Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

Device Description

A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

AI/ML Overview

This Renishaw Mayfield 510(k) summary does not contain information about acceptance criteria and a study demonstrating the device meets those criteria. Instead, it describes a device (Neuromate Frameless Gen II) as a technical update of a previously cleared predicate device (Frameless Neuromate). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than proving performance against specific acceptance criteria with a dedicated study.

Specifically, the document states:

No clinical data are submitted (Section 8). This indicates that there was no human-based study to assess the device's performance against clinical endpoints or acceptance criteria.
Bench and performance testing showed that neuromate performed as designed and intended (Section 7). This refers to engineering-level testing to verify the device's functionality and compliance with standards (IEC 60601-1, IEC 60601-1-2, FDA software guidance, and IEC 62304), but it does not detail specific acceptance criteria or an associated study.
The primary justification for market clearance is that the device "is equivalent in design and performance to the predicate device" (Section 9). The "Substantial Equivalence Summary" (Section 10) compares the new device to the predicate across various characteristics, noting similarities and minor differences.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them based on the provided text, as this type of information is not present in the document.

Summary

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RENISHAW mayfie

510(k) SUMMARY

APR 2 9 2014

1. SUBMITTER: . Renishaw Mayfield sarl 31. rue Ampère 69680 Chassieu FRANCE 011-33 4 37 23 89 00 Phone: Fax: 011-33 4 78 90 75 22
  Contact person:

Stéphane Vinot Quality Assurance & Regulatory affairs Manager stephane.vinot@renishawmayfield.com

Preparation date:

July 11, 2013

2. DEVICE NAME:

Trade name:	neuromate Frameless Gen II
Common name:	Stereotactic neurological system
Classification name:	Stereotaxic Instrument (HAW)

3. PREDICATE DEVICE(s):

K991081 - Frameless Neuromate - Integrated Surgical Systems Inc

DEVICE DESCRIPTION: 4.

5. INTENDED USE:

Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

Renishaw Mayfield sarl 31 rue ampère F-69680 Chassieu - France Téléphone +33 (0) 4 37 23 89 00 +33 (0) 4 78 90 75 22 Fax

RCS Lyon 480 820 307 SIRET 48082030700027 APE 3250A Nº identification TVA FR26 480 820 307 Capital : 250 000 €

Société Générale Lyon République Code Banque 30003 Code quichet 01200 N° compte 00020839167 Clé 57 IBAN FR76 30003 01200 00020839167 BIC SOGEFRPP

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6. COMPARISON TO PREDICATE DEVICE:

6.1 Similarities

The neuromate system is a technical update of the cleared Frameless NeuroMate. It has the same intend and is similar in all the following respects:

the patient benefits .
the architecture of the product .
the materials and components used .
. the construction and method of manufacture
. the embedded software
. the planning and imaging software
the operational modes offered ●
. the attachments used

6.2 Differences

The only areas of difference between the neuromate and the cleared Frameless NeuroMate are:

a. The new neuromate system is type BF applied part while the cleared Frameless NeuroMate is type B applied part.
- Note: The terms "Type BF applied part" and "Type B applied part" are used in the IEC60601-1 standard (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) to define the level of electrical isolation of an electrical medical equipment that has a part(s) in contact with a patient under normal use. The electrical isolation is between the patient and an external electrical source. In the IEC60601-1 standard, a "Type BF applied part" has a higher degree of electrical isolation compared to a "Type B applied part".
b. The neuromate system uses absolute digital encoders to control the position of the axis of the robot arm of the system while the cleared Frameless NeuroMate uses analogical ones.
c. The image-feedback sensor has been removed from the standard tool-holder, thereby removing the image-feedback functionality of the system

6.3 Conclusion

Except for the above stated changes, the proposed Neuromate is identical in design, intended use, construction and operation to the predicate K991081.

The itemised comparison between the device and its predicate is provided in paragraph 10 (Substantial Equivalence Summary) of this document.

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7. NONCLINICAL DATA:

Bench and performance testing showed that neuromate performed as designed and intended. The neuromate was tested to and found compliant with the requirements of IEC 60601-1 and IEC 60601-1-2.

Software was developed in compliance with FDA software guidance and IEC 62304.

CLINICAL DATA: 8.

No clinical data are submitted.

CONCLUSIONS DRAWN FROM TESTING: 9.

Øi

The testing showed that the neuromate performs as designed and intended, and is equivalent in design and performance to the predicate device.

10. SUBSTANTIAL EQUIVALENCE SUMMARY

Device	neuromate Frameless Gen II(this submission)	Frameless Neuromate(510(k) K991081)	SE
Manufacturer	Renishaw Mayfield	Integrated Surgical Systems Inc	SE
	Intended Use/Indications for Use
Intended Use	Stereotactic spatial positioning andorientation of an instrument holder ortool quide to be used by a surgeonto manually guide standardneurosurgical instruments.	Stereotactic spatial positioning andorientation of an instrument holder ortool quide to be used by a surgeonto manually guide standardneurosurgical instruments.	Same
Clinicalapplication	Neurological surgery	Neurological surgery	Same
Sites of use	Operating rooms	Operating rooms	Same
User	Neurosurgeon	Neurosurgeon	Same
Anatomical site	Head	Head	Same
Technical Characteristics
General devicedescription	Computer-controlledelectromechanical multi-jointed arm	Computer-controlledelectromechanical multi-jointed arm	Same
Principle ofOperation	Patient imaging data is visualizedon the supplied workstation runningthe VoXim software. It is thesurgeon who chooses the tool,trajectory, point of access andorientation.The data is communicated to therobot which locates the tool holderaccordingly and accurately.	Patient imaging data is visualizedon the supplied workstation runningthe VoXim software. It is thesurgeon who chooses the tool,trajectory, point of access andorientation.The data is communicated to therobot which locates the tool holderaccordingly and accurately.	Same
Device	neuromate Frameless Gen II(this submission)	Frameless Neuromate(510(k) K991081)	SE
	The surgeon performs theprocedure by inserting tools throughthe tool-holder, the robot ensuringthe continued stability of theposition.	The surgeon performs theprocedure by inserting tools throughthe tool-holder, the robot ensuringthe continued stability of theposition.
	Patient registration uses anultrasound system.	Patient registration uses anultrasound system.
May be used inframe-basedmode	Yes: the patient wears a stereotacticframe and the frame is attached tothe robot (mechanical registration)	Yes: the patient wears astereotactic frame and the frame isattached to the robot (mechanicalregistration)	Same
May be used inframeless mode	Yes: the patient wears a light-weightmicrophone frame and theregistration is made by ultrasound.	Yes: the patient wears a light-weight microphone frame and theregistration is made by ultrasound.	Same
Image feedback	No: the surgeon controls the depthof insertion of a biopsy needlethrough the rule on the cannula.	Yes: the position of the tool'sextremity is shown superposed tothe brain scan image.
		However, the surgeon is advisednot to use this information to controltool depth (use instead the rule onthe cannula)	SE
SystemArchitecture	• a robot, made of a computer-controlled articulated motorizedarm and the base that supports itand contains the controlelectronics;• a workstation on which runssoftware for scanned imageprocessing, procedure planning,robot configuration, robot controland system diagnostic;• a series of attachments to connectthe robot to the patient, to performpatient registration and to supportthe tools used by the surgeon	• a robot, made of a computer-controlled articulated motorizedarm and the base that supports itand contains the controlelectronics;• a workstation on which runssoftware for scanned imageprocessing, procedure planning,robot configuration, robot controland system diagnostic;a series of attachments toconnect the robot to the patient, toperform patient registration and tosupport the tools used by thesurgeon	Same
Attachments	• remote control handset• standard tool-holder• tool laser holder• frame adapter• head-holder• ultrasound tool-holder• microphone frame• temporary implant insert• CT image localizer• MRI image localizer• angiographic module localizer	• remote control handset• standard tool-holder• tool laser holder• frame adapter• head-holder• ultrasound tool-holder• microphone frame• temporary implant insert• CT image localizer• MRI image localizer• angiographic module localizer	Same
Device	neuromate Frameless Gen II(this submission)	Frameless Neuromate(510(k) K991081)	SE
Construction	• Mechanical arm in four parts with5 joints (5 degrees of freedom)• Rigid fixation between thestereotactic ring attachment orhead holder attachment and theneuromate robot• Each arm joint is an electrome-chanical subassembly composedof a motor; planetary reducer;gear reducer; and worm-wheeladjustment system with variablebacklash, providing non-reversiblemotion and guaranteeing rigidposition locking.	• Mechanical arm in four parts with5 joints (5 degrees of freedom)• Rigid fixation between thestereotactic ring attachment orhead holder attachment and theneuromate robot• Each arm joint is an electrome-chanical subassembly composedof a motor; planetary reducer;gear reducer; and worm-wheeladjustment system with variablebacklash, providing non-reversiblemotion and guaranteeing rigidposition locking.	Same
Axis controltechnology	Incremental digital encodersAbsolute digital encoders	Incremental digital encoderAbsolute analogical encoder	SE
Software/firmware/ microprocessorcontrol	Yes	Yes	Same
Controller S/W	Main Controller	Main Controller	Same
Planning S/W	VoXim neuromate 6.4	VoXim 1.0	SE
Imaging S/W	VoXim neuromate 6.4	VoXim 1.0	SE
Compliance withvoluntarystandards	YesIEC 60601-1:2005 + AC1 + AC2IEC 60601-1-2:2007IEC 60601-1-4:2000IEC 62366: 2007ISO 14971: 2007IEC 62304: 2006DICOM 3ISO 17665-1:2006	YesEN 55011, Group 1, Class BEN 50082-1 (IEC 801-2)EN 50082-1 (IEC 801-3)EN 50082-1 (IEC 801-4)IEC 601.1	SE

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 29, 2014

Renishaw Mayfield Sarl Mr. Stephane Vinot Quality Assurance & Regulatory Affairs Manager 31 Rue Ampere Chassieu. France 69680

Re: K132755

Trade/Device Name: Neuromate Frameless Gen II Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 21, 2014 Received: January 29, 2014

Dear Mr. Vinot:

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 fray of subject to additions, 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 that I DA has made a dolor regulations administered by other Federal agencies. You must

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Page 2 – Mr. Stephane Vinot

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetw/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 yours,

Felipe Aquel -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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132755

Device Name Neuromate Frameless Gen II

Indications for Use (Describe)

Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

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)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY :54 : 1 . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.04.2 18:06:23 -04'00'

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 443-6740

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).