K Number

Device Name

SENTIO MMG Pedicle Access Needles

Manufacturer

Medos International SARL

Date Cleared

2018-03-22

(174 days)

Product Code

PDQ PDO

Regulation Number

874.1820

Intended Use

The SENTIO MMG Pedicle Access Needles are indicated for use in pedicle pilot hole preparation and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Device Description

The SENTIO MMG Pedicle Access Needles are surgical instruments that incorporate insulated probes with standard connectors to ensure maximum ease of use and compatibility with the Sentio MMG Nerve Mapping and Avoidance System for use during surgeries in which a motor nerve is at risk. The SENTIO MMG Pedicle Access Needles are utilized for pedicle preparation in spine surgery with application of dynamic stimulation for nerve detection. They are provided sterile (ethylene oxide) and have two components: Needle (cannula and trocar) and 2.5m Stimulation Cable. The cannula is marked with equidistant reference depth markers (1cm) relative to the distal [to user] end.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K100992, K112709

Reference Devices

NeuralMAS™ (K100992)

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a surgical instrument for nerve stimulation and mapping, with no mention of AI or ML capabilities. The performance studies focus on physical and electrical properties, not algorithmic performance.

Therapeutic

No
The device is described as a surgical instrument used for pedicle pilot hole preparation and stimulation of peripheral motor nerves for location and identification during surgery. Its primary function is diagnostic and interventional tool during surgery, not to treat, cure, or mitigate a disease or condition.

Diagnostic

Yes

The device is used for "stimulation of peripheral motor nerves for location and identification during surgery," which is a diagnostic function to determine the presence and location of nerves.

SaMD (Software as a Medical Device)

The device description explicitly states it is a surgical instrument with physical components (needles, cannula, trocar, stimulation cable) and is provided sterile. It is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The SENTIO MMG Pedicle Access Needles are surgical instruments used during surgery to prepare a pilot hole and stimulate nerves in situ (within the body). They are not used to analyze specimens taken from the body.
Intended Use: The intended use clearly states "pedicle pilot hole preparation and stimulation of peripheral motor nerves for location and identification during surgery". This is an intraoperative procedure, not an in vitro diagnostic test.

Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

PDO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pedicle, spinal nerve roots, peripheral motor nerves

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was conducted to demonstrate the safety and effectiveness of the subject devices.
Durability: Durability testing served to determine that materials and mating interfaces of the subject device survive the force of entering the pedicle, the interface between the top and bottom handles remains intact, the stylet is sufficiently sharp to pass through bone, and the needle cannula beveled edge is sufficient to dig into bone. Testing was completed using simulated bone material. All samples passed the acceptance criteria. The durability of the subject device has been determined substantially equivalent to the predicate.
Wire to Plug Connection: The wire to plug connection of the subject device was tested for tensile force resistance. The plug from the connection wire component part was inserted into a test sample intended to accommodate a resistance fit. The sample construct was subject to tensile force until the wire disconnected from the sample handle. All samples passed the acceptance criteria. The subject device connection assembly has been determined substantially equivalent to the predicate.
System Compatibility: Needle stimulation testing was conducted to verify that the subject device maintains compatibility with the NeuralMAS™ (K100992) predicate, and provides electrical isolation such that energy delivery is focused from only the distal tip of the needle. Test results demonstrated subject device compatibility with the predicate NeuralMAS™ (K100992) system.
Electrical Stimulation: The subject device was tested for compatibility with electrical stimulation sources of 100V, 200V, and 300V. Compatibility with electrical stimulation sources was verified, supporting substantial equivalence of the subject device.
Biocompatibility: Per ISO 10993-1, the subject device is categorized as an external communicating device for tissue/bone contact of limited duration. The Parylene C conformal coating remains unchanged from the NeuralMAS™ (K100992) predicate. Stainless Steel has a history of clinical use and biocompatibility; cleaning validations were conducted to confirm removal of processing reagents. The biocompatibility of the subject device has been assessed as substantially equivalent to the predicate.
Sterility: The ethylene oxide sterilization method was validated per ISO 11135-1 for the subject device. Sterilization residual levels were tested for compliance to ISO 10993-7. The subject devices will be provided sterile with a SAL of 10⁻⁶. The sterilization residual levels were determined compliant with ISO 10993-7 for limited exposure devices. Delivery state of the subject device is determined to be substantially equivalent to the predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100992, K112709

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 22, 2018

Medos International SARL % Sheree Geller Regulatory Affairs Specialist DePuy Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767

Re: K173134

Trade/Device Name: SENTIO MMG Pedicle Access Needles Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDO Dated: February 20, 2018 Received: February 21, 2018

Dear Sheree Geller:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K173134

Device Name SENTIO MMG Pedicle Access Needles

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

A.	Submitter Information
	Manufacturer:	Medos International SARL
Chemin-Blanc 38
2400 Le Locle, Switzerland
	Submitter:	DePuy Synthes Spine
325 Paramount Drive
Raynham, MA 02767
	Contact Person:
Telephone:
Fax:
Email:	Sheree Geller
325 Paramount Drive
Raynham, MA 02767
(508) 828-3291
(508) 828-3797
sgeller1@its.jnj.com
B.	Date Prepared	March 22, 2018
C.	Device Name
	Trade/Proprietary Name:	SENTIO MMG® Pedicle Access Needles
	Common/Usual Name:	Nerve Stimulator/Locator
	Classification Name:	21 CFR §874.1820
Surgical nerve stimulator/locator
	Regulatory Class:	II
	Product Code & Review Panel:	PDQ; Neurology
D.	Predicate Device Names
	Primary Predicate:	NeuralMAS™ (K100992)
	Additional Predicate:	NuVasive® Stimulation/Dissection
Instruments (K112709)

E. Device Description

F. Intended Use

Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use G.

The intended use and technological characteristics, including material, design, and performance, of the SENTIO MMG Pedicle Access Needles are consistent with those of the predicate devices.

	Predicate Devices		Subject Device
	NeuralMASTM (K100992)	NuVasive® Stimulation/Dissection
Instruments (K112709)	SENTIO MMG® Pedicle Access
Needles	Substantially
Equivalent
Intended Use	NeuralMAS is intended for use in
surgical procedures to assist in locating
and mapping motor nerves through the
use of mechanomyographic (MMG)
signals and electrical stimulus of nerves.
This device is indicated for locating and
identifying spinal nerve roots and
peripheral motor nerves origination
from spinal levels C3-T1 and L2-S2.	The Stimulation/Dissection Instruments
are indicated for tissue dissection and
stimulation of peripheral motor nerves
for location and identification during
surgery, including spinal nerve roots.	The SENTIO MMG® Pedicle Access
Needles are indicated for use in pedicle
pilot hole preparation and stimulation of
peripheral motor nerves for location and
identification during surgery, including
spinal nerve roots.	Yes
Product Code	ETN	ETN	PDQ	Yes
Regulation	21 CFR §874.1820	21 CFR §874.1820	21 CFR §874.1820	Yes
Electrical
Insulation	The sterile stimulation instruments have
biocompatible electrical insulation
applied to select portions. The distal
surfaces of the instruments are
selectively non-insulated stainless steel
to provide for mechanical, manual
dissection, probing, cannulation, and
tissue stimulation.	Some instruments have electrical
insulation on surfaces not intended to
provide electrical contact with the
patient and connection while others are
used with an insulation accessory that
provides electrical insulation on surfaces
not intended to provide electrical
contact with the patient and connection.	The subject devices have biocompatible
electrical insulation applied to select
portions. The distal surfaces of the
instruments are selectively non-
insulated stainless steel to provide for
mechanical, manual dissection, probing,
cannulation, and tissue stimulation.	Yes
Proximal
Stimulator
Connector	Yes	Yes	Yes	Yes
Patient
Contacting
Material	Biocompatible:
Stainless Steel
Parylene C	Biocompatible:
Stainless Steel,
Anodized Aluminum
Radel	Biocompatible:
Stainless Steel
Parylene C	Yes
Delivery	Sterile for single use	Some instruments are provided sterile
for single use only while others are
provided as non-sterile reusable
instruments.	Sterile for single use	Yes

H. Materials

The patient contacting materials of the subject devices are biocompatible stainless steel with Parylene C conformal coating.

I. Performance Data

Non-clinical testing was conducted to demonstrate the safety and effectiveness of the subject devices. The SENTIO MMG Pedicle Access Needles were evaluated as follows:

Characteristic	Evaluation Summary	Conclusion
Durability	Durability testing served to determine that materials and
mating interfaces of the subject device survive the force
of entering the pedicle, the interface between the top and
bottom handles remains intact, the stylet is sufficiently
sharp to pass through bone, and the needle cannula
beveled edge is sufficient to dig into bone. Testing was
completed using simulated bone material.	All samples passed the acceptance
criteria. The durability of the subject
device has been determined
substantially equivalent to the
predicate.
Wire to Plug
Connection	The wire to plug connection of the subject device was
tested for tensile force resistance. The plug from the
connection wire component part was inserted into a test
sample intended to accommodate a resistance fit. The
sample construct was subject to tensile force until the
wire disconnected from the sample handle.	All samples passed the acceptance
criteria. The subject device
connection assembly has been
determined substantially equivalent to
the predicate.
System
Compatibility	Needle stimulation testing was conducted to verify that
the subject device maintains compatibility with the
NeuralMAS™ (K100992) predicate, and provides
electrical isolation such that energy delivery is focused
from only the distal tip of the needle.	Test results demonstrated subject
device compatibility with the
predicate NeuralMAS™ (K100992)
system.
Electrical
Stimulation	The subject device was tested for compatibility with
electrical stimulation sources of 100V, 200V, and 300V.	Compatibility with electrical
stimulation sources was verified,
supporting substantial equivalence of
the subject device.
Biocompatibility	Per ISO 10993-1, the subject device is categorized as an
external communicating device for tissue/bone contact of
limited duration. The Parylene C conformal coating
remains unchanged from the NeuralMAS™ (K100992)
predicate. Stainless Steel has a history of clinical use and
biocompatibility; cleaning validations were conducted to
confirm removal of processing reagents.	The biocompatibility of the subject
device has been assessed as
substantially equivalent to the
predicate.
Sterility	The ethylene oxide sterilization method was validated per
ISO 11135-1 for the subject device. Sterilization residual
levels were tested for compliance to ISO 10993-7.	The subject devices will be provided
sterile with a SAL of 10⁻⁶. The
sterilization residual levels were
determined compliant with ISO
10993-7 for limited exposure devices.
Delivery state of the subject device is
determined to be substantially
equivalent to the predicate.

J. Conclusion

Evaluation of the subject device intended use, technological characteristics, and performance data demonstrates substantial equivalence with the predicate devices.