(102 days)
Not Found
No
The 510(k) summary describes standard multifunction electrodes for defibrillation, pacing, monitoring, and cardioversion. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on biocompatibility and electrical performance standards, not algorithmic performance.
Yes
The device is described as being used for "external defibrillation, pacing, monitoring and cardioversion," which are all therapeutic interventions or closely related to therapeutic interventions.
No
This device is described as electrodes for external defibrillation, pacing, monitoring, and cardioversion, which are therapeutic and monitoring functions, not diagnostic ones.
No
The device description explicitly states it is a "self-adhesive, non-sterile, single use disposable electrode," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Skintact® Radioiransparent Multifunction Electrodes are applied externally to the patient's skin for procedures like defibrillation, pacing, monitoring, and cardioversion. They are directly involved in delivering electrical signals to or sensing electrical signals from the body.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The electrodes are used for direct interaction with the patient's body.
Therefore, based on the provided information, this device falls under the category of a medical device used for external therapeutic and monitoring purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Skintact Radiotransparent Multifunction Electrodes are for use on adults and children over 8 years old or weighing more than 25 kg in external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.
Skintact® Radioiransparent Multifunction Electrodes are for use on adults and children over eight years old or 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, MLN
Device Description
All Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. Multifunction electrodes can be used for defibrillation, pacing, cardioversion and monitoring. These multifunction electrodes have the additional feature "radiotransparent" which allows these electrodes to stay on the patient when moving through different departments.
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 over 8 years old or 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)
Biocompatibility testing was conducted and passed ISO 10993 for intact skin. The performance data of Skintact Radiotransparent Multifunction Electrodes and predicate device (K072233) met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003.
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
SECTION 5
FEB 8 2011
510(K) SUMMARY
SUBMITTER
| Submitted on behalf of: | Company Name: | Leonhard Lang GmbH |
|---|---|---|
| Address: | Archenweg 56 | |
| 6020 Innsbruck | ||
| Austria | ||
| Telephone: | ++ 43 / 512 / 33 4 25 7 | |
| Fax: | ++ 43 / 512 / 39 22 10 | |
| Registration Number: | 8020045 | |
| Owner/Operator Number: | 8020045 | |
| by: | Elaine Duncan, MS.M.E., RAC | |
| President, Paladin Medical, Inc. | ||
| PO Box 560 | ||
| Stillwater, MN 55082 | ||
| Telephone: 715-549-6035 | ||
| Fax: 715-549-5380 | ||
| Contact Person: | Elaine Duncan (see address above) | |
| Date prepared: | October 28, 2010 | |
| Trade Name: | Skintact Radiotransparent Multifunction Electrodes | |
| (and also to be offered for sale under various private label tradenames) | ||
| Common Name: | Defibrillation Electrodes | |
| Classification Name: | Dc-defibrillator, low-energy, (including paddles) | |
| Regulation: | Defibrillators, Automatic, External, 21 CFR § 870.5310 | |
| Regulatory Class | This device is Class III | |
| Device Panel and Product Code: | 74 Cardiovascular, MKJ, MLN |
Reason for 510(k) Submission: additional feature "radiotransparent"
Substantial Eguivalence: Skintact Radiotransparent Multifunction Electrodes are substantially equivalent to the stated predicate devices:
Leonhard Lang Skintact Multifunction Electrodes with DH02 Gel K072233
available with different connectors compatible with different devices
PadPro 2001, 2001-S, 2001-C, 2001-EPS Multifunction Electrodes K014209
Description of device: All Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable electrodes. Multifunction electrodes can be used for defibrillation, pacing, cardioversion and monitoring. These multifunction electrodes have the additional feature "radiotransparent" which allows these electrodes to stay on the patient when moving through different departments.
Indications for use: Skintact Radiotransparent Multifunction Electrodes are for use on adults and children over 8 years old or weighing more than 25 kg in external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.
Basis for Equivalence - performance testing: Biocompatibility testing was conducted and passed ISO 10993 for intact skin. The performance data of Skintact Radiotransparent Multifunction Electrodes and predicate device (K072233) met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. The introduction of Skintact Radiotransparent Multifunction Electrodes (and also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness and Skintact Radiotransparent Multifunction Electrodes are substantially equivalent to the predicate devices K072233 and K014209.
Traditional 510(k): Skintact Radiotransparent Multifunction Electrodes
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 8 2011
Paladin Medical®, Inc. c/o Ms. Elaine Duncan President P.O. Box 560 Stillwater, MN 55082-0560
Re: K103186
Skintact® Radiotransparent Multifunction Electrodes Regulation Number: 21 CFR 870.5310 Regulation Name: Defibrillators, Automatic, External Regulatory Class: Class III Product Code: MKJ Dated: January 18, 2011 Received: January 20, 2011
Dear Ms. 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.
. . . . .
2
Page 2 – Ms. Elaine Duncan
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Page 3-Ms. Elaine Duncan
Indications for Use
510(k) Number: K103186
Device Name: Skintact® Radiotransparent Multifunction Electrodes
Indications For Use: Skintact® Radioiransparent Multifunction Electrodes are for use on adults and children over eight years old or weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non - sterile and single use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W. W.
(Division Sinn off) Division of Caralovascular Devices
510(k) Number K03186