(117 days)
No
The device description and performance studies focus on the physical properties and function of a patient return electrode, with no mention of AI or ML.
No
The device is a patient return electrode, which is an accessory used with a therapeutic system (GDC System) but does not directly provide therapy itself. Its purpose is for patient comfort and has no effect on the safety or efficacy of the GDC system.
No
This device is a patient return electrode, used in conjunction with a medical system (GDC system). Its purpose is to provide a comfortable return path for electrical currents, not to diagnose medical conditions or analyze patient data.
No
The device description explicitly states it is a single-use, disposable, non-sterile electrode, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "patient return electrode" for an electrosurgical system (Target Therapeutics GDC System). This is a device used on the patient's body during a medical procedure, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description clearly states it's an electrode applied to the skin. It's a component of a larger system used for treatment or intervention, not for diagnosis.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples, detecting markers, or providing any kind of diagnostic information about a patient's health status. Its purpose is purely functional within the electrosurgical system.
IVD devices are specifically designed to perform tests on specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.
Product codes
Not Found
Device Description
Target Therapeutics' Patient Return Electrode (PRE) is a single use, disposable, non-sterile electrode. The PRE is intended to be used as an alternative patient return electrode for Target Therapeutics GDC system (K951256 & K960705). A hypodermic needle is currently used as the patient return electrode. The PRE is applied to the skin on the patient's upper arm (deltoid). The PRE is being made available for patient comfort and has no effect on the safety or efficacy of the GDC system as functional testing indicates.
A small Prep pad is included with the PRE to exfoliate the skin prior to applying the PRE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's upper arm (deltoid)
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
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Summary of Performance Studies
The results of bench testing (Tensile Test, Impedance Test), animal studies, and biocompatibility testing support the substantial equivalence claims of the PRE for its intended use. Results of the bench testing, animal studies, and biocompatibility testing in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PRE is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
Image /page/0/Picture/1 description: The image shows the logo for Target Therapeutics. The logo consists of a black circle on the left, followed by the word "TARGET" in large, bold, black letters. A horizontal black line extends from the right edge of the circle to the right edge of the word "TARGET". Below the line and the word "TARGET" is the word "THERAPEUTICS" in smaller, black letters.
DEC 1 7 1996
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
CONTACT PERSON: Laraine Pangelina Sr. Manager, Regulatory Affairs Target Therapeutics, Inc. 47201 Lakeview Blvd. Fremont, CA 94538-6530
DEVICE NAME: Patient Return Electrode (PRE); Class II
DEVICE DESCRIPTION:
Target Therapeutics' Patient Return Electrode (PRE) is a single use, disposable, non-sterile electrode. The PRE is intended to be used as an alternative patient return electrode for Target Therapeutics GDC system (K951256 & K960705). A hypodermic needle is currently used as the patient return electrode. The PRE is applied to the skin on the patient's upper arm (deltoid). The PRE is being made available for patient comfort and has no effect on the safety or efficacy of the GDC system as functional testing indicates.
A small Prep pad is included with the PRE to exfoliate the skin prior to applying the PRE.
INDICATIONS FOR USE:
The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.
PREDICATE DEVICE:
| Product Design: | Silver Sircuit™, Sentry Medical Products | K851522 |
|---|---|---|
| Indications for Use: | Polyhesive® II, Valleylab, Inc | K861036 |
| Functional Performance: | Hypodermic Needle, Target Therapeutics | K951256 |
1
TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:
The results of bench testing (Tensile Test, Impedance Test), animal studies, and biocompatibility testing support the substantial equivalence claims of the PRE for its intended use. Results of the bench testing, animal studies, and biocompatibility testing in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PRE is substantially equivalent to the predicate devices.