(35 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 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.
The provided text is a 510(k) summary for a medical device. It describes the device, its intended use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain a detailed study with acceptance criteria and reported device performance in the way a clinical or diagnostic AI study would.
Instead, the "study" referred to here is a series of engineering and biocompatibility tests conducted to demonstrate that the device, which is an electrosurgical grounding plate with a new gel formulation, meets the safety and performance requirements of a recognized standard (ANSI/AAMI HF 18:2001) and is substantially equivalent to a previously cleared predicate device.
Therefore, I will extract information based on this context.
Here's an interpretation based on the provided text, recognizing its nature as a 510(k) summary rather than a standalone AI or clinical study:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter / Acceptance Criteria (from ANSI/AAMI HF 18:2001) | Reported Device Performance |
|---|---|
| Cytotoxicity (Biocompatibility) | No adverse results |
| Skin Irritation (Biocompatibility) | No adverse results |
| Sensitization (Biocompatibility) | No adverse results |
| Maximum safe temperature rise | According to ANSI/AAMI HF 18:2001 (implied met) |
| Electrode contact impedance | According to ANSI/AAMI HF 18:2001 (implied met) |
| Electrode adherence: Pull test | According to ANSI/AAMI HF 18:2001 (implied met) |
| Electrode adherence: Conformability test | According to ANSI/AAMI HF 18:2001 (implied met) |
| Electrode adherence: Fluid tolerance test | According to ANSI/AAMI HF 18:2001 (implied met) |
Notes on Acceptance Criteria: The document states that "All performance and safety tests are according to ANSI/AAMI HF 18:2001." This implies that the acceptance criteria for each test are those set forth in that recognized standard. The summary does not provide specific numerical thresholds from the standard, but affirms that the device met them.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The testing involved "Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel" across a "range of electrodes with different geometry and area." The specific number of units tested per parameter is not provided.
- Data Provenance: The tests were conducted by Leonhard Lang GmbH, Austria, and Univ. Klinik für Radiodiagnostik, Innsbruck, Austria. This indicates the data is prospective, generated specifically for this submission. The country of origin is Austria.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Two experts are mentioned: Dr. Michael Verius and Dr. Ralf Huttary.
- Qualifications: Both are from the Univ. Klinik für Radiodiagnostik, Anichstraße 35, 6020 Innsbruck, Austria. Their specific specialties or years of experience are not listed, but their affiliation with a university radiology clinic suggests medical and perhaps technical expertise relevant to device performance evaluation. They acted as a testing facility rather than establishing a ground truth in a diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. This was not a study involving human interpretation of diagnostic data requiring adjudication of ground truth. The "adjudication" was effectively the testing against a standard and the determination of "no adverse results" or "according to standard."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this was not an MRMC study. It was a technical performance and biocompatibility study comparing the new device characteristics to those required by a recognized standard and demonstrating equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the performance tests outlined (Maximum safe temperature rise, Electrode contact impedance, etc.) represent a "standalone" evaluation of the device's physical and electrical properties without human intervention during the measurement process. However, this is not an "algorithm-only" performance in the context of AI.
7. Type of Ground Truth Used
The ground truth was based on:
- Recognized Standard: ANSI/AAMI HF 18:2001, which defines the safety and performance requirements for electrosurgical devices.
- Biocompatibility Standards: Implicitly, the biocompatibility tests (Cytotoxicity, Skin Irritation, Sensitization) follow established standards for evaluating material safety for medical devices.
- Predicate Device: The performance and materials were assessed for equivalence to the predicate device (K030362).
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning study.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set mentioned.
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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 566020 InnsbruckAustria | |
| Telephone: | ++ 43 / 512 / 33 4 25 7 | |
| Fax: | ++ 43 / 512 / 39 22 10 | |
| by: | Elaine Duncan, MS.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, 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 Plateswith 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.
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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
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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
§ 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.