(57 days)
Not Found
No
The device description and performance studies focus on the physical properties, biocompatibility, and electrical performance of the electrodes, with no mention of AI or ML.
Yes
The device is used for external defibrillation, pacing, and cardioversion, which are therapeutic interventions.
Yes
The "Intended Use / Indications for Use" states that the electrodes are used for "monitoring," which is a diagnostic function.
No
The device description clearly states that the device consists of physical components like foam backing, metallic substrate, and conductive adhesive gel, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for external defibrillation, pacing, monitoring, and cardioversion. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The device is described as self-adhesive electrodes with a foam backing, metallic substrate, and conductive adhesive gel. This aligns with devices used for electrical contact with the skin for therapeutic or monitoring purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver or receive electrical signals through the skin for direct patient care procedures.
N/A
Intended Use / Indications for Use
The Skintact® Multifunction Electrodes are for use on adults and children over eight years old for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single-use only.
Product codes
MKJ
Device Description
Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable clectrodes. Skintact® Multifunction Electrodes consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH 02. Several shapes and sizes are offered, in accordance with standards. Skintact® Multifunction Electrodes are packaged in pairs with color-coded cabling within watervapor-proof, heat-sealed, non-transparent, aluminized pouches.
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
adults and children over 8 years old
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 tests in accordance with ISO 10993 have been performed on the hydrogel. The testing confirms that the gel is biocompatible and does not introduce any risks. Testing to evaluate the performance of the Skintacte Multifunction Electrodes in accordance with internationally recognized standards demonstrated that the performance of the Skintact Multifunction Electrodes meet specifications and are suitable for use with the monophasic and biphasic defibrillators. Skintact Multifunction Electrodes are packaged in the same packaging used by Leonhard Lang GmbH in many previously approved products with demonstrated 24 month shelf-life. In addition, the Skintact Multifunction Electrodes were tested in accelerated aging. confirming the shelf-life of 24 months for DH02 gel and materials. Skintact Multifunction Electrodes used for adult defibrillation (and children over 8 years) and pacing have a minimum active (gel) area of 82 cm² and the total area of the two electrodes is at least 164 cm2, thus meeting the standard requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
| Date Summary Prepared: | July 9, 2004 | |
|---|---|---|
| Submitter's name and address: | Company Name: | |
| Address: | Leonhard Lang GmbH | |
| Archenweg 56 | ||
| 6020 Innsbruck | ||
| Austria | ||
| Telephone: | ++ 43 / 512 / 33 4 25 7 | |
| Fax: | ++ 43 / 512 / 39 22 10 | |
| Contact Person: | Elaine Duncan, MS.M.E., RAC | |
| President, Paladin Medical, Inc. | ||
| PO Box 560 | ||
| Stillwater, MN 55082 | ||
| Telephone: | 715-549-6035 | |
| Fax: | 715-549-5380 | |
| Device Name | ||
| Proprietary Name: | Skintact® Multifunction Electrodes | |
| Common Name: | Defibrillation Electrodes | |
| Classification Name: | Electrocardiograph (multifunction) electrodes |
Substantially Equivalent to: The Skintact® Multifunction Electrodes are substantially equivalent to the Philips HeartStart Defibrillation Pads (model DP2). Philips Medical Systems, formerly Heartstream, cleared the HeartStart Defibrillation Pads (model DP2) under K955628, a bundled submission including defibrillator and accessories.
Device Description: Skintact Multifunction Electrodes are self-adhesive, non-sterile, single use disposable clectrodes. Skintact® Multifunction Electrodes consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH 02. Several shapes and sizes are offered, in accordance with standards. Skintact® Multifunction Electrodes are packaged in pairs with color-coded cabling within watervapor-proof, heat-sealed, non-transparent, aluminized pouches.
Indication for Usc: The Skintact Multifunction Electrodes are for use on adults and children over 8 years for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.
Summary of Comparison and Testing to Demonstrate Equivalence: Biocompatibility tests in accordance with ISO 10993 have been performed on the hydrogel. The testing confirms that the gel is biocompatible and does not introduce any risks. Testing to evaluate the performance of the Skintacte Multifunction Electrodes in accordance with internationally recognized standards demonstrated that the performance of the Skintact Multifunction Electrodes meet specifications and are suitable for use with the monophasic and biphasic defibrillators. Skintact Multifunction Electrodes are packaged in the same packaging used by Leonhard Lang GmbH in many previously approved products with demonstrated 24 month shelf-life. In addition, the Skintact Multifunction Electrodes were tested in accelerated aging. confirming the shelf-life of 24 months for DH02 gel and materials. Skintact Multifunction Electrodes used for adult defibrillation (and children over 8 years) and pacing have a minimum active (gel) area of 82 cm² and the total area of the two electrodes is at least 164 cm2, thus meeting the standard requirements. Other comparisons demonstrated that the Skintact Multifunction Electrodes do not introduce new risks and are substantially equivalent to the legally marketed predicate device.
1
Image /page/1/Picture/11 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2004
Paladin Medical, Inc. c/o Elaine Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, MN 55082-0560
Re: K041883
Trade name: Skintact® Multifunction Electrodes Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: July 09, 2004 Received: July 12, 2004
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 -- Elaine Duncan, M.S.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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil RP Ogden
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® Multifunction Electrodes
Indications For Use:
The Skintact® Multifunction Electrodes are for use on adults and children over eight years old for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single-use only.
Prescription Use __ V__ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
1
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Neil R.P.Ogden | |
|---|---|
| -- | ---------------- |
| for B02 | |
|---|---|
| -- | --------- |
| vision Sign-Off) | |
|---|---|
| ision of Cardiovascular Devices |
| (k) Number | K041883 |
|---|---|
| ------------ | --------- |
Page 1 of