The CRW Stereotactic System is a stereotactic system to be used for neurosurgical procedures that require precise target localization, such as craniotomies, biopsies, and functional stereotaxy. Localization is performed using CT or MR imaging.

Device Description

Part of the CRW™ Stereotactic System is comprised of the following components:

Universal Compact Head Ring (UCHR),
Luminant Localizer Frame (LL01) ●
Disposable Head Ring Screws (DHRSS- Short, DHRSL- long) ●
The Universal Compact Head Ring is placed on the patient and secured with the Disposable Head Ring Screws. The Luminant Localizer Frame is then attached to the base ring and the patient is taken to the neuroradiology department where a CT or MR imaging is performed. The image obtained in conjunction with the localizer allows the neurosurgeon to compute the exact three dimensional position of the region of interest.

AI/ML Overview

The provided text describes the 510(k) summary for the CRW Stereotactic System, focusing on non-clinical testing for a labeling change to add an MR Conditional claim. It's important to note that this document is not a study proving device performance against clinical acceptance criteria in the sense of accuracy for a diagnostic or therapeutic medical AI device. Instead, it describes tests performed to establish safety and compatibility for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
MR testing (Magnetic Resonance safety and compatibility)	Compliance with FDA Guidance: "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment (August 21, 2008)" and relevant ASTM Standards (F2052, F2213, F2182, F2119). Specifically, to support an MR conditional claim.	"Results met pre-established acceptance criteria. MR labeling included in the submission is in compliance with FDA Guidance and ASTM F2503. The results demonstrate substantial equivalence by complying with current FDA Guidance and consensus standards requirements." (For 1.5T and 3.0T MR environments)
Sterilization – Devices provided to the user sterile	Sterilization to a Sterility Assurance Level (SAL) of 10-6, in accordance with FDA Guidance regarding devices packaged sterile.	"Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of sterility for devices provided to the user sterile."
Sterilization – Devices to be sterilized by the end user	Sterilization to a SAL of 10-6 using EtO, steam, and Sterrad® cycles.	"Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of sterility for devices intended to be sterilized by the end user."
Shipping/Stability	Maintenance of sterile device packaging integrity and stability to support a three-year shelf life claim, according to ASTM D4169 and ASTM F1980.	"Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device of the sterile device packaging in terms of shipping integrity and stability."
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 for patient-contacting devices.	"Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of biocompatibility."

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical bench testing of the physical device components, not a clinical study involving patient data. Therefore, there is no "test set" in the context of patient data, nor a "data provenance" (like country of origin, retrospective/prospective). The "samples" referred to are physical units or worst-case samples of the device components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth in this context refers to established standards and guidelines (e.g., ASTM standards, FDA guidance, ISO standards) for physical device testing, rather than expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined engineering and safety standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device and its safety/compatibility in specific environments, not a diagnostic or AI-assisted system where human reader performance would be a factor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for these tests is based on:

Established engineering and safety standards (e.g., ASTM F2052, F2213, F2182, F2119, F2503 for MR; ASTM D4169, F1980 for shipping/stability; ISO 10993 series for biocompatibility).
Regulatory guidance documents (e.g., FDA Guidance: "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment," FDA Guidance regarding devices packaged sterile).
Scientific principles for sterilization (SAL of 10-6).

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set, there's no ground truth established for one.

Summary

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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 stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol.

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

December 6, 2016

Integra Lifesciences Corporation Timothy Connors Senior Regulatory Affairs Associate 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K160811

Trade/Device Name: CRW Stereotactic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 4, 2016 Received: November 7, 2016

Dear Mr. Connors:

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 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.

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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 yours,

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

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Indications for Use

510(k) Number (if known) K160811

Device Name CRW Stereotactic System

Indications for Use (Describe)

The CRW Stereotactic System is a stereotactic system to be used for neurosurgical procedures that require precise target localization, such as craniotomies, biopsies, and functional stereotaxy.

Localization is performed using CT or MR imaging.

Type of Use (Select one or both, as applicable)
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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 summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

807.92(a)(1) – Submitter information
Name	Integra LifeSciences Corporation
Address	311 Enterprise Drive Plainsboro, NJ 08536 USA
Phone Number	609-936-5531
Fax Number	NA
Establishment RegistrationNumber	3003418325
Name of Contact Person	Timothy Connors, Senior Regulatory Affairs Specialist
Date Prepared	March 24, 2016
807.92(a)(2) – Name of device
Trade or Propriety Name	CRWTM Stereotactic System
Common or Usual Name	Universal Compact Head RingLuminant Localizer FrameDisposable Head Ring Screws
Classification Name	Neurological Stereotaxic Instrument
Classification Panel	Neurology
Regulation	882.4560
Product Code(s)	HAW
807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed
CRW-1 SYSTEM; K944463
807.92(a)(4) - Device description

Part of the CRW™ Stereotactic System is comprised of the following components:

Universal Compact Head Ring (UCHR),
Luminant Localizer Frame (LL01) ●
Disposable Head Ring Screws (DHRSS- Short, DHRSL- long) ●

The Universal Compact Head Ring is placed on the patient and secured with the Disposable Head Ring Screws. The Luminant Localizer Frame is then attached to the base ring and the patient is taken to the neuroradiology department where a CT or MR imaging is performed. The image obtained in conjunction with the localizer allows the neurosurgeon to compute the exact three dimensional position of the region of interest.

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807.92(a)(5) – Intended use of the device
Indications for Use	The CRW-1 System is a stereotactic system to be used forneurosurgical procedures that require precise targetlocalization, such as craniotomies, biopsies, and functionalstereotaxy.Localization is performed using CT or MR imaging.

807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate

The CRWTM Stereotactic System design is not changing as a result of this submission; this submission is primarily for a labeling change to add an MR Conditional claim and associated MRI safety information.

CRW Stereotactic System and the predicate device have the same device classification, product code and measureable parameters as outlined within the submission.

807.92(b)(1-2) – Nonclinical tests submitted

CRW Stereotactic System was tested in accordance with FDA's Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment (August 21, 2008) and the relevant ASTM Standards covered in the guidance document. Testing includes Magnetic Resonance testing only to support an MR conditional claim for components used in the MR environment.

Additional tests to support sterilization information, shelf life information and biocompatibility have also been included.

The table below outlines the testing performed, test method summary and the results of the testing.

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Test	Test Method Summary	Results
MR testing	Testing on the device assembly was executed per the suite of ASTM standards called out in the FDA Guidance regarding passive implants in the MR environment. Standards used for testing include ASTM F2052, ASTM F2213, ASTM F2182 and ASTM F2119.	Results met pre-established acceptance criteria. MR labeling included in the submission is in compliance with FDA Guidance and ASTM F2503. The results demonstrate substantial equivalence by complying with current FDA Guidance and consensus standards requirements.
Sterilization – Devices provided to the user sterile	Testing was executed on the worst-case sample from a device family to demonstrate the subject devices could be sterilized to the SAL of 10-6. The testing was performed in accordance with FDA Guidance regarding devices packaged sterile.	Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of sterility for devices provided to the user sterile.
Sterilization - Devices to be sterilized by the end user	Three different types of end user sterilization cycles were tested to demonstrate the cycles could sterilize the devices to the SAL of 10-6: EtO, steam and Sterrad®.	Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of sterility for devices intended to be sterilized by the end user.
Shipping/Stability	The worst-case sample was identified of those devices provided to the user sterile. Ship testing and stability testing were executed according to ASTM D4169 and ASTM F1980 to support a three-year shelf life claim.	Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device of the sterile device packaging in terms of shipping integrity and stability.
Biocompatibility	Biocompatibility testing was	Results met pre-established
	executed for patient	acceptance criteria,
	contacting devices, as	demonstrating substantial
	identified in ISO 10993-1,	equivalence to the predicate
	per ISO 10993-5, ISO	device in terms of
	10993-10 and ISO 10993-11.	biocompatibility.

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807.92(b)(3) – Conclusions drawn from non-clinical data

All necessary testing has been conducted per ASTM standards for the relevant CRW Stereotactic System components to be used in an MR environment (1.5 T and 3.0 T) and the test results support the addition of an MR conditional claim to the device labeling. All other testing performed raised no additional concerns of safety or efficacy. In conclusion, the components are safe and effective for use under conditions specified in the product labeling and the device is substantially equivalent to the predicate device.

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).