(90 days)
Not Found
No
The device description focuses solely on the physical components and materials of electrical stimulation electrodes and their accessories, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is described as electrodes used as accessories to nerve and muscle stimulation equipment, which are therapeutic in nature. The intended use "Electrical Stimulation" further supports its therapeutic purpose.
No
The device description clearly states "nerve and muscle stimulation equipment" and "electrical stimulation" for its intended use, which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly details physical components made of carbon-filled silicon rubber (electrodes), sponge pads, and fixation straps, which are hardware accessories for electrical stimulation equipment. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Electrical Stimulation," which is a therapeutic application, not a diagnostic one performed on in vitro samples.
- Device Description: The device is described as "Flexible Rubber Electrodes" used as accessories to nerve and muscle stimulation equipment. This further reinforces its role in delivering electrical stimulation to the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The device is clearly intended for applying electrical stimulation to a patient's body for therapeutic purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Electrical Stimulation
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Flexible Rubber Electrodes are a family of electrodes that are supplied as accessories to Enraf-Nonius B.V. nerve and muscle stimulation equipment. Depending on electrode size and connection terminals, the following parts apply:
| 1460265 | 6 x 8 cm electrode with 4 mm female connection terminal |
|---|---|
| 1460272 | 4 x 6 cm electrode with 4 mm female connection terminal |
| 1460274 | 8 x 12 cm electrode with 4 mm female connection terminal |
| 3444128 | 4 x 6 cm electrode with 2 mm female connection terminal |
| 3444129 | 6 x 8 cm electrode with 2 mm female connection terminal |
| 3444130 | 8 x 12 cm electrode with 2 mm female connection terminal |
The electrodes consist of carbon filled silicon rubber. For proper electrical contact with the patient the electrodes should be used in combination with moistened sponge pads. The electrode/sponge assembly is wrapped to the patient using fixation straps. Instructions for use are available in the Operating Instructions of the Enraf-Nonius B.V. nerve and muscle stimulators that the electrodes are to be used with. The following accessories apply:
| 1460266 | Sponges Pads 6 x 8 cm, set of 4 pc |
|---|---|
| 1460273 | Sponges Pads 4 x 6 cm, set 4 pc |
| 1460275 | Sponges Pads 8 x 12 cm, set 4 pc |
| 3444020 | Fixation strap 100 x 3 cm |
| 3444021 | Fixation strap 250 x 3 cm |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
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
K0 30297
APR 2 8 2003
. .
Image /page/0/Picture/2 description: The image is a black and white logo for ENRAF NONIUS. The logo consists of the words "ENRAF NONIUS" stacked on top of each other in a bold, sans-serif font. Above the words are three horizontal lines that decrease in length from top to bottom. Below the words is a geometric shape that resembles an upside-down trapezoid with a pointed bottom.
Partner for Life
Image /page/0/Picture/3 description: The image is a black and white circular logo or seal. The text "EN ISO 9001 / EN 46001" is at the top of the circle, and "ZERTIFIZIERT CERTIFIED" is at the bottom. Inside the circle is a triangle above the text "TUV Rheinland Product Safety".
Enraf-Nonius B.V. Röntgenweg 1, 2624 BD Delft P.O. Box 810, 2600 AV Delft The Netherlands Tel: +31 (0) 15 269 8400 Fax: +31 (0) 15 262 8351 Email: info@enraf-nonius.com Trade Register No.: 272.30.375
510(k) Summary Flexible Rubber Electrodes 1460265/272/274 and 3444128/129/130
510(k) Number
| Date of Preparation : | January 21, 2003 |
|---|---|
| Contact Person : | Mr. Rick Coelet |
| Project Manager | |
| Device Name : | |
| Common Name : | |
| Classification Name : | Flexible Rubber Electrodes |
| Reusable electrodes for electrical stimulation | |
| Electrode, Cutaneous | |
| Predicate Device : | K880699 |
| Endomed CV405 and Accessories |
Device Description
The Flexible Rubber Electrodes are a family of electrodes that are supplied as accessories to Enraf-Nonius B.V. nerve and muscle stimulation equipment. Depending on electrode size and connection terminals, the following parts apply:
| 1460265 | 6 x 8 cm electrode with 4 mm female connection terminal |
|---|---|
| 1460272 | 4 x 6 cm electrode with 4 mm female connection terminal |
| 1460274 | 8 x 12 cm electrode with 4 mm female connection terminal |
| 3444128 | 4 x 6 cm electrode with 2 mm female connection terminal |
| 3444129 | 6 x 8 cm electrode with 2 mm female connection terminal |
| 3444130 | 8 x 12 cm electrode with 2 mm female connection terminal |
The electrodes consist of carbon filled silicon rubber. For proper electrical contact with the patient the electrodes should be used in combination with moistened sponge pads. The electrode/sponge assembly is wrapped to the patient using fixation straps. Instructions for use are available in the Operating Instructions of the Enraf-Nonius B.V. nerve and muscle stimulators that the electrodes are to be used with. The following accessories apply:
| 1460266 | Sponges Pads 6 x 8 cm, set of 4 pc |
|---|---|
| 1460273 | Sponges Pads 4 x 6 cm, set 4 pc |
| 1460275 | Sponges Pads 8 x 12 cm, set 4 pc |
| 3444020 | Fixation strap 100 x 3 cm |
| 3444021 | Fixation strap 250 x 3 cm |
1
510(k) Summary Flexible Rubber Electrodes 1460265/272/274 and 3444128/129/130
Indications for Use Statement
510(k) Number
: Enraf-Nonius B.V. Applicant
:
Device Name : Flexible Rubber Electrodes
Indications for Use:
Electrical Stimulation
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
2
510(k) Summary Flexible Rubber Electrodes 1460265/272/274 and 3444128/129/130
Substantial Equivalence Summary
Electrodes 1460265, 1460272 combined with sponge pads 1460266 and 1460273, were already used as accessories to the Enraf-Nonius B.V. Endomed CV405 powered muscle stimulator, a device no longer in production. The electrodes were continued to be used with newer Enraf-Nonius B.V. stimulator designs marketed outside the USA. During this time the electrodes have undergone the following changes:
- Electrode size 8 x 12 cm was added to the family .
- Electrodes were made available with 2 mm female terminations ●
- A new material formulation was used .
Comparison of Technological Characteristics:
| Device | New | Predicate |
|---|---|---|
| Maximum Current Density: | ||
| Electrode size : 4 x 6 | ||
| Stimulation current : 100 mA r.m.s. | ||
| (IEC 60601-2-10 limit at frequencies above | ||
| 1500 Hz) | 4.2 mA/cm² | 4.2 mA/cm² |
| Maximum Power Density: | ||
| Electrode size : 4 x 6 | ||
| Current type : Premodulated | ||
| carrier freq : 2 kHz | ||
| beat freq : 0 Hz | ||
| amplitude : 100 mA | ||
| Current type : Diadynamic DP | ||
| amplitude : 70 mA | ||
| (measured with sponge pads moistened with | ||
| tap water) |