(357 days)
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.
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.
This submission is for a modification to a Stimuplex®-DIG-RC Nerve Stimulator, not a new device requiring a full clinical study with acceptance criteria and a test set. Therefore, much of the requested information regarding performance, sample sizes, expert involvement, and ground truth is not applicable.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or report device performance data. The submission is for a modification to an existing device, and the primary demonstration is substantial equivalence to the predicate device. The "Substantial Equivalence" section states: "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." This implies that the acceptance criteria for the modifications were likely related to ensuring the modified device met the same functional and safety requirements as the predicate, possibly through engineering verification tests, but these specific criteria are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. Since this is a modification to an existing device and not a de novo submission requiring efficacy testing, there is no mention of a test set or clinical data of this nature. The evaluation appears to be based on engineering analysis rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts is described for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or related adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a nerve stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth of this nature was established, as the submission focuses on modifications to an existing device and substantial equivalence based on engineering and risk analysis.
8. The sample size for the training set
Not applicable. No training set is mentioned or relevant for this submission type.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for it was established.
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510(k) Summary KOZI O 33 7.0
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2375Contact: Sheri L. Musgnung, RA Manager | |
|---|---|---|
| DEVICE NAME: | Stimuplex® STIM-DIG-RC Nerve Stimulator | |
| COMMON OR USUALNAME: | Nerve Stimulator | |
| DEVICECLASSIFICATION: | Class II, 21 CFR 868.2275: Stimulator, Nerve, BatteryPowered | |
| PREDICATE DEVICE: | B. Braun Medical Inc. Stimuplex® Nerve Stimulator | |
| DESCRIPTION: | The modified Stimuplex®-DIG-RC Nerve Stimulatorconsists of a hand held remote control unit with separatefinger rings for the remote control. The STIM-DIG RCconsists of a closed circuit led, a current regulator, aninternal connection for electrode cable, a frequency switch,and a battery led. The digital display indicates the currentsettings. | |
| INTENDED USE: | The Stimuplex®-DIG-RC Nerve Stimulator is intended foruse with B. Braun Medical Inc. Stimuplex and Contiplex®insulated needle sets for use in regional anesthesia andregional pain therapy. Peripheral nerves are stimulated andlocated via electrical current impulses flowing through aninsulated needle. | |
| SUBSTANTIALEQUIVALENCE: | The modifications that were made to the STIM-DG-RC donot affect the indication for use and does not alter thefundamental technology of the device. The operation andfunction of the unit remains the same. The risk analysismethod used to access the impact of the modifications wasa 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 (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
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2.0 Indications for Use Statement
| 70000)1 | CCS | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| Labels | Values |
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| 510(k) Number (if known): | K021033 |
| Device Name: |
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
§ 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).