(17 days)
No
The summary describes standard ECG electrodes and their performance against established standards, with no mention of AI or ML capabilities.
No The device is used for monitoring and diagnosis (ECG surveillance and ECG diagnosis recording), not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "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." The mention of "ECG diagnosis recording" directly indicates a diagnostic purpose.
No
The device description clearly states it is a physical electrode, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the electrodes are for "general electrocardioaraphic procedures where ECG monitoring is deemed necessary and is ordered by a physician." This involves measuring electrical activity of the heart on the patient's body.
- Device Description: The description details a self-adhesive electrode applied to the skin.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, or tissue. The device is applied directly to the patient's skin to capture physiological signals.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct physiological measurement on the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRX
Device Description
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.
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
Not Found
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 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.
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
§ 870.2360 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.
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
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