(65 days)
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).
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 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 provided text is a 510(k) summary for the Stimuplex® HNS 12, a peripheral nerve stimulator. It focuses on demonstrating substantial equivalence to a predicate device and outlines the device's technical specifications and intended use. It does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of clinical performance or diagnostic accuracy.
The summary states: "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."
This indicates that internal quality control procedures are in place, but it does not detail a study with the characteristics requested in your prompt (e.g., sample size, ground truth, expert adjudication, statistical performance metrics).
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample size, ground truth details, expert qualifications, adjudication methods, MRMC studies, or training set information based on the provided text.
The information given is primarily about regulatory clearance based on substantial equivalence, rather than a detailed performance study as you've outlined.
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MAR 2 2 2007
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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.
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The technical data of the device are:
| Battery: | 9 Volt alkaline |
|---|---|
| Display: | 1 graphic LCD Module1 tricolor (green, yellow, red) LED for status display |
| Operation: | 1 control button to switch on/off the deviceAdjustment knob to adjust the wanted stimulation current3 control buttons to switch the stimulation parameters4 control buttons for navigation and settings in the menusRemote 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.
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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
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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.
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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
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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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100 million to the county of
§ 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).