(102 days)
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.
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.
This document is a 510(k) summary for a medical device called "Skintact Radiotransparent Multifunction Electrodes." It is not a study report or clinical trial. Therefore, it does not contain the detailed information necessary to answer all the questions about acceptance criteria, device performance, and study methodology as typically found in a clinical study report for AI/ML-based devices.
However, I can extract the information that is present and explain why certain details are missing.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of "acceptance criteria" for an AI/ML device or detailed "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity, accuracy).
Instead, it states that the device's performance met specifications established in existing standards:
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ANSI/AAMI DF80:2003 | Met specifications |
| IEC/EN 60601-2-4:2003 | Met specifications |
| ISO 10993 (intact skin) | Passed |
These standards relate to the electrical safety and performance of defibrillation electrodes and biocompatibility, not to the diagnostic performance of an AI/ML algorithm.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes performance testing against established standards for medical devices, which typically involves laboratory testing or bench testing, not clinical studies with "test sets" in the context of AI/ML evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided as the device is a piece of hardware (multifunction electrodes) and not an AI/ML diagnostic tool requiring expert-established ground truth for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided for the same reason as above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and therefore not provided. The device is an electrode, not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided. The device is a physical electrode, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically discussed for AI/ML devices is not applicable here. The "ground truth" for this device's performance would be objective measurements against the technical specifications outlined in the mentioned standards (ANSI/AAMI DF80:2003, IEC/EN 60601-2-4:2003, ISO 10993).
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. There is no training set for this device.
Summary of Device and Evaluation:
The document describes the submission of "Skintact Radiotransparent Multifunction Electrodes" for 510(k) clearance. The purpose of the submission is for an additional feature: "radiotransparent," allowing the electrodes to remain on a patient during imaging.
The basis for equivalence (and thus, acceptance) to predicate devices is primarily focused on:
- Biocompatibility testing: Passed ISO 10993 for intact skin.
- Performance data: Met specifications as established in ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003. These standards relate to the electrical and functional performance of defibrillation electrodes.
The crucial point is that this document is for a traditional medical device (electrodes), not an AI/ML-driven diagnostic or treatment device. Therefore, the questions related to AI/ML specific evaluation metrics, ground truth, expert adjudication, and training/test sets are not relevant to this submission. The "study" mentioned refers to performance testing against established safety and efficacy standards for the hardware itself.
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SECTION 5
FEB 8 2011
510(K) SUMMARY
SUBMITTER
| Submitted on behalf of: | Company Name: | Leonhard Lang GmbH |
|---|---|---|
| Address: | Archenweg 566020 InnsbruckAustria | |
| 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., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082 | |
| Telephone: 715-549-6035Fax: 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
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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.
. . . . .
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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
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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
§ 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.