(14 days)
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. 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® ECG Electrodes with Conductive Adhesive are composed of the same naterials as the predicate devices by Leonhard Lang except the gel, which is made by AmGel Technologies.
Here's a breakdown of the acceptance criteria and study information for the Skintact® ECG Electrodes with Conductive Adhesive, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Criteria | Acceptance Criteria (Set by ANSI/AAMI EC12:2000) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993 standards for intact skin. | "Biocompatibility testing was the same as predicate devices and passed ISO 10993 for intact skin." The new device's gel, made by AmGel Technologies, had been previously cleared in a submission by the manufacturer, implying its biocompatibility was established. |
| Electrical Performance (Initial) | Meets specifications as established in ANSI/AAMI EC12:2000. This standard covers areas like DC offset voltage, combined offset instability and internal noise, AC impedance, and defibrillation overload recovery. | "The performance data of Skintact® ECG Electrodes with Conductive Adhesive and the predicate devices (K023503, K040249) met specifications as established in ANSI/AAMU EC12:2000." This indicates the device performed within the limits defined by the standard for electrical characteristics. |
| Electrical Performance (After Shelf-Life) | Meets specifications as established in ANSI/AAMI EC12:2000 after accelerated aging. | "The shelf life of Skintact® ECG Electrodes with Conductive Adhesive was tested in accelerated aging in the same manner as the predicate devices." The implication, given the overall substantial equivalence claim, is that the device also met ANSI/AAMI EC12:2000 specifications after accelerated aging, demonstrating stability over its claimed shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size for the test set used in the performance testing. It refers to "performance data" and "biocompatibility testing."
Regarding data provenance:
- Country of Origin: Not explicitly stated, but the submitter (Leonhard Lang GmbH) is based in Austria. The testing itself could have been conducted anywhere.
- Retrospective or Prospective: Not explicitly stated. For performance standards like ANSI/AAMI EC12:2000, testing typically involves prospective laboratory measurements of electrode characteristics. Biocompatibility testing is also generally prospective lab testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. ECG electrodes are physical medical devices, and their "ground truth" for performance is established by objective measurements against recognized engineering and safety standards (like ISO 10993 for biocompatibility and ANSI/AAMI EC12:2000 for electrical performance). There are no experts establishing "ground truth" in the way one would for diagnostic image interpretation.
4. Adjudication Method for the Test Set
This is not applicable. As discussed above, the "truth" is determined by objective measurements against established standards, not by expert consensus or adjudication.
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 primarily relevant for diagnostic imaging systems or AI algorithms where human interpretation is a key component and the AI's effect on human performance is being evaluated. This 510(k) is for a disposable ECG electrode, a hardware component.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
No, a "standalone" study in the context of an algorithm's performance was not done. This 510(k) is for a hardware device, not an algorithm. The performance evaluation focuses on the physical and electrical characteristics of the electrode itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurements against recognized industry standards:
- Biocompatibility: Conformance to ISO 10993 standards.
- Electrical Performance: Conformance to ANSI/AAMI EC12:2000 for ECG electrodes.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device (ECG electrode), not an AI algorithm or a diagnostic system that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
{0}------------------------------------------------
510(k) Summary K073104
| SUBMITTER | ||
|---|---|---|
| Submitted on behalf of: | Company Name:Address: | Leonhard Lang GmbHArchenweg 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 55082Telephone: 715-549-6035Fax: 715-549-5380 | |
| Contact Person: | Elaine Duncan | |
| Date prepared: | October 31, 2007 | |
| Trade Name: | Skintact® ECG Electrodes with Conductive Adhesive(and as also to be offered for sale under various private label tradenames) | |
| Common Name: | Disposable ECG Electrodes | |
| Classification Name: | Electrocardiograph (ECG) Electrode | |
| Regulation | 21 CFR 870.2360 | |
| Regulatory Class | This device is Class II | |
| Device Panel and Product Code: | Cardiovascular: 74 DRX | |
| Reason for 510(k) Submission: | change in material: gel |
Substantial Equivalence: Skintact® ECG Electrodes with Conductive Adhesive are substantially equivalent to the stated predicate devices. The only change between the original Skintact® ECG Electrodes and the Skintact® ECG Electrodes with Conductive Adhesive is the change in the conducting media gel, Conductive gel electrodes were previously cleared by FDA (3M Red Dot) and the gel has been previously, cleared in a submission by the manufacturer.
K023503 Leonhard Lang Skintact® ECG Electrodes with solid adhesive gel
- K040249 Leonhard Lang Skintact® radiolucent and MRI-compatible ECG Electrodes
- K000690 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive
K000206 Pals Neonatal Pediatric ECG Electrodes, Models PN100 PN200
Description of device: All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Electrodes with Conductive Adhesive are composed of the same naterials as the predicate devices by Leonhard Lang except the gel, which is made by AmGel Technologies.
Skintact® ECG Electrodes with Conductive Adhesive have the same indications for Indications for use: use as approved in predicate 510(k)s: Skintact® ECG Electrodes are designed for use in general electrocurdiographic 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. Skintacle ECG Electrodes are single-use, non-sterile, disposable and are to be used on intact (uninjured) skin.
Basis for Equivalence: performance testing: Biocompatibility testing was the same as predicate devices and passed ISO 10993 for intact skin. The performance data of Skintact® ECG Electrodes with Conductive Adhesive and the predicate devices (K023503, K040249) met specifications as established in ANSI/AAMU EC12:2000. The shelf life of Skintact® ECG Electrodes with Conductive Adhesive was tested in accelerated aging in the same manner as the predicate devices. The introduction of the Skintact® 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 and the Skintact® ECG Electrodes with Conductive Adhesive are substantially equivalent to the predicate devices.
Page 1 OF 1
గ్రా
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is composed of three parallel lines that curve and converge, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2007
Leonhard Lang GmbH c/o Ms. Elaine Duncan, MSME, RAC President Paladin Medical Inc., P.O. Box 560 Stillwater, MN 55082
Re: K073104
Skintact® ECG Electrodes with Conductive Adhesive (and various private label tradenames) Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: October 31, 2007 Received: November 2, 2007
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
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) I mis lotter will and w yourse of substantial equivalence of your device to a legally promation in the 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,
B.Bummimo for
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®ECG Electrodes with Conductive Adhesive
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.
Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
| Prescription Use | X | 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)
Bhumma
§ 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.