DMS Disposable Subdermal Needle Electrodes

K161566 · Daehan Medical Systems Co., Ltd. · GXZ · Dec 21, 2016 · Neurology

Device Facts

• Record ID: K161566
• Device Name: DMS Disposable Subdermal Needle Electrodes
• Applicant: Daehan Medical Systems Co., Ltd.
• Product Code: GXZ · Neurology
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

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 Story

DMS Disposable Subdermal Needle Electrodes are sterile, single-use stainless steel needles; used to record biopotential signals (EEG, EMG, nerve potentials) or provide stimulation during neurophysiological monitoring. Needles feature touch-proof connectors (DIN 42 802 1.5mm) for interface with external recording/monitoring equipment. Operated by clinicians in clinical settings; device acts as a passive interface between patient tissue and diagnostic equipment. Benefits include standardized, disposable access to subdermal sites for neurological assessment, reducing cross-contamination risk.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization), performance testing (stiffness, breakage, bond, electrical properties), and shelf-life testing per ASTM F1980-07.

Technological Characteristics

Needle material: stainless steel; Lead wire: PVC insulated tin-plated copper; Connectors: DIN 42 802 1.5mm touch-proof; Sterilization: Ethylene Oxide (EO) to SAL 10^-6; Dimensions: 0.41 mm diameter, 12-16 mm length; Lead lengths: 0.5-2.5 m.

Indications for Use

Indicated for use in recording biopotential signals (EEG, EMG, nerve potential) and stimulation/recording of EMG and nerve potential signals. Intended for subdermal, nerve, or muscle tissue application.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Predicate Devices

• Disposable Monopolar and Subdermal Needle Electrodes (K130136)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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 (EMC) and nerve potential signals.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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,<br>Republic of Korea, 15084 |
| Contact Name: | Dong Cheul Kim / R&D Manager |

- Contact Name: Dong Cheul Kim / R&D Manager
- -Telephone No.: [phone]
- [phone] -Fax No.:
- -Email Address: [e-mail]
- . 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 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.

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

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.

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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 Needle<br>Electrode | Disposable Monopolar and<br>Subdermal 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 Subdermal<br>Needle Electrodes are intended for<br>use with recording, monitoring<br>equipment for the recording of<br>biopotential signals including<br>electroencephalograph (EEG),<br>electromyograph (EMG) and nerve<br>potential signals, and are intended<br>for stimulation/recording with<br>stimulation/recording equipment<br>for electromyograph (EMG) and<br>nerve potential signals. | Needle Electrodes for Neurological<br>purposes are intended for use with<br>recording, monitoring equipment<br>for the recording of biopotential<br>signals including<br>electroencephalograph (EEG),<br>electromyograph (EMG) and nerve<br>potential signals, and are intended<br>for stimulation/recording with<br>stimulation/recording equipment<br>for electromyograph (EMG) and<br>nerve 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 Wire<br>Length | 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 with<br>copper | PVC insulated tin plated with<br>copper |
| Connectors | DIN 42 802 1.5mm and Touch<br>proof connector | DIN 42 802 1.5mm and Touch<br>proof connector |
| Sterilization<br>Method | EO ethylene oxide | EO ethylene oxide |
| Sterility<br>assurance 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
- 2) 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.