sample size for performance evaluation. Approval is based on substantial equivalence to existing devices.
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. No ground truth was established by experts for an independent test set. The "ground truth" for equivalence is rooted in the FDA's prior clearances of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was used.
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, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, and its performance is not evaluated in a standalone or human-in-the-loop context. Its function is to facilitate drug delivery when connected to an iontophoresis machine and used by a medical professional.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the regulatory clearance and established safety and effectiveness profile of the predicate devices. The argument is that because the proposed device is identical to the predicates (even manufactured by the same company), its historical "performance" (safety and effectiveness) is already established through the predicates' market history and prior FDA clearances.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for which ground truth would need to be established.
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JUN I 8 2008
510 Summary
(As required by 21CFR section 807.92(c)
Submitter Information
Axelgaard Manufacturing Co., Ltd. Name:
| Address: | 520 Industrial WayFallbrook, CA 92028 |
|---|---|
| ---------- | ------------------------------------------- |
760-451-8000 Phone:
760-723-2356 Fax:
Contact Person: Dan Jeffery
Revised June 16, 2008 Date Prepared:
Device Information
| Device Name: | Comfort Iontophoresis ElectrodesBuffered Iontophoresis Electrode Treatment Kit |
|---|---|
| Common Name: | Iontophoresis Electrodes |
| Classification Name: | Device, Iontophoresis, Other Uses (per 21 CFR section 890.5525) |
Predicate Devices
Based on technical, functional, and physical comparisons, the Comfort Iontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) are substantially equivalent to the following legally marketed devices of North Coast Medical and Dynatronics Axelgaard Manufacturing Co, Ltd has manufactured this product for both North Coast Medical and Dynatronics for the past two years.
| Trade Name | Manufacturer/Distributor | 510(k) Number |
|---|---|---|
| Buffered Iontophoresis Drug Delivery Electrodes | North Coast Medical | K052019 |
| Dynatron Ion | Dynatronics | K060814 |
Device Description
Comfort lontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) consist of an active drug delivery electrode and a passive return electrodes are designed for one use on a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are four sizes and for the roundinen a releaser of roles to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes as the maximum delivery of 80 milliamp-minutes is the same regardless of size. Comfort lontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and abeling.
Intended Use
Comfort lontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
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Image /page/1/Picture/1 description: The image shows the logo for AXELGAARD. The logo features a stylized graphic to the left of the company name, "AXELGAARD," which is written in all capital letters. Below the company name, there is additional text, likely indicating the company's business or legal status.
Substantial Equivalence Comparison
-
- Predicate device names:
- A. North Coast Medical Buffered Iontophoresis Electrodes
- B. Dynatron Ion
2. Predicate 510(k) number
3. Comparison with predicate:
Comfort lontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) are equivalent to North Coast Medical Buffered Iontophoresis Electrodes (previously cleared under K0502019) and Dynatron Ion Ovacificalibal Barrero William Show the similarities, equivalencies, and differences between the proposed and predicate devices.
Similarities
| Item | Comfort IontophoresisElectrodes (BufferedIontophoresis ElectrodeTreatment Kit) | North Coast BufferedIontophoresis Electrodes | Dynatron Ion |
|---|---|---|---|
| Proposed Device | Predicate Device(K052019 | Predicate device(K060814) | |
| Intended use | Iontophoresis is indicatedfor the administration ofsoluble salts or other drugsinto the body for medicalpurposes and can be usedas an alternative tohypodermic injection. | Iontophoresis is indicatedfor the administration ofsoluble salts or other drugsinto the body for medicalpurposes and can be usedas an alternative tohypodermic injection. | Iontophoresis is indicatedfor the administration ofsoluble salts or other drugsinto the body for medicalpurposes and can be usedas an alternative tohypodermic injection. |
| Target population | Medical professionals withpatients requiringiontophoresis treatment. | Medical professionals withpatients requiringiontophoresis treatment. | Medical professionals withpatients requiringiontophoresis treatment. |
| Design | Shapes: Small Square,Butterfly, Medium Square,Large Square, ReturnElectrode. | Shapes: Small Square,Butterfly, Medium Square,Large Square, ReturnElectrode. | Shapes: Small Square,Butterfly, Medium Square,Large Square, ReturnElectrode. |
| Materials | Buffering Agent –Silver/SilverChloride(Ag/AgCl).Conductive layer onpolyester. | Buffering Agent –Silver/SilverChloride(Ag/AgCl).Conductive layer onpolyester. | Buffering Agent –Silver/SilverChloride(Ag/AgCl).Conductive layer onpolyester. |
| Chemical safety | Electrodes backed withnon-irritating adhesive. | Electrodes backed withnon-irritating adhesive. | Electrodes backed withnon-irritating adhesive. |
| Anatomical sites | For epidermal use (variouslocations). | For epidermal use (variouslocations). | For epidermal use (variouslocations). |
| Energyused/delivered | Not to exceed 80mA-minutes total dosage | Not to exceed 80mA-minutes total dosage. | Not to exceed 80mA-minutes total dosage |
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Image /page/2/Picture/1 description: The image shows the logo for AXELGAARD MANUFACTURING CO., LTD. The logo features a stylized graphic to the left of the company name. The text is in a simple, sans-serif font and is stacked, with the company name on top and the company type below.
| Item | Comfort IontophoresisElectrodes (BufferedIontophoresis ElectrodeTreatment Kit)Proposed Device | North Coast BufferedIontophoresis ElectrodesPredicate Device(K052019) | Dynatron IonPredicate device(K060814) |
|---|---|---|---|
| Compatibility withother devices | Designed for use withiontophoresis devices only. | Designed for use withiontophoresis devices only. | Designed for use withiontophoresis devices only. |
| Where used | Hospitals, medical clinics. | Hospitals, medical clinics. | Hospitals, medical clinics. |
| Electrical safety | Does not have electrodewires. | Does not have electrodewires. | Does not have electrodewires. |
| Electrode FillVolume (treatmentfluid volume) | Small Square (1.5 to 2.0cc)Butterfly (2.0 to 2.5cc)Medium Square (2.5 to3.0cc)Large Square (4.0 to 4.5cc) | Small Square (1.5 to 2.0cc)Butterfly (2.0 to 2.5cc)Medium Square (2.5 to3.0cc)Large Square (4.0 to 4.5cc) | Small Square (1.5 to 2.0cc)Butterfly (2.0 to 2.5cc)Medium Square (2.5 to3.0cc)Large Square (4.0 to 4.5cc) |
Equivalencies
| Item | Comfort lontophoresisElectrodes (Bufferedlontophoresis Electrode | North Coast BufferedIontophoresis Electrodes | Dynatron Ion |
|---|---|---|---|
| Treatment Kit) | Predicate Device(K052019 | Predicate device(K060814) | |
| Proposed Device | |||
| Design (ElectrodeSize) | Electrode Size -Small Square (2.75"x2.75")Butterfly (3.75"x3.38")Medium Square(3.25"x3.25")Large Square (3.50"x3.50")Return Electrode(2.20"x1.82") | Electrode Size -Small Square (2.75"x2.75")Butterfly (3.75"x3.38")Medium Square(3.25"x3.25")Large Square (3.50"x3.50")Return Electrode(2.20"x1.82") | Electrode Size -Small Square (2.75"x2.75")Butterfly (3.75"x3.38")Medium Square(3.25"x3.25")Large Square (3.50"x3.50")Return Electrode(2.20"x1.82") |
| Design (ActiveArea) | Active Area -Small Square (7.6 cm²)Butterfly (8.3 cm²)Medium Square (11.4 cm²)Large Square (18.1 cm²)Return Electrode (25.5 cm²) | Active Area -Small Square (7.6 cm²)Butterfly (8.3 cm²)Medium Square (11.4 cm²)Large Square (18.1 cm²)Return Electrode (25.5 cm²) | Active Area -Small Square (7.6 cm²)Butterfly (8.3 cm²)Medium Square (11.4 cm²)Large Square (18.1 cm²)Return Electrode (25.5 cm²) |
| Maximum Current | 4 mA | 4mA | 4mA |
| Maximum Dosage | 80 mA-minutes | 80 mA-minutes | 80 mA-minutes |
| Materials | Reservoir Layer - CottonBlend | Reservoir Layer - CottonBlend | Reservoir Layer - CottonBlend |
Differences
Differences other than the packaging and labeling information specific to the distributing company.
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Image /page/3/Picture/1 description: The image shows the logo for AXELGARD. The logo consists of a stylized letter "A" followed by the word "AXELGARD" in capital letters. Below the word "AXELGARD" is the text "WWW.AXELGARD.CO.LTD".
Discussion
In comparing the Comfort lontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) (proposed device) to the North Coast Medical, North Coast Buffered lontophoresis Electrodes (predicate device), and the Dynatronics, Dynatron Ion (predicate device ), it must be noted that there are no product differences since Axelgaard Manufacturing Co., Ltd. manufactures both these electrodes. Additionally, the packaging/labeling differences are not substantial enough to deny equivalence between the three products.
The intended use, operation, and target population of the three products are almost identical. Also, the product shapes are the same, so they can conform to the same anatomical locations. The product size is the same so there will be no difference with adhesion and coverage of the affected area. Since the same buffering agents are used, as well as non-irritating backing, conduction and adhesion of the electrodes shall be safe as the same. The reservoir layer is composed of the same materials. Finally, the products are applied identically, and they use comparable power sources.
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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an eagle with its wings spread, clutching a caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 18 2008
Axelgaard Manufacturing Company, Limited % Mr. Dan P. Jeffery President 520 Industrial Way Fallsbrook, California 92028-2244
K080580 Re:
Trade Name: Comfort Iontophoresis Electrodes / Buffered Iontophoresis Electrode Treatment Kit Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class III Product Code: EGJ Dated: April 28, 2008 Received: April 30, 2008
Dear Mr. Jeffery:
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) 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. 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 such 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. Dan P. Jeffery
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.
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 (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/6/Picture/1 description: The image shows the logo for ANFLGAARD. The logo consists of a stylized graphic to the left of the text "ANFLGAARD" in all caps. Below the company name is the text "MANUFACTURING CO. LTD." in a smaller font size. The text and graphic are in a dark color, contrasting with the background.
Indications for Use
http://www.fda.gov/cdrh/ode/indicate.pdf
K080280 510K Number:
Comfort Iontophoresis Electrodes Device Name Buffered Iontophoresis Electrode Treatment Kit
Indications for Use:
Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.
× 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)
(As required by 21CFR section 807.92(c))
Neilke Ogle for mkm
Page 1 of 1
and Neurological
510(k) Number K080580
Page 1
6/16/2008
§ 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.