Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and electrical functions of a surgical instrument, with no mention of AI or ML capabilities.

Therapeutic

No
The device is a surgical instrument used for removing secretions and testing surgical tissue with nerve stimulation. It is not indicated for the treatment or prevention of disease.

Diagnostic

No

Explanation: The device is described as a surgical instrument used for removing secretions and nerve stimulation during surgery, not for diagnostic purposes. Its functions are "aspiration during tumor resection" and "monopolar stimulation during intraoperative surgical interventions," which are therapeutic and intraoperative monitoring activities, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a surgical instrument combining a suction instrument and a monopolar stimulation probe, which are physical hardware components. The performance studies also detail testing of physical and electrical properties of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "remove secretions and test surgical tissue with nerve stimulation simultaneously." This is a surgical procedure performed in vivo (within the living body) to assess nerve function during surgery.
Device Description: The device combines a surgical suction instrument and a monopolar stimulation probe. Both of these functions are used directly on the patient during surgery.
Lack of In Vitro Testing: The description of performance studies focuses on bench testing related to electrical, mechanical, and suction performance. There is no mention of testing biological samples in vitro (outside the body) for diagnostic purposes.
No Mention of Analyzing Samples: The device is used to stimulate nerves and remove secretions, not to analyze biological samples for diagnostic information.

IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

ETN

Device Description

The Mapping Suction Probe is a surgical instrument which combines surgical suction instrument and a monopolar stimulation probe in one instrument. 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.

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

Not Found

Intended User / Care Setting

licensed physician and in conjunction with compatible nerve locator monitor systems.

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)

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

Test: Sensitization, Test Performed: Guinea Pig Maximization Test with polar and non-polar extract, Results and Conclusion: The sensitization rate after application of the test item extract was 0%. Conclusion: The item under test is considered to have no sensitizing properties.

Test: Irritation / Intracutaneous Reactivity, Test Performed: Irritation Test (Intracutaneous Reactivity) in the Rabbit with polar and non-polar extract, Results and Conclusion: The primary irritation index of the polar and the nonpolar test item extracts compared to the controls were 0. Conclusion: The item under test is classified as not irritant.

Test: Acute Systemic Toxicity, Test Performed: Acute Systemic Toxicity in the Mouse with polar and non-polar extract, Results and Conclusion: No compound-related mortalities and no other signs of toxicity were recorded within 72 hours post-dose for any of the animals. Conclusion: The item under test showed no acute systemic toxic characteristics.

Test: Material Mediated Pyrogenicity, Test Performed: Rabbit Pyrogen Test according to USP, Results and Conclusion: Temperature increase for each rabbit was not > 0.50°C. Conclusion: The materials of the item under test are considered non pyrogenic.

Test: Hemolysis, Test Performed: Direct and indirect contact test under static conditions according to ASTM F 756-17, Results and Conclusion: The data show that the haemolytic indices of the blood substrate supernatants with direct (0.11%) and indirect (0.08%) contact to the test item were below 2% and therefore the material is classified as non-haemolytic. Conclusion: The item under test does not induce haemolysis.

Test: Bacterial Endotoxins, Test Performed: Limulus-Amoebocyte-Lysate (LAL) Test - Kinetic Turbidimetric Assay (KTA), Results and Conclusion: The endotoxin content of each test items was 30 % reduction -) of cell proliferation and/or cell viability. With the highest extract concentration (100 %) the dehydrogenase activity was reduced to 89 %. Microscopically, slightly reduced cell growth was observable from 66.7 % extract concentration onwards. Slight cell lysis was observable only in the undiluted extract. Conclusion: The item under test is considered non-cytotoxic.

Test: Sensitization, Test Performed: Guinea Pig Maximization Test with polar and non-polar extract, Results and Conclusion: The sensitization rate after application of the test item extract was 0%. Conclusion: The item under test is considered to have no sensitizing properties.

Test: Irritation / Intracutaneous Reactivity, Test Performed: Irritation Test (Intracutaneous Reactivity) in the Rabbit with polar and non-polar extract, Results and Conclusion: The primary irritation index of the polar and the nonpolar test item extracts compared to the controls were 0. Conclusion: The item under test is classified as not irritant.

Test: Acute Systemic Toxicity, Test Performed: Acute Systemic Toxicity in the Mouse with polar and non-polar extract, Results and Conclusion: No compound-related mortalities and no other signs of toxicity were recorded within 72 hours post-dose for any of the animals. Conclusion: The item under test showed no acute systemic toxic characteristics.

Test: Material Mediated Pyrogenicity, Test Performed: Rabbit Pyrogen Test according to USP, Results and Conclusion: Temperature increase for each rabbit was not > 0.50°C. Conclusion: The materials of the item under test are considered non pyrogenic.

Test: Bacterial Endotoxins, Test Performed: Limulus-Amoebocyte-Lysate (LAL) Test — Kinetic Turbidimetric Assay (KTA), Results and Conclusion: The endotoxin content of the test items was 0.6300, 0.7800 and 0.6600 EU/test item. Conclusion: The test items are non-pyrogenic under consideration of the acceptance criterion (

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.

Summary

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

| Submission

Date:	08 July 2021
510(k) Holder:	inomed Medizintechnik GmbH
Im Hausgrün 29
79312 Emmendingen, Germany
Contact Person:	Shuofei Cheng Ph.D.
Phone: +49 7641 9414 849
Email: S.Cheng@inomed.com
Manufacturing
Site:	inomed Medizintechnik GmbH
Im Hausgrün 29
79312 Emmendingen, Germany
Name of Device:	Mapping Suction Probe
Common and
Classification
Name:	Suction Stimulator Probe
Classification
Name:	Surgical nerve stimulator/locator (21 CFR 874.1820)
Regulatory
Class:	II
Product Code:	ETN
Regulation
Medical
Specialty:	Surgical nerve stimulator/locator
		Predicate
510(k)
Number	Predicate Manufacturer/ Model
	Predicate Device:	K110712	Neurovision™ Medical
Products, Inc.™./ DryTouch
Suction Stimulator Probe
Device
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
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.
The instrument is intended for use only by a
licensed physician and in conjunction with
compatible nerve locator monitor systems."	The Suction Stimulator Probe is a dedicated
manual surgical instrument that allows the
surgeon to clear secretions and test surgical
tissue with nerve stimulation at the same
time and with the same instrument.
It is intended for use only by a licensed
physician and in conjunction with the
Neurovision SE (Nerve; na) Nerve locator
Monitor System.
Contraindicati
ons	The use of muscle relaxants is
contraindicated, as these cause significant	The use of paralytic anaesthetics will cause
abnormal EMG performance. Advise the
	reductions in the evoked muscle potentials.	anaesthesia provider of this
contraindication.
User group	Surgeon and Neurophysiologist	Licensed physician
Risk
management	Risk Management according to standard:
ISO 14971: 2019	Risk Management according to standard:
ISO 14971: 2007
	• The device is a disposable surgical
instrument	• The device is a disposable surgical
instrument
	• The product combines a surgical
suction instrument and a
monopolar stimulation probe
simultaneously	• The product combines a surgical
suction instrument and a
monopolar stimulation probe
simultaneously
	• Monopolar stimulation on the non-
insulated tip of the suction probe
component to localize and identify
nervous structures and to prevent
their damage during surgery.	• Monopolar stimulation on the non-
insulated tip of the suction probe
component to localize and identify
nervous structures and to prevent
their damage during surgery.
Operating
Principle	• To ensure a specific stimulation at
the point of interest, the residual
metal part of the probe's shaft is
insulated.	• To ensure a specific stimulation at
the point of interest the residual
metal part of the probe's shaft is
insulated.
	• The connector on the end of the
suction probe component is for
mechanical connection to suction
devices via suction tubes.	• The connector on the end of the
suction probe component is for
mechanical connection to suction
devices via suction tubes.
	• Depending on the case, the
suction function is used for
aspiration during tumor resection
or to clear the surgical field from
fluids for better visualization.	• Depending on the case the suction
function is used for aspiration
during tumor resection or to clear
the surgical field from fluids for
better visualization.
Materials	The instrument consists of a stainless-
steel shaft, partially insulated with
biocompatible PTFE and ending with an
oblong hole suction.	The instrument consists of a stainless-
steel shaft, partially insulated with
biocompatible PTFE and ending with a
ball- tip suction.
Tissue
contact	The medical device comes in direct tissue
contact.	The medical device comes in direct tissue
contact.
Shelf life	3 years	1 year
Sterilization	• EO validation is compliant with
ISO 11135:2014 + A1:2018
• residuals analysis is compliant with
ISO 10993-7:2008
• The Sterility Assurance Level is
10-6
• Device is not labeled non-pyrogenic.	• EO validation is compliant with
ISO 11135-1:2007
• EO residuals analysis is compliant
with ISO 10993-7:2008
• The Sterility Assurance Level is 10-6
• Device is not labeled non-
pyrogenic.
Product length	• 9 cm
• 13 cm	• 13 cm
Inner
diameter
(Lumen)	9fg 6fg	6fg
Insulated tip
length	2mm	2mm
Accessories	1 Subdermal Needle Electrode
(black lead wire) 3.0m wire, 20 mm
Needle-0.45mm gauge Connection Cable (red) 3.0m cable
length	2 Neurovision™ Subdermal Needle
Electrodes (white and green lead
wire) 2.5m wire, 12 mm Needle-0.4
mm gauge, 27G 2 Alcohol Wipes
Site of
application	No specific site	No specific site
Duration of
use	0.50°C.
Conclusion: The materials of the item under test are
considered non pyrogenic.
Hemolysis	Direct and indirect
contact test under
static conditions
according to ASTM
F 756-17	The data show that the haemolytic indices of the blood
substrate supernatants with direct (0.11%) and indirect
(0.08%) contact to the test item were below 2% and
therefore the material is classified as non-haemolytic.
Conclusion: The item under test does not induce
haemolysis.
Bacterial
Endotoxins	Limulus-
Amoebocyte-Lysate
(LAL) Test - Kinetic
Turbidimetric Assay
(KTA)	The endotoxin content of each test items was 30 % reduction -) of cell proliferation
and/or cell viability. With the highest extract
concentration (100 %) the dehydrogenase activity was
reduced to 89 %.
Microscopically, slightly reduced cell growth was
observable from 66.7 % extract concentration
onwards. Slight cell lysis was observable only in the
undiluted extract.
Conclusion: The item under test is considered non-
cytotoxic.
Sensitization	Guinea Pig
Maximization Test
with polar and non-
polar extract	The sensitization rate after application of the test item
extract was 0%.
Conclusion: The item under test is considered to have
no sensitizing properties.
Irritation /
Intracutaneous
Reactivity	Irritation Test
(Intracutaneous
Reactivity) in the
Rabbit with polar
and non-polar
extract	The primary irritation index of the polar and the nonpolar
test item extracts compared to the controls were 0.
Conclusion: The item under test is classified as not
irritant.

8

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