(28 days)
Not Found
No
The description focuses on the physical properties and functionality of external electrodes for defibrillation, pacing, and monitoring, with no mention of AI or ML algorithms for data analysis, interpretation, or decision support.
Yes
The device is used for external pacing, defibrillation, and cardioversion, which are therapies to treat cardiac conditions.
No
This device is described for use in external pacing, defibrillation, cardioversion, and monitoring applications by providing a conductive interface. It does not mention analyzing or interpreting patient data to identify diseases or conditions.
No
The device description clearly describes physical electrodes ("PadPro radiotransparent external electrodes") which are hardware components, not software.
No, 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. This testing is done outside of the body (in vitro).
- Device Function: The PadPro electrodes are applied directly to the patient's skin to facilitate electrical signals for pacing, defibrillation, and monitoring. They are a conductive interface between the medical equipment and the patient's body.
- Intended Use: The intended use clearly states applications like external pacing, defibrillation, and monitoring, which are all procedures performed on the patient's body.
The device description and intended use clearly indicate that this is a device used for direct patient treatment and monitoring, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The PadPro radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Product codes
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 or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.
Model differentiation:
2001 - Standard connector (2 contacts)
2001-S - Split connector (separate contacts)
2001-C - Radiotransparent leadwire (carbon fiber)
2001-EPS - Larger rear pad, 334 cm sq.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
Adult patients
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 December 12, 2000 510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: "PadPro" 2001, 2001-S, 2001-C, 2001-EPS Multifunction Electrodes Classification Name: Electrode, Electrocardiograph, Multi-Function; MLN Common/Usual Name: Defibrillator Electrode
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- Equivalent legally marketed device: This identical in function to the Katecho KDP-60A (K002806) and nearly identical in design.
-
- Indications for Use: The PadPro radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
-
- Description of the Devices: Features & Benefits:
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 or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.
1
Model differentiation:
| Model | Feature/difference |
|---|---|
| 2001 | Standard connector (2 contacts) |
| 2001-S | Split connector (separate contacts) |
| 2001-C | Radiotransparent leadwire (carbon fiber) |
| 2001-EPS | Larger rear pad, 334 cm sq. |
-
- Safety and Effectiveness, comparison to predicate device:
| Comparison Areas | Katecho KDP-60A (K002806) | "PadPro" Defibrillator Electrodes |
|---|---|---|
| Indications for use | For use as disposable electrodes for automatic and manual external defibrillators for monitoring, pacing, cardioversion, and defibrillation | SAME |
| Where used | Hospitals and Paramedic situations | SAME |
| Basic features | Radiotransparent, non sterile, latex free, single patient use, self adhesive, in sealed foil pouch. | SAME |
| 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 |
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- Conclusion In all respects, the PadPro System Defibrillator Electrodes are substantially equivalent to other electrodes that are legally marketed for this purpose. The device meets the standards referenced above.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which is a stylized image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2002
PadPro LLC. c/o Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K014209
Trade Name: "PadPro" 2001, 2001-S, 2001-C, and 2001-EPS Multifunction Electrodes Regulation Number: 21 CFR 870.1025 Regulation Name: Accessory to Automatic External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: December 20, 2001 Received: December 21, 2001
Dear Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 may be subject 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.
3
Page 2 - Mr. Daniel Kamm, P.E.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Dela Teh
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
j) Indications for Use
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Device Name: "PadPro" 2001, 2001-S, 2001-C, 2001-EPS Multifunction Electrodes
Indications for Use:
The PadPro radiotransparent external electrodes are indicated for use in external pacing, I he r adi to laciotransparent ontential erse as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external only. The electrodes provide the conceeers and the patient's skin. The electrode is intended for use on adult patients.
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be willen a patient requires deficitiations the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over the Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
Dale tu
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K014209 |
|---|---|
| --------------- | --------- |