(35 days)
Not Found
No
The document describes a passive electrosurgical grounding plate and does not mention any AI or ML components or functionalities.
No.
The device is an accessory used with electrosurgical generators for cutting and coagulation, not a device that directly provides therapy itself.
No
The device, an electrosurgical grounding plate, is used during electrosurgical procedures for cutting and coagulation of human tissue. Its function is to complete the electrical circuit and safely return current to the generator, not to diagnose a condition or disease.
No
The device description clearly states it is a physical, self-adhesive, nonsterile, single-use disposable electrode (grounding plate) with gel, available in various shapes and sizes, with or without lead wires. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of human tissue" using electrosurgical generators. This is a direct interaction with the patient's body during a surgical procedure.
- Device Description: The device is a "self-adhesive, nonsterile, single use disposable electrode." This is a physical component used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the Skintact® Cool Contact Electrosurgical Grounding Plates are considered a surgical accessory used in conjunction with an electrosurgical generator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel (and as also to be offered for sale under various private label tradenames) are self-adhesive, nonsterile, single use disposable electrodes, available in a comprehensive range of shapes and sizes (adult and pediatric), standard and split, with or without lead wires.
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
adult and pediatric
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing confirms the materials are biocompatible and do not introduce any new risks. The following testing showed no adverse results: Cytotoxicity; Skin Irritation; Sensitization. The ANSI/AAMI HF 18:2001 "Electrosurgical devices" was used to define the requirements for Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel. All performance and safety tests are according to ANSI/AAMI HF 18:2001 and were conducted by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria, and Dr. Michael Verius and Dr. Ralf Huttary, Univ. Klinik für Radiodiagnostik, Anichstraße 35, 6020 Innsbruck, Austria. The testing conducted was: Maximum safe temperature rise; Electrode contact impedance; Electrode adherence: Pull test, Conformability test, Fluid tolerance test.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
NOV 2 1 2006
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be "K063161". The characters are written in black ink on a white background. The handwriting is somewhat messy, but the characters are still legible.
510(k) Summary
| SUBMITTED ON BEHALF OF: | 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: | Elaine Duncan | |
| DATE PREPARED: | October 13, 2006 | |
| Trade Name: | Skintact® Cool Contact Electrosurgical Grounding Plates | |
| with NH 04 gel | ||
| Common Name: | Electrosurgical Grounding Plates | |
| Classification Name: | Electrosurgical Grounding Plates |
SUBSTANTIALLY EQUIVALENT TO: Skintact® Cool Contact Electrosurgical Grounding Plates will now be offered with new gel NH 04, in otherwise the grounding plates are equivalent to the materials of construction used in the Skintact Cool Contact Electrosurgical Grounding Plates (the manufacturer's predicate device) cleared via 510(k) [K030362]. The Skintact® Cool Contact Electrosurgical Grounding Plates with new NH 04 gel include also a range of electrodes with different geometry and area is also equivalent to the Skintact Cool Contact Electrosurgical Grounding Plates (the manufacturer's predicate device) cleared via 510(k) [K030362]. Based upon these similar features and conformance with the recognized standard ANSI/AAMI HF 18:2001, the Leonhard Lang Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel are substantially equivalent.
DESCRIPTION of the DEVICE: Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel (and as also to be offered for sale under various private label tradenames) are self-adhesive, nonsterile, single use disposable electrodes, available in a comprehensive range of shapes and sizes (adult and pediatric), standard and split, with or without lead wires.
INDICATIONS FOR USE: Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.
SUMMARY of TESTING: Biocompatibility testing confirms the materials are biocompatible and do not introduce any new risks. The following testing showed no adverse results: Cytotoxicity; Skin Irritation; Sensitization. The ANSI/AAMI HF 18:2001 "Electrosurgical devices" was used to define the requirements for Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel. All performance and safety tests are according to ANSI/AAMI HF 18:2001 and were conducted by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria, and Dr. Michael Verius and Dr. Ralf Huttary, Univ. Klinik für Radiodiagnostik, Anichstraße 35, 6020 Innsbruck, Austria. The testing conducted was: Maximum safe temperature rise; Electrode contact impedance; Electrode adherence: Pull test, Conformability test, Fluid tolerance test. All Skintact Cool Contact Grounding Plates are packaged in water-vapor-profeed, heatsealed, non-transparent, aluminized pouches. Leonhard Lang has 20 years of experience with this packaging and has met requirements for 24 months shelf-life. No differences were required for packaging the Skintact Cool Contact Electrosurgical Grounding Plates with NH 04 gel compared to the predicate device.
1
Image /page/1/Picture/12 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Leonhard Lang, GmbH % Paladin Medical, Inc. Elaine Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, Minnesota 55082-0560
NOV 2 1 2006
Re: K063161
Trade/Device Name: Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 7, 2006 Received: November 8, 2006
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.
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
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Page 2 – Elaine Duncan, M.S.M.E., RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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) 276-0115. 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,
Rum
D. 1924
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known)
Device Name: Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel
Indications for Use:
Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.
Prescription Use
OR
Over -The-Counter Use
(Optional Format 1-2
(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number