(30 days)
The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.
This document describes a 510(k) submission for the Nikomed Electrosurgical Grounding Pad. However, the provided text does not contain detailed acceptance criteria or a study design with specific performance metrics (like sensitivity, specificity, AUC, etc.) that are typically associated with AI/ML device evaluations.
The submission is for a medical device that appears to be a passive electrosurgical grounding pad, not an AI/ML-driven diagnostic or therapeutic device. The "SUMMARY of TESTING" section only mentions biocompatibility testing.
Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this particular document.
Here's an attempt to answer the questions based on the provided text, highlighting where information is missing or not applicable:
Description of Acceptance Criteria and Study for Nikomed Electrosurgical Grounding Pad
This 510(k) submission is for a traditional medical device (an electrosurgical grounding pad), not an AI/ML diagnostic or therapeutic device. Consequently, the "acceptance criteria" and "study" described herein are primarily focused on safety, fundamental device function, and substantial equivalence to a predicate device, rather than performance metrics typically associated with AI/ML.
1. A table of acceptance criteria and the reported device performance
Given the nature of the device (an electrosurgical grounding pad), the "acceptance criteria" appear to be related to safety and material compatibility rather than diagnostic performance.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility (e.g., irritation, sensitization, cytotoxicity based on ISO 10993-1 for acute <24 hr intact skin contact) | "The materials passed all screens." | This confirms the device materials are safe for their intended contact with skin. |
| Electrical Conductivity (implied for effective grounding) | Not explicitly stated in the summary, but implied by the device's function as an electrosurgical grounding pad and substantial equivalence to K853291. | |
| Adhesive Strength (implied for secure attachment) | Not explicitly stated in the summary, but implied by the device's function and substantial equivalence. | |
| Mechanical Integrity (e.g., cable durability, pad flexibility) | Not explicitly stated in the summary, but implied by the device's function and substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document states: "Biocompatibility testing consistent with the ISO 10993-1, recommended material evaluations for acute (less than 24-hour) intact skin contacting devices. The materials passed all screens."
- Sample Size: Not explicitly stated. For biocompatibility testing, this would typically refer to the number of samples of the device materials tested using various in-vitro and/or in-vivo models (e.g., cell cultures, animal models for irritation/sensitization). The specific numbers are not provided in this summary.
- Data Provenance: Not specified, but generally, biocompatibility testing is conducted in accordance with international standards (ISO 10993-1) by specialized laboratories. The original source animals or human participants (if any patch testing were performed) are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For biocompatibility testing, ground truth is established by standardized laboratory methods and readings, not expert consensus on medical images or patient diagnoses. The results are interpreted by toxicologists or material scientists, but it's not "experts establishing ground truth" in the diagnostic sense.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies (e.g., reading medical images). This submission is for biocompatibility testing, where results are typically objective and determined by laboratory protocols.
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
Not applicable. This device is a passive electrosurgical grounding pad, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used
The ground truth for the reported testing is based on standardized laboratory test results for biocompatibility, as defined by ISO 10993-1. For example, cytotoxicity tests measure cell viability, irritation tests evaluate inflammatory responses, and sensitization tests assess allergic reactions against established benchmarks and controls.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set exists for this type of device.
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510(k) Summary
SUBMITTED ON BEHALF OF:
| Company Name: | Nikomed U.S.A., Inc. |
|---|---|
| Address: | 206 Airport Blvd.Doylestown, PA 18901 |
| Telephone: | 215-230-8455 |
| Fax: | 215-230-8446 |
by:
Elaine Duncan, M.S.M.E., RAC President, Paladin Medical®, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380
CONTACT PERSON:
Telephone: Fax:
Elaine Duncan
DATE PREPARED:
October 1, 1999
Nikopad* Electrosurgical Grounding Pad (*or sold under TRADE NAME: various commercial names) COMMON NAME: Electrosurgical Grounding Pad
SUBSTANTIALLY EQUIVALENT TO:
K853291: GP-100 Adult Electrosurgical Ground Pad
DESCRIPTION of the DEVICE:
The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.
INDICATIONS FOR USE:
The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
SUMMARY of TESTING:
Biocompatibility testing consistent with the ISO 10993-1, recommended material evaluations for acute (less than 24-hour) intact skin contacting devices. The materials passed all screens.
Nikomed U.S.A., Inc.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov - 3 1999
Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082-0560
Re: K993306 Trade Name: Nikomed Electrosurgical Grounding Pad Regulatory Class: II Product Code: HAM, GEI Dated: October 1, 1999 Received: October 4, 1999
Dear Ms. Duncan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K993306 510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
Device Name: Nikomed Electrosurgical Grounding Pad
Indications for Use:
The Nikomed USA electrosurgical grounding pad (sold under various commercial names I he Ankomed CBA electronical is indicated for use with electrosurgical generators for cutting and coagulation.
(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) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K993306 |
|---|---|
| --------------- | --------- |
(
§ 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.