(14 days)
Not Found
No
The document describes a standard nerve stimulator with constant current and square wave output. There is no mention of AI, ML, or any learning or adaptive capabilities.
No
This device is for nerve stimulation for mapping and locating, which are diagnostic/guiding purposes for surgical procedures, not for treatment or therapy.
No
Explanation: The device is described as a nerve stimulation device used for nerve mapping and locating during regional anesthesia. Its purpose is to stimulate nerves, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "battery powered peripheral nerve stimulator" and includes hardware components like a "constant current source," "permanently attached nerve mapping probe (supplied)," and relies on "invasive electrodes/needles (not supplied)." This indicates it is a hardware device with associated 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The STIMPOD NMS400 is a nerve stimulation device. It applies electrical stimulation to the body to help locate nerves. It does not analyze samples taken from the body.
- Intended Use: The intended use is for nerve mapping and locating during regional anesthesia, which is a procedure performed directly on the patient.
Therefore, based on the provided information, the STIMPOD NMS400 falls under the category of a therapeutic or diagnostic device used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is a nerve stimulation device designed to be used by an anesthetist during regional anesthesia for the purpose of
- nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
- nerve locating using invasive electrodes/needles (not supplied)
Product codes
BXN
Device Description
The STIMPOD NMS400 is a battery powered peripheral nerve stimulators that can be used for
- nerve mapping using the non-invasive Nerve Mapping Probe (supplied) ◆
- nerve locating using invasive electrodes/needles (not supplied)
The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.
The anode comprises of an ECG electrode (not supplied). The cathode comprises a permanently attached nerve mapping probe (supplied), and/or a separate nerve locating needle (not supplied), depending on the mode of the unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
an anesthetist
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)
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
KC093591
SECTION 4
DEC - 3 2009
ﺎ
SECTION 4 - 510(k) SUMMARY
[As required by 21CFR807.92]
Image /page/0/Picture/5 description: The image shows the logo for Xavant Technology. The logo features a stylized "X" with an orbital path around it, followed by the text "AVANT" in bold, uppercase letters. Below "AVANT" is the word "TECHNOLOGY" in a smaller, uppercase font.
4.1 Date Prepared [21CFR807.92(a)(1)] May 11, 2009
: "
1 く
4.2 Submitter's Information [21CFR807.92(a)(1)]
| Company Name: | XAVANT TECHNOLOGY (PTY) LTD |
|---|---|
| Street Address: | Ravello 1st Floor, Delmondo Office Park |
| 169 Garsfontein Road | |
| Ashlea Gardens 0081 | |
| City: | Pretoria |
| State/Province: | Gauteng |
| Country: | South Africa |
| Telephone: | +27(0) 12 755 9491 |
| Facsimile: | +27(0) 86 547 0026 |
| Contact Person: | Brian Rothman |
| Contact Title: | Quality Assurance and Regulatory |
| Compliance Officer | |
| Contact Email: | brian@xavant.com |
4.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]
Trade Name: STIMPOD NMS400 Nerve Stimulator Common Name: Classification Name: per 21 CFR § 868.2775 Device Class:
Product Code:
Battery Powered Peripheral Nerve Stimulator Battery Powered Nerve Stimulator Class II BXN
1
SECTION 4
4.4 Identification of Predicate Device(s) [21CFR807.92(a)(3)[
Image /page/1/Figure/2 description: The image shows a list of predicate devices. The first device is the HDC Corporation, NeuroTrace III (K023342). The second device is the Xavant Technology, XPOD/XMAP Nerve Stimulator (K072092). The third device is the Stockert GmbH, Stimuplex HNS12 (K052313).
There are no significant differences between the STIMPOD NMS400 Nerve Stimulator and the predicate devices that would adverselv affect the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
4.5 Description of the Device [21CFR807.92(a)(4)]
The STIMPOD NMS400 is a battery powered peripheral nerve stimulators that can be used for
- nerve mapping using the non-invasive Nerve Mapping Probe (supplied) ◆
- nerve locating using invasive electrodes/needles (not supplied)
The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.
The anode comprises of an ECG electrode (not supplied). The cathode comprises a permanently attached nerve mapping probe (supplied), and/or a separate nerve locating needle (not supplied), depending on the mode of the unit.
4.6 Intended Use [21CFR807.92(a)(5)]
This product is a nerve stimulation device designed to be used by an anesthetist during regional anesthesia for the purpose of
-
- nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
-
- nerve locating using invasive electrodes/needles (not supplied)
11
2
SECTION 4
4.7 Technological Characteristics [21CFR807.92(a)(6)]
Stimulus Modes
11 ﺷ
Monophasic Square wave, repeating at 1Hz or 2Hz
Current Ranges
| Nerve mapping: | 0 – 20mA |
|---|---|
| Pulse Width: | 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms |
| Nerve Locating: | 0.0 - 5.0mA |
| Pulse Width: | 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms |
Stimulation Voltages
| Nerve Mapping: | Max 300V p-p |
|---|---|
| Nerve Locating: | Max 100V p-p |
Waveform
· Constant Current Monophasic Squarewave
Nerve Mapping Probe
Nerve Mapping Probe designed for non-invasive nerve mapping
Technical Specifications
| Power Supply | 4 x AAA Alkaline Batteries |
|---|---|
| Weight | 130g |
| Dimensions | 145mm x 90mm x 30mm |
STIMPOD NMS400 Nerve Stimulator Doc No: XAV-510k-02 Ver 2.00
Page 4-3 XAVANT TECHNOLOGY
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text reading "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract symbol resembling an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Xavant Technology Party, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-5926
DEC - 3 2009
Re: K093591
Trade/Device Name: STIMPOD NMS400 Nerve Stimulator Regulation Number: 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: October 26, 2009 Received: November 19, 2009
Dear Mr. Mouser:
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 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.
4
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1]15809.htm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): KC99359)
Device Name:
ﺋ
STIMPOD NMS400 Nerve Stimulator
Indications for Use:
This product is a nerve stimulation device designed to be used by an anesthetist during regional anesthesia for the purpose of
-
nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
-
nerve locating using invasive electrodes/needles (not supplied)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
- 510(k) Number: K093591