(262 days)
No
The document describes a passive electrode system for electrical stimulation and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is described as an electrode for an electrical stimulator, not the stimulator itself. The intended use states it is a conductive adhesive interface between the patient's skin and the electrical stimulator, indicating it is an accessory to a therapeutic device rather than a therapeutic device itself.
No
Explanation: The "Intended Use" section explicitly states that the electrodes are "intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator." They are designed to be used with stimulators (TENS, EMS), which deliver electrical signals for therapeutic purposes, not for diagnosing conditions.
No
The device description clearly outlines physical components such as laminated flexible materials, vinyl tape, tin, carbon, hydrogel, and lead wires. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for providing a conductive interface between the patient's skin and an electrical stimulator (TENS, EMS, MANS). This is a direct interaction with the patient's body for therapeutic or stimulation purposes.
- Device Description: The description details the physical components of the electrodes and their function in conducting electrical signals to the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples. This device operates in vivo (on the body) to deliver electrical stimulation.
N/A
Intended Use / Indications for Use
The Transfer Technology PRO-TECH Delivery System electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator Transfer Technology's reusable electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), and MANS (Muscle and Neurological Stimulators)
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Transfer Technology reusable neurostimulator electrodes are laminated flexible materials widely used in this application
Top layer Vinyl tape or non-woven fabrics with biocompatible adhesive
Second layer Grade "A" pure tin or electrically conductive carbon with Ag or Ag/AgCl
Third layer 1.25" flexible vinyl tape with biocompatible adhesive laminated around the outer perimeter of electrode
Patient layer Conductive hydrogel Amgel AG703
Lead Wire Constructed of a silicone-insulated stainless steel yarn wire with a standard 080" recessed female contact crimped and then insulated to one end By design, the insulated contact prevents the conductive connection to earth or hazardous voltages as required in IEC 60601-1 Subclause 56 3(c) Wire assembly is in compliance with FDA performance standard 21 CFR Part 898
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
Not Found
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 Testing: The critical components used in Transfer Technology PRO-TECH Delivery System electrodes (Amgel AM703 K983741) are the same as used in the predicate devices Therefore there is no reason to believe that the Transfer Technology PRO-TECH Delivery System electrodes will perform any different than the predicate device.
Clinical Testing: Not Applicable
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.
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
§ 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
JAN 2 9 2009
Koss1279
/
510(k) Summary
| Submitter's Information | Joseph J Arbour
Transfer Technology
37822 Oxford Drive
Murrieta, CA 92562
Phone 951-677-0631
Fax 951-677-0631 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date of Preparation | May 6, 2008 | |
| Proprietary Name | PRO-TECH Delivery System Electrodes | |
| Common Name | Neurostimulation Electrodes | |
| Classification Name | Electrodes, Cutaneous | |
| Predicate Device | K000870 (Katecho Inc )
K970426 (Axelgaard Manufacturing)
K875284 (Medtronic Inc ) | |
| Description of Device | Electrodes, Cutaneous | |
| Intended Use | The Transfer Technology PRO-TECH Delivery System
electrodes are intended for use as a disposable, conductive
adhesive interface between the patient's skin and the Electrical
Stimulator Transfer Technology's reusable electrodes are
designed and intended to be used with marketed Electrical
Stimulators, i.e. TENS (Transcutaneous Electrical Nerve
Stimulation), EMS (Electrical Muscular Stimulation), and MANS
(Muscle and Neurological Stimulators) | |
| Technological Comparison | The Transfer Technology PRO-TECH Delivery System
electrodes exhibit technological characteristics that are
substantially equivalent to those of the predicate device, as
determined by both component usage and physical testing | |
| Labeling Comparison | The labeling of Transfer Technology PRO-TECH Delivery
System electrodes substantially equivalent to those of the
predicate devices | |
| Device Description | Transfer Technology reusable neurostimulator electrodes are
laminated flexible materials widely used in this application | |
| | Top layer Vinyl tape or non-woven fabrics with biocompatible
adhesive | |
| | Second layer Grade "A" pure tin or electrically conductive
carbon with Ag or Ag/AgCl | |
| | Third layer 1.25" flexible vinyl tape with biocompatible adhesive
laminated around the outer perimeter of electrode | |
| | Patient layer Conductive hydrogel Amgel AG703 | |
| Device Description
(continued) | Lead Wire Constructed of a silicone-insulated stainless steel
yarn wire with a standard 080" recessed female contact
crimped and then insulated to one end By design, the insulated
contact prevents the conductive connection to earth or
hazardous voltages as required in IEC 60601-1 Subclause
56 3(c) Wire assembly is in compliance with FDA performance
standard 21 CFR Part 898 | |
| Non-clinical Testing | The critical components used in Transfer Technology
PRO-TECH Delivery System electrodes
(Amgel AM703 K983741) are the same as used in the
predicate devices Therefore there is no reason to believe that
the Transfer Technology PRO-TECH Delivery System electrodes
will perform any different than the predicate device | |
| Clinical Testing | Not Applicable | |
| Packaging | Electrodes are stored in a 2-mil poly re-sealable bag to comply
with the shelf life specifications of the hydrogel manufacturer
Labeling is compliant to 21CFR Part 801 | |
| Conclusion | The Transfer Technology PRO-TECH Delivery System
electrodes are substantially equivalent to those of the submitted
predicate devices and any difference between the devices do not
pose new questions of safety and effectiveness | |
1
ר
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized strokes forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Transfer Technology % Mr Joseph J Arbour 37822 Oxford Drive Murrieta, California 92562
JAN 2 3 2009
Re K081279
Trade/Device Name PRO-TECH Delivery System Electrodes Regulation Number 21 CFR 882 1320 Regulation Name Cutaneous electrode Regulatory Class II Product Code GXY Dated November 17, 2008 Received November 17, 2008
Dear Mr Arbour
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 pror 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
3
Page 2 - Mr Joseph J Arbour
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 Brometric'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 Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Mark N Milham
Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known) | K081279 |
|---|---|
| Device Name | PRO-TECH Delivery System Electrodes |
| Indications For Use | The Transfer Technology PRO-TECH Delivery |
| System electrodes are intended for use as a | |
| disposable, conductive adhesive interface | |
| between the patient's skin and the Electrical | |
| Stimulator Transfer Technology's reusable | |
| electrodes are designed and intended to be used | |
| with marketed, Electrical Stimulators, i.e. TENS | |
| (Transcutaneous Electrical Nerve Stimulation), | |
| EMS (Electrical Muscular Stimulation), and MANS | |
| (Muscle and Neurological Stimulators) |
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)
David Keane by MKM 1/23/2009
Division Sign-Off
Jivision of General, Restorative. and Neurological Devices
Page 1 of __
~~(k) Number K081279