(38 days)
Not Found
No
The document describes a standard nerve stimulator with different modes and power options. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The user is explicitly stated to provide the interpretation of the nerve response.
No.
The device provides electrical stimulation to nerves during diagnostic and surgical procedures, which is not a therapeutic use. It is used for monitoring and identification of nerves rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides electrical stimulation to nerves "during diagnostic and surgical procedures," indicating its involvement in diagnostic functions.
No
The device description explicitly states it is a "self contained, battery powered device," indicating it includes hardware components.
Based on the provided information, the Hilger Dual-Stim Nerve Stimulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide electrical stimulation to nerves during diagnostic and surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) test performed on biological samples.
- Device Description: The description focuses on the electrical stimulation function and modes, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. There is no mention of reagents, assays, or any of the typical components or processes associated with IVD devices.
- Anatomical Site: The device acts directly on nerves within the body.
Therefore, the Hilger Dual-Stim Nerve Stimulator is a medical device used for nerve stimulation in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
The Hilger Dual-Stim Nerve Stimulator is a self contained, battery powered device. There is an option to provide a line powered option in the future.
Two modes of nerve stimulation are provided, a Clinical Mode and a Surgical Mode.
The only variations of the Hilger Dual-Stim Nerve Stimulator are a battery powered device and a future optional AC line operated device. The safety standards that these two variations meet are the same.
Accessories applied to the Hilger Dual-Stim Nerve Stimulator are probe configurations compatible with the two different stimulation modes:
- Bipolar Clinical Probe
- Remote Surgical Probe
- Monopolar Disposable Probe
- Silverstein Adapter for Continuous Stimulation (SACS Kit)
- Hilger Dual-Stim Adapter.
The Hilger Dual-Stim Nerve Stimulator is used in hospitals, operating rooms and clinical environments to support clinical evaluation of nerves. The Hilger Dual-Stim Nerve Stimulator provides the nerve stimulation; the user provides the interpretation of appropriate nerve response.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, operating rooms and clinical environments
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)
Testing of the Hilger Dual-Stim Nerve Stimulator was performed in compliance with the WR Medical Electronics CO. design control process. Testing included:
- Software verification and validation, and
- Declaration of safety standard compliance prior to commercial distribution.
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.
Preamendment - Hilger Facial Nerve Stimulator, K895838 - Brackman EMG Monitoring System, K021595 - Gyrus ENT Nerve Stimulator
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
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
5063567
First Ronkes CO
/ORTH SECOND STREET, STILLWATER, MN 55082 ■ 651-430-1200 ■ TOLL-FREE 800-321-6387 ■ TAX 651-4.9-9733 ■ WWW.WWWFD C CM
510(k) Summary
| Company Name: | WR Medical Electronics CO. | |||
|---|---|---|---|---|
| Device Name: | Hilger Dual-Stim Nerve Stimulator | |||
| JAN - 5 2007 | ||||
| 510(k) Sponsor, Contact: | WR Medical Electronics CO. | |||
| 123 North 2nd Street | ||||
| Stillwater, MN 55082 | ||||
| Jack Blais, President | ||||
| Phone: (651) 430-1200 | ||||
| Fax: (651) 439-9733 | ||||
| Summary Date: | November 21, 2006 | |||
| Common Name: | Nerve Stimulator | |||
| Classification Name: | Nerve Stimulator 21 CFR 874.1820, Product Code: ETN, Class II | |||
| Predicate Device(s): | Preamendment - Hilger Facial Nerve Stimulator | |||
| K895838 - Brackman EMG Monitoring System | ||||
| K021595 - Gyrus ENT Nerve Stimulator |
1.0 Description of Device
The Hilger Dual-Stim Nerve Stimulator is a self contained, battery powered device. There is an option to provide a line powered option in the future.
Two modes of nerve stimulation are provided, a Clinical Mode and a Surgical Mode. Table 1.0-1 summarizes the differences in these stimulation modes.
| Feature | Clinical Mode | Surgical Mode |
|---|---|---|
| Stimulation Current | Up to 10 mA | Up to 10 mA |
| Stimulation Pulse Width | 0.0006 micro second | 0.0002 micro second |
| Stimulation Frequency | 6 Hz | 5 Hz |
File: Hilger Dual Stim 510k 11-21-2006 final
1
1.1 Variations and Accessories
The only variations of the Hilger Dual-Stim Nerve Stimulator are a battery powered device and a future optional AC line operated device. The safety standards that these two variations meet are the same.
Accessories applied to the Hilger Dual-Stim Nerve Stimulator are probe configurations compatible with the two different stimulation modes:
-
- Bipolar Clinical Probe
-
- Remote Surgical Probe
- Monopolar Disposable Probe 3.
-
- Silverstein Adapter for Continuous Stimulation (SACS Kit)
-
- Hilger Dual-Stim Adapter.
The Hilger Dual-Stim Nerve Stimulator is used in hospitals, operating rooms and clinical environments to support clinical evaluation of nerves. The Hilger Dual-Stim Nerve Stimulator provides the nerve stimulation; the user provides the interpretation of appropriate nerve response.
2.0 Intended use of Device
The intended use of the Hilger Dual-Stim Nerve Stimulator is:
The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.
3.0 Technological Characteristics
The technical characteristics of the Hilger Dual-Stim Nerve Stimulator are equivalent to those of the predicate devices. The following table summarizes significant feature comparisons.
File: Hilger Dual Stim 510k 11-21-2006 final
2
| | Feature | Hilger Dual-Stim
Nerve Stimulator
Under Review | Predicate
Hilger
(Preamendment) | Predicate
Brackman
(K895838) | Predicate
Gyrus ENT Nerve
Stimulator
(K021595) |
|----|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended Use,
Indications for
Use | The Hilger Dual-Stim
Nerve Stimulator
provides electrical
stimulation to nerves
during diagnostic and
surgical procedures. | The Hilger Facial
Nerve Stimulator
provides electrical
stimulation to nerves
to aid in nerve location
during diagnostic and
surgical procedures. | The Brackman EMG
Monitor/Stimulator is
used to stimulate and
monitor cranial nerves | The Gyrus ENT Nerve
Stimulator is intended
to provide electrical
stimulation to cranial
and peripheral motor
nerves to aid in nerve
location during
surgical procedures. |
| 2. | Environment
of Use | Hospital, Operating
Room, Clinic | Hospital, Operating
Room, Clinic | Hospital, Operating
Room, Clinic | Hospital, Operating
Room, Clinic |
| 3. | Stimulation
Modes | Two
Clinical Mode
Surgical Mode | One
Same as Hilger Dual-
Stim Clinical Mode | One
Same as Hilger Dual-
Stim Surgical Mode | One |
| 4. | Stimulation
Probes | Bipolar Clinical Probe
Remote Surgical Probe
Monopolar Disposable
Probe | Bipolar Stimulator
Probe | Bipolar Stimulator
Probe
Monopolar Surgical
Stimulating Probe
Needle and Hook Wire
Electrodes | Monopolar and
Bipolar |
| 5. | Stimulation
Current | 0 to 10 mA | 0 to 10 mA | 0.01 to 4 mA | 0 to 5 mA |
| 6. | Stimulation
Pulse Width | Clinical Mode:
0.0006 seconds
Surgical Mode:
0.0002 seconds | 0.0006 seconds | 0.002 seconds | Unknown |
| 7. | Stimulation
Frequency | Clinical Mode: 6 Hz
Surgical Mode: 5 Hz | 6 Hz | 5 Hz | 3, 10, 30 Hz |
| 8. | Power | Battery 6 VDC
(4 – "C" Cells)
Option for AC Power | Battery 6 VDC
(4 -- "C" Cells) | Battery
(Lead Acid)
Battery Charger
Accessory option | AC Power |
| 9. | Safety
Standards
Compliance | EN/IEC 60601-1
EN/IEC 60601-1-2
EN/IEC 60601-2-10
EN/IEC 60601-2-40 | EN/IEC 60601-1
EN/IEC 60601-1-2 | EN/IEC 60601-1
EN/IEC 60601-1-2 | IEC 601-1
IEC 601-1-2 |
4.0 Data Summary
Testing of the Hilger Dual-Stim Nerve Stimulator was performed in compliance with the WR Medical Electronics CO. design control process. Testing included:
-
- Software verification and validation, and
-
- Declaration of safety standard compliance prior to commercial distribution.
File: Hilger Dual Stim 510k 11-21-2006 final
3
5.0 Conclusions
The safety and effectiveness of the Hilger Dual-Stim Nerve Stimulator was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Hilger Dual-Stim Nerve Stimulator is the same as the predicate devices. No new questions of safety or effectiveness are raised.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WR Medical Electronics Co. c/o Gary Syring Principal Consultant Quality & Regulatory Associates 800 Lavanger Lane Stoughton. WI 53589
JAN - 5 2007
Re: K063560
Trade/Device Name: Hilger Dual-Stim Nerve Stimulator Regulation Number: 21 CFR 874:1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: November 21, 2006 Received: November 27, 2006
Dear Mr. Syring:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
5
Page 2 - Gary Syring
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 a legally marketed predicate device results in a classification for your device and thus, permits 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelmisi MD
Malvina B Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use 510(k) Number (if known): KOR3560
Device Name: Hilger Dual-Stim Nerve Stimulator
Indications for Use:
The Hilger Dual-Stim Nerve Stimulator provides electrical stimulation to nerves during diagnostic and surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Karen H. Baker
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
KOGSSLA 510(k) Number.
Prescription Use
(Per 21 CFR 801.109) X