CRW STEREOTACTIC SYSTEM

K160811 · Integra LifeSciences Corporation · HAW · Dec 6, 2016 · Neurology

Device Facts

• Record ID: K160811
• Device Name: CRW STEREOTACTIC SYSTEM
• Applicant: Integra LifeSciences Corporation
• Product Code: HAW · Neurology
• Decision Date: Dec 6, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The CRW-1 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 Story

CRW Stereotactic System is a neurosurgical instrument for precise target localization. Components include Universal Compact Head Ring (UCHR), Luminant Localizer Frame (LL01), and Disposable Head Ring Screws. System is secured to patient head; localizer frame attached; CT or MR imaging performed. Neurosurgeon uses images and localizer to compute 3D coordinates of region of interest. Used in clinical settings by neurosurgeons to guide surgical interventions like biopsies or craniotomies. Device facilitates accurate targeting, potentially improving surgical outcomes. Submission adds MR Conditional claim for 1.5T and 3.0T environments.

Clinical Evidence

Bench testing only. Testing included MR compatibility (ASTM F2052, F2213, F2182, F2119), sterilization validation (EtO, steam, Sterrad), shipping/stability (ASTM D4169, F1980), and biocompatibility (ISO 10993-1, -5, -10, -11). All results met pre-established acceptance criteria.

Technological Characteristics

Stereotaxic instrument; passive mechanical assembly. Components: Universal Compact Head Ring, Luminant Localizer Frame, Disposable Head Ring Screws. MR Conditional (1.5T/3.0T). Sterilization: EtO, steam, or Sterrad. Biocompatibility per ISO 10993. No software or electronic components.

Indications for Use

Indicated for patients undergoing neurosurgical procedures requiring precise target localization, including craniotomies, biopsies, and functional stereotaxy, using CT or MR imaging.

Regulatory Classification

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.

Predicate Devices

• CRW-1 SYSTEM (K944463)

Submission Summary (Full Text)

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

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.

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

## 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### 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 [e-mail]

"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

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 Registration<br>Number | 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 Ring<br>Luminant Localizer Frame<br>Disposable 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.

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

| 807.92(a)(5) – Intended use of the device | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The CRW-1 System is a stereotactic system to be used for<br>neurosurgical procedures that require precise target<br>localization, such as craniotomies, biopsies, and functional<br>stereotaxy.<br>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.

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

| 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. |

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

## 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.