(178 days)
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.
The Disposable Electrode series devices are intended to conduct radio frequency (RF) current for cutting and coagulation from the electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
Not Found
The provided text is a 510(k) summary for a Disposable Grounding Pad Series and Disposable Electrode Series. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria for a new clinical claim. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for proving performance is not typically found within this kind of regulatory submission.
The document primarily states that:
- The device is designed and tested according to mandatory and voluntary standards (IEC 60601-1, IEC 60601-2-2).
- It is determined to be Substantially Equivalent (SE) to predicate devices (K063161 and K081791), implying it is as safe and effective.
Consequently, I cannot extract the specific details you've asked for, such as a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or results of MRMC or standalone studies, because these are not part of a substantial equivalence claim for this type of medical device's 510(k) submission.
The "Test Conclusion" section only mentions adherence to safety standards, not a clinical performance study with specific acceptance criteria.
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510(k) Report - Section 3 510(k) Summary Report SN: A2009-06-01
Section 3 510(k) Summary
As required by 807.97
The assigned 510(k) Number is ________________________________________________________________________________________________________________________________________________
| Sponsor | Shuyou Electric Medical Science Co., Ltd. |
|---|---|
| Anji · Economic Development Zone Health(medicine) | |
| Industrial Park ,Huzhou ,Zhejiang,China, 313300 | |
| Ms. Wei Liu | |
| Tel:+86-572-5300005 ext. 801 | |
| Fax: +86-572-5300004 | |
| Email: shuyou_china001@sina.com | |
| Submission | Ms. Diana Hong / Mr. Tarzan Wang |
| Correspondent | Shanghai Mid-Link Business Consulting Co., Ltd |
| Sute 8D, No. 19, Lane 999, Zhongshan No.2 Road(S) | |
| Shanghai, 200030, China | |
| Tel: +86-21-64264467 | |
| Fax: 240-238-7587 | |
| Email: diana.hong@mid-link.net | |
| Proposed Product | |
| Trade Name | Disposable Grounding Pad series/ Disposable Electrode |
| series | |
| Product Code: | GEI |
| Regulation Number: | 21 CFR 878.4400 |
| Device Class: | Class II |
| Submission Purpose: | New Device |
| Predicate Device: | Skintact Cool Contact Electrosurgical Grounding Plates |
| (K063161) | |
| E-Z Clean electrosurgical electrodes (K081791) | |
| Test Conclusion | The Disposable Grounding Pad and Disposable Electrode are |
| designed, tested and will be manufactured in accordance with | |
| both mandatory and voluntary standards, including: | |
| IEC 60601-1, Medical Electrical Equipment - Part 1: General |
. 3-1
4 2009
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510(k) Report – Section 3 510(k) Summary Report SN: A2009-06-01
| Report SN: A2009-06-01 | Requirements for Safety, 1988; Amendment 1, 1991-11,Amendment 2, 1995. |
|---|---|
| IEC 60601-2-2, Medical Electrical Equipment - Part 2-2:Particular requirements for the safety of high frequencysurgical equipment. | |
| SE Determination | The proposed device is Substantially Equivalent (SE) to thepredicate device which is US legally market device.Therefore, the subject device is determined as safe andeffectiveness. |
| IntendedUse/Indication for Use | The Disposable Grounding Pad series devices are to conductelectrosurgical energy from target tissue of a patient back toan electrosurgical unit (ESU), or generator. |
| The Disposable Electrode series devices are intended toconduct radio frequency (RF) current for cutting andcoagulation from the electrosurgical generator to target softtissue in a broad range of surgical procedures requiring theuse of electrosurgery for cutting and cauterization. |
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Image /page/2/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 emblem featuring a stylized depiction of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC - 4 2009
Shuyou Electric Medical Science Co., Ltd. % Shanghai Mid-Link Business Consulting Co., Ltd. Ms. Diana Hong, General Manager Suite 8D, No. 19, Lane 999, Zhongshan No. 2 Road(S) Shanghai, 200030, China
Re: K091672
Trade/Device Name: Disposable Grounding Pad Series and Disposable Electrode Series Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, ODR Dated: November 13, 2009 Received: November 17, 2009
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.
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
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Page 2 – Ms. Diana Hong
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.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 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,
Mark McMullen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication For Use
510(k) Number (if known): ___ Pending_________________________________________________________________________________________________________________________________________
Device Name: Disposable Grounding Pad Series
Indications for Use:
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.
Prescription Use _ J (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Us __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M. MELKERSON
on Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091672
Page 1_of_2
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Indication For Use
510(k) Number (if known):
Device Name: Disposable Electrode Series.
Indications for Use:
The Disposable Electrode series devices are intended to conduct radio frequency (RF) current for cutting and coagulation from the electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
FOR M. MELKERSON
K091672 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page 2 of 2
§ 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.