PADPRO, MODEL 2603

K020288 · Padpro, LLC · MKJ · Feb 27, 2002 · Cardiovascular

Device Facts

• Record ID: K020288
• Device Name: PADPRO, MODEL 2603
• Applicant: Padpro, LLC
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 27, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

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

Device Story

PadPro 2603 are non-sterile, disposable, multifunction electrodes; provide conductive interface between defibrillator/pacemaker and pediatric patient skin. Used for defibrillation, cardioversion, pacing, and monitoring. Operated by clinicians in hospitals or paramedic settings. Features high-tack adhesive polymer gel for uniform current distribution and repositioning; radiotranslucent; latex-free. Adapter system allows connection to various OEM cables (Physio-control, Zoll, Hewlett Packard). Enables standardization of electrodes across different defibrillator brands within an institution. Benefits include patient comfort, effective therapy delivery, and simplified clinical workflow.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Multifunction electrode; radiotranslucent; latex-free; high-tack polymer adhesive gel. Dimensions: 4.5 x 8.2 cm. Connectivity: Adapter system for OEM cables. Standards: IEC 601-1 (1988) with amendments, ANSI/AAMI DF-39.

Indications for Use

Indicated for pediatric patients weighing less than 10kg (22 lbs) requiring external pacing, defibrillation, cardioversion, or monitoring. Intended for use with defibrillators limited to 30 joules maximum output.

Regulatory Classification

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.

Predicate Devices

• PadPro 2602 Pediatric Electrode (K002280)

Submission Summary (Full Text)

{0}------------------------------------------------

K020288

## EXHIBIT 2

PadPro LLC. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: [phone] Fax: [phone] 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<br>Electrodes (K002280). | "PadPro" 2603 Pediatric<br>Defibrillator Electrodes |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indications for use | For use as disposable electrodes for<br>automatic and manual external<br>defibrillators for monitoring, pacing,<br>cardioversion, and defibrillation.<br>Pediatric application | SAME |
| Where used | Hospitals and Paramedic situations | SAME |
| Basic features | Radiotranslucent, non sterile, latex<br>free, single patient use, self adhesive,<br>in sealed foil pouch. | SAME. Slightly larger than<br>2602. |
| Size | 4.1 x 5.1 cm | 4.5 x 8.2 cm |
| Standard met | International Electrotechnical<br>Commission (IEC) 601-1: Medical<br>Electrical Equipment 601-1 (1988)<br>Part 1: General requirements for<br>safety Amendment No. 1 (1991)<br>Amendment No. 2 (1995 and<br>Sec.898.12 Performance standard;<br>ANSI/AAMI DF-39 (3.3.19)<br>standard, self adhesive electrodes for<br>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 [phone]. First of Compliance at [phone]. 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 [phone] or [phone] 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 < pediatric patients whose weight is less than 10kg (22 lbs).

pediathic patient whose weight is tess than 1005 (42 to 100 )
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied when a patient requires defibrination, carents . This. device is intended for use on defibrillators whose of specifical fea to the patient and collined to the unstrum. The 2017 pediatric electrodes are designed for, ~ output is can be ininted to bio-control, Zoll, and Hewlett Packard defibrillators.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>✓</div> |
|------------------|--------------|
|------------------|--------------|

OR

| Over the Counter Use (Per 21 CFR 801.109) | |
|-------------------------------------------|--|
|-------------------------------------------|--|

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K202288 |
|---------------|---------|
|---------------|---------|