(192 days)
Medline's Universal Grounding Pads are designed for surgical applications where monopolar electrosurgery is utilized in order to provide a safe return path for the electrosurgical current. Solid Grounding Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Grounding Pads are for use with electrosurgical units (ESU) that have a CQMS (i.e. REM, ARM, NESSY etc.). Medline's Universal Grounding Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this universal style grounding pad. Use of this product for unintended applications could lead to an unsafe condition.
Not Found
The provided document is an FDA 510(k) clearance letter for the Medline Universal Grounding Pad. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device.
However, this document DOES NOT contain information about acceptance criteria, device performance testing, study methodologies (like sample sizes, expert ground truth, adjudication methods, MRMC studies), or detailed performance metrics like sensitivity, specificity, or AUC.
The letter is a regulatory document stating that the device is cleared for market based on its similarity to existing devices and compliance with general controls. It does not include the detailed technical study data that would typically be associated with an AI/ML device or a device requiring extensive performance validation against acceptance criteria through a study.
Therefore, I cannot fulfill your request for the specific points listed below based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
- 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 is not an AI/ML device, nor is a MRMC study mentioned).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is not an AI/ML device).
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/provided.
- The sample size for the training set: Not applicable (this is not an AI/ML device that requires a training set).
- How the ground truth for the training set was established: Not applicable.
This document is for a medical device (a grounding pad for electrosurgery) that gains 510(k) clearance through demonstrating substantial equivalence to a predicate, not through a performance study that would typically be described with the criteria you've outlined. The clearance process for such a device focuses on electrical safety, biocompatibility, and functional equivalence, rather than a clinical performance study with human readers or AI algorithms.
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January 14, 2022
Medline Industries, Inc Matt Clausen Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K212093
Trade/Device Name: Medline Universal Grounding Pad Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 17, 2021 Received: December 17, 2021
Dear Matt Clausen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212093
Device Name Medline Universal Grounding Pad
Indications for Use (Describe)
Medline's Universal Grounding Pads are designed for surgical applications where monopolar electrosurgery is utilized in order to provide a safe return path for the electrosurgical current. Solid Grounding Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Grounding Pads are for use with electrosurgical units (ESU) that have a CQMS (i.e. REM, ARM, NESSY etc.). Medline's Universal Grounding Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this universal style grounding pad. Use of this product for unintended applications could lead to an unsafe condition.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 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.