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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) summary for the Xian Friendship Electronics Co., Ltd.'s Subdermal Needle Electrodes, seeking clearance from the FDA for substantial equivalence to predicate devices. It does not contain information about a study proving device performance against specific acceptance criteria in the context of AI/ML or comparative effectiveness. Instead, it relies on demonstrating similarity to already cleared predicate devices.

Therefore, many of the requested sections (e.g., specific acceptance criteria for performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) are not applicable or not provided in the document.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance Study for Xian Friendship Electronics Co., Ltd.'s Subdermal Needle Electrodes

This submission primarily focuses on demonstrating substantial equivalence to predicate devices through similarities in materials, design, and function, rather than presenting a de novo study with explicit performance acceptance criteria typical of novel or AI/ML-driven devices.

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, explicit performance acceptance criteria and reported numerical performance metrics are not provided as they would be for a direct performance study. The "acceptance criteria" here are implicitly meeting the safety and effectiveness standards demonstrated by the predicate devices. The device meets these by being "identical" or "similar" in key characteristics.

Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance (as claimed by applicant)
Safety (biocompatibility, electrical safety)	Materials of construction are identical to predicate devices; safety feature and other functional/performance characteristics are identical to predicate devices. Biocompatibility materials (medical grade 304/316 series Stainless Steel) are of known biocompatibility and were tested in previous 510(k)s (K050194, K022914).
Effectiveness (ability to detect electrophysiological signals and provide electrical stimulation subcutaneously)	Functional and performance characteristics are identical to predicate devices, which were "already verified and validated."
Sterility	Supplied in a sterile pouch.
Single-Use Only	Disposable, for "Single Use Only."
Compatibility with recording/monitoring equipment	Employs an industry standard DIN 42802 protected, "touch proof" safety connector.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable. There was no formal "test set" of patient data or images in the context of evaluating performance metrics.
Data Provenance: Not applicable. The submission relies on design and material comparisons to predicate devices, not on data from specific patients or studies.
Retrospective or Prospective: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. No ground truth establishment by experts was detailed for a test set.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size: Not applicable as no such study was performed or described.

6. If a Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical medical electrode, not a software algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the traditional sense of AI/ML or diagnostic device evaluation. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, which this new device aims to match through identical or similar design, materials, and function.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This document does not describe the development or evaluation of an AI/ML model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. There was no training set for an AI/ML model.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the (implicit) acceptance criteria for safety and effectiveness is primarily a non-clinical comparative analysis against legally marketed predicate devices (Axon Systems, Inc.'s Subdermal Needle Electrodes (K050194), Rhythmlink International Subdermal Needle Electrodes (K022914), and Medtronic Functional Diagnostics A/S Disposable Monopolar Needle Electrodes (K990375)).

The manufacturer states:

"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."
"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." (No further details on this simulated use test were provided, such as sample size, methodology, or specific criteria).
Biocompatibility relies on the known biocompatibility of the materials (medical grade 304/316 series Stainless Steel) and prior testing reported in the predicate device 510(k) submissions.

In essence, the "study" is a justification for substantial equivalence based on direct comparison of design specifications and materials to already cleared devices, coupled with a brief mention of a simulated use test.

Summary

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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 DevelopZone, Xi'an, Shaanxi Province, 710075 P. R.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 the510(k) summary:	11 May 2008
3 Device Name:	Subdermal Needle Electrodes
Common Name:	Subdermal Needle Electrodes
Device Trade name:	(1) Subdermal Needle Electrodes(a)Subdermal Needle Electrodes-Single(b)Twisted Pair Needle Electrodes(c)Parallel Pair Subdermal NeedleElectrodes(d)Dual Needle Electrodes(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)

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Manufacturer: Medtronic Functional Trade Name: Diagnostics A/S Disposable Monopolar Needle Electrodes FDA number: K990375

5. Description of device

The safety connector is an industry standard DIN 42802 protected, "touch proof connector and cannot be connected to an AC outlet.

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

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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.

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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

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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

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INDICATIONS FOR USE Section I

Applicant:____________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): *

Device Name:____Subdermal Needle Electrodes

Indications For Use:

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

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)

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).