(357 days)
Not Found
No
The description focuses on basic electrical stimulation and digital display, with no mention of AI/ML terms or functionalities.
Yes
The device is described as being used for "regional anesthesia and regional pain therapy", which are therapeutic applications.
No
The device is used to locate peripheral nerves via electrical current impulses and does not diagnose a medical condition.
No
The device description clearly outlines hardware components such as a hand-held remote control unit, finger rings, a closed circuit led, a current regulator, an internal connection for electrode cable, a frequency switch, a battery led, and a digital display. This indicates it is a hardware device with integrated software, not a software-only medical device.
No, 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.
- Device Function: The Stimuplex®-DIG-RC Nerve Stimulator is used to stimulate and locate peripheral nerves in the body using electrical current. It is a device used directly on the patient for a therapeutic or diagnostic procedure, not for analyzing samples taken from the patient.
- Intended Use: The intended use clearly states it's for "regional anesthesia and regional pain therapy" and involves stimulating nerves via an insulated needle. This is an in-vivo procedure.
Therefore, based on the provided information, the Stimuplex®-DIG-RC Nerve Stimulator is a medical device used in a clinical setting for a procedure performed directly on a patient, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
BXN
Device Description
The modified Stimuplex®-DIG-RC Nerve Stimulator consists of a hand held remote control unit with separate finger rings for the remote control. The STIM-DIG RC consists of a closed circuit led, a current regulator, an internal connection for electrode cable, a frequency switch, and a battery led. The digital display indicates the current settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral nerves
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
B. Braun Medical Inc. Stimuplex® Nerve Stimulator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) Summary KOZI O 33 7.0
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2375
Contact: Sheri L. Musgnung, RA Manager | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| DEVICE NAME: | Stimuplex® STIM-DIG-RC Nerve Stimulator | |
| COMMON OR USUAL
NAME: | Nerve Stimulator | |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR 868.2275: Stimulator, Nerve, Battery
Powered | |
| PREDICATE DEVICE: | B. Braun Medical Inc. Stimuplex® Nerve Stimulator | |
| DESCRIPTION: | The modified Stimuplex®-DIG-RC Nerve Stimulator
consists of a hand held remote control unit with separate
finger rings for the remote control. The STIM-DIG RC
consists of a closed circuit led, a current regulator, an
internal connection for electrode cable, a frequency switch,
and a battery led. The digital display indicates the current
settings. | |
| 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. | |
| SUBSTANTIAL
EQUIVALENCE: | The modifications that were made to the STIM-DG-RC do
not affect the indication for use and does not alter the
fundamental technology of the device. The operation and
function of the unit remains the same. The risk analysis
method used to access the impact of the modifications was
a Failure Modes and Effects Analysis. | |
1
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
2
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 (301) 594-4646. 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 (301) 443-6597 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
3
2.0 Indications for Use Statement
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| Labels | Values |
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| 510(k) Number (if known): | K021033 |
| Device Name: | |
| 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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