(70 days)
Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.
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.
The provided text describes the 510(k) premarket notification for the Skintact® Cool Contact Electrosurgical Grounding Plates. This documentation primarily focuses on establishing substantial equivalence to existing predicate devices and demonstrating compliance with safety and performance standards for electrosurgical grounding plates. It does not describe a device that uses AI, nor does it involve a test set with expert adjudication for AI performance evaluation. Therefore, many of the requested fields are not applicable to the information contained within this document.
Here's an analysis based on the provided text, addressing the applicable criteria for this type of medical device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by ANSI/AAMI HF 18:2001) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | No adverse results reported |
| Skin Irritation | No adverse results reported |
| Sensitization | No adverse results reported |
| Performance & Safety (according to ANSI/AAMI HF 18:2001): | |
| Maximum safe temperature rise | Conforms to standard |
| Electrode contact impedance | Conforms to standard |
| Electrode adherence (Pull test) | Conforms to standard |
| Conformability test | Conforms to standard |
| Fluid tolerance test | Conforms to standard |
| Shelf-life: | |
| 24 months | Met requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state specific sample sizes for the individual tests (biocompatibility, temperature rise, impedance, etc.). It generally refers to "the following testing." The testing was conducted by TÜV Product Service GmbH in Munich, Germany, indicating the country of origin for the data is Germany. The nature of these engineering and materials tests (e.g., maximum safe temperature rise, pull test) is typically prospective as they are performed in a controlled laboratory setting to evaluate the device's characteristics against predefined standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. This is a submission for an electrosurgical grounding plate, not an AI-powered device that requires expert-established ground truth for a test set. The "ground truth" here is defined by established engineering standards and validated laboratory test methodologies referenced in ANSI/AAMI HF 18:2001.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. This type of device does not involve human adjudication of a test set in the way AI performance is evaluated. Compliance is determined by objective measurements against a standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This device is an electrosurgical grounding plate, not an AI diagnostic or assistive tool. No human readers or AI assistance are involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device does not have an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcome data, etc.)
The "ground truth" for the performance and safety tests is defined by recognized international standards and validated test methodologies, specifically ANSI/AAMI HF 18:2001 "Electrosurgical devices." For biocompatibility, it's based on established biological evaluation standards.
8. The sample size for the training set
This is not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established
This is not applicable. This device does not use machine learning or require a training set.
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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
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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.
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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
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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
§ 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.