(173 days)
Not Found
No
The description mentions a microprocessor that adapts voltage to maintain constant current, which is a control system function, not AI/ML. There is no mention of learning, pattern recognition, or data-driven decision making beyond this basic control loop.
Yes
The device is used for nerve stimulation during anesthesia delivery to identify and localize peripheral nerves, which aids in a medical procedure. While it doesn't directly treat a disease, it plays a role in facilitating treatment and is not merely diagnostic.
No
The device is intended for nerve stimulation to identify and localize peripheral nerves during anesthesia delivery and for relaxation monitoring by interpreting muscular feedback to stimulation pulses, not for diagnosing a disease or condition.
No
The device description explicitly states it is a "hand-held, battery-driven peripheral nerve stimulator" and describes hardware components like a microprocessor, constant-current-source, and the generation of electrical pulses applied through needles or electrodes. 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Pajunks's MultiStim SENSOR is a nerve stimulator that applies electrical pulses to the human body (either through needles or electrodes on the skin) to locate nerves or monitor muscle relaxation. It does not analyze samples taken from the body.
The device is an active medical device used for diagnosis and monitoring in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
N/A
Intended Use / Indications for Use
Pajunks's MultiStim SENSOR is intended for nerve stimulation during anaesthesia delivery; first for percutaneous identification of peripheral nerves and second for percutaneous localizations. This device is indicated for adults only.
Product codes
KOI, BXN
Device Description
The MultiStim SENSOR devices are hand-held, battery-driven peripheral nerve stimulators for this purpose. The devices can be used for:
- . Nerve finding with peripheral nerve stimulation needles
- Percutaneous localization .
In relaxation monitoring for general anesthesia, the peripheral nerve stimulation technique is used to interpret the muscular feedback to stimulation pulses applied through adhesive skin electrodes in regards to the level of muscle relaxing drugs in the patient. Special functions do support this. Due to the fact, that the stimulation is done through the skin, much more electrical power is needed. That's why a stimulation current range of 0-60mA is needed.
In both applications, negative, monophasic pulses are to be generated by the devices and applied to humans either through peripheral nerve stimulation needles or through self-adhesive stimulation electrodes on the skin. Since the human body acts as a variable resistor and the anesthesiologist sets the device to a certain stimulation current, the nerve stimulator has to act as a constant-current-source. A built in microprocessor constantly adapts the voltage applied to the patient in order to compensate the varying patient's resistance and to provide a constant current through the patient.
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
adults only.
Intended User / Care Setting
Not Found
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 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
Ko61172
Section 6.0
510(k) Summary of Safety and Effectiveness
This section contains the 510(k) Summary of Safety and Effectiveness. (This document can be copied and submitted to interested parties as required by 21CFR 807.92).
510(k) Summary of Safety and Effectiveness
Submitter's Information:
Pajunk Medical Technology GmbH Karl-Hall-Str. 1 78187 Geisingen Germany
OCT 1 7 2006
USA Contact:
.
Lynette Howard (Pajunk's USA agent) Lyle Howard Corporation 106 East 5th Ave. Mount Dora, Florida 32757 USA P 908.788.4580 F 352.383.8338 e-mail: Lylehoward@aol.com
Device Name:
Trade Names: MultiStim SENSOR
Common Names: Peripheral Nerve Stimulator
Classification Name: Electrical Peripheral Nerve Stimulator (Reference, 21 CFR, 868.2775)
Product Class: Class II
Product Code: KOI
68
1
Predicate Devices:
Pajunk's MultiStim SENSOR Nerve Stimulators are substantially equivalent to Pajunk's MultiStim VARIO Nerve Stimulators marketed under 510(k) number K011308.
Device Description:
The MultiStim SENSOR devices are hand-held, battery-driven peripheral nerve stimulators for this purpose. The devices can be used for:
- . Nerve finding with peripheral nerve stimulation needles
- Percutaneous localization .
In relaxation monitoring for general anesthesia, the peripheral nerve stimulation technique is used to interpret the muscular feedback to stimulation pulses applied through adhesive skin electrodes in regards to the level of muscle relaxing drugs in the patient. Special functions do support this. Due to the fact, that the stimulation is done through the skin, much more electrical power is needed. That's why a stimulation current range of 0-60mA is needed.
In both applications, negative, monophasic pulses are to be generated by the devices and applied to humans either through peripheral nerve stimulation needles or through selfadhesive stimulation electrodes on the skin. Since the human body acts as a variable resistor and the anesthesiologist sets the device to a certain stimulation current, the nerve stimulator has to act as a constant-current-source. A built in microprocessor constantly adapts the voltage applied to the patient in order to compensate the varying patient's resistance and to provide a constant current through the patient.
Intended Use:
Pajunks's MultiStim SENSOR is intended for nerve stimulation during anaesthesia delivery; first for percutaneous identification of peripheral nerves and second for percutaneous localizations. This device is indicated for adults only.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2006
Pajunk GmbH Medizintechnologie C/O Ms. Lynette L. Howard Lyle Howard Corporation 106 East 5th Avenue Mount Dora, Florida 32757
Re: K061172
Trade/Device Name: Pajunk Anesthesia MultiStim SENSOR-Nerve Stimulators Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: September 22, 2006 Received: September 26, 2006
Dear Ms. Howard:
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.
3
Page 2 - Ms. Howard
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,
Clare
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
4
Indications for Use
510(k) Number (if known):
Pajunk Anesthesia MultiStim SENSOR - Nerve Stimulators Device Name:
Indications For Use:
Pajunks's MultiStim SENSOR is intended for nerve stimulation during anaesthesia delivery; first for percutaneous identification of peripheral nerves and second for percutaneous localizations. This device is indicated for adults only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Replacement for original pages 8 & 27
Aun Saffron
Jl Siam-CM
u of Anesthesielogy, General Hospital con Control, Dental Devices