(206 days)
Not Found
No
The summary describes a passive electrode and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is described as an electrode for electrical neuromuscular and transcutaneous electrical nerve stimulation, acting as a conductive interface between the patient's skin and an electromedical stimulator. Its intended use is to deliver electrical stimulation, not to provide a therapeutic effect itself. The therapeutic effect would come from the stimulator, not the electrode.
No
Explanation: The device is described as an interface for electrical stimulation, specifically "Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation," which are therapeutic applications, not diagnostic. There is no mention of capabilities to detect, identify, or monitor a disease or condition. The performance studies focus on physical and electrical properties relevant to stimulation, such as conductivity and wire strength, rather than diagnostic accuracy metrics.
No
The device description clearly states it is a sterile, disposable, adhesive conductive interface, which are physical components, not software. The performance studies also focus on physical properties like conductivity, wire strength, and material type.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation." This describes a therapeutic or pain management application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an "adhesive conductive interface between the patient's skin and the electromedical stimulator." This is a component used in a stimulation system, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
Therefore, this device falls under the category of an electrical stimulator accessory or component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Target Sterile Electrodes are intended for use as a single patient, sterile, disposable, adhesive conductive interface between the patient's skin and the electromedical stimulator as ordered by a physician.
The sterile Target electrode is intended for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Target Sterile Electrodes are intended for use as a single patient, sterile, disposable, adhesive conductive interface between the patient's skin and the electromedical stimulator as ordered by a physician.
The sensor has a circular head with a diameter of 3.0 inches and is connected to a wire that is 18 inches long. The connector has an inner diameter of 0.059 inches. The overall thickness is less than 1/16 inch.
Sterilization Methods: 25kGy Gamma Radiation
Properties include: Non-woven electrode backing material, Polyester Circular Disk method of attaching wire to electrode, Silicone Coated Paper release liner card, 2 Mil Vinyl With Carbon Loaded Pigment Coated With Silver / Silver chloride Ink conductive electrode element, Comfort Gel A (Promeon RG 63B Formulation) Hydrogel with thickness .032", Leadwire connector .080" or .059" electrode leadwire.
Labeling states: Sterile for Single Patient Use, States Potential Adverse Reactions is Skin Irritation.
Electrode Impedance @ 1000 Hertz: Less Than 100 Ohms. Force Required to Remove Wire From Electrode: More Than 6 Pounds of Force.
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
physician
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)
Performance comparison was based on the following properties:
- Measurement of conductivity of the total electrode circuit from wire connector to the hydrogel.
- The strength of the electrode wire and the integrity of wire attachment.
- The type of materials used in each of the electrode components.
- The thickness of the hydrogel.
- Leadwire connector.
- Labeling information.
Key results indicate similarity to the predicate device in material type, strain relief, release liner, conductive element, hydrogel formulation, connector type, and labeling. The subject device also showed similar conductive properties (Electrode Impedance @ 1000 Hertz: Less Than 100 Ohms) and exceeded the predicate device in force required to remove wire from electrode (More Than 6 Pounds of Force vs. More Than 5 Pounds of Force).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Electrode Impedance @ 1000 Hertz: Less Than 100 Ohms
Force Required to Remove Wire From Electrode: More Than 6 Pounds of Force
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
§ 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
510(k) SUMMARY
APR 2 4 2008
| Statement: | This summary of 510(k) substantial equivalence is being submitted
in accordance with the requirements of 21 CFR 807.92.
K072799 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Identification: | Vision Quest Industries, Inc.
18011 Mitchell South
Irvine, CA 92614
Contact Person: Jaime Pulley, V.P. of Quality Assurance/
Regulatory Affairs
Phone: (760) 477-8201
Fax: (760) 734-1577 |
| Date Summary Prepared: | September 29, 2007 |
| Name of Device: | Proprietary Name: Target Sterile Electrode
Common Name: Cutaneous Electrode |
| Classification Name: | (GXY) |
| Predicate Device Name: | Surgi-Stim Sterile Electrodes
510(k) # K041953
ConMed Corporation
525 French Rd.
Utica, NY 13502 |
:
1
Description and Intended use:
The Target Sterile Electrodes are intended for use as a single patient, sterile, disposable, adhesive conductive interface between the patient's skin and the electromedical stimulator as ordered by a physician.
Device Dimensions
Image /page/1/Figure/3 description: This image shows a technical drawing of a sensor. The sensor has a circular head with a diameter of 3.0 inches and is connected to a wire that is 18 inches long. The connector has an inner diameter of 0.059 inches. The drawing also shows an edge view of the sensor, which indicates that the overall thickness is less than 1/16 inch. The file name is 1222B07.
Sterilization Methods: 25kGy Gamma Radiation
For predicate device comparison performance comparison was based on the following properties.
-
- Measurement of conductivity of the total electrode circuit from wire connector to the hydrogel
-
- The strength of the electrode wire and the integrity of wire attachment.
-
- The type of materials used in each of the electrode components.
- The thickness of the hydrogel 4.
- క. Leadwire connector
- Labeling information 6.
2
| Properties or
Performance
Characteristics | Target Sterile
Electrode | Surgi-Stim
Sterile Electrode | Reason for
Substantial
Equivalence |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Electrode Backing
Material | Non-woven | Non-woven | Using the same
type of material |
| Method of
attaching wire to
electrode | Polyester Circular
Disk | Polyester Circular
Disk | Using similar
strain relief made
of the same
material |
| Release liner card
the electrode is
stored on | Silicone Coated
Paper | Silicone Coated
Paper | Using the same
type of material |
| Conductive
Electrode Element | 2 Mil Vinyl With
Carbon Loaded
Pigment Coated
With Silver / Silver
chloride Ink | 2 Mil Vinyl With
Carbon Loaded
Pigment Coated
With Silver / Silver
chloride Ink | Using the same
type of material |
| Hydrogel | Comfort Gel A
(Promeon RG 63B
Formulation)
Thickness .032" | Promeon RG 63B
Formulation
Thickness .032" | The Comfort Gel
A and the RG 63B
formulation are
almost identical |
| Electrode
Leadwire | Leadwire
connector .080" or
.059" | Leadwire
connector .080" or
.059" | Using the same
type of connector |
| Labeling | Sterile for Single
Patient Use | Sterile for Single
Patient Use | Descriptive
wording very
similar |
| Labeling | States Potential
Adverse
Reactions is Skin
Irritation | States Potential
Adverse
Reactions is Skin
Irritation | Descriptive
wording very
similar |
| Electrode
Impedance @
1000 Hertz | Less Than 100
Ohms | Less Than 100
Ohms | Similar conductive
properties |
| Force Required to
Remove Wire
From Electrode | More Than 6
Pounds of Force | More The 5
Pounds of Force | Exceeds Surgi-
Stim Electrode |
Indications for Use:
The sterile Target electrode is intended for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation.
Comparison to Predicate:
This device is substantially equivalent to its predicate device, the Surgi-Stim sterile electrodes. They provide similar indications for use and are all derived from similar materials, except the hydrogel.
3
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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2008
Vision Quest Industries, Inc. c/o Ms. Jaime Pulley 18011 Mitchell South Irvine, CA 92614
Re: K072799 Trade/Device Name: Target Sterile Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: April 18, 2008 Received: April 22, 2008
Dear Ms. Pulley:
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. Iisting 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.
4
Page 2 - Ms. Jaime Pulley
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.
Murli N. Melkote
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: TARGET STERILE ELECTRODE
Indications for Use:
Sterile - Single Patient Use Only - Disposable
The sterile Target electrode is intended for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation.
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)
Nil R.P. Ogl
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K072799