(56 days)
Not Found
No
The device description and intended use are for passive electrodes used for defibrillation, pacing, monitoring, and cardioversion. There is no mention of any computational or analytical capabilities that would involve AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for external defibrillation, pacing, monitoring, and cardioversion, which are therapeutic interventions for cardiac conditions.
No
The device is described as electrodes for external defibrillation, pacing, monitoring, and cardioversion, which are therapeutic and monitoring functions, not primarily diagnostic. While "monitoring" can involve collecting data, in this context, it's for physiological parameters during treatment piuttosto than for diagnosing a condition.
No
The device description explicitly details physical components like foam backing, metallic substrate, and conductive adhesive gel, indicating it is a hardware device.
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 device is for "external defibrillation, pacing, monitoring and cardioversion." These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description details the physical components of the electrodes and their packaging. There is no mention of reagents, test strips, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other bodily fluids to diagnose, monitor, or screen for diseases or conditions.
Therefore, the Skintact® Multifunction Electrodes are a medical device used for direct patient treatment and monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators 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 (comma separated list FDA assigned to the subject device)
MKJ
Device Description
Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators (and as also to be offered for sale under various private label tradenames) consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH02 [all materials cleared in existing 510(k) K041883]. Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are packaged in pairs in water-vapor-proof, heatsealed, non-transparent, aluminized pouches, non-sterile and single-use.
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 eight 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)
Bench testing demonstrated that the performance of the Skintact® Multifunction Electrodes with DH02 Gel available with different compatible with different defibrillators meets is specifications.
Skintact Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators met the same requirements as those of the predicate. Performance and safety tests were conducted according to ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003 and were conducted by SGS.
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.
Not Found
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
§ 870.5310 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
KO72233
510(k) Summary
| SUBMITTED ON BEHALF OF:
| OCT 5 2007 | Company Name: | Leonhard Lang GmbH |
|---|---|---|
| Address: | Archenweg 56 | |
| 6020 Innsbruck | ||
| Austria | ||
| Telephone: | ++ 43 / 512 / 33 4 25 7 | |
| Fax: | ++ 43 / 512 / 39 22 10 | |
| 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: | ||
| DATE PREPARED: | Elaine Duncan | |
| August 8, 2007 | ||
| Trade Name: | Skintact® Multifunction Electrodes | |
| with DH02 gel available with different connectors compatible with | ||
| different defibrillators | ||
| Common Name: | ||
| Classification Name: | Defibrillation Electrodes | |
| DC-defibrillator, low-energy, (including paddles) |
Substantially equivalent to Predicate Device
Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are equivalent to Skintact® Multifunction electrodes with DH02 Gel (cleared in existing 510(k) K041883) There are no changes to the materials used in the construction. Test results are provided which show that this change does not introduce any new issues of safety and performance.
Device description
Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators (and as also to be offered for sale under various private label tradenames) consist of a foam backing, a laminated metallic substrate and conductive adhesive gel DH02 [all materials cleared in existing 510(k) K041883]. Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are packaged in pairs in water-vapor-proof, heatsealed, non-transparent, aluminized pouches, non-sterile and single-use.
Indications for use
Skintact Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators 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.
Comparison of Characteristics
There are no technological or material differences between the The Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators and the predicate device.
Data Used in Determination of Substantial Equivalence
Special 510(k): Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators
1
510(k) Summary-Continued
Bench testing demonstrated that the performance of the Skintact® Multifunction Electrodes with DH02 Gel available with different compatible with different defibrillators meets is specifications.
Summary of Testing
Performance Testing:
Skintact Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators met the same requirements as those of the predicate. Performance and safety tests were conducted according to ANSI/AAMI DF80:2003 and IEC/EN 60601-2-4:2003 and were conducted by SGS (All test reports are available for access at: Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria).
All Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators are packaged in pairs in water-vapor-proofed, heat-sealed, non-transparent. aluminized pouches. Leonhard Lang has met requirements for 30 months shelf-life.
Biocompatibility testing:
All materials were cleared in 510(k) K041883: Results of updated testing for skin irritation and sensitization testing are included. (Cytoxicity tests were not repeated since previous submission. )
Conclusion
Skintact® Multifunction Electrodes with DH02 gel available with different connectors compatible with different defibrillators does not introduce new issues of safety or effectiveness.
2
Image /page/2/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 symbol resembling an abstract caduceus or a series of overlapping human profiles, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 2007
Paladin Medical, Inc. c/o Ms. Elain Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, MN 55082
Re: K072233
Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: September 6, 2007 Received: September 10, 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 (sec 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.
3
Page 2 - Ms. Elain 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 (OS) 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 vours.
Briminista for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known)
Device Name: Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators
Indications for Use:
Skintact® Multifunction Electrodes with DH02 Gel available with different connectors compatible with different defibrillators 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.
ಸ Prescription Use
OR
Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________
(Please Do Not Write Below This Line-Continue On Another Page If Necded) Concurrence of CDRH, Office of Device Evaluation (ODE)
Blymmlepon
13