(257 days)
CRW-1 SYSTEM; K944463
No
The description focuses on mechanical components and image-based localization without mentioning any AI/ML algorithms for image processing, analysis, or decision support. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a "stereotactic system to be used for neurosurgical procedures that require precise target localization, such as craniotomies, biopsies, and functional stereotaxy." This indicates it is a tool for guiding medical procedures rather than directly treating a disease or condition. While used in a therapeutic context, it is not therapeutic itself.
No
The device is a stereotactic system used for precise target localization during neurosurgical procedures, employing CT or MR imaging for guidance, rather than diagnosing conditions.
No
The device description explicitly lists hardware components (Universal Compact Head Ring, Luminant Localizer Frame, Disposable Head Ring Screws) that are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for neurosurgical procedures requiring precise target localization using imaging. This is a surgical guidance and planning tool, not a diagnostic test performed on biological samples.
- Device Description: The components described are physical devices used to secure the head and provide reference points for imaging. They do not involve the analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is a core characteristic of IVD devices.
The device is a stereotactic system used in conjunction with medical imaging to guide surgical procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
HAW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR imaging
Anatomical Site
Not Found
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: Nonclinical tests. Tests were conducted in accordance with FDA's Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment (August 21, 2008) and relevant ASTM Standards (ASTM F2052, ASTM F2213, ASTM F2182 and ASTM F2119).
Key Results: Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device. MR labeling is in compliance with FDA Guidance and ASTM F2503. Sterilization testing demonstrated that devices could be sterilized to an SAL of 10-6. Shipping/stability testing supported a three-year shelf life. Biocompatibility testing results met acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
CRW-1 SYSTEM; K944463
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.
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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) |
|---|
| ------------------------------------------------- |
| 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 Registration | |
| 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 |
| Luminant Localizer Frame | |
| 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.
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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 for |
| neurosurgical procedures that require precise target | |
| localization, such as craniotomies, biopsies, and functional | |
| stereotaxy. | |
| 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.