(108 days)
Not Found
No
The description focuses on basic electrical stimulation and circuit detection, with no mention of AI/ML terms or functionalities.
No.
The device is used for nerve stimulation to map and locate nerves during regional anesthesia procedures, which is a diagnostic or procedural aid, not a therapeutic treatment itself.
No
Explanation: The device is described as a nerve stimulation device for nerve mapping and localization during regional anesthesia procedures, which are therapeutic and procedural applications, not diagnostic ones. It helps identify the location of nerves to aid in anesthesia administration, rather than diagnosing a condition.
No
The device description explicitly details hardware components such as a battery, constant current source, LCD screen, anode (ECG type pad), cathode (nerve mapping probe or nerve locating needle), and mentions generating a stimulus and checking for a closed circuit. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The XPOD/XMAP is a nerve stimulation device used in vivo (within the living body) to locate nerves during regional anesthesia procedures. It applies electrical current to the body to elicit a response (nerve twitch).
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the patient's body.
Therefore, the XPOD/XMAP falls under the category of a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/needles (not supplied).
Product codes (comma separated list FDA assigned to the subject device)
BXN
Device Description
The XPod/XMap devices are 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 2 options for pulse width. These are: 0.1 and 0.3 milliseconds.
The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected.
Visual feedback of the current amplitude as well as pulse-width is given by means of an LCD screen.
The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises a permanently attached nerve mapping probe, in the XMap model, and a separate nerve locating needle in the XPod model.
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 during regional anesthesia procedures wherever peripheral anesthesia is normally applied.
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): 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.
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
§ 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
SECTION 4
ION 4 -- 510(k) SUMMARY SECT
NOV 1 5 2007
[As required by 21CFR807.92]
Image /page/0/Picture/5 description: The image shows the logo for Xavant Technologies. The logo features a large, bold "X" followed by the word "AVANT" in a similar bold font. Below "AVANT" is the word "TECHNOLOGIES" in a smaller, less bold font.
4.1 Date Prepared [21CFR807.92(a)(1)]
July 26, 2007
4.2 Submitter's Information [21CFR807.92(a)(1)]
| Company Name: | XAVANT Technology (Pty) LTD |
|---|---|
| Street Address: | 181 Soutpansberg Road, Rietondale |
| City: | Pretoria |
| State/Province: | Gauteng |
| Country: | South Africa |
| Telephone: | +27(0) 12 329 1188 |
| Facsimile: | +27(0) 86 671 8334 |
| Contact Person: | Roché van Rensburg |
| Contact Title: | Director |
| Contact Email: | roche@xavant.com |
4.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]
| Trade Name: | The XPOD/XMAP Nerve Stimulator |
|---|---|
| Common Name: | Battery Powered Peripheral Nerve Stimulator |
| Classification Name: | Battery Powered Nerve Stimulator |
| per 21 CFR § 868.2775 | |
| Device Class: | Class II |
| Product Code: | BXN |
XAVANT Technology Nerve Stimulator
1
SECTION 4
4.4 Identification of Predicate Device(s) [21CFR807,92(a)(3)]
| PREDICATE DEVICES |
|---|
| HDC CORP, Neuro-Trace III |
| (K023342) |
| Stockert GmbH, Stimuplex HNS12 |
| (K052313) |
There are no significant differences between the XPOD/XMAP Nerve Stimulator and the predicate devices which would adversely affect the use of 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 XPod/XMap devices are battery powered peripheral nerve stimulators that can be used for
- nerve mapping using the non-invasive Nerve Mapping Probe (supplied) ﻬ
- nerve locating using invasive electrodes/needles (not supplied) ◆ ◆
The stimulus is generated by a constant current source. The waveform is a square wave with 2 options for pulse width. These are: 0.1 and 0.3 milliseconds.
The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected.
Visual feedback of the current amplitude as well as pulse-width is given by means of an LCD screen.
The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises a permanently attached nerve mapping probe, in the XMap model, and a separate nerve locating needle in the XPod model.
4.6 Intended Use [21CFR807.92(a)(5)]
The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/needles (not supplied).
XAVANT Technology Nerve Stimulator
2
SECTION 4
4.7 Technological Characteristics [21CFR807.92(a)(6)]
Stimulus Modes
Square wave, repeating at 2Hz
Current Ranges
| Xmap: | 0 - 20mA adjustable in 1mA increments |
|---|---|
| Pulse Width: | 0.1ms, 0.3ms |
| Xpod: | 0.0 - 1.6mA adjustable in 0.1mA increments |
| 1.6 - 5.0mA adjustable in 0.2mA increments | |
| Pulse Width: | 0.1ms, 0.3ms |
Stimulation Voltages
| XMap: | Max 100V p-p |
|---|---|
| XPod: | Max 100V p-p |
Waveform
Constant Current Monophasic Squarewave
Nerve Mapping Probe
Ergonomically designed cutaneous Nerve Mapping Probe
Technical Specifications
| Power Supply | 2x 1.5V AAAA Alkaline Batteries |
|---|---|
| Weight | 60g |
| Dimensions | 80mm x 80mm x 22mm |
XAVANT Technology Nerve Stimulator
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and four horizontal bars above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2007
Mr. Roche Van Rensburg Director Xavant Technology Party, Limited 181 Soutpansberg Road, Rietondale Pretoria, Gauteng 0084 South Africa
Re: K072092
Trade/Device Name: XPOD/XMAP Nerve Stimulator Regulation Number: 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: October 5, 2007 Received: October 29, 2007
Dear Mr. Rensburg:
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.
4
Page 2 - Mr. Rensburg
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 (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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Chiu Liu, Ph.D.
Chiu Lin. Ph.D. 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):
| Device Name: |
|---|
| -------------- |
The XPOD/XMAP Nerve Stimulator
Indications for Use:
The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/needles (not supplied).
Prescription Use × (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)
Mrij Thlhl
Comment sion of Anesthesion)
Non of Anesthesiology, General Hornital,
Continuesthesional Device: Device al Chirol, Dental Device