(198 days)
Not Found
No
The summary describes a passive electrode device for recording biopotential signals and does not mention any computational processing, analysis, or algorithms, let alone AI/ML.
No.
The device is used for recording and monitoring biopotential signals (EEG, EMG, nerve potentials) and for stimulation/recording in conjunction with equipment for these purposes, not for treating a disease or condition.
Yes
The device's intended use is to record and monitor biopotential signals such as EEG, EMG, and nerve potentials, which are diagnostic indicators used to assess neurological and muscular function.
No
The device description clearly describes physical, sterile, disposable needle electrodes, which are hardware components. The performance studies also focus on physical properties and biocompatibility of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The DMS Disposable Subdermal Needle Electrodes are used to record or stimulate electrical signals directly from within the body (subdermal, nerve, or muscle tissue). This is an in vivo procedure, meaning it takes place within a living organism.
- Intended Use: The intended use clearly states recording and stimulation of biopotential signals (EEG, EMG, nerve potentials). This is a direct interaction with the patient's electrical activity, not the analysis of a sample taken from the patient.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GXZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Subdermal, nerve or muscle tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary:
-
- 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
-
- Performance Testing
- Stiffness Test
- Breakage Test
- Bond Test
- Electrical Properties Test
- Shelf-life Testing
- ASTM F1980-07:2011, Standard guide for accelerated aging of sterile barrier systems for medical devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 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 | |
| Electrode | Disposable Monopolar and | |
| 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 | |
| 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. | Needle Electrodes for Neurological | |
| purposes 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. | ||
| 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 | ||
| 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 | |
| copper | PVC insulated tin plated with | |
| copper | ||
| Connectors | DIN 42 802 1.5mm and Touch | |
| proof connector | DIN 42 802 1.5mm and Touch | |
| proof connector | ||
| Sterilization | ||
| Method | EO ethylene oxide | EO ethylene oxide |
| Sterility | ||
| 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:
-
- 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
-
- 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.