(57 days)
Not Found
No
The summary describes a passive electrical component (grounding pad) and makes no mention of AI, ML, image processing, or data-driven algorithms.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a grounding pad used during electrosurgical procedures to complete an electrical circuit, not to directly treat a medical condition.
No
Explanation: The device is described as a "Single Use Grounding Pad" used to complete an electrosurgical circuit during procedures, providing a path for RF current. Its function is to facilitate a surgical procedure by safely dispersing electrical current, not to diagnose a condition or disease.
No
The device description explicitly states it is a "non-sterile dispersive electrode with a pre-attached cord," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a path for RF current during electrosurgical procedures on the patient. This is a direct interaction with the patient's body for a surgical purpose.
- Device Description: The description reinforces its role in completing an electrosurgical circuit on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This grounding pad does not perform such a function.
N/A
Intended Use / Indications for Use
This device is applied to the patient during electrosurgical procedures to provide a path for the RF current to leave the patient during electrosurgical
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.
Product codes
GEI, JOS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Limited |
| Add: FLAT 1801A ,18/F., ON HONG COMMERCIAL BLDG, 145 | |
| HENNESSY ROAD, WANCHAI, HONGKONG | |
| Primary Contact Person: | Mike Gu |
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd. | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Email: mike.gu@osmundacn.com | |
| Secondary Contact Person: | Mrs. Elizabeth Ma |
| Vice President | |
| LCCS Products Limited | |
| Tel: +852-81368758 | |
| Fax: + 852-35430978 | |
| Email: 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 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. | |
| Intended Use: | This device is applied to the patient during electrosurgical |
| procedures to provide a path for the RF current to leave the | |
| patient 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
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.
3
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)