STIMUPLEX-DIG-RC NERVE STIMULATOR

K021033 · B.Braun Medical, Inc. · BXN · Mar 21, 2003 · Anesthesiology

Device Facts

• Record ID: K021033
• Device Name: STIMUPLEX-DIG-RC NERVE STIMULATOR
• Applicant: B.Braun Medical, Inc.
• Product Code: BXN · Anesthesiology
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2775
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stimuplex®-DIG-RC Nerve Stimulator is intended for use with B. Braun Medical Inc. Stimuplex and Contiplex® insulated needle sets for use in regional anesthesia and regional pain therapy. Peripheral nerves are stimulated and located via electrical current impulses flowing through an insulated needle.

Device Story

Stimuplex®-DIG-RC Nerve Stimulator is a battery-powered device used for peripheral nerve localization during regional anesthesia and pain therapy. The system comprises a handheld remote control unit with finger rings, a current regulator, an internal connection for electrode cables, a frequency switch, and a digital display for current settings. The device operates by delivering electrical current impulses through B. Braun Stimuplex or Contiplex insulated needles to stimulate peripheral nerves. Clinicians use the device to guide needle placement; the digital display provides feedback on current settings to assist in nerve location. The device is intended for professional use in clinical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Battery-powered nerve stimulator; includes handheld remote control, current regulator, frequency switch, and digital display. Operates via electrical current impulses through insulated needles. Class II device (21 CFR 868.2275).

Indications for Use

Indicated for use in regional anesthesia and regional pain therapy to stimulate and locate peripheral nerves using insulated needle sets.

Regulatory Classification

Identification

An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

Predicate Devices

• B. Braun Medical Inc. Stimuplex® Nerve Stimulator

Submission Summary (Full Text)

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## 510(k) Summary KOZI O 33 7.0

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2375<br><br>Contact: Sheri L. Musgnung, RA Manager | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| DEVICE NAME: | Stimuplex® STIM-DIG-RC Nerve Stimulator | |
| COMMON OR USUAL<br>NAME: | Nerve Stimulator | |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR 868.2275: Stimulator, Nerve, Battery<br>Powered | |
| PREDICATE DEVICE: | B. Braun Medical Inc. Stimuplex® Nerve Stimulator | |
| DESCRIPTION: | The modified Stimuplex®-DIG-RC Nerve Stimulator<br>consists of a hand held remote control unit with separate<br>finger rings for the remote control. The STIM-DIG RC<br>consists of a closed circuit led, a current regulator, an<br>internal connection for electrode cable, a frequency switch,<br>and a battery led. The digital display indicates the current<br>settings. | |
| INTENDED USE: | The Stimuplex®-DIG-RC Nerve Stimulator is intended for<br>use with B. Braun Medical Inc. Stimuplex and Contiplex®<br>insulated needle sets for use in regional anesthesia and<br>regional pain therapy. Peripheral nerves are stimulated and<br>located via electrical current impulses flowing through an<br>insulated needle. | |
| SUBSTANTIAL<br>EQUIVALENCE: | The modifications that were made to the STIM-DG-RC do<br>not affect the indication for use and does not alter the<br>fundamental technology of the device. The operation and<br>function of the unit remains the same. The risk analysis<br>method used to access the impact of the modifications was<br>a Failure Modes and Effects Analysis. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with three horizontal lines representing its wings and a curved line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

Ms. Sheri L. Musgnung B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, PA 18109-9341

Re: K021033

Trade/Device Name: Stimuplex®-DIG-RC Nerve Stimulator Regulation Number: 868.2775 Regulation Name: Battery Powered Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: March 13, 2003 Received: March 14, 2003

Dear Ms. Musgnung:

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

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Page 2 – Ms. Musgnung

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Susan Runner, DDS, MA

Interim Director Division of Anesthesiology, General Hospital, . Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2.0 Indications for Use Statement

| 7<br>0000<br>)<br>1 | C<br>C<br>S | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|----------------------------------------------------|
| 510(k) Number (if known): | K021033 |
| Device Name: | ~~Stimypten~~ Stimuplex-DIG-RC<br>NERVE STIMULATOR |

Indications For Use:

The Stimuplex®-DIG-RC Nerve Stimulator is intended for use with B. Braun Medical Inc. Stimuplex and Contiplex® insulated needle sets for use in regional anesthesia and regional pain therapy. Peripheral nerves are stimulated and located via electrical current impulses flowing through an insulated needle.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

000005

Jan E. Harris 3/21/03

510(k) Number: ki21033