(65 days)
K915159A, K960676
K915159A, K960676
No
The summary describes a passive electrode device and does not mention any AI/ML components or functions.
Yes
The device is intended for defibrillation, non-invasive pacing, and cardioversion, which are therapeutic medical interventions.
Yes
Explanation: The device is indicated for "ecg monitoring," which is a diagnostic function.
No
The device description explicitly states it consists of "a pair of liquid gel electrodes with permanently attached lead wires," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The pedirpadz™ Radiolucent MFE's are electrodes used for external procedures on the patient's body (defibrillation, pacing, cardioversion, ECG monitoring). They do not analyze samples taken from the body.
- Intended Use: The intended use clearly describes external electrical stimulation and monitoring, not the analysis of biological samples.
Therefore, based on the provided information, this device falls under the category of a medical device used for external therapeutic and diagnostic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The pedi•padz™ Radiolucent MFE's are intended to be used on pediatric patients, 0-8 years of age at
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
| 2004 | pedi•padz™ Radiolucent Pediatric Multi-Function Electrode
510(k) Premarket-Notification Submission |
| ------ | ------------------------------------------------------------------------------------------------------- |
|---|
| Company: | BIO-DETEK
525 Narragansett Park Drive
Pawtucket, RI 02861-4323 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Robert Morse
QA/QC Manager |
| Date Prepared: | February 3, 2004 |
| Name of Device: | pedi•padz™ Radiolucent Pediatric Multi-
Function Electrode |
| Predicate Device: | ZOLL Pediatric Multi-Function Electrode
K915159A & ZOLL stat•padz™ Radiolucent Adult
Multi-Function Electrode K960676 |
510(k) Summary; pedi•padz™ Radiolucent Pediatric Multi-Function Electrodes 10.0
Device Description and Intended Use:
The pedi•padz™ Radiolucent Pediatric Multi-Function Electrodes will connect to ZOLL Pacemakers/Defibrillators, as defined by ZOLL Medical Corporation, for pediatric patients, 0-8 years of age at