(14 days)
No
The document describes standard ECG electrodes and their materials, with no mention of AI or ML capabilities for data analysis or interpretation.
No.
The device is used for monitoring and diagnosis, not for treating a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is designed for "ECG diagnosis recording," which is a diagnostic procedure.
No
The device description explicitly states it is composed of physical materials and is a disposable electrode, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician." This describes a procedure performed on the patient's body to measure electrical activity of the heart.
- Device Description: The device is an "ECG Electrode," which is a component used to acquire physiological signals from the body surface.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are specifically designed for testing these types of samples in a laboratory or clinical setting.
The device is clearly intended for direct application to the patient's skin to facilitate the recording of electrical signals from the heart, which is a medical device used for physiological monitoring, not an in vitro diagnostic device.
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® 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.
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 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.
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 K073104
| SUBMITTER | ||
|---|---|---|
| Submitted on behalf of: | Company Name: | |
| Address: | Leonhard Lang GmbH | |
| 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 | |
| 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.
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గ్రా
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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