(65 days)
No
The description focuses on electrical stimulation parameters and user interface configuration, with no mention of AI or ML algorithms for data analysis, decision support, or automated adjustments based on learned patterns.
No.
The device is used for diagnostic purposes (to test the level of pharmacological effects of anesthetic drugs, and as a nerve locator for verification of needle placement), not to treat a disease or condition.
Yes
The device is explicitly stated to be used to "test the level of pharmacological effects of anaesthetic drugs and gases to the patient" and "as a nerve locator for the verification of needle placement," which are diagnostic applications.
No
The device description clearly details hardware components such as a battery, amplitude controller, pulse drivers, and an output amplifier, indicating it is a physical 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 Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Stimuplex® HNS 12 is a peripheral nerve stimulator. Its function is to apply electrical stimulation to locate nerve fibers and assess the effects of anesthetic drugs in vivo (within the living body).
- Intended Use: The intended use clearly states it's used to "test the level of pharmacological effects of anaesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anaesthetics." This involves interacting directly with the patient's body, not analyzing samples taken from the body.
- Device Description: The description details how the device generates electrical pulses and is used by a physician during a procedure on a patient.
Therefore, the Stimuplex® HNS 12 is a medical device used for in vivo procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Stimuplex® HNS 12 is a peripheral nerve stimulator used to test the level of pharmacological effects of anaesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anaesthetics. This device can be used wherever peripheral anaesthesia is normally applied (i.e. physicians office or hospital).
Product codes
BXN
Device Description
The nerve stimulator Stimuplex® HNS 12 is a battery powered peripheral nerve stimulator for localization of nerve fibers in the tissue. During the operation the operating physician holds a stimulation cannula in his right hand. Simultaneous the operation of the device happens with his left hand. The physician can hold the device with the left hand and simultaneous alter the stimulation amplitude at the amplitude controller.
The device's technical specifications are:
- Battery: 9 Volt alkaline
- Display: 1 graphic LCD Module, 1 tricolor (green, yellow, red) LED for status display
- Operation: 1 control button to switch on/off the device, Adjustment knob to adjust the wanted stimulation current, 3 control buttons to switch the stimulation parameters, 4 control buttons for navigation and settings in the menus, Remote control (optional stimulation current adjustment)
- Power consumption: 6 mA (8 mA max in warning/alarm state)
- Stimulation current: max. 5mApp / 0Ω - 12 kΩ
- Stimulation voltage: max. 95 Vpp
- Stimulation frequency: 1 Hz / 2 Hz
- Flowing current measuring tolerance: +/- 0.02 mA
- Weight: 0.25 kg (with battery)
The electrode connection uses a 4 pin plug connection system for correct polarity. The Stimuplex® HNS 12 generates negative, current-stabilized square pulses with selectable frequency, selectable pulse width and fine adjustable stimulation current. The pulse is shaped at both slopes by extremely fast active pulse drivers. An output amplifier specially designed for this application has an extraordinarily wide dynamic range and produces reproducible settings even below 0.1 mA. The stimulation frequency and the pulse width can be varied for different applications. The Stimuplex® HNS 12 nerve stimulator offers the facility for selecting a frequency of either 1 Hz or 2 Hz together with pulse widths of 0.1 ms, 0.3 ms or 1.0 ms. Two additional pulse widths: 0.05 ms and 0.50 ms can be enabled in options menu. Stimuplex® HNS 12 has a menu structure (in 26 languages) where the switch on parameters and options and setup parameters like tone volume, contrast, automatically switch off time, language can be configured. The battery voltage is in info menu in volt and percentage and during stimulation menu as symbol displayed.
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
for adult, pediatric and/or infant use.
Intended User / Care Setting
Physician, physicians office or hospital
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)
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to: physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's.
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
MAR 2 2 2007
Image /page/0/Picture/2 description: The image shows the logo for Stockert GmbH. The logo features a crest on the left side and the company name on the right side. The crest is black and white and features a helmet and shield. The company name is written in a simple, sans-serif font.
510(k) Summary
February 9th, 2007
Bötzinger Straße 72 79111 Freiburg phone: ++49-761-20716-0 ++49-761-20716-20 Fax: eMail: info@stockert.de http://www.stockert.de
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Contact: Dominika Schuler, Management Representative
Trade Name: Stimuplex® HNS 12
Common Name: Battery powered peripheral Nerve Stimulator
Classification Name:
Anesthesiology Devices, Class II, 73 BXN Battery Powered Nerve Stimulator 21 CFR 868.2775
Predicate Device: Stimuplex® HNS 11 K052313
The nerve stimulator Stimuplex® HNS 12 is a battery powered peripheral nerve stimulator for localization of nerve fibers in the tissue. During the operation the operating physician holds a stimulation cannula in his right hand. Simultaneous the operation of the device happens with his left hand. The physician can hold the device with the left hand and simultaneous alter the stimulation amplitude at the amplitude controller.
1
The technical data of the device are:
| Battery: | 9 Volt alkaline |
|---|---|
| Display: | 1 graphic LCD Module |
| 1 tricolor (green, yellow, red) LED for status display | |
| Operation: | 1 control button to switch on/off the device |
| Adjustment knob to adjust the wanted stimulation current | |
| 3 control buttons to switch the stimulation parameters | |
| 4 control buttons for navigation and settings in the menus | |
| Remote control (optional stimulation current adjustment) | |
| Power consumption: | 6 mA (8 mA max in warning/alarm state) |
| Stimulation current : | max. 5mApp / 0Ω - 12 kΩ |
| Stimulation voltage : | max. 95 Vpp |
| Stimulation frequency : | 1 Hz / 2 Hz |
| Flowing current | |
| measuring tolerance: | +/- 0.02 mA |
| Weight: | 0.25 kg (with battery) |
The configuration of the electrode connection is realized with a 4 pin plug connection system, which ensures correct polarity of the electrode at all times. The Stimuplex® HNS 12 generates negative, current-stabilized square pulses with selectable frequency, selectable pulse width and fine adjustable stimulation current. The pulse is shaped at both slopes by extremely fast active pulse drivers. An output amplifier specially designed for this application has an extraordinarily wide dynamic range and produces reproducible settings even below 0.1 mA. The stimulation frequency and the pulse width can be varied for different applications. The Stimuplex® HNS 12 nerve stimulator offers the facility for selecting a frequency of either 1 Hz or 2 Hz together with pulse widths of 0.1 ms, 0.3 ms or 1.0 ms. Two additional pulse widths: 0.05 ms and 0.50 ms can be enabled in options menu. Stimuplex® HNS 12 has a menu structure (in 26 languages) where the switch on parameters and options and setup parameters like tone volume, contrast, automatically switch off time, language can be configured. The battery voltage is in info menu in volt and percentage and during stimulation menu as symbol displayed.
The intended use is a peripheral nerve stimulator to test the level of pharmacological effect of anesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anesthetics. This device can be used wherever peripheral anesthesia is normally applied (i.e. physicians office or hospital). There are no known contraindications for the use of this device on any patient population.
2
The fundamental scientific technology and the characteristics of the modified Stimuplex® HNS 12 are entirely equivalent in materials, form and intended use to the predicate device. The only diference between the modified Stimuplex® HNS 12 and the predicate device consist in additional accessories Stimuplex® Switch alternative electrode cable for ergonomic connecting of the stimulation needle or the stimulation catheter. The intended use of the modified Stimuplex® HNS 12 has not changed as a result of the modification.
The Stimuplex® HNS 12 is highly specific for its intended use in anesthesiology. The instruction of the Stimuplex® Switch doesn't affect safety and effectiveness for the intended use.
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to: physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's.
signed:
Dominika Schuler, Management Representative Stockert GmbH
te: 2007-02-20
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dominika Schuler Management Respresentative Stockert GmbH Böetzinger Strasse 72 D-79111 Freiburg GERMANY
MAR 2 2 2007
Re: K070134
Trade/Device Name: Stimuplex® HNS 12 Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: February 20, 2007 Received: February 26, 2007
Dear Ms. Schuler:
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 - Ms. Schuler
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 (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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clive
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: Stimuplex ® HNS 12
Indications for Use:
Stimuplex® HNS 12 is a peripheral nerve stimulator used to test the level of pharmacological effects of anaesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anaesthetics. This device can be used wherever peripheral anaesthesia is normally applied (i.e. physicians office or hospital). Intended patient population: for adult, pediatric and/or infant use.
This is the same intended use as previously cleared for the Stimuplex® HNS 12, 510(k) Number K 052313, date 2005-11-17.
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)
chle indo
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