(30 days)
Not Found
No
The summary describes standard pediatric defibrillator electrodes and their features, with no mention of AI or ML capabilities.
No
The device is described as electrodes used for external pacing, defibrillation, cardioversion, and monitoring, which are all diagnostic or life-support functions, not therapeutic treatments in themselves, although they can be part of a therapeutic regimen. These electrodes facilitate the delivery or measurement of electrical signals, not a treatment or cure for a disease.
No
The device is described as electrodes used for external pacing, defibrillation, cardioversion, and monitoring. These functions are therapeutic or for vital sign tracking, not for diagnosing a condition or disease.
No
The device description clearly describes physical electrodes with adhesive gel and connectors, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PadPro pediatric electrodes are used externally on the patient's skin for procedures like defibrillation, pacing, cardioversion, and monitoring. They are directly applied to the patient and interact with their electrical signals, not with samples taken from the body.
- Intended Use: The intended use clearly describes external applications on the patient for therapeutic and monitoring purposes.
Therefore, the function and intended use of the PadPro pediatric electrodes fall outside the scope of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The PadPro pediatric electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use only. The PadPro 2603 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 10kg (22 Ibs). When a patient requires defibrillation, cardioversion or external pasing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose valput is van be limited to 30 joules musimum. The Padlyro 2003 pediative electrodes are designed for, and to be used with the Physio-control, Zoll, and Hewlett Packard defibrillators
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand of defibrillation/pacing unit is being used. All PadPro products are Latex free.
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
pediatric patients whose weight is less than 10kg (22 Ibs).
Intended User / Care Setting
Hospitals and Paramedic situations
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
§ 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
EXHIBIT 2
PadPro LLC. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: 734-663-0132 Fax: 734-663-1306 Contact: Cliff Poppy, President February 26, 2002 510(k) Summary of Safety and Effectiveness
- Identification of the Device: l. IGentification of the Same: "PadPro" 2603 Pediatric Multifunction Electrodes Classification Name: Electrode, Electrocardiograph, Multi-Function; MLN Common/Usual Name: Defibrillator Electrode
- Equivalent legally marketed device: This identical in function and nearly identical in design to 2. the PadPro 2602 Pediatric Electrode (K002280).
- Indications for Use: The PadPro pediatric electrodes are indicated for use in external pacing, 3. defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use only. The PadPro 2603 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 10kg (22 Ibs).
When a patient requires defibrillation, cardioversion or external pasing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose valput is van be limited to 30 joules musimum. The Padlyro 2003 pediative electrodes are designed for, and to be used with the Physio-control, Zoll, and Hewlett Packard defibrillators
- Description of the Devices: Features & Benefits: 4.
The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand of defibrillation/pacing unit is being used. All PadPro products are Latex free.
1
| Comparison Areas | "PadPro" 2602 Pediatric Defibrillator
Electrodes (K002280). | "PadPro" 2603 Pediatric
Defibrillator Electrodes |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indications for use | For use as disposable electrodes for
automatic and manual external
defibrillators for monitoring, pacing,
cardioversion, and defibrillation.
Pediatric application | SAME |
| Where used | Hospitals and Paramedic situations | SAME |
| Basic features | Radiotranslucent, non sterile, latex
free, single patient use, self adhesive,
in sealed foil pouch. | SAME. Slightly larger than
2602. |
| Size | 4.1 x 5.1 cm | 4.5 x 8.2 cm |
| Standard met | International Electrotechnical
Commission (IEC) 601-1: Medical
Electrical Equipment 601-1 (1988)
Part 1: General requirements for
safety Amendment No. 1 (1991)
Amendment No. 2 (1995 and
Sec.898.12 Performance standard;
ANSI/AAMI DF-39 (3.3.19)
standard, self adhesive electrodes for
monitoring and defibrillation | SAME |
-
Safety and Effectiveness, comparison to predicate device: న.
. . -
Conclusion In all respects, the PadPro System Defibrillator Electrodes are substantially 6. equivalent to other electrodes that are legally marketed for this purpose. The device meets the standards referenced above.
:
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized caduceus symbol, which is a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2002
PadPro LLC. c/o Mr. Daniel Kamm President Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K020288
Trade Name: "PadPro" 2603 Pediatric Multifunction Electrodes Regulation Number: 21 CFR 870.1025 Regulation Name: Defibrillator Automatic, External Regulatory Class: Class III (three) Product Code: MKJ Dated: January 24, 2002 Received: January 28, 2002
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren or see fee device is substantially equivalent (for the indications forchered a oo re and in revelopment to legally marketed predicate devices marketed in interstate for use surve in the encreases) 76 the enactment date of the Medical Device Amendments, or to conninered pror to ria) 2011-12-11 accordance with the provisions of the Federal Food, Drug, devices that have boom require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, atteresy mains of the Act include requirements for annual registration, listing 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 rr your device 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 r load be act not a determination that your device complies with other requirements of the Act that I Dr Hab made a and regulations administered by other Federal agencies. You must or any I outhal the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Daniel Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I DPT 3 ibsualler or our device complies with other requirements of the Act that I DA has made a colorimiation administered by other Federal agencies. You must of any I edical statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cr K Fat 807), labeling (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis ictier will anow you to begin maing of substantial equivalence of your device to a legally premail.cated 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 and If you desire speomle ad 100 for you in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 80%. Additionally, for questions on the promotion and advertising of Compliance at (301) 597-1010. First of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Togulation chittion, "Miooranang of esponsibilities under the Act may be obtained from the Other general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Zuckerman, M.D. Bram D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
i) Indications for Use
510(k) Number K020288
Device Name: "PadPro" 2603 Pediatric Multifunction Electrodes
Indications for Use:
The PadPro pediatric electrodes are indicated for use in external pacing, defibiliation and monitoring I he PadPro pediative electrodes are maleated for single pediatric use only. The PadPro 2603 electrodes applications as a non-sterne, disposable as rios and/or the external transcutaneous provide ine conductive meetiatic patient's skin. The electrode is intended for use on ✓ |
| ------------------ | -------------- |
|---|
OR
| Over the Counter Use (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------- | -- |
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K202288 |
|---|---|
| --------------- | --------- |