(167 days)
No
The device description and performance studies focus on the physical construction and electrical conductivity of the electrodes, with no mention of AI or ML technologies.
No.
The device itself is an electrode, which facilitates the transmission of electrical current from a nerve stimulation device to the patient's skin. It does not generate or perform the therapeutic electrical stimulation; it is an accessory to a therapeutic device rather than a therapeutic device in itself.
No
The device is described as an electrode for electrical stimulation, facilitating current transmission to the patient's skin, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (hydrogel, carbon dispersion pad, non-conductive top layer, wire/lead wire) that constitute the medical device. It is a hardware device (electrode) used in conjunction with other hardware (nerve stimulation devices).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the physical components of an electrode designed to deliver electrical current to the skin. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Performance Studies: The performance studies focus on electrical conductivity and biocompatibility, which are relevant to a device that interacts with the skin for electrical stimulation, not for analyzing biological markers.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample preparation, or any other elements typically associated with in vitro diagnostics.
In summary, the device is designed to deliver electrical stimulation to the patient's skin for therapeutic purposes, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin.
Single patient use - re-usable.
Self adhering and re-positionable.
Over the counter use.
Product codes
GXY
Device Description
Theratrode electrodes are constructed as a layered assembly comprised of four components:
- A patient contacting layer of hydrogel material which has been tested and . found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin.
- A carbon dispersion pad middle layer that evenly distributes the electrical . current across the surface of the electrode,
- A non-conductive top layer of various materials such as spun lace (fabric), . polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode.
- A wire or conductive carbon fiber lead wire which is glued to the assembly . of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today. The female connector complies with IEC60601-1 Sub clause 56 3(c).
Theratrode electrodes are non-sterile and are intended for multiple use by a single patient to apply electrical stimulation. Theratrode's construction is equivalent to the predicate device's construction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the counter use.
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)
Comparison testing was performed between the Predicate Device and the Theratrode Electrode. There are no established performance standards for cutaneous electrodes so we chose to measure the electrical conductivity (inverse of impedance) as an appropriate measure of the electrode's performance. The comparison tests conclusively prove that Theratrode is at a minimum as efficient at conducting electricity as the Predicate device.
Theratrode's hydrogel has passed three biocompatibility tests; skin irritation, cytotoxicity and delaved contact sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Attachment H
Image /page/0/Picture/2 description: The image shows the logo for Phoenix Medical Devices. The logo features a stylized phoenix bird with its wings spread above the company name. The text "PHOENIX MEDICAL DEVICES" is written in a bold, sans-serif font, with "PHOENIX" on the top line and "MEDICAL DEVICES" on the bottom line.
JAN 2 5 2012
510(k) Summary for the Theratrode Family of Cutaneous Electrodes
1. Sponsor
Phoenix Medical Devices, LLC 2458 Alton Parkway Irvine, Ca 92606
Registration Number: 3004620982
Contact Person: Jim Klett Telephone: (800) 689-9892 (949) 266-8126 Fax:
Date Prepared: February 26, 2011
2. Device Name
Theratrode Brand Cutaneous Electrodes comprised of the following model numbers and descriptions:
T1 = 2" (5 0.5mm) Square Electrode ("Squircle")
T2 = 2" (5cm) Round Electrode
T3 = 2″ x 4″ (5cm x 10cm) Rectanqu lar Electrode
T4 = 2" x 4" (5cm x 10cm) Oval Electrode
T5 = 1.25" (3cm) Round Electrode
T6 = 2.75" (7cm) Round Electrode
T7 = 1.5" (4cm) Square Electrode
T8 = 1.5" x 2.5" (4cm x 6cm) Rectanqular Electrode
T9 = 1.5" x 2.5" (4cm x 6cm) Oval Electrode
T 10= 1.5" x 3.5" (4cm x 9cm) Rectangular Electrode
T 1 = 3" x 5" (7.5cm x 13cm) Rectangular Electrode
T12= 2″ (5 0mm) Square Electrode
Common/Usual Name: Cutaneous Electrode Classification Names: Electrode, Cutaneous Classification Panel: Neurology Panel/Product Code: 882.1320 / GXY
1
3. Legally Marketed Device to Which Equivalence is Claimed Marketed Device #1
Proprietary Name: Lifecare Electrodes, K083302 Common/Usual Name: Lifecare Neurostimulation Electrodes Classification Names: Electrode, Cutaneous Classification Panel: Neurology Panel/Product Code: Neurology / GXY
4. Intended Use / Indications For Use
To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin.
Single patient use - re-usable.
Self adhering and re-positionable.
Over the counter use.
5. Device Description
Theratrode electrodes are constructed as a layered assembly comprised of four components:
- A patient contacting layer of hydrogel material which has been tested and . found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin.
- A carbon dispersion pad middle layer that evenly distributes the electrical . current across the surface of the electrode,
- A non-conductive top layer of various materials such as spun lace (fabric), . polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode.
- A wire or conductive carbon fiber lead wire which is glued to the assembly . of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today. The female connector complies with IEC60601-1 Sub clause 56 3(c).
Theratrode electrodes are non-sterile and are intended for multiple use by a single patient to apply electrical stimulation. Theratrode's construction is equivalent to the predicate device's construction.
6. Basis for Substantial Equivalence
2
We have examined the Theratrode electrodes in comparison to the Predicate Device and determined the Theratrode electrodes to be Substantially Equivalent to the Predicate Device because they both:
- . Are constructed in the same manner,
- are constructed of same or similar materials, .
- have identical indications for use, and .
- have very similar performance characteristics (see bench test data . included in this submission).
Any minor visual, dimensional or labeling differences between the Predicate device and the Theratrode electrodes do not pose any risk to their safe and effective use.
-
- Differences between the Marketed Device and the Theratrode family of cutaneous electrodes.
There are no significant differences between the Theratrode Electrodes and the Marketed device.
- Differences between the Marketed Device and the Theratrode family of cutaneous electrodes.
8. Bench Testing (non-clinical)
Comparison testing was performed between the Predicate Device and the Theratrode Electrode. There are no established performance standards for cutaneous electrodes so we chose to measure the electrical conductivity (inverse of impedance) as an appropriate measure of the electrode's performance. The comparison tests conclusively prove that Theratrode is at a minimum as efficient at conducting electricity as the Predicate device.
Theratrode's hydrogel has passed three biocompatibility tests; skin irritation, cytotoxicity and delaved contact sensitization
9. Conclusion
Through careful examination of the construction, materials, indications for use and performance we conclude the Theratrode electrodes are Substantially Equivalent to the Predicate Device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Phoenix Medical Devices, LLC c/o Mr. Jim Klett President 2458 Alton Parkway Irvine, CA 92606
Re: K112312
Trade/Device Name: Theratrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: November 23, 2011 Received: November 29, 2011
Dear Mr. Klett:
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. 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.
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 (reporting of medical
JAN 2 5 2012
4
Page 2 - Mr. Jim Klett
device-related adverse events) (21 CFR 803); 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. .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Deboral Fills
Malvina B. Eydelman, M.D. Director
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 《//23/2
Device Name: Theratrode
Model Numbers:
T1 = 2" (50.5mm) Square Electrode (Squircle Shape) T2 = 2" (5cm) Round Electrode T3 = 2" x 4" (5cm x 10cm) Rectangular Electrode T4 = 2" x 4" (5cm x 10cm) Oval Electrode T5 = 1.25" (3cm) Round Electrode T6 = 2.75" (7cm) Round Electrode T7 = 1.5" (4cm) Square Electrode T8 = 1.5" x 2.5" (4cm x 6cm) Rectangular Electrode T9 = 1.5" x 2.5" (4cm x 6cm) Oval Electrode T10= 1.5" x 3.5" (4cm x 9cm) Rectangular Electrode T11= 3" x 5" (7.5cm x 13cm) Rectangular Electrode T12 = 2" (50mm) Square Electrode
Indications for Use:
To conduct electrical stimulation from common varieties of electrical stimulators to the patients skin.
Single patient use - re-usable.
Self adhering and re-positionable.
Over the counter use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear. Nose and Throat Devices
510(k) Number K112312
Page of
Phoenix Medical Devices 510(k) Submission for Theratrode 1-800-689-9892
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