(70 days)
Not Found
No
The summary describes a passive electrosurgical grounding plate and does not mention any AI or ML components or functionalities.
No.
The device is an electrosurgical grounding plate, which is a component used with electrosurgical generators for cutting and coagulation of tissue, rather than a device that directly provides therapy. It facilitates the function of a therapeutic device (electrosurgical generator) but is not therapeutic itself.
No
Explanation: The device, Skintact® Cool Contact Electrosurgical Grounding Plates, is described as an electrosurgical accessory used for cutting and coagulation of human tissue with electrosurgical generators. Its function is to provide a return path for electrosurgical current and not to diagnose any condition or disease.
No
The device description explicitly states it is a "self-adhesive, non-sterile, single use disposable electrode," which is a physical hardware component, 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 therapeutic/surgical application, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a self-adhesive electrode used on the patient's skin during surgery. This is a device applied in vivo (on the body).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
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 safely complete the electrical circuit during electrosurgery, which is a treatment procedure.
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 (and as also to be offered for sale under various private label tradenames) are self-adhesive, non-sterile, 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
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 confirms the materials are biocompatible and do not introduce any 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. All performance and safety tests are according to ANSI/AAMI HF 18:2001 and were conducted by TÜV Product Service GmbH, Zertifizierstelle, Ridlerstraße 65, 80339 München, Germany. A certification to conformance ANSVA AMI HF 18:2001 with this standard has been provided. The testing conducted was: Maximum safe temperature rise; Electrode contact impedance; Electrode adherence: Pull test, Conformability test, Fluid tolerance test. All Skintact® Grounding Plates are packaged in water-vapor-proofed, heat-sealed, 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 compared to the predicate device.
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
APR 1 4 2003
K030362
510(k) Summary
SUBMITTED ON BEHALF OF:
Company Name: Address:
Leonhard Lang GmbH Archenweg 56 6010 Innsbruck Austria
++ 43 / 512 / 33 4 25 7
++ 43 / 512 / 39 22 10
Telephone: Fax:
by:
Elaine Duncan, MS.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380
Telephone: Fax:
CONTACT PERSON: DATE PREPARED:
Trade Name: Common Name: Classification Name: Elaine Duncan January 30, 2003
Skintact® Cool Contact Electrosurgical Grounding Plates Electrosurgical Grounding Plates Electrosurgical Grounding Plates
SUBSTANTIALLY EQUIVALENT TO: Skintact® Cool Contact Electrosurgical Grounding Plates are equivalent to the materials of construction and gel used in the ERBE Disposable Patient Return Electrode cleared via 510(k) [K972269] and produced by Leonhard Lang, GmbH. However the Skintact® Electrosurgical Grounding Plates have a different geometry and area. This area and geometry is equivalent to that found with Nikopad Electrosurgical grounding plates, previously cleared by FDA (K993306.) Based upon these similar features and conformance with the recognized standard ANSUAAMI HF 18:2001, the Leonhard Lang Skintact® Electrosurgical Grounding Plates are substantially equivalent.
DESCRIPTION of the DEVICE: Skintact® Cool Contact Electrosurgical Grounding Plates (and as also to be offered for sale under various private label tradenames) are self-adhesive, non-sterile, 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 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. All performance and safety tests are according to ANSI/AAMI HF 18:2001 and were conducted by TÜV Product Service GmbH, Zertifizierstelle, Ridlerstraße 65, 80339 München, Germany. A certification to conformance ANSVA AMI HF 18:2001 with this standard has been provided. The testing conducted was: Maximum safe temperature rise; Electrode contact impedance; Electrode adherence: Pull test, Conformability test, Fluid tolerance test. All Skintact® Grounding Plates are packaged in water-vapor-proofed, heat-sealed, 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 compared to the predicate device.
Abbreviated 510(k): Skintact® Cool Contact Electrosurgical Grounding Plates
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2003
Leonhard Lang GmbH c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082
Re: K030362
Trade/Device Name: Skintact® Cool Contact Electrosurgical Grounding Plates Regulation Number: 21 CFR 878.4400 Regulation Names: Electrosurgical cutting and coagulation device and accessoreis Regulatory Class: II Product Codes: GEI Dated: January 30, 2003 Received: February 3, 2003
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 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.
2
Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC
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) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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.
Sincerely, yours,
Mark N. Mulberan
Celia M. Witten, Ph.D., M.D. 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)
Skintact® Cool Contact Electrosurgical Grounding Plates Device Name:
Indications for Use:
Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.
(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over -The-Counter Use _
(Optional Format 1-2-96)
for Mark A. Millner
(Division Sign-Off) Division & General, Restorative and Neurological Devices
510(k) Number K03036