(17 days)
Skintact ECG Electrodes are designed for use in general electrocardioaraphic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pre-wired ECG Electrodes with Conductive Adhesive are composed of the same materials as the predicate devices by Leonhard Lang except the pre-attached lead wire. The lead wires are similar to those in predicate devices.
This 510(k) submission is for a modification to an existing device, the Skintact® Pre-wired ECG Electrodes with Conductive Adhesive. The primary change is the addition of a pre-attached lead wire to an already cleared ECG electrode. As such, the submission focuses on demonstrating that this modification does not introduce new issues of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission (a modification to an existing device, primarily adding a pre-attached lead wire), the acceptance criteria generally revolve around demonstrating that the new feature (pre-attached lead wire) and the overall device performance meet established standards for ECG electrodes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility (Intact Skin) | Met: "Biocompatibility testing was cleared in predicate devices and passed ISO 10993 for intact skin." The submission implies no new materials were introduced that would challenge the previous biocompatibility assessment. |
| ECG Electrode Performance (Electrical & Mechanical) | Met: "According to the performance data, Leonhard Lang Skintact® Pre-wired ECG Electrodes with Conductive Adhesive met specifications as established in ANSI/AAMI EC12:2000, as did the predicate devices (K073104, K000206, K053011, K053550)." This standard covers various performance aspects, including impedance, offset voltage, DC offset, AC impedance, and adhesion. The pre-attached lead wire is implicitly covered by this standard for connectivity and signal integrity. |
| Shelf Life | Met: "The shelf life of Skintact® Pre-wired ECG Electrodes with Conductive Adhesive was tested in accelerated aging in the same manner as the predicate device K073104." This ensures the device maintains its performance characteristics over its intended storage period. |
| No New Issues of Safety or Effectiveness | Met: "The introduction of the Skintact® Pre-wired ECG Electrodes with Conductive Adhesive... does not introduce new issues of safety or effectiveness." This is the overarching criterion for demonstrating substantial equivalence for a minor modification. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state specific sample sizes for the performance tests (biocompatibility, ANSI/AAMI EC12:2000, shelf life). It refers to the tests being conducted and meeting standards, implying that sufficient samples were used to generate statistically meaningful results in line with the standards' requirements.
The data provenance is not explicitly stated regarding country of origin or retrospective/prospective nature for these specific tests. However, given the submitting company (Leonhard Lang GmbH) is based in Austria, it's reasonable to infer that some testing might have been conducted in Europe. The reference to FDA-recognized standards (ANSI/AAMI EC12:2000 and ISO 10993) indicates adherence to internationally accepted methodologies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is not applicable to this 510(k) submission. The device is a medical accessory (ECG electrode) and the performance testing described (biocompatibility, electrical/mechanical performance, shelf life) relies on objective measurements against established engineering and safety standards (ISO 10993, ANSI/AAMI EC12:2000). There is no "ground truth" in the clinical diagnostic sense that would require expert consensus for these particular tests.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable here. Adjudication methods are typically employed in clinical trials or studies where subjective assessments by multiple experts need to be resolved to establish a definitive "ground truth" (e.g., in image interpretation studies). The performance tests mentioned in this submission are objective laboratory tests against pre-defined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to assess improvements in reader performance with or without AI assistance. The Skintact® Pre-wired ECG Electrodes are not a diagnostic imaging device, nor do they involve AI assistance or human interpretation in their intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept is specifically applicable to AI/ML software as a medical device (SaMD) where the algorithm's performance is assessed independently of human intervention. The Skintact® Pre-wired ECG Electrodes are a physical medical device (an electrode), not a software algorithm.
7. The Type of Ground Truth Used
For the performance tests mentioned:
- Biocompatibility: The "ground truth" is adherence to the criteria outlined in ISO 10993. This involves laboratory tests to detect potential cytotoxic, irritation, or sensitization effects.
- ECG Electrode Performance: The "ground truth" is meeting the technical specifications and criteria defined in the ANSI/AAMI EC12:2000 standard. This involves objective measurements of electrical and mechanical properties in a laboratory setting.
- Shelf Life: The "ground truth" is stability over time, demonstrated by maintaining performance (e.g., adhesion, electrical properties) after accelerated aging that simulates real-time aging, according to established test protocols.
These are all objective, laboratory-based performance benchmarks against recognized standards, rather than clinical outcomes or pathology data.
8. The Sample Size for the Training Set
Not applicable. This submission is for an ECG electrode, which is a hardware medical device. It does not involve any artificial intelligence (AI) or machine learning (ML) models that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment process for a training set.
{0}------------------------------------------------
510(k) Summary
K080/06
P/1
SUBMITTER
Submitted on behalf of:
Classification Name:
Regulatory Class
Regulation:
Company Name: Address: Telephone: Fax:
Registration Number:
Leonhard Lang GmbH Archenweg 56 6020 Innsbruck Austria ++ 43 / 512 / 33 4 25 7 ++ 43 / 512 / 39 22 10 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 Date prepared: Trade Name: Common Name:
January 11, 2007 Skintact® Pre-wired ECG Electrodes with Conductive Adhesive (and as also to be offered for sale under various private label tradenames) Disposable ECG Electrodes Electrocardiograph (ECG) Electrode Electrocardiographic electrode, 21 CFR 870.2360 This device is Class II Device Panel and Product Code: Cardiovascular: 74 DRX Reason for 510(k) Submission: addition of pre-attached lead wire
Substantial Equivalence: Skintact® Pre-wired ECG Electrodes with Conductive Adhesive are substantially equivalent to K073104 Leonhard Lang Skintact® ECG Electrodes with Conductive Adhesive and have the same indications for use. The only change between the original Skintact® ECG Electrodes with Conductive Adhesive and the Skintact® Pre-wired ECG Electrodes with Conductive Adhesive is the addition of preattached lead wire. No new technology is required for this change since ECG Electrodes with pre-attached lead wires have been previously cleared in predicate devices using similar materials:
| K000206 | Pals Neonatal Pediatric ECG Electrode |
|---|---|
| K053011 | Pro-Neo Neonatal ECG Electrode |
| K053550 | Ambu Blue sensor Neo and Neo X |
Description of device: All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pre-wired ECG Electrodes with Conductive Adhesive are composed of the same materials as the predicate devices by Leonhard Lang except the pre-attached lead wire. The lead wires are similar to those in predicate devices.
Indications for use: Skintact ECG Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintace ECG Electrodes are single-use, non-sterile and disposable and are to be used on intact (uninjured) skin.
Basis for Equivalence - performance testing: Biocompatibility testing was cleared in predicate devices and passed ISO 10993 for intact skin. According to the performance data, Leonhard Lang Skintact® Pre-wired ECG Electrodes with Conductive Adhesive met specifications as established in ANSI/AAMI EC12:2000, as did the predicate devices (K073104, K000206, K053011, K053550). The shelf life of Skintact® Pre-wired ECG Electrodes with Conductive Adhesive was tested in accelerated aging in the same manner as the predicate device K073104. The introduction of the Skintact® Pre-wired ECG Electrodes with Conductive Adhesive (and as also to be offered for sale under various private label tradenames) does not introduce new issues of safety or effectiveness.
{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff entwined with a serpent.
Public Health Service
FEB - 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Leonhard Lang GMBH c/o Ms. Elaine Duncan, MS.M.E, RAC President, Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082-0560
Re: K080106
Skintact® Pre-wired ECG Electrodes with Conductive Adhesive Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II (two) Product Code: DRX Dated: January 11, 2008 Received: January 15, 2008
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.
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.
{2}------------------------------------------------
Page 2 - Ms. Elaine Duncan, MS.M.E, RAC
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bhimima fo
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Skintact® Pre-wired ECG Electrodes with Conductive Adhesive
Indications For Use:
Skintact ECG Electrodes are designed for use in general electrocardioaraphic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording.
Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Ramirez
Page 1 of __ 1
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.