(64 days)
No
The device description explicitly states that the electrodes are passive devices and do not contain active electronics, software, or firmware.
No
The device itself is a passive accessory (electrodes) to defibrillators, which are therapeutic devices. However, the electrodes themselves do not perform the therapeutic action.
No
The device is described as electrodes used for external defibrillation, pacing, monitoring, and cardioversion. While "monitoring" might suggest some diagnostic capability, the "Intended Use" specifically states its purpose for external defibrillation, pacing, monitoring and cardioversion of adults and children. It is also explicitly stated that the device does not contain active electronics, software, or firmware and are accessories to defibrillators. The mention of "monitoring" in the context of defibrillation electrodes typically refers to monitoring the heart's electrical activity using these electrodes as inputs, but the electrodes themselves are passive devices and do not provide a diagnosis.
No
The device description explicitly states that the electrodes are passive devices and do not contain active electronics, software, or firmware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for external defibrillation, pacing, monitoring, and cardioversion. These are all procedures performed directly on the patient's body, not on samples taken from the body.
- Device Description: The device is described as an accessory to defibrillators, applied to intact skin. It's a passive device used for electrical contact with the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Skintact® Multifunction Electrodes are for use on adults and children weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
Skintact® Multifunction Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin. Skintact® Multifunction Electrodes are accessories to defibrillators. Skintact® Multifunction Electrodes are passive devices and do not contain active electronics, software or firmware.
Skintact® Multifunction Electrodes consist of a backing material, conductive layer and conductive adhesive gel. The Multifunction Electrodes are applied on a release liner. This is the same composition like used for devices approved in existing K072233.
The shape of the electrodes has been slightly modified in comparison with K072233. The difference in shape of electrodes is an enhanced total area, but the active area is equivalent like approved in existing K072233.
Also this submission adds additional models of multifunction electrodes compatible with additional models of defibrillators.
An additional type of packaging is offered. This type of packaging is substantially equivalent to reference device approved in existing 510(k) K082090 9131 Defibrillation Electrodes, Cardiac Science Corporation, decision date: 12/12/2008.
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
Adults and children weighing more than 25 kg
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)
Performance testing was conducted according standard IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, relevant clauses. Results are within limits.
Biocompatibility testing has been performed for materials with direct skin contact. Biocompatibility testing confirms the materials are biocompatible and do not introduce new risks.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2014
Leonhard Lang Gmbh % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082
Re: K142803
Trade/Device Name: Skintact® Multifunction Electrodes Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: October 2, 2014 Received: October 3, 2014
Dear Elaine Duncan,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K142803
Device Name Skintact® Multifunction Electrodes
Indications for Use (Describe)
Skintact® Multifunction Electrodes are for use on adults and children weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
10(K) SUMMA
This 510(k) summary has been prepared in accordance with the requirements of 21CFR 807.92:
SUBMITTER:
Submitted on behalf of:
| Company Name:
Address: | Leonhard Lang GmbH
Archenweg 56
6020 Innsbruck
Austria |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:
Fax: | +43 512 334257
+43 512 392210 |
| Contact Person:
Telephone:
Fax: | Elaine Duncan, M.S.M.E., RAC
President, Paladin Medical, Inc.
PO Box 560
Stillwater, MN 55082
715-549-6035
715-549-5380 |
| Date prepared: | November 26, 2014 |
| Device Identification: | |
| TRADE NAME: | Skintact® Multifunction Electrodes
(and also to be offered for sale under various
private label tradenames) |
| COMMON NAME:
CLASSIFICATION NAME:
PRO CODE:
Regulation No.:
Classification: | Defibrillation Electrodes
DC-defibrillator, low-energy, (including paddles)
MKJ
21CFR 870.5310
Class III |
| SUBSTANTIALLY EQUIVALENT TO: | |
| K072233 | Skintact® Multifunction Electrodes with DH02 Gel |
ト available with different connectors compatible with different devices, Leonhard Lang GmbH, decision date: 10/05/2007 K082090 9131 Defibrillation Electrodes, Cardiac Science Corporation, decision date: 12/12/2008
INDICATIONS FOR USE:
Skintact® Multifunction Electrodes are for use on adults and children weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.
4
510(k) Summary-Continued
DESCRIPTION of the DEVICE:
Skintact® Multifunction Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin. Skintact® Multifunction Electrodes are accessories to defibrillators. Skintact® Multifunction Electrodes are passive devices and do not contain active electronics, software or firmware.
Skintact® Multifunction Electrodes consist of a backing material, conductive layer and conductive adhesive gel. The Multifunction Electrodes are applied on a release liner. This is the same composition like used for devices approved in existing K072233.
The shape of the electrodes has been slightly modified in comparison with K072233. The difference in shape of electrodes is an enhanced total area, but the active area is equivalent like approved in existing K072233.
Also this submission adds additional models of multifunction electrodes compatible with additional models of defibrillators.
An additional type of packaging is offered. This type of packaging is substantially equivalent to reference device approved in existing 510(k) K082090 9131 Defibrillation Electrodes, Cardiac Science Corporation, decision date: 12/12/2008.
Substantial Equivalence Summary [21CFR 807.92(a) (6)]
Skintact® Multifunction Electrodes have the same indications for use as Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different devices approved in existing 510(k)s K072233. The indicated limitation of use on children is by age in K072233 but in this submission it is being changed to weight. Children may have variations in weight at the same age and weight is the more important characteristic for safe performance on children.
| Indications for Use | |
|---|---|
| K072233 | This submission |
| Skintact® Multifunction Electrodes | |
| with DH02 Gel available with different | |
| connectors compatible with different | |
| defibrillators | Skintact® Multifunction Electrode |
| are for use on adults | are for use on adults |
| and children | and children |
| over eight years old | weighing more than 25 kg |
| for external defibrillation, pacing, | |
| monitoring and cardioversion. | for external defibrillation, pacing, |
| monitoring and cardioversion. | |
| The device is non-sterile | |
| and single use only. | The device is non-sterile |
| and single use only. |
5
Skintact® Multifunction Electrodes are substantially equivalent to predicate devices:
| Comparison | Skintact® Multifunction Electrodes | |
|---|---|---|
| K072233 | This submission | |
| Description | Hydrogel polymeric self-adhesive electrode pads | |
| Technical | ||
| Characteristics | ||
| / Features | Emergency treatment of cardiac arrest patients | |
| for use on adults | ||
| and children | ||
| over eight years old | for use on adults | |
| and children | ||
| weighing more than 25 kg | ||
| for short term use ( |