(163 days)
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.
PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the MultiStim ECO handheld, battery powered peripheral nerve stimulator.
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.
The provided text is a 510(k) summary for the MultiStim ECO, a peripheral nerve stimulator, seeking substantial equivalence to the MultiStim SENSOR. The document focuses on demonstrating that the new device performs as effectively as the predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The core of the performance acceptance criteria appears to be the congruence of output graphs between the MultiStim ECO (subject device) and the MultiStim SENSOR (predicate device) across various current (mA) settings. The device's performance is tested against specific current outputs and the corresponding voltage (mV).
Table of Acceptance Criteria and Reported Device Performance:
| Current (mA) | Expected Voltage (mV) for Congruence | Reported Device Performance (MultiStim ECO Output Voltage) | Outcome of Comparison |
|---|---|---|---|
| 0.2 | Approx. 202 | 202 | Congruent |
| 0.5 | Approx. 500 | 500 | Congruent |
| 0.7 | Approx. 712 | 712 | Congruent |
| 1.0 | Approx. 1000 | 1000 | Congruent |
| 1.5 | Approx. 1520 | 1520 | Congruent |
| 2.0 | Approx. 2040 | 2040 | Congruent |
Additional Implicit Acceptance Criteria:
- Identical Intended Use: The MultiStim ECO must have the same intended use as the MultiStim SENSOR. This is explicitly stated and claimed to be identical, with a minor change in wording ("percutaneous" removed as obsolete).
- Identical Basic Technical Description Relevant to Clinical Use: The fundamental method of impulse generation (quartz crystal) and the non-software hardware solution are presented as core to this.
- Compliance with Recognized Standards: The device must meet a comprehensive list of IEC/EN standards for medical electrical equipment, including safety, electromagnetic compatibility, usability, and specific requirements for nerve and muscle stimulators. (See the list of standards provided on pages 10-11).
- Physical and Functional Equivalence (where applicable): Various characteristics like dimensions, FDA classification, product code, biocompatibility, power supply, pulse form, and protection type are compared, and deviations are rationalized as either equivalent or improvements/simplifications that do not negatively impact safety or effectiveness.
Study Details Proving Acceptance Criteria
-
Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of number of devices tested. It describes a bench test where "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." This implies testing of at least one MultiStim ECO device against a MultiStim SENSOR for the specified current settings. There is no indication of a large-scale clinical trial or patient data.
- Data Provenance: The data is generated from bench testing ("the desired signal combination was adjusted and visualized with an oscilloscope"). The location of the test is not specified, but the manufacturer is based in Germany. The data is prospective in the sense that it was generated for this submission to verify performance.
-
Number of Experts and Qualifications for Ground Truth:
- This submission does not involve experts establishing ground truth in the typical sense of clinical image review or diagnostic performance. Instead, the "ground truth" is established by the engineering specifications and the measured output of the predicate device (MultiStim SENSOR), which is itself a legally marketed device. The comparison is objective, based on instrument readings (oscilloscope).
-
Adjudication Method for the Test Set:
- Not applicable. This was a bench test with objective measurements and comparison to a known standard (predicate device output).
-
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. This device is a nerve stimulator, not an imaging AI or diagnostic aid that would typically involve human readers interpreting results. The comparison is at the engineering/performance level, not human-in-the-loop effectiveness.
-
Standalone Performance:
- Yes, a standalone (algorithm only without human-in-the-loop performance) was done. The core performance testing involved measuring the output signals of the MultiStim ECO device in isolation and comparing them to those of the predicate device, using an oscilloscope. This is purely a device performance assessment independent of human interpretation or use in a clinical setting.
-
Type of Ground Truth Used:
- The "ground truth" is the measured output characteristics (voltage at specific current settings and pulse shape) of the predicate device (MultiStim SENSOR), along with compliance to relevant medical device standards (e.g., consistency of square pulse form, 1Hz frequency, 0.1ms pulse width). It's an engineering/device specification ground truth, not a clinical outcome or pathology report.
-
Training Set Sample Size:
- Not applicable. This is a hardware device without a "training set" in the context of machine learning or AI algorithms. The device's design is based on established electrical engineering principles and the performance of its predicate.
-
How Ground Truth for Training Set was Established:
- Not applicable, as there is no "training set." The design and "training" (if one could use the term loosely) of the device come from established medical device engineering practices and the existing predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number:
9611612
Submitter Information/ production site:
PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number: 9611612
Contact:
Christian G. H. Quass Director Regulatory Affairs, Safety Officer Patricia Weisbrod Regulatory Affairs Manager Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com E-Mail: patricia.weisbrod@pajunk.com
USA Contact:
PAJUNK MEDICAL SYSTEMS 6611 Bay Circle, Suite 140 Norcross, GA 30071 Phone +1 (888) 9PAJUNK (72-5865) Fax +1 (678) 514-3388
Establishment Registration Number: 3004076349
Contact
Marco Wohnig President PAJUNK® Medical Systems L.P. Phone: (770) 493-6832 Direct: (470) 448-4070 (770) 757-2449 Cell: Fax: (678) 514-3388 E-Mail: marco.wohnig@pajunk-usa.com
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Image /page/4/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and slightly blurred, giving them a soft appearance. A small registered trademark symbol is visible to the right of the letter "K".
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 NERVESTIMULATORS |
| 510(k) owner | Pajunk GmbH MedizintechnologieKarl-Hall-Str. 178187 Geisingen, Baden-Wuerttemberg,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 ofcomparison, ifnecessary withrationale | |
|---|---|---|---|
| Characteristics | MultiStim SENSOR | MultiStim ECO | |
| Picture(not for scale) | Image: MultiStim SENSOR | Image: MultiStim ECO | n.a. |
| Dimensions | 65mm x 120mm x 27mm | 65mm x 93mm x 20mm | n.a. |
| FDAClassification | Class II | Class II | Identical |
| FDA ProductCode | BXN | BXN | Identical |
| FDA CommonName | Peripheral Nerve Stimulator | Peripheral Nerve Stimulator | Identical |
| FDAClassificationname | 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 | |||
| Physicalconfiguration | Handheld | Handheld | Identical |
| User Input | Menu structure in display,pushbutton, membrane switch | Membrane switch, direct feedback | Reduced |
| User Feedback | LED, Display | LED | Reduced |
| Predicate deviceMultiStim SENSOR | Subject DeviceMultiStim ECO | Result ofcomparison, ifnecessary withrationale | |
| Power Supply | Battery | Battery | Identical |
| Accessories | Commonly available self-adhesiveelectrodePatient Main Cable NeedlePatient Main Cable HandleStimulation Handles (monopolar,bipolar)Extension cable | Commonly available self-adhesiveelectrodeExtension Cable | S. E. |
| CompatibleDevices | Anaesthesia Conducting Needles:SonoPlex-seriesUniPlex-seriesMonopolar HandleBipolar Handle | Anaesthesia Conducting Needles:SonoPlex-seriesUniPlex-series | S. E. |
| Technologicalimpulsegeneration | Software-controlled | Hardware-Controlled | DifferentSubject isintended to beeasy to handle |
| Cleaning/Desinfaction | Disinfect/ clean prior to each use:Only use soft, moistened cloths to clean and disinfect the device and theelectrode cables. Water, soapsuds or denaturated alcohol are particularlysuitable for this purpose. Take care that no water or moisture enters into thedevice. Alcohol, or commercially available alcohol based disinfectantscontaining no methyl alcohol may be used for disinfection.Attention:The following agents may not be employed for cleaning purposes:trichloroethylene, acetone, butanone (methyl ethyl ketone), benzene, methylalcohol or cellulose thinner (cellosolve, etc.). | Identical | |
| Features/Technology | |||
| Pulse form | Square pulseImage: Square Pulse | Square pulseImage: Square Pulse | Identical |
| Stimulationpulse width | 0.1 ms | 0.1 ms | Identical |
| Impulse current | 0,0mA - 6,0mA (needle)0,0mA - 60mA (PEG handle) | 0,20 mA/ 0,50 mA/0,70 mA/1,00 mA/ 1,50 mA/ 2,00 mA | S. E. |
| MaximalVoltage | 90VSS | max. 24 V | Different; Highervalues inpredicate due topercutaneousindication |
| Type of device | BF | BF | identical |
| Predicate device | Subject Device | Result ofcomparison, ifnecessary withrationale | |
| Characteristics | MultiStim SENSOR | MultiStim ECO | |
| Battery | 9 V alkali-manganese batteries(VARTA 4022, DURACELL MN1604) | 2x 1.5-volt N batteries(LR1, LADY, size N) | Different |
| Resistance | 0 kOhm -60 kOhm | 0 kOhm -12 kOhm | Different; Greaterbandwidth inpredicate due topercutaneousindication |
| StimulationFrequency | 1 Hz/2 Hz | 1 Hz | Equivalent1 Hz is mostcommonly used |
| Stimulationimpulsebandwidth: | 0,05 ms / 0,10 ms / 0,20 ms/0,30 ms/0,50 ms/1,00 ms | 0,10 ms | DifferentSubject device forneedles only |
| OperatingConditions | Temperature: 10°C to 30°CAtmospheric humidity: 20% – 65% | Temperature: 10 °C to 30 °CAir humidity: 20 % – 65 %Air pressure: 700 hPa to 1060 hPa | Identical |
| Transportationand Storage | Temperature: 10°C to 30°CAtmospheric humidity: 20% to 65% | Temperature: 10 °C to 30 °CAir humidity: 20 % - 65 %Air pressure: 700 hPa to 1060 hPa | Identical |
| Protection TypeIEC 60529 | IP54 | IP54 | Identical |
| Sound level | AdjustableSound level selection: off, low,medium, loud, very loud | AdjustableSound level selection: medium, loud,soft | DifferentSubject device isless complex |
| Functional SelfTest | 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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Image /page/8/Picture/0 description: The image shows the word "PAJUNK" in white letters against a green background. The letters are bold and sans-serif. There is a small circle with an R inside it to the right of the K, indicating that the word is a registered trademark.
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Image /page/9/Picture/0 description: The image features the word "PAJUNK" in a bold, sans-serif font. The letters are white with a subtle, light blue glow or shadow effect, giving them a three-dimensional appearance. The background is a solid teal color, providing a strong contrast that makes the text stand out. A small "®" symbol is present next to the letter "K", indicating that the name is a registered trademark.
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 - Collateralstandard: 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 - Collateralstandard: 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 - CollateralStandard: Usability | |
| 6. | EN 60601-1-6: 2004 |
| Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - CollateralStandard: 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: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: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 andmuscle 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:2010Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests |
| 12. | EN 61000-4-3Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency,electromagnetic field immunity test (IEC 61000-4-3:2006 + A1:2007 + A2:2010); German version EN 61000-4-3:2006 +A1:2008 + A2:2010 |
| 13. | EN ISO 14971: 2012Medical devices - Application of risk management to medical devices |
| 14. | EN 62366: 2008Medical devices - Application of usability engineering to medical devices |
| 15. | EN 150 13485: 2012 + AC: 2012Medical devices - Quality management systems - Requirements for regulatory purpos- es |
| 16. | EN 60529: 1991 + A1: 2000Degrees of protection provided by enclosures |
| 17. | EN ISO 15223-1:2012Medical devices. Symbols to be used with medical device labels, labelling and infor- mation to be supplied. Generalrequirements |
| 18. | EN-980:2008Symbols 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.
§ 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).