(192 days)
Not Found
No
The device description and performance studies focus on the physical properties and electrical safety of a disposable grounding pad, with no mention of AI or ML technologies.
No
This device is a grounding pad used to conduct energy in electrosurgery, which is a surgical procedure, not a therapeutic treatment itself.
No
The device description states its purpose is to conduct electrosurgical energy from the patient back to an electrosurgical unit, which is a functional role within a surgical procedure, not for diagnosis.
No
The device description clearly outlines a physical product made of aluminum foil, foam, and hydro-gel, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing is done outside of the living body ("in vitro").
- Device Function: The description clearly states the device's intended use is to "conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator." This is a function performed on the patient's body during a surgical procedure, not on a specimen taken from the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is an accessory used in an electrosurgical procedure performed directly on a patient.
N/A
Intended Use / Indications for Use
Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
Product codes
ODR
Device Description
Electrosurgical disposable grounding pads construct of a layer of conductive aluminum foil with a foam as the supportive base of the pad. The aluminum foil is coated with adhesive hydro-gel layer. There is another film placed above the adhesive hydro-gel layer, which is used to protect the gel during the transportation and storage and will be removed prior to use. They are available in different combinations of configurations, types, intended populations and conductive area. They are not provided in sterile conditions and not required to be sterilized by the end user prior to operation. However, they are for single use only.
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1: 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
- IEC 60601-2-2: 2009 Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical access;
- IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
No clinical study is included in this submission.
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.
0
Image /page/0/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 a stylized image of three human profiles facing right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2016
TOP-RANK Health Care Co., Ltd % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China
Re: K160366
Trade/Device Name: Electrosurgical Disposable Grounding Pads Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: ODR Dated: August 10, 2016 Received: August 15, 2016
Dear Ms. Hong:
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. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education 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,
Christopher J. Ronk -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160366
Device Name
Electrosurgical disposable grounding pads
Indications for Use (Describe)
Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
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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Tab #7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K160366
-
- Date of Preparation: 01/30/2016
-
- Sponsor Identification
TOP-RANK Health Care Co. Ltd.
Checun Village, Dongguan Street, Shangyu District Shaoxing, Zhejiang, 312352, China
Establishment Registration Number: 3006626283
Contact Person: Ms. Liubo Shen Position: Management Representative Tel: +86-575-82912999 Fax: +86-575-82670000 Email: liubo.shen@etop-rank.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
-
- Identification of Proposed Device
Trade Name: Electrosurgical disposable grounding pads Common Name: Electrosurgical Patient Return Electrode
- Identification of Proposed Device
Regulatory Information Classification Name: Electrosurgical Patient Return Electrode Classification: II
4
Product Code: ODR Regulation Number: 21 CFR part 878.4400 Review Panel: General & Plastic Surgery
Intended Use Statement:
Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
Device Description
Electrosurgical disposable grounding pads construct of a layer of conductive aluminum foil with a foam as the supportive base of the pad. The aluminum foil is coated with adhesive hydro-gel layer. There is another film placed above the adhesive hydro-gel layer, which is used to protect the gel during the transportation and storage and will be removed prior to use.
They are available in different combinations of configurations, types, intended populations and conductive area.
They are not provided in sterile conditions and not required to be sterilized by the end user prior to operation. However, they are for single use only.
-
ર. Identification of Predicate Device(s)
K091672 SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. Disposable Grounding Pad Series -
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
V IEC 60601-1: 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
-
IEC 60601-2-2: 2009 Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical access;
-
イ IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
-
イ ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
5
- く ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Code | ODR | ODR |
| Regulation #. | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Intended Use | Electrosurgical disposable grounding | |
| pads are to conduct electrosurgical | ||
| energy from target tissue of a patient | ||
| back to an electrosurgical unit (ESU), | ||
| or generator. | The Disposable Grounding Pad | |
| series devices are to conduct | ||
| electrosurgical energy from target | ||
| tissue of a patient back to an | ||
| electrosurgical unit (ESU), or | ||
| generator. | ||
| Configuration | Single and Split aluminum film | |
| Adult and pediatric | ||
| Single Use | Single and Split aluminum film | |
| Adult and pediatric | ||
| Single Use | ||
| Biocompatibility | Adhesive hydro-gel | |
| Aluminum foil | ||
| POLYESTER (PET) | ||
| Foam (Polyster Fibre) | ||
| Tested with ISO 10993 Series | ||
| Standards | Adhesive hydro-gel | |
| Aluminum foil | ||
| PET | ||
| Foam | ||
| Tested with ISO 10993 Series | ||
| Standards | ||
| Electrical Safety | IEC 60601-1:2005 | |
| IEC 60601-2-2: 2009 | IEC 60601-1 | |
| IEC 60601-2-2 | ||
| EMC | IEC 60601-1-2: 2007 | IEC 60601-1-2 |
Table 1 Comparison of Technology Characteristics (Scalpel System)
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- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion