MultiStim ECO

K162086 · PAJUNK GmbH Medizintechnologie · BXN · Jan 6, 2017 · Anesthesiology

Device Facts

• Record ID: K162086
• Device Name: MultiStim ECO
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: BXN · Anesthesiology
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pajunk's MultiStim ECO is intended for nerve stimulation during anaesthesia delivery; first for identification of peripheral nerves and second for localizations. This device is indicated for adults only.

Device Story

Handheld, battery-powered peripheral nerve stimulator; used by clinicians during anesthesia delivery. Device inputs: manual user settings via membrane switch (amplitude 0.2–2.0 mA). Device transforms inputs via hardware-based quartz crystal pulse generator (fixed 1 Hz frequency, 0.1 ms pulse width). Output: electrical stimulation pulses delivered to patient via connected stimulation needle (e.g., SonoPlex, UniPlex). Clinician uses output to verify needle tip position relative to nerve via landmark or ultrasound guidance; stimulation stops once target reached. Benefits: optimized puncture accuracy; simplified one-hand operation; compact design.

Clinical Evidence

Bench testing only. Performance verified by comparing output signals (mA/mV) of MultiStim ECO against MultiStim SENSOR using an oscilloscope. Results demonstrated congruent pulse generation across all amplitude settings (0.2 mA to 2.0 mA). Compliance with electrical safety and EMC standards (EN 60601 series) confirmed.

Technological Characteristics

Handheld, battery-powered (2x 1.5V N batteries). Hardware-controlled pulse generation via quartz crystal (32.768 kHz). Output: 1 Hz frequency, 0.1 ms pulse width, 0.2–2.0 mA amplitude. Dimensions: 65mm x 93mm x 20mm. IP54 protection. No software. Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for adults requiring peripheral nerve identification and localization during anesthesia delivery.

Regulatory Classification

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.

Predicate Devices

• MultiStim SENSOR (K061172)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2017

PAJUNK® GmbH Medizintechnologie Christian Quass Director Regulatory Affairs Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg GERMANY

Re: K162086 Trade/Device Name: MultiStim ECO Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: BXN Dated: December 8, 2016 Received: December 9, 2016

Dear Christian Quass:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. 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 MultiStim ECO

Indications for Use (Describe)

Pajunk's MultiStim ECO is intended for nerve stimulation during anaesthesia delivery; first for identification of peripheral nerves and second for localizations. This device is indicated for adults only.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary as required by 21 CFR 807.92(c).

Date of Preparation: January 6t0 2017

### Document Control Number:

#### 510(k) owner:

PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany Fon: [phone] Fax: [phone] Establishment Registration Number:

#### 9611612

#### Submitter Information/ production site:

PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany Fon: [phone] Fax: [phone] Establishment Registration Number: 9611612

#### Contact:

Christian G. H. Quass Director Regulatory Affairs, Safety Officer Patricia Weisbrod Regulatory Affairs Manager Fon: [phone] Fax: [phone] E-Mail: [e-mail] E-Mail: [e-mail]

#### USA Contact:

PAJUNK MEDICAL SYSTEMS 6611 Bay Circle, Suite 140 Norcross, GA 30071 Phone +1 (888) 9PAJUNK (72-5865) Fax [phone]

Establishment Registration Number: 3004076349

#### Contact

Marco Wohnig President PAJUNK® Medical Systems L.P. Phone: [phone] Direct: [phone] [phone] Cell: Fax: [phone] E-Mail: [e-mail]

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# Device Information:

Document Control Number

Device Name:

MultiStim ECO

| Classification Name: | Battery Powered Nerve Stimulator |
|------------------------------------|----------------------------------|
| Classification Reference: | 21 CFR § 868.2775 |
| Product Code: | BXN |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |

# Predicate Device Information:

| Device Name: | MultiStim SENSOR |
|------------------------------------|-------------------------------------------------------------------------------------------------------|
| Document Control Number | K061172 |
| 510(k) title | PAJUNK MULTISTIM SENSOR NERVE<br>STIMULATORS |
| 510(k) owner | Pajunk GmbH Medizintechnologie<br>Karl-Hall-Str. 1<br>78187 Geisingen, Baden-Wuerttemberg,<br>Germany |
| Classification Name: | Peripheral Nerve Stimulator |
| Classification Reference: | 21 CFR § 868.2775 |
| Product Code: | BXN, KOI |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Panel: | Anesthesiology |

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PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the MultiStim ECO handheld, battery powered peripheral nerve stimulator.

The use of nerve stimulators for the identification of peripheral nerves is established as a routine procedure.

In this way simultaneous control of the distance of the cannula to the nerve using stimulation enables an optimization of the puncture accuracy for each anaesthetist.

The MultiStim ECO is a nerve stimulator that is suitable for stimulation technique. It is characterized in particular by the following properties:

- small, compact device complies with the requirements of combined procedures -
- -Simple operation - manual settings are limited to the parameters proven in practice
- -No additional patient cable - cannula is directly connected to the device

The MultiStim ECO settings are adapted to standard applications as well as the intuitively operated keyboard enable one-hand operation. A keystroke is all that is necessary for activation after switching on - an additional function selection is not required.

#### Basic functions/ features:

#### Fixed defined settings:

The frequency is predefined at 1 Hz and the stimulation pulse width at 0.1 ms.

Due to safety reasons, stimulation is first activated by a touch of the stimulation button.

#### Variation of the current strength

Depending on the special requirements of an application, the current strength can be gradually set on a six-level amplitude scale from 0.2 to 2.0 mA. Arrow buttons are used for the plus/minus key.

#### Fixation by an adhesive electrode

The MultiStim ECO has a pushbutton connection on the lower side of the device and is clicked directly on the adhesive electrode. The stimulateable cannula is connected directly to the MultiStim ECO.

#### Sequence of use:

The needle (e.g. SonoPlex, UniPlex, separately available and cleared for market) is directly connected to the MultiStim ECO via the stimulation cable equipped with a Ø2mm plug.

The stimulator is turned on. The needle then is advanced through the patient´s skin and directed towards the nerve (e. g. via landmark technique or by means of ultrasound). The stimulation is activated to verify the position of the needle´s tip.

Once the desired target is reached, the stimulator is turned off and the anesthetic agent is applied.

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Image /page/6/Picture/0 description: The image shows the word "PAJUNK" in white letters against a teal background. The letters are slightly blurred, giving them a soft, glowing effect. A small circled R symbol is present to the right of the K, indicating a registered trademark.

#### Intended Use

#### Subject device:

Pajunk's MultiStim ECO is intended for nerve stimulation during anaesthesia delivery; first for identification of peripheral nerves and second for localizations. This device is indicated for adults only.

#### Predicate Device K061172:

Pajunk'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.

#### Determination methods and results of Substantial Equivalence Determination:

The intended use as well as the basic technical description of the stimulator which is relevant to clinical use is identical to the predicate device K061172 and has been cleared in 510(k) sent in earlier by the sponsor and cleared by the Food and Drug Administration.

The pulse is generated by pre-built hardware settings only. The options for the user are realized using a hardware solution.

Both devices generate the individual pulse with a quartz crystal:

Image /page/6/Figure/11 description: The image shows a block diagram of a system. The diagram starts with a "Quartz crystal 32,768 kHz" block, which leads to a "Clock Generation for stimulation frequency" block, which then leads to an "Impulse Generation for stimulation impulse duration" block. In parallel, an "Energy Source (Battery)" block leads to a "Power Supply" block, which then connects to "Current sources". Finally, both the "Impulse Generation" and "Current sources" blocks lead to a "Connectivity to patient" block.

The difference between the predicate device, the MultiStim SENSOR and the subject device, the MultiStim ECO is the ECO does neither contain nor employ any software.

The clinical technique and the indications for use are absolutely identical. None of these is affected by the hardware solution as it is subject to this submission.

#### Intended Use

#### Intended Use Subject Device

Pajunk's MultiStim ECO is intended for nerve stimulation during anaesthesia delivery, first for identification of peripheral nerves and second for localizations. This device is indicated for adults only.

#### Intended Use K061172 (Predicate Device)

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# PAJUNK®

#### Pioneering medical technology

Pajunk'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.

#### Discussion of differences

For both, the subject device and the predicate device the indications for use is exactly the same. The Predicate device as well as the subject device is used with stimulation needles. The word "percutaneous" has been eliminated in the subject submission because it is obsolete and even misleading.

Conclusion: Substantially Equivalent

| | Predicate device | Subject Device | Result of<br>comparison, if<br>necessary with<br>rationale |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Characteristics | MultiStim SENSOR | MultiStim ECO | |
| Picture<br>(not for scale) | Image: MultiStim SENSOR | Image: MultiStim ECO | n.a. |
| Dimensions | 65mm x 120mm x 27mm | 65mm x 93mm x 20mm | n.a. |
| FDA<br>Classification | Class II | Class II | Identical |
| FDA Product<br>Code | BXN | BXN | Identical |
| FDA Common<br>Name | Peripheral Nerve Stimulator | Peripheral Nerve Stimulator | Identical |
| FDA<br>Classification<br>name | 868.2775 | 868.2775 | Identical |
| Biocompatibility | ISO 10993-1 compliant material | | Identical |
| Labeling | 21 CFR and European Medical Devices Directive compliant | | Identical |
| Packaging | Hard Case | Hard Case | Similar |
| Overall design | | | |
| Physical<br>configuration | Handheld | Handheld | Identical |
| User Input | Menu structure in display,<br>pushbutton, membrane switch | Membrane switch, direct feedback | Reduced |
| User Feedback | LED, Display | LED | Reduced |
| | Predicate device<br>MultiStim SENSOR | Subject Device<br>MultiStim ECO | Result of<br>comparison, if<br>necessary with<br>rationale |
| Power Supply | Battery | Battery | Identical |
| Accessories | Commonly available self-adhesive<br>electrode<br>Patient Main Cable Needle<br>Patient Main Cable Handle<br>Stimulation Handles (monopolar,<br>bipolar)<br>Extension cable | Commonly available self-adhesive<br>electrode<br>Extension Cable | S. E. |
| Compatible<br>Devices | Anaesthesia Conducting Needles:<br>SonoPlex-series<br>UniPlex-series<br>Monopolar Handle<br>Bipolar Handle | Anaesthesia Conducting Needles:<br>SonoPlex-series<br>UniPlex-series | S. E. |
| Technological<br>impulse<br>generation | Software-controlled | Hardware-Controlled | Different<br>Subject is<br>intended to be<br>easy to handle |
| Cleaning/<br>Desinfaction | Disinfect/ clean prior to each use:<br>Only use soft, moistened cloths to clean and disinfect the device and the<br>electrode cables. Water, soapsuds or denaturated alcohol are particularly<br>suitable for this purpose. Take care that no water or moisture enters into the<br>device. Alcohol, or commercially available alcohol based disinfectants<br>containing no methyl alcohol may be used for disinfection.<br>Attention:<br>The following agents may not be employed for cleaning purposes:<br>trichloroethylene, acetone, butanone (methyl ethyl ketone), benzene, methyl<br>alcohol or cellulose thinner (cellosolve, etc.). | | Identical |
| Features/<br>Technology | | | |
| Pulse form | Square pulse<br>Image: Square Pulse | Square pulse<br>Image: Square Pulse | Identical |
| Stimulation<br>pulse width | 0.1 ms | 0.1 ms | Identical |
| Impulse current | 0,0mA - 6,0mA (needle)<br>0,0mA - 60mA (PEG handle) | 0,20 mA/ 0,50 mA/0,70 mA/<br>1,00 mA/ 1,50 mA/ 2,00 mA | S. E. |
| Maximal<br>Voltage | 90VSS | max. 24 V | Different; Higher<br>values in<br>predicate due to<br>percutaneous<br>indication |
| Type of device | BF | BF | identical |
| | Predicate device | Subject Device | Result of<br>comparison, if<br>necessary with<br>rationale |
| Characteristics | MultiStim SENSOR | MultiStim ECO | |
| Battery | 9 V alkali-manganese batteries<br>(VARTA 4022, DURACELL MN<br>1604) | 2x 1.5-volt N batteries<br>(LR1, LADY, size N) | Different |
| Resistance | 0 kOhm -60 kOhm | 0 kOhm -12 kOhm | Different; Greater<br>bandwidth in<br>predicate due to<br>percutaneous<br>indication |
| Stimulation<br>Frequency | 1 Hz/2 Hz | 1 Hz | Equivalent<br>1 Hz is most<br>commonly used |
| Stimulation<br>impulse<br>bandwidth: | 0,05 ms / 0,10 ms / 0,20 ms/<br>0,30 ms/0,50 ms/1,00 ms | 0,10 ms | Different<br>Subject device for<br>needles only |
| Operating<br>Conditions | Temperature: 10°C to 30°C<br>Atmospheric humidity: 20% – 65% | Temperature: 10 °C to 30 °C<br>Air humidity: 20 % – 65 %<br>Air pressure: 700 hPa to 1060 hPa | Identical |
| Transportation<br>and Storage | Temperature: 10°C to 30°C<br>Atmospheric humidity: 20% to 65% | Temperature: 10 °C to 30 °C<br>Air humidity: 20 % - 65 %<br>Air pressure: 700 hPa to 1060 hPa | Identical |
| Protection Type<br>IEC 60529 | IP54 | IP54 | Identical |
| Sound level | Adjustable<br>Sound level selection: off, low,<br>medium, loud, very loud | Adjustable<br>Sound level selection: medium, loud,<br>soft | Different<br>Subject device is<br>less complex |
| Functional Self<br>Test | Self-Check Short-Circuit test | Self-Check Short-Circuit test | Identical |
| Battery Warning | optical | optical | Identical |

#### Side-by-side comparison table

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#### Performance Testing:

Both devices, the MultiStim ECO and the MultiStim SENSOR generate a rectangular 1Hz impulse. This impulse is generated by a quartz crystal.

The output signals of values which are adjustable at the MultiStim ECO have been compared to those with the same settings at the MultiStim SENSOR.

The desired signal combination was adjusted and visualized with an oscilloscope. The graphs were compared to each other in order to verify proper performance and substantial equivalence.

The results are as listed below:

| mA | mV | Output graphs compared |
|----|----|------------------------|
|----|----|------------------------|

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# PAJUNK®

# Pioneering medical technology

| mA | mV | Output graphs compared |
|-----|------|------------------------|
| 0,2 | 202 | Congruent |
| 0,5 | 500 | Congruent |
| 0,7 | 712 | Congruent |
| 1,0 | 1000 | Congruent |
| 1,5 | 1520 | Congruent |
| 2,0 | 2040 | Congruent |

In addition, testing was performed per methods in the following standards:

| # | Title |
|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996 |
| | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 2. | EN 60601-1: 2006 + AC: 2010 |
| | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 3. | EN 60601-1-2: 2007 + AC 2010 |
| | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral<br>standard: Electromagnetic compatibility - Requirements and tests |
| 4. | EN 60601-1-2: 2001 + A1: 2006 |
| | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral<br>standard: Electromagnetic compatibility - Requirements and tests |
| 5. | EN 60601-1-6: 2007 + AC:2010 |
| | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral<br>Standard: Usability |
| 6. | EN 60601-1-6: 2004 |
| | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral<br>Standard: Usability |
| 7. | EN 60601-1-8: 2007 + AC 2010 |
| | Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard:<br>General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 8. | EN 60601-1-8: 2004 + A1: 2006 |
| | Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance - Collateral Standard:<br>General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 9. | EN 60601-2-10: 2000 + A1: 2001 |
| | Medical electrical equipment -- Part 2-10: Particular requirements for the safety of nerve and muscle stimulators |
| 10. | IEC 60601-2-10: 2012 |
| | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and<br>muscle stimulators |

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Image /page/11/Picture/0 description: The image features the word "PAJUNK" in bold, white letters against a teal background. The font is sans-serif and appears to be a custom typeface. A registered trademark symbol is present to the right of the letter "K". The overall impression is clean and professional, suggesting a corporate logo or brand name.

| # | Title |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11. | EN 60601-1-2 2006 AC:2010<br>Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests |
| 12. | EN 61000-4-3<br>Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency,<br>electromagnetic field immunity test (IEC 61000-4-3:2006 + A1:2007 + A2:2010); German version EN 61000-4-3:2006 +<br>A1:2008 + A2:2010 |
| 13. | EN ISO 14971: 2012<br>Medical devices - Application of risk management to medical devices |
| 14. | EN 62366: 2008<br>Medical devices - Application of usability engineering to medical devices |
| 15. | EN 150 13485: 2012 + AC: 2012<br>Medical devices - Quality management systems - Requirements for regulatory purpos- es |
| 16. | EN 60529: 1991 + A1: 2000<br>Degrees of protection provided by enclosures |
| 17. | EN ISO 15223-1:2012<br>Medical devices. Symbols to be used with medical device labels, labelling and infor- mation to be supplied. General<br>requirements |
| 18. | EN-980:2008<br>Symbols for medical device labeling |

#### Conclusion:

The comparison between the predicate devices and the subject device of this submission as well as the results of the standard testing and bench testing demonstrates that the subject device are substantially equivalent to the predicate devices already cleared for market and therefore demonstrated to perform as effective as the legal predicate device.

The performance of the stimulation impulse generated by the subject device is at least as accurate as the impulse generated by the predicate device.