The DMS Disposable Subdermal Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

Device Description

The DMS Disposable Subdermal Needle Electrodes are supplied sterile and intended for single use. This subdermal needle electrodes can be used to record the neurological and neurophysiological evoked potentials. The connector is provided with touch-proof and cannot be connected to an AC outlet. This connector is designed for connecting the recording or monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals. The DMS Disposable Subdermal Needle Electrodes are supplied sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DMS Disposable Subdermal Needle Electrodes, formatted to answer your questions:

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

The document does not explicitly state acceptance criteria in terms of specific performance thresholds for each test (e.g., "stiffness must be X Newton-meters"). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion is that the device passes or meets the requirements of these standards and tests, demonstrating performance comparable to the predicate.

Acceptance Criteria (Implied: Pass Standard/Test)	Reported Device Performance
Biocompatibility:
ISO 10993-5 (In vitro cytotoxicity tests)	Compliant / Passed
ISO 10993-10 (Irritation and skin sensitization)	Compliant / Passed
Performance Testing:
Stiffness Test	Compliant / Passed
Breakage Test	Compliant / Passed
Bond Test	Compliant / Passed
Electrical Properties Test	Compliant / Passed
Shelf-life Testing:
ASTM F1980-07:2011 (Accelerated aging)	Compliant / Passed

Note: The document states that the proposed device was "found to be similar to predicate device with regard to design, function, and technical characteristics" and "presented the substantial equivalence," implying all tests were successfully passed and demonstrated equivalency.

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

The document does not specify the sample sizes used for any of the non-clinical tests (biocompatibility, performance, shelf-life). These are typically laboratory tests performed on a limited number of device samples. The data provenance (country of origin, retrospective/prospective) is not mentioned, but given it's a 510(k) submission from "Daehan Medical Systems Co., Ltd." in "Republic of Korea," it's highly probable the testing was conducted in South Korea or by certified labs on behalf of the company. These are non-clinical, controlled laboratory studies, not human clinical trials, so the terms "retrospective" or "prospective" are not generally applicable in the same way they would be for 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 information is not applicable to the type of studies described. The "ground truth" here is based on standardized test methods and measurement results rather than expert interpretation of medical images or patient outcomes. The studies are non-clinical (biocompatibility, mechanical performance, electrical properties, shelf-life).

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly when interpreting ambiguous medical data. The tests performed here are objective laboratory measurements against established standards.

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

Not applicable. MRMC studies are clinical studies involving human readers (e.g., radiologists) evaluating cases, often with and without AI assistance, to assess diagnostic performance. This submission is for a medical device (subdermal needle electrodes) and focuses on non-clinical testing to demonstrate substantial equivalence, not AI algorithm performance.

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

Not applicable, as this device does not involve an AI algorithm.

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

The ground truth for the non-clinical tests is based on established industry standards and test methods. For example:

Biocompatibility: Ground truth is defined by the criteria within ISO 10993-5 (absence of cytotoxicity) and ISO 10993-10 (absence of irritation/sensitization).
Performance (Stiffness, Breakage, Bond, Electrical Properties): Ground truth is defined by the expected physical and electrical characteristics as determined by engineering specifications and comparative data to the predicate device.
Shelf-life: Ground truth is defined by the ability of the device and its packaging to maintain sterility and functional integrity after accelerated aging, conforming to ASTM F1980-07:2011.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."

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

Not applicable.

Summary

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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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or movement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 21, 2016

Daehan Medical Systems Co., Ltd. Dong Cheul Kim R&D Manager 250 Okgucheondong-ro Siheung City, 15084 KR

Re: K161566

Trade/Device Name: DMS Disposable Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ, Dated: November 15, 2016 Received: November 21, 2016

Dear Dong Cheul Kim:

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 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.

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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,

Carlos L. Pena -5 Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161566

Device Name

DMS Disposable Subdermal Needle Electrodes

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Daehan Medical Systems Co., Ltd. The logo consists of the letters "DMS" in a stylized font, with a swooping line underneath. The text "Daehan Medical Systems Co., Ltd." is written in a smaller font to the right of the letters. The logo is in blue color.

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

Nov. 15, 2016

Submitter's Information [21 CFR 807.92(a)[1]] 2.

Name of Sponsor:	Daehan Medical Systems Co., Ltd.
Address:	250 Okgucheondong-Ro, Siheung-City, Gyeonggido,Republic of Korea, 15084
Contact Name:	Dong Cheul Kim / R&D Manager

Contact Name: Dong Cheul Kim / R&D Manager
-Telephone No.: +82-31-432-6275
+82-31-432-6276 -Fax No.:
-Email Address: dckim@dmsleadwire.com
. Establishment Registration No.: 3002893037
Name of Manufacturer: ● Same as Sponsor Address: Same as Sponsor -

3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

Trade Name: DMS Disposable Subdermal Needle Electrodes
- Regulation Name: Needle Electrode
Classification:

●

Classification Panel	Neurology
Classification Regulation	21 CFR 882.1350
Product Code	GXZ
Device Class	II

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Image /page/4/Picture/0 description: The image shows the logo for Daehan Medical Systems Co., Ltd. The logo features the letters "DMS" in a stylized font, with a swooping line encircling the letters. The text "Daehan Medical Systems Co., Ltd." is written in a smaller, sans-serif font to the right of the letters.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate device within this submission is shown as follow;

510(k) Number: K130136
Applicant: Technomed Europe
Regulation Name: Needle Electrode ●
Device Name: Disposable Monopolar and Subdermal Needle Electrodes

There are no significant differences between the DMS Disposable Subdermal Needle Electrodes and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, and technical characteristics.

Description of the Device [21 CFR 807.92(a)(4)] 5.

The connector is provided with touch-proof and cannot be connected to an AC outlet. This connector is designed for connecting the recording or monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

The DMS Disposable Subdermal Needle Electrodes are supplied sterile.

6. Intended Use [21 CFR 807.92(a)(5)]

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Image /page/5/Picture/0 description: The image shows the logo for Daehan Medical Systems Co., Ltd. The logo features the letters "DMS" in a stylized font, with horizontal lines running through the letters. A curved line wraps around the letters. The text "Daehan Medical Systems Co., Ltd." is written in a smaller font to the right of the logo.

7. Technological Characteristics [21 CFR 807.92(a)(6)]

The DMS Disposable Subdermal Needle Electrode are based on a technical feature comparison, the subject device was found to be similar to predicate device with regard to design, function, and technical characteristics.

	Proposed Device	Predicate Device
K Number	K161566	K130136
Model	DMS Disposable Subdermal NeedleElectrode	Disposable Monopolar andSubdermal Needle Electrodes
Manufacturer	Daehan Medical Systems Co., Ltd.	Technomed Europe
Device Class	Class II	Class II
Product code	GXZ	GXZ and IKT
Intended Use	The DMS Disposable SubdermalNeedle Electrodes are intended foruse with recording, monitoringequipment for the recording ofbiopotential signals includingelectroencephalograph (EEG),electromyograph (EMG) and nervepotential signals, and are intendedfor stimulation/recording withstimulation/recording equipmentfor electromyograph (EMG) andnerve potential signals.	Needle Electrodes for Neurologicalpurposes are intended for use withrecording, monitoring equipmentfor the recording of biopotentialsignals includingelectroencephalograph (EEG),electromyograph (EMG) and nervepotential signals, and are intendedfor stimulation/recording withstimulation/recording equipmentfor electromyograph (EMG) andnerve potential signals.
Anatomical sites	Subdermal, nerve or muscle tissue	Subdermal, nerve or muscle tissue
Needle Diameter	0.41 mm	0.30 to 0.60 mm
Needle Length	12, 13, 14 and 16 mm	7 to 20 mm
Lead WireLength	0.5, 1.0, 1.5, 2.0 and 2.5 m	1.0, 1.5 and 2.5 m
Needle material	Stainless steel	Stainless steel
Lead wire	PVC insulated tin plated withcopper	PVC insulated tin plated withcopper
Connectors	DIN 42 802 1.5mm and Touchproof connector	DIN 42 802 1.5mm and Touchproof connector
SterilizationMethod	EO ethylene oxide	EO ethylene oxide
Sterilityassurance level	10-6	10-6

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Image /page/6/Picture/0 description: The image contains the logo for Daehan Medical Systems Co., Ltd. The logo features the letters "DMS" in a stylized, blue font with a swooping line underneath. To the right of the logo, the company name "Daehan Medical Systems Co., Ltd." is written in a smaller, sans-serif font, also in blue. The overall design is clean and professional, suggesting a company in the medical technology sector.

Non-Clinical Test Summary:

1. Biocompatibility
- ISO 10993-5: Biological evaluation of medical devices - Part 5: tests for in vitro cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices - Part 10: tests for irritation and skin sensitization
1. Performance Testing
- Stiffness Test ●
- Breakage Test ●
- Bond Test
- Electrical Properties Test ●
Shelf-life Testing 3)
- ASTM F1980-07:2011, Standard guide for accelerated aging of sterile barrier systems ● for medical devices

Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.

When compared to the predicate device (K130136), the DMS Disposable Subdermal Needle Electrode in this submission presented the substantial equivalence in terms of:

Intended use ●
Device design ●
Components and materials
Technological characteristics ●

9. Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Daehan Medical Systems Co., Ltd., concludes that the DMS Disposable Subdermal Needle Electrodes are substantially equivalent to predicate device as described herein.

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).