SUBDERMAL NEEDLE ELECTRODES

{0}------------------------------------------------ K072276 # MAY 1 6 2008 Section II 510(k) Summary of Safety and Effectiveness | 1. 510(k) owner: | Xian Friendship Electronics Co., Ltd. | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company address : | No.9 Gao Xin 1st Road, High-Tech Develop<br>Zone, Xi'an, Shaanxi Province, 710075 P. R.<br>China | | Phone number : | ( 86 ) 29 88225200 | | Fax number : | ( 86 ) 29 88236285 | | contact person: | Zhai Ying Chuan ,General Manager | | E-mail: | georgezhai2616@163.com | | 2 Preparation date of the<br>510(k) summary: | 11 May 2008 | | 3 Device Name: | Subdermal Needle Electrodes | | Common Name: | Subdermal Needle Electrodes | | Device Trade name: | (1) Subdermal Needle Electrodes<br>(a)Subdermal Needle Electrodes-Single<br>(b)Twisted Pair Needle Electrodes<br>(c)Parallel Pair Subdermal Needle<br>Electrodes<br>(d)Dual Needle Electrodes<br>(2)Disposable Concentric Needle Electrodes | | | (3)Disposable Monopalar Needle Electrodes | | | (4)Corkscrew (spiral) Needle Electrode | | | Other clients private labeling | | Classification Name: | Needle Electrode | | Product Code: | GXZ | # 4. Identifies the legally marketed device to which equivalence is claimed | Predicate Devices | | |-------------------|-------------------------------| | Manufacturer: | Axon Systems, Inc. | | Trade Name: | Subdermal Needle Electrodes | | FDA number: | K050194 | | Manufacturer: | Rhythmlink International, LLC | Manufacturer: Rhythmlink International, LLC Trade Name: Rhythmlink International Subdermal Needle Electrodes FDA number: K022914 : Section II-1(ver1.0) {1}------------------------------------------------ Manufacturer: Medtronic Functional Trade Name: Diagnostics A/S Disposable Monopolar Needle Electrodes FDA number: K990375 #### 5. Description of device Xian Friendship Electronics Co., Ltd.s' Subdermal Needle Electrodes are disposable (for "Single Use Only"),sterile devices used to detect electrophysiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment. The safety connector is an industry standard DIN 42802 protected, "touch proof connector and cannot be connected to an AC outlet. Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician. #### 6. The intended use Xian Friendship Electronics Co., Ltd.' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. #### 7. Indications for Use Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The electrodes are sterile and for single patient use only. {2}------------------------------------------------ ## 8. Summary of the technological Characteristics Xian Friendship Electronics Co., Ltd.' s Subdermal Needle Electrode consists of an insulated wire, of various lengths, electrically connected to a small gauge, stainless steel needle on one end, and a DIN 42802 "touch-proof" safety connector on the other end. The connector is specifically designed so that it cannot be plugged into AC power outlet. The electrode is supplied in a sterile pouch. Materials used are the same as in the predicate devices. ### 9. Brief discussion of the nonclinical tests submitted The materials of construction of the Subdermal Needle Electrodes are identical to those for the Axon Systems, Inc.'s Subdermal Needle Electrodes and Rhythmlink International Subdermal Needle Electrodes. The safety feature and other functional and performance characteristics of the Subdermal Needle Electrodes are identical to those "Predicate Devices". Those features and characteristics were already verified and validated. ### 10.Brief discussion of the clinical tests submitted Clinical studies were not deemed necessary regarding the Subdermal Needle Electrodes due to their similarity in materials, design and function to those "Predicate Devices". The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use. ### 11. Biocompatibility testing The contact material of the tip is a medical grade 304/316 series Stainless Steel. This material is of known biocompatibility. And those materials were already tested for material safety and biocompatibility as indicated in previous 510(K) submissions, K050194 and K022914. Therefore, no new biocompatibility tests are necessary. ### 12. Conclusions drawn from the non clinical, clinical and biocompatibility tests Xian Friendship Electronics Co., Ltd. s' Subdermal Needle Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Xian Friendship Electronics Co., Ltd. % Beijing Easy-Link Company Mr. Chu Xiaoan Room 1606, Building 1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, 100083, People's Republic of China MAY 1 6 2008 K072276 Re: Trade/Device Name: Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: May 11, 2008 Received: May 14, 2008 Dear Mr. Xiaoan: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated) 77 the enactment date of the Medical Device Amendments, or to conninered print to May 20, 1978, as accordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). alle Cosmette Act (110t) that do not required to the general controls provisions of the Act. The Tourmay, dicierore, maxiet the act include requirements for annual registration, listing of general vonnolo provisions of ractice, 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 If your device to such additional controls. Existing major regulations affecting your device can Inay be subject to suen additional connotions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs over ents concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dri o losaantes vour device complies with other requirements of the Act that I DA has mude a determinations administered by other Federal agencies. You must or any I coclar statutes and regaranents, including, but not limited to: registration and listing (21 {4}------------------------------------------------ Page 2 - Mr. Chu Xiaoan CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ecctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, perceite your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pro (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device advervee events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Mark M. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### INDICATIONS FOR USE Section I Applicant:____________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): * Device Name:____Subdermal Needle Electrodes Indications For Use: · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The electrodes are sterile and for single patient use only. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ (21 CFR 801 Subpart C) (Division Sign-Off) FOR MARK MECKERSON Division of General, Restorative, and Neurological Devices (PLEASE DO NOT WRITE BELOW THIS LINESC Concurrence of CDRH, Office of Device Evaluation (ODE)