(57 days)
The Single Use Grounding Pad is applied to the patient during electrosurgical procedures to provide a path for the RF current to leave the patient and return to the generator.
The single use grounding pad is a non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode and the patient. The grounding pad is to be used on any patient where full skin contact and a suitable placement site can be obtained. Use of this device for unintended application could lead to an unsafe condition.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LCCS Products Limited Single Use Grounding Pad (K132136):
Device: Single Use Grounding Pad
Premarket Notification Number: K132136
1. Table of Acceptance Criteria and Reported Device Performance
The provided document indicates that the device met the requirements of IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. However, it does not explicitly list specific acceptance criteria values or show them in a table format alongside the reported device performance results. It only states that the device "meets applicable sections of the standards referenced."
Therefore, based only on the provided text, a table with specific criteria and performance values cannot be fully constructed. The acceptance criteria are implicitly defined by the referenced standard, and the reported performance is a general statement of compliance.
| Acceptance Criteria (Defined by Standard) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-2 Edition 5.0 2009-02: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (specific sections not enumerated in the summary) | "Results of performance testing indicate that the grounding pad meets applicable sections of the standards referenced and are safe and effective for their intended use." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for performance testing (e.g., number of grounding pads tested).
The data provenance is not explicitly stated. Given that the submitter is LCCS Products Limited in Hong Kong, and the primary contact is in China, it's likely the testing was conducted in Asia, but this is an inference, not a stated fact. The document does not indicate whether the testing was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The testing described appears to be technical performance testing against a recognized electrical safety standard (IEC 60601-2-2), which typically relies on instrumentation and engineering measurements rather than expert human interpretation to establish 'ground truth'.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Technical performance testing against an electrical safety standard typically does not involve an adjudication method in the way medical device clinical studies might. Results are generally objective measurements.
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 information is not provided and is not applicable. The device is a "Single Use Grounding Pad," which is a passive medical accessory for electrosurgery. It is not an AI-powered diagnostic or therapeutic device, nor does it involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not provided and is not applicable. The device is a physical grounding pad, not an algorithm.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" was established by the requirements and methodologies outlined in the IEC 60601-2-2 standard. This standard specifies objective performance and safety criteria for high-frequency surgical equipment and accessories. The testing would have involved engineering measurements to verify compliance with these objective criteria.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a physical medical accessory, not a software or AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 8.
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Traditional 510(k) Premarket Notification_Single Use Grounding Pad
Page 1 of (2)
510(k) Summary
In accordance with the requirements of SMDA 1990 and 21 CFR 807.92 the following summary of information is provided:
| Date: | 30 June 2013 |
|---|---|
| Submitter: | LCCS Products LimitedAdd: FLAT 1801A ,18/F., ON HONG COMMERCIAL BLDG, 145HENNESSY ROAD, WANCHAI, HONGKONG |
| Primary Contact Person: | Mike GuRegulatory Affairs ManagerOSMUNDA Medical Device Consulting Co., Ltd.Tel: (+86) 20-6232 1333Fax: (+86) 20-8633 0253Email: mike.gu@osmundacn.com |
| Secondary Contact Person: | Mrs. Elizabeth MaVice PresidentLCCS Products LimitedTel: +852-81368758Fax: + 852-35430978Email: lccsmed@126.com |
| Device: Trade Name: | Single Use Grounding Pad |
| Common/Usual Name: | Grounding Pad |
| Classification Names: | Electrode, Electrosurgical |
| Product Code: | GEI, JOS |
| Predicate Device(s): | K120476, K052878 |
| Device Description: | The single use grounding pad is a non-sterile dispersive electrodewith a pre-attached cord. The purpose of the return electrode isto complete the electrosurgical circuit between the generator,the active electrode and the patient. The grounding pad is to beused on any patient where full skin contact and a suitableplacement site can be obtained. Use of this device forunintended application could lead to an unsafe condition. |
| Intended Use: | This device is applied to the patient during electrosurgicalprocedures to provide a path for the RF current to leave thepatient during electrosurgical |
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Technology:
Determination of Substantial Equivalence: The technological characteristics of the proposed device are identical to the predicate device. Both devices are intended for single use.
Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalence to the predicate device:
IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories;
Results of performance testing indicate that the grounding pad meets applicable sections of the standards referenced and are safe and effective for their intended use.
The comparison between the predicate devices and the Conclusion: proposed devices demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices. Grounding Pad can be claimed to be Substantially Equivalent (SE) to the predicate device, K120476 and K052878.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2013
LCCS Products Limited % Mrs. Elizabeth Ma. Vice President FLAT 1801A, 18/F., ON HONG COMMERCIAL BUILDING 145 HENNESY ROAD, WANCHAI, HONGKONG
Re: K132136
Trade/Device Name: Single Use Grounding Pad Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, JOS Dated: July 9, 2013 Received: July 11, 2013
Dear Mrs. Ma:
We have reviewed your Section 510(k) promarket 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. 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 (sec 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mrs. Elizabeth Ma
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.him for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -A
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510{k) Premarket Notification_Single Use Grounding Pad
510(k) Number (if known): K132136
Device Name: Single Use Grounding Pad
Indications for Use:
The Single Use Grounding Pad is applied to the patient during electrosurgical procedures to provide a path for the RF current to leave the patient and return to the generator.
Prescription Use_X__ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nip er -S
§ 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.