This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only.

Device Description

Medical disposable sterile needle electrodes are sterile, single use products that penetrate the skin and directly contact the extracellular fluid during use, forming a good electrolyte interface. The pointed part of the needle electrode makes contact with the nerves, muscles, or other tissues under examination to collect and transmit the corresponding bioelectrical signals (myoelectric currents) to the electromyography (EMG) recorder. Needle electrodes are used in conjunction with EMG diagnostic instruments and serve as accessories to the EMG machine for detecting myoelectric potentials. Medical disposable sterile needle electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician. The subject device, available in configurations with and wires, which encompasses subdermal, monopolar, spiral, and concentric designs. The subject device's configurations of monopolar and concentric needles correspond to those without lead wires, while the configurations involving spiral and subdermal designs include lead wires.

AI/ML Overview

This appears to be an FDA 510(k) clearance letter for a Medical Disposable Sterile Needle Electrode. The document describes the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.

Crucially, this document is for a medical device (a physical needle electrode), not a software/AI-driven device that would involve a test set, ground truth experts, MRMC studies, or training sets in the way your request describes. Therefore, many of the requested criteria are not applicable.

However, I can extract the information that is present and explain why other sections are not relevant.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this type of device are primarily based on non-clinical performance (physical and biological safety) and demonstrating substantial equivalence to a predicate device. There isn't a "performance" metric in the sense of accuracy, sensitivity, or specificity as one would find for an AI algorithm.

Test / Attribute	Acceptance Criteria (Implied by standard and "Pass" result)	Reported Device Performance
Non-Clinical Testing	Meets specified standards for functional performance.
Surface quality	Acceptable surface finish; no defects impacting safety or performance.	Pass
Sharpness index	Meets specified sharpness requirements for penetration.	Pass
Toughness	Withstands expected stresses without breakage or loss of integrity.	Pass
Connection strength	Connections (e.g., needle to wire) maintain integrity during use.	Pass
Electrical conductivity	Conducts electrical signals effectively as intended.	Pass
Conductive terminals and needle body insulation	Insulation prevents unintended electrical paths.	Pass
Sterility testing	Achieves and maintains sterility (SAL of $10^{-6}$).	Pass (and SAL $10^{-6}$ demonstrated)
Biocompatibility Testing	Meets biological safety requirements per ISO 10993-1 for subdermal communicating devices with muscle.
In vitro cytotoxicity	Non-cytotoxic (as per ISO 10993-5).	Non-cytotoxic
Skin sensitization	Non-sensitive (as per ISO 10993-10).	Non-sensitive
Intracutaneous reactivity	Non-irritation (as per ISO 10993-23).	Non-irritation
Acute systemic toxicity	Non-acute systemic toxicity (as per ISO 10993-11).	Non-acute systemic toxicity
Pyrogen	Non-pyrogenic (as per ISO 10993-11).	Non-pyrogenic
Sterilization	Validated according to ISO 11135:2014, achieving SAL of $10^{-6}$ and meeting EO residuals per ISO 10993-7.	Yes (meets ISO 11135, SAL $10^{-6}$, and ISO 10993-7 residuals)
Shelf-Life	Maintains performance and safety for stated duration.	3 years (based on accelerated and real-time aging)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this type of device. The "tests" mentioned are physical and chemical laboratory tests on manufactured samples of the device, not clinical data sets of patients. There is no concept of "data provenance" in the context of clinical images or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. There is no "ground truth" established by experts in the context of an electromyography needle electrode. The performance is assessed through standardized laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There is no "test set" requiring adjudication in the context of an electromyography needle electrode.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is a physical medical device, not an AI software. MRMC studies are used for evaluating diagnostic imaging AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As mentioned, "ground truth" in the AI/software sense is not applicable. For this device, the "truth" is established by adherence to recognized international standards for biocompatibility (ISO 10993 series), sterilization (ISO 11135), and general physical performance testing (e.g., surface quality, sharpness, electrical conductivity).

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device.

9. How the ground truth for the training set was established

This is not applicable. There is no "training set" or associated "ground truth" for a physical medical device. The "truth" is established through engineering design, material science, and adherence to established manufacturing and testing standards.

Summary

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December 4, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Suzhou Haishen Medical Device Associates Co., Ltd % Jie Gao Consultant Sinow Medical AS Høyteknologisenteret Thormøhlens Gate 55 Bergen, 5008 Norway

Re: K232581

Trade/Device Name: Medical Disposable Sterile Needle Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: August 23, 2023 Received: August 25, 2023

Dear Jie Gao:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/8 description: The image shows the name "Patrick Antkowiak -S" in black text. The name "Patrick" is on the first line, and "Antkowiak -S" is on the second line. To the left of the name is a faded FDA logo.

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical,

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Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Medical Disposable Sterile Needle Electrode

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. SUBMITTER

Submitter: Suzhou Haishen United Medical Device Associates Co., Ltd

Address: 3F, 4F 401, 4F 402, 5F, Building 10, No. 168 Majian Road, Suzhou, Jiangsu Province, China

Telephone: +86 18921623557

Email: 785445240@qq.com

Contact Person: Leyi Dai

Date Prepared: 01.07.2023

II. Consultant

Company: Sinow Medical AS

Address: Høyteknologisenteret Thormøhlens Gate 55, Bergen, Norway

Contact Person: Jie Gao

Telephone: +47 99127913

Email: gao@bergemed.com

III. DEVICE

Trade Name: Medical Disposable Sterile Needle Electrode

Classification Name: Needle Electrode

Regulatory Class: II

Product Code: GXZ

IV. PREDICATE DEVICE

Product Name: Subdermal Needle Electrodes

510(k) Number: K072276

Product Code: GXZ

Manufacture: Xian Friendship Electronics Co., Ltd.

V. DEVICE DESCRIPTION

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other tissues under examination to collect and transmit the corresponding bioelectrical signals (myoelectric currents) to the electromyography (EMG) recorder. Needle electrodes are used in conjunction with EMG diagnostic instruments and serve as accessories to the EMG machine for detecting myoelectric potentials. Medical disposable sterile needle electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.

The subject device, available in configurations with and wires, which encompasses subdermal, monopolar, spiral, and concentric designs. The subject device's configurations of monopolar and concentric needles correspond to those without lead wires, while the configurations involving spiral and subdermal designs include lead wires.

VI. INDICATIONS FOR USE

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The technological characteristics comparing to the predicate device are outlined in the Substantial Equivalent table.

Attribute	Medical DisposableSterile Needle Electrodes(Subject Device)	Friendship SubdermalNeedle Electrodes(Predicate deviceK072276)	Comment
RegulationNumber	21 CFR 882.1350	21 CFR 882.1350	SE
Regulation Name	Needle Electrode	Needle Electrode	SE
Regulatory Class	Class II	Class II	SE
Product Code	GXZ	GXZ	SE
Indications forUse	This product is intended foruse with recording,monitoring equipment forthe recording ofbioelectrical signals, suchas electromyograph(EMG). The electrodes aresterile and for single patientuse only.	Subdermal NeedleElectrodes are intended foruse with recording,monitoring andstimulation/recordingequipment for the recordingof biopotential signalsincludingelectroencephalograph(EEG), electromyograph(EMG) and nerve potentialsignals and for stimulationduring the intraoperativediagnosis of acutedysfunction in corticospinal	SubjectDevicewithoutstimulationfunction;SubjectDevice onlyrecords inEMG
		axonal conduction. Theelectrodes are sterile and forsingle patient use only.
Environment ofUse	Hospital	Hospital	SE
Provided Sterile	Yes	Yes	SE
Method ofSterilization	Ethylene Oxide	Ethylene Oxide	SE
Sterilityassurance level(SAL)	$10^{-6}$	$10^{-6}$	SE
Single Use,Disposable	Yes	Yes	SE
Basic Principle	A needle electrode is anelectrode that requirespenetration through theskin to directly contactextracellular fluid. It formsa good electrode-electrolyteinterface and is used inconjunction withelectromyography (EMG)diagnostic instruments asan electrode for detectingmuscle electrical activity.	A needle electrode is anelectrode that requirespenetration through the skinto directly contactextracellular fluid. It formsa good electrode-electrolyteinterface and is used inconjunction with recording,monitoring andstimulation/recordingequipment for the recordingof biopotential signalsincludingelectroencephalograph(EEG), electromyograph(EMG) and nerve potentialsignals and for stimulationduring the intraoperativediagnosis of acutedysfunction in corticospinalaxonal conduction.	Same basicprinciple butSubjectDevice hasless clinicalusage thanPredicateDevice
Target Population	Adults, children and infants	Adults, children and infants	SE
Anatomical Sites	Subdermal, muscle tissue	Subdermal, nerve or muscletissue	SubjectDevice haslessAnatomicalSites
Needle material	Stainless steel	Stainless steel	SE
Needle length	Spiral needle:$20 \pm 1.5mm$Concentric needle:$(20 - 75) \pm 1.5mm$Subdermal needle:	Spiral needle:NAConcentric needle:20 - 75mmSubdermal needle:	Equivalent

	(6, 7, 13, 19, 20, 22) ±1.5mm	7, 13, 17, 23mm
	Monopolar needle:(20, 25, 30, 37, 50, 75) ±1.5mm	Monopolar needle:20, 25, 30, 38, 50, 75mm
Needle diameter	Spiral needle:0.60 ± 0.15mm	Spiral needle:0.60 mm	Equivalent
	Concentric needle:(0.25 - 0.65) ± 0.15mm	Concentric needle:0.25 - 0.65mm
	Subdermal needle:(0.35, 0.40, 0.45) ±0.15mm	Subdermal needle:0.35, 0.40, 0.45mm
	Monopolar needle:(0.25, 0.30, 0.35, 0.40,0.45, 0.50, 0.65) ± 0.15mm	Monopolar needle:0.25, 0.30, 0.35, 0.40, 0.45,0.50, 0.65mm
Lead wirematerial	PVC insulated tin platedwith copper	PVC insulated tin platedwith copper	SE
Lead wire length	(1000 - 2500) ± 25mm	1200 - 2500mm	Equivalent

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VIII. NON-CLINCAL TESTING

Suzhou Haishen United Medical Device Associates Co., Ltd has performed the following nonclinical laboratory testing to determine substantial equivalence.

Test	Result
Surface quality	Pass
Sharpness index	Pass
Toughness	Pass
Connection strength	Pass
Electrical conductivity	Pass
Conductive terminals and needle body insulation	Pass
Sterility testing	Pass

IX. BIOCOMPATIBILITY TESTING

The contact classification for the Medical Disposable Sterile Needle Electrode component of the subject device is a subdermal communicating device with muscle. The biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and in accordance with FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk

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management process", Guidance for Industry and Food and Drug Administration Staff. The results of biocompatibility testing included in the table below demonstrate that the device meets biological safety requirements per ISO 10993-1 for subdermal communicating devices with muscle.

Test	Standard	Result
In vitro cytotoxicity	ISO 10993-5	Non-cytotoxic
Skin sensitization	ISO 10993-10	Non-sensitive
Intracutaneous reactivity	ISO 10993-23	Non- irritation
Acute systemic toxicity	ISO 10993-11	Non-acute systemic toxicity
Pyrogen	ISO 10993-11	Non-pyrogenic

X. STERILIZATION AND SHELF-LIFE TESTING

The subject device is sterilized using Ethylene Oxide. The sterilization validation has been performed in accordance with the principles of ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. A sterility assurance level (SAL) of 100 has been demonstrated. The device meets EO residuals per ISO 10993-7.

A shelf-life of 3 years has been established based on accelerated and real-time aging.

XI. CONCLUSIONS

The subject and predicate device share intended use - for temporary use with recording and monitoring equipment for the recording and monitoring of bioelectrical signals from the corresponding muscle parts of the human body, such as electromyography (EMG). The subject device does not have stimulation function as the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness, and the nonclinical performance data submitted in the 510(k) demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.

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).