Mapping Suction Probe

K212164 · Inomed Medizintechnik GmbH · ETN · Nov 11, 2022 · Ear, Nose, Throat

Device Facts

• Record ID: K212164
• Device Name: Mapping Suction Probe
• Applicant: Inomed Medizintechnik GmbH
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Nov 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.

Device Story

Mapping Suction Probe is a single-use, disposable surgical instrument combining a suction lumen and a monopolar stimulation probe. Used by surgeons and neurophysiologists in the OR to aspirate fluids/tissue during tumor resection while simultaneously identifying nervous structures to prevent damage. The device connects to external suction equipment via tubing and to external neuromonitoring systems via a standard connector cable. A counter electrode is placed at the resection margin to complete the circuit. The probe shaft is partially insulated with PTFE to ensure localized stimulation at the non-insulated tip. The device provides the surgeon with real-time feedback on nerve proximity through the connected monitor, facilitating safer surgical navigation and tissue preservation.

Clinical Evidence

No clinical data was performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series), electrical conductivity, dielectric strength, suction performance (vacuum/flow rate), mechanical stability (pull-out/bending stress), and shelf-life testing.

Technological Characteristics

Stainless-steel shaft, partially insulated with PTFE. Monopolar stimulation principle. Dimensions: 9cm or 13cm length; 6fg or 9fg lumen. Connectivity: DIN 42802 touch-proof connector for neuromonitoring; standard suction tube interface. Sterilization: Ethylene Oxide (ISO 11135). No software or internal power source.

Indications for Use

Indicated for use by licensed physicians during surgical procedures to remove secretions and simultaneously test surgical tissue via nerve stimulation in conjunction with compatible nerve locator monitor systems.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

• DryTouch Suction Stimulator Probe (K110712)

Submission Summary (Full Text)

{0}------------------------------------------------

November 11, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

inomed Medizintechnik GmbH Shuofei Cheng Regulatory Affairs Manager Im Hausgruen 29 Emmendingen. Baden-Wuerttemberg 79312 Germany

Re: K212164

Trade/Device Name: Mapping Suction Probe Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: September 29, 2022 Received: October 3, 2022

Dear Ms. Cheng:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Patrick Antkowiak -S

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K212164

#### Device Name

Mapping Suction Probe 3/90 monopolar (Art. No. 525650), Mapping Suction Probe 3/130 monopolar (Art. No. 525651), Mapping Suction Probe 2/90 monopolar (Art. No. 525655), Mapping Suction Probe 2/130 monopolar (Art. No. 525656)

#### Indications for Use (Describe)

The Mapping Suction Probe is a surgical instrument that allows the surgeon to remove secretions and test surgical tissue with nerve stimulation simultaneously and with the same instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------|--------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

| Submission<br>Date: | 08 July 2021 | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------|
| 510(k) Holder: | inomed Medizintechnik GmbH<br>Im Hausgrün 29<br>79312 Emmendingen, Germany | | |
| Contact Person: | Shuofei Cheng Ph.D.<br>Phone: [phone]<br>Email: [e-mail] | | |
| Manufacturing<br>Site: | inomed Medizintechnik GmbH<br>Im Hausgrün 29<br>79312 Emmendingen, Germany | | |
| Name of Device: | Mapping Suction Probe | | |
| Common and<br>Classification<br>Name: | Suction Stimulator Probe | | |
| Classification<br>Name: | Surgical nerve stimulator/locator (21 CFR 874.1820) | | |
| Regulatory<br>Class: | II | | |
| Product Code: | ETN | | |
| Regulation<br>Medical<br>Specialty: | Surgical nerve stimulator/locator | | |
| | | Predicate<br>510(k)<br>Number | Predicate Manufacturer/ Model |
| | Predicate Device: | K110712 | Neurovision™ Medical<br>Products, Inc.™./ DryTouch<br>Suction Stimulator Probe |
| Device<br>Description: | The Mapping Suction Probe is a surgical instrument which combines surgical suction instrument and a monopolar stimulation probe in one instrument | | |

a

{4}------------------------------------------------

| The stimulation function of the Mapping Suction Probe is used for | | | |
|---------------------------------------------------------------------------|--|--|--|
| monopolar stimulation during intraoperative surgical interventions and | | | |
| is connected to electrical stimulators of neuromonitoring devices outside | | | |
| the sterile field via an appropriate integrated connection cable. To | | | |
| ensure a correct monopolar stimulation, a counter electrode is also | | | |
| included in the sterile package which must be placed at the resection | | | |
| marqin. | | | |

The suction function of the Mapping Suction Probe is used for aspiration during tumor resection and is connected to suction devices via a tube, which is not part of the delivered package.

The Mapping Suction Probe is a surgical instrument that allows the Indications for surgeon to remove secretions and test surgical tissue with nerve Use: stimulation simultaneously and with the same instrument.

> The instrument is intended for use only by a licensed physician and in conjunction with compatible nerve locator monitor systems.

Comparison of Technological Characteristics with the Predicate Device:

| Characteristic | Subject device | Predicate device |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System | Mapping Suction Probe | DryTouch Suction Stimulator Probe |
| Manufacturer | inomed Medizintechnik GmbH | Neurovision Medical Produtcts, Inc. |
| 510(k)Number | K212164 | K110712 |
| Picture | Image: Mapping Suction Probe | Image: DryTouch Suction Stimulator Probe |
| Indications<br>for use | The Mapping Suction Probe is a surgical<br>instrument that allows the surgeon to<br>remove secretions and test surgical tissue<br>with nerve stimulation simultaneously and<br>with the same instrument.<br>The instrument is intended for use only by a<br>licensed physician and in conjunction with<br>compatible nerve locator monitor systems." | The Suction Stimulator Probe is a dedicated<br>manual surgical instrument that allows the<br>surgeon to clear secretions and test surgical<br>tissue with nerve stimulation at the same<br>time and with the same instrument.<br>It is intended for use only by a licensed<br>physician and in conjunction with the<br>Neurovision SE (Nerve; na) Nerve locator<br>Monitor System. |
| Contraindicati<br>ons | The use of muscle relaxants is<br>contraindicated, as these cause significant | The use of paralytic anaesthetics will cause<br>abnormal EMG performance. Advise the |
| | reductions in the evoked muscle potentials. | anaesthesia provider of this<br>contraindication. |
| User group | Surgeon and Neurophysiologist | Licensed physician |
| Risk<br>management | Risk Management according to standard:<br>ISO 14971: 2019 | Risk Management according to standard:<br>ISO 14971: 2007 |
| | • The device is a disposable surgical<br>instrument | • The device is a disposable surgical<br>instrument |
| | • The product combines a surgical<br>suction instrument and a<br>monopolar stimulation probe<br>simultaneously | • The product combines a surgical<br>suction instrument and a<br>monopolar stimulation probe<br>simultaneously |
| | • Monopolar stimulation on the non-<br>insulated tip of the suction probe<br>component to localize and identify<br>nervous structures and to prevent<br>their damage during surgery. | • Monopolar stimulation on the non-<br>insulated tip of the suction probe<br>component to localize and identify<br>nervous structures and to prevent<br>their damage during surgery. |
| Operating<br>Principle | • To ensure a specific stimulation at<br>the point of interest, the residual<br>metal part of the probe's shaft is<br>insulated. | • To ensure a specific stimulation at<br>the point of interest the residual<br>metal part of the probe's shaft is<br>insulated. |
| | • The connector on the end of the<br>suction probe component is for<br>mechanical connection to suction<br>devices via suction tubes. | • The connector on the end of the<br>suction probe component is for<br>mechanical connection to suction<br>devices via suction tubes. |
| | • Depending on the case, the<br>suction function is used for<br>aspiration during tumor resection<br>or to clear the surgical field from<br>fluids for better visualization. | • Depending on the case the suction<br>function is used for aspiration<br>during tumor resection or to clear<br>the surgical field from fluids for<br>better visualization. |
| Materials | The instrument consists of a stainless-<br>steel shaft, partially insulated with<br>biocompatible PTFE and ending with an<br>oblong hole suction. | The instrument consists of a stainless-<br>steel shaft, partially insulated with<br>biocompatible PTFE and ending with a<br>ball- tip suction. |
| Tissue<br>contact | The medical device comes in direct tissue<br>contact. | The medical device comes in direct tissue<br>contact. |
| Shelf life | 3 years | 1 year |
| Sterilization | • EO validation is compliant with<br>ISO 11135:2014 + A1:2018<br>• residuals analysis is compliant with<br>ISO 10993-7:2008<br>• The Sterility Assurance Level is<br>10-6<br>• Device is not labeled non-pyrogenic. | • EO validation is compliant with<br>ISO 11135-1:2007<br>• EO residuals analysis is compliant<br>with ISO 10993-7:2008<br>• The Sterility Assurance Level is 10-6<br>• Device is not labeled non-<br>pyrogenic. |
| Product length | • 9 cm<br>• 13 cm | • 13 cm |
| Inner<br>diameter<br>(Lumen) | 9fg 6fg | 6fg |
| Insulated tip<br>length | 2mm | 2mm |
| Accessories | 1 Subdermal Needle Electrode<br>(black lead wire) 3.0m wire, 20 mm<br>Needle-0.45mm gauge Connection Cable (red) 3.0m cable<br>length | 2 Neurovision™ Subdermal Needle<br>Electrodes (white and green lead<br>wire) 2.5m wire, 12 mm Needle-0.4<br>mm gauge, 27G 2 Alcohol Wipes |
| Site of<br>application | No specific site | No specific site |
| Duration of<br>use | < 30 days | < 30 days |
| Single use or<br>reusable | Single use | Single use |
| Provided sterile | Yes | Yes |
| Connector<br>standard | DIN 42802 | DIN 42802 |
| Connector | Touch Proof | Touch Proof |

{5}------------------------------------------------

## inomed fi

www.inomed.com

### K212164

# 510(k) Summary Mapping Suction Probe

FM 3-1

Page 3 of 7

Stand 1.1 vom 2017-11-02

{6}------------------------------------------------

### Performance Data:

Biocompatibility:

The Mapping Suction Probe and Needle Electrode component were tested according to the following standards:

- -ISO 10993-1:2018
- ISO 10993-5:2009 -
- ISO 10993-7:2008 .
- -ISO 10993-17:2002
- ISO 10993-18:2005 -

| Test | Test Performed | Results and Conclusion |
|--------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | Cell Growth<br>Analysis via XTT-Staining | The results showed no reduction of cell proliferation<br>and/or cell viability. With the highest extract<br>concentration (100 %) the dehydrogenase activity was<br>101 %.<br>Microscopically, no inhibition of cell growth and no cell<br>lysis were observed at all extract concentrations<br>used. |

{7}------------------------------------------------

| | | Conclusion: The item under test is considered non-<br>cytotoxic. |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitization | Guinea Pig<br>Maximization Test<br>with polar and non-<br>polar extract | The sensitization rate after application of the test item<br>extract was 0%.<br>Conclusion: The item under test is considered to have<br>no sensitizing properties. |
| Irritation /<br>Intracutaneous<br>Reactivity | Irritation Test<br>(Intracutaneous<br>Reactivity) in the<br>Rabbit with polar<br>and non-polar<br>extract | The primary irritation index of the polar and the nonpolar<br>test item extracts compared to the controls were 0.<br>Conclusion: The item under test is classified as not<br>irritant. |
| Acute<br>Systemic<br>Toxicity | Acute Systemic<br>Toxicity in the<br>Mouse with polar<br>and non-polar<br>extract | No compound-related mortalities and no other signs of<br>toxicity were recorded within 72 hours post-dose for any<br>of the animals.<br>Conclusion: The item under test showed no acute<br>systemic toxic characteristics. |
| Material<br>Mediated<br>Pyrogenicity | Rabbit Pyrogen<br>Test according to<br>USP | Temperature increase for each rabbit was not > 0.50°C.<br>Conclusion: The materials of the item under test are<br>considered non pyrogenic. |
| Hemolysis | Direct and indirect<br>contact test under<br>static conditions<br>according to ASTM<br>F 756-17 | The data show that the haemolytic indices of the blood<br>substrate supernatants with direct (0.11%) and indirect<br>(0.08%) contact to the test item were below 2% and<br>therefore the material is classified as non-haemolytic.<br>Conclusion: The item under test does not induce<br>haemolysis. |
| Bacterial<br>Endotoxins | Limulus-<br>Amoebocyte-Lysate<br>(LAL) Test - Kinetic<br>Turbidimetric Assay<br>(KTA) | The endotoxin content of each test items was < 1.55<br>EU/test item.<br>Conclusion: The test items are non-pyrogenic under<br>consideration of the acceptance criterion (< 2.15<br>EU/device) |

The tests are conducted on the Device: '525651 Mapping Suction Probe 3/130, monopolar'.

The following tests were performed for the Needle Electrode component.

| Test | Test Performed | Results and Conclusion |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | Cell Growth<br>Analysis via XTT-<br>Staining | The results showed no relevant reduction (- relevant<br>meaning > 30 % reduction -) of cell proliferation<br>and/or cell viability. With the highest extract<br>concentration (100 %) the dehydrogenase activity was<br>reduced to 89 %.<br>Microscopically, slightly reduced cell growth was<br>observable from 66.7 % extract concentration<br>onwards. Slight cell lysis was observable only in the<br>undiluted extract.<br>Conclusion: The item under test is considered non-<br>cytotoxic. |
| Sensitization | Guinea Pig<br>Maximization Test<br>with polar and non-<br>polar extract | The sensitization rate after application of the test item<br>extract was 0%.<br>Conclusion: The item under test is considered to have<br>no sensitizing properties. |
| Irritation /<br>Intracutaneous<br>Reactivity | Irritation Test<br>(Intracutaneous<br>Reactivity) in the<br>Rabbit with polar<br>and non-polar<br>extract | The primary irritation index of the polar and the nonpolar<br>test item extracts compared to the controls were 0.<br>Conclusion: The item under test is classified as not<br>irritant. |

{8}------------------------------------------------

| Acute<br>Systemic<br>Toxicity | Acute Systemic<br>Toxicity in the<br>Mouse with polar<br>and non-polar<br>extract | No compound-related mortalities and no other signs of<br>toxicity were recorded within 72 hours post-dose for any<br>of the animals.<br>Conclusion: The item under test showed no acute<br>systemic toxic characteristics. |
|--------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material<br>Mediated<br>Pyrogenicity | Rabbit Pyrogen<br>Test according to<br>USP | Temperature increase for each rabbit was not > 0.50°C.<br>Conclusion: The materials of the item under test are<br>considered non pyrogenic. |
| Bacterial<br>Endotoxins | Limulus-<br>Amoebocyte-Lysate<br>(LAL) Test — Kinetic<br>Turbidimetric Assay<br>(KTA) | The endotoxin content of the test items was 0.6300,<br>0.7800 and 0.6600 EU/test item.<br>Conclusion: The test items are non-pyrogenic under<br>consideration of the acceptance criterion (< 20.0<br>EU/device) |

Test results indicate that the Mapping Suction Probe and the Needle Electrode component comply with the applicable standards and demonstrated the safety of subject device.

The Mapping Suction Probe does not contain any kind of software, Software: and therefore, this section does not apply to it.

The Mapping Suction Probe is a device which is not electrically-Electrical Safety: powered, and therefore, this section does not apply to it.

Electromagnetic The Mapping Suction Probe is a device which is not electrically-Compatibility: powered, and therefore, this section does not apply to it.

The Mapping Suction Probe was tested for performance in Performance Testing - Bench accordance with internal requirements and the following standards:

- IEC 60601-1:2005/AMD1:2012 -
- IEC 60601-1-2:2014 -
- IEC 60601-2-40:2016 -
- . Electrical Tests: Electrical Conductivity, Dielectric Strength Functional Tests: Impedance Measurement, Stimulation Current Test Dimension Test: Dimension of Components
- Suction Performance Tests: Reached Vacuum in Air, . Volumetric Flow Rate
- . Mechanical Suction Tests: Deformation Test, Leakage Test
- Mechanical Tests: Pull-out Force Test, Distractive Force Test, . Mechanical Stability Test, Bending Stress Test
- Insulation Test Shelf-Life Tests

The tests were conducted on the subject device Mapping Suction Probe and/or its component.

{9}------------------------------------------------

Performance Clinical testing was not performed for the Mapping Suction Probe. Testing – Clinical

- Conclusions The testing and assessments performed demonstrate that the subject device performs comparable to the predicate device that is currently marketed for the same intended use.