(126 days)
833695
Not Found
No
The device description and intended use clearly define the product as a passive ECG electrode for signal acquisition, with no mention of any analytical or processing capabilities that would involve AI/ML. The performance studies focus on the electrode's physical and electrical properties for signal acquisition and biocompatibility, not on any data analysis or interpretation.
No
The device is described as an ECG electrode used to acquire electrocardiographic activity for display and analysis, which is a diagnostic function, not a therapeutic one.
Yes
The device acquires electrocardiographic activity of the heart which can be displayed and analyzed, fitting the definition of a diagnostic device.
No
The device description explicitly states the product is a polymer electrode comprised of physical components (top polymer, conductive adhesive hydrogel, radiotranslucent stud) and is applied to the skin, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- BodyTrode Function: The BodyTrode ECG electrode is applied to the intact skin surface to acquire electrical signals from the heart. This is a non-invasive procedure performed on the body (in vivo).
The device description and intended use clearly indicate that the BodyTrode is used for acquiring physiological signals directly from the patient's body, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The BodyTrode is a short term, single use (disposable), adult and pediatric ECG electrode which is applied to the intact skin surface to acquire electrocardiographic activity of the heart which can be displayed and analyzed when used in combination with leadwires, cables, and a monitor. They are intended to be used in both hospital and prehospital settings under the direction of a licensed health care practitioner.
Product codes
Not Found
Device Description
The Marquette BodyTrode ECG Electrodes are adhesive hydrogelled, single use ECG electrodes intended for use with adult and pediatric patients. The product is a polymer electrode comprised of three elements: a top polymer, a conductive adhesive hydrogel, and a radiotranslucent stud. The BodyTrode electrodes are applied to the patient's skin surface to acquire electrocardiographic activity of the heart. They are used in combination with patient leadwires, cables, and a monitor to display and/or analyze a patient's ECG.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin surface
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
hospital and prehospital settings under the direction of a licensed health care practitioner.
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
Non-clinical tests were conducted:
- Tests recommended in ANSI/AAMI voluntary standard of EC12-1991 with package aging using both real time and the Von't Hoff rule were conducted to demonstrate performance and technological characteristics.
- Bio-compatibility tests were conducted for the patient contact materials (the hydrogel). The tests were selected in accordance to ISO 10993-1:1992 and the FDA Matrix.
Key Metrics
Not Found
Predicate Device(s)
510(k) 833695
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Section 16: April 2, 1996
1. Establishment Information
| Manufacturer/Submitter: | Marquette Electronics, Inc. |
|---|---|
| 100 Marquette Drive | |
| Jupiter, FL 33469 | |
| Contact Name/Phone # | Michael Laughran |
| Regulatory Affairs | |
| Marquette Electronics, Inc. | |
| Phone: (407) 574-5000 |
2. General Device Information
| Common/Usual Name: | Electrocardiograph (ECG) Electrode |
|---|---|
| Trade/Proprietary Name: | BodyTrode |
| Classification Name: | Electrocardiograph electrode (CFR |
| 870.2360) | |
| Device Classification: | Class II |
| Performance Standards: | None established under section 514 |
3. Substantial Equivalence:
BodyTrode is substantially equivalent to Marquette ECG electrodes which are currently legally marketed under 510(k) 833695.
4. Device Description:
The Marquette BodyTrode ECG Electrodes are adhesive hydrogelled, single use ECG electrodes intended for use with adult and pediatric patients. The product is a polymer electrode comprised of three elements: a top polymer, a conductive adhesive hydrogel, and a radiotranslucent stud. The BodyTrode electrodes are applied to the patient's skin surface to acquire electrocardiographic activity of the heart. They are used in combination with patient leadwires, cables, and a monitor to display and/or analyze a patient's ECG.
5. Intended Use:
The BodyTrode is a short term, single use (disposable), adult and pediatric ECG electrode which is applied to the intact skin surface to acquire electrocardiographic activity of the heart which can be displayed and analyzed when used in combination with leadwires, cables, and a monitor. They are intended to be used in both hospital and prehospital settings under the direction of a licensed health care practitioner.
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) Section 16:
6. Comparison to legally marketed predicate device.
| CHARACTERISTIC | PREDICATE DEVICE
PN 9408-401 | PROPOSED DEVICE
BODYTRODE |
| ---------------- | --------------------------------- | ------------------------------ |
|---|
| Intended Use | A disposable device for the detection of
physiological potentials such as ECG, EEG,
etc. through skin surface contact. | The BodyTrode is a short term, single use
(disposable), adult and pediatric ECG
electrode which is applied to the intact skin
surface to acquire electrocardiographic
activity of the heart which can be displayed
and analyzed when used in combination with
leadwires, cables, and a monitor. They are
intended to be used in both hospital and
prehospital settings under the direction of a
licensed health care practitioner. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials/Construction | Oval lamination consisting of an adhesive
coated foam pad and ring, a styrene ring,
and conductive gel which is connected by a
silver/silver chloride coated
radiotranslucent plastic electrode and stud.
The assembly is placed in a plastic holder
and packaged in foil coated paper. | Round lamination consisting of a layer of
conductive adhesive hydrogel and a top
polymer with a silver/silver chloride coated
radiotranslucent plastic stud. The assembly
is placed in a plastic holder and packaged in
foil coated paper. |
| Expiration Date | 15 months from date of manufacture | 12 months from date of manufacture |
7. The following non-clinical tests were conducted and submitted for determination of substantial equivalence.
- Tests recommended in ANSI/AAMI voluntary standard of EC12-1991 with package aging using both real time and the Von't Hoff rule were conducted to demonstrate performance and technological characteristics.
- Bio-compatibility tests were conducted for the patient contact materials (the hydrogel). The tests were selected in accordance to ISO 10993-1:1992 and the FDA Matrix.
8. Conclusion
Testing done on the proposed BodyTrode and the predicate Marquette ECG electrode (PN 9408-401) indicates that the proposed provides an equivalent when compared to the ANSI/AAMI standard of EC12-1991 and ISO 10993-1:1992 and the FDA Matrix when tested as specified in the pre-market submission.
Marquette Electronics, Inc. concludes that the proposed BodyTrode is as safe and effective and performs substantially equivalent to the predicate Marquette ECG Electrode.
42