(102 days)
No reference devices were used in this submission.
No
The description focuses on the mechanical function of the reducing tubes and their compatibility with a navigation system, with no mention of AI/ML in the device itself or its operation.
No.
The device's intended use is to maintain the position of instruments or devices during neurological procedures, not to directly treat a disease or condition.
No
The device is described as an accessory that maintains the position of instruments or devices during surgical procedures, working with a navigation system that uses pre-operative scans. Its function is to aid in the physical placement and stable positioning of surgical tools, not to analyze patient data, diagnose conditions, or provide diagnostic information.
No
The device description explicitly states the device is "metallic, reusable accessories" and describes physical dimensions (inner diameters), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cranial Reducing Tubes are described as metallic, reusable accessories used to maintain the position of instruments or devices during neurosurgical procedures guided by a navigation system. They are used in vivo (within the body) during surgery, not in vitro (outside the body) on patient samples.
- Intended Use: The intended use clearly states they are for "maintaining the position of instruments or devices placed using stereotactic guidance during planning and operation of neurological procedures." This is a surgical aid, not a diagnostic test.
The device's function and intended use are entirely focused on assisting with surgical procedures, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Cranial Reducing Tubes are intended to maintain the position of instruments or devices placed using stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation System Image Guided Workstation. The devices were not tested for MR compaibility, and are not intended for use in an MRI environment.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Medtronic Cranial Reducing Tubes (CRT) are metallic, reusable accessories that maintain the position of instruments or devices placed using stereotactic guidance during neurosurgical procedures. The CRTs have differing inner diameters (4.0 mm, 3.2 mm, and 1.7mm). The CRT inserts into the Precision Aiming Device accessory of the Medtronic StealthStation System. This is conducted in an operating room environment where navigational trajectories are determined by the StealthStation System using preoperative MR/CT scans of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
preoperative MR/CT scans
Anatomical Site
neurological procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room environment / user's needs and product usability
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)
System Accuracy
- Results: The CRTs when used with compatible accessories and the StealthStation system have demonstrated accuracy with a mean positional error of
§ 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).
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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. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2016
Medtronic Navigation, Inc. Christopher Perman Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K162604
Trade/Device Name: Cranial Reducing Tubes Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 8, 2016 Received: December 9, 2016
Dear Mr. Perman:
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
for Carlos L. Peña, PhD, MS 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) K162604
Device Name Cranial Reducing Tubes
Indications for Use (Describe)
The Cranial Reducing Tubes are intended to maintain the position of instruments or devices placed using stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation System Image Guided Workstation. The devices were not tested for MR compaibility, and are not intended for use in an MRI environment.
| 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
I. SUBMITTER
Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA
Telephone: 720-890-3200 Fax: 720-890-3500
Contact Person: Christopher Perman Date Prepared: September 16, 2016
II. DEVICE
Name of Device: Cranial Reducing Tubes Common Name: Stereotaxic Instrument Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Regulatory Class: Class II (21 CFR 882.4560) Product Code: HAW
III. PREDICATE DEVICE
Navigus Trajectory Guide. K992304 (Medtronic Neuromodulation) Navigus II Trajectory Guide, K012366 (Medtronic Neuromodulation)
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Medtronic Cranial Reducing Tubes (CRT) are metallic, reusable accessories that maintain the position of instruments or devices placed using stereotactic guidance during neurosurgical procedures. The CRTs have differing inner diameters (4.0 mm, 3.2 mm, and 1.7mm). The CRT inserts into the Precision Aiming Device accessory of the Medtronic StealthStation System. This is conducted in an operating room environment where navigational trajectories are determined by the StealthStation System using preoperative MR/CT scans of the patient.
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V. INDICATIONS FOR USE
The Cranial Reducing Tubes are intended to maintain the position of instruments or devices placed using stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation System Image Guided Workstation. The devices were not tested for MR compatibility, and are not intended for use in an MRI environment.
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| | Cranial Reducing Tubes
(Subject Device) | Navigus II Trajectory Guide
(Predicate Device) | Navigus Manual Trajectory Guide
(Predicate Device) |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | | | |
| 510k Number | K162604 | K012366 | K992304 |
| Indications for Use | The Cranial Reducing Tubes are
intended to maintain the position
of instruments or devices placed
using stereotactic guidance during
planning and operation of
neurological procedures
performed in conjunction with the
use of the Medtronic
StealthStation System Image
Guided Workstation. The devices
were not tested for MR
compatibility, and are not
intended for use in an MRI
environment. | The Navigus II Trajectory Guide is
intended to provide stereotactic
guidance for the placement and
operation of instruments or devices
during planning and operation of
neurological procedures within the
MRI/CT environment and in
conjunction with the use of an Image
Guided Workstation System using
preoperative MR and/or CT imaging.
These procedures include biopsies,
catheter and electrode introduction. The
device is ETO sterilized and for one
time use. | The Trajectory Guide is intended to provide
stereotactic guidance for the placement and
operation of instruments or devices during
planning and operation of neurological
procedures within the MRI/CT environment
and in conjunction with MR/CT-imaging. The
Trajectory Guide is intended as an integral part
of procedures that have traditionally used
stereotactic methodology. These procedures
include biopsies, catheter and electrode
introduction. The device will provide accurate
delivery of devices or instruments to target
sites 3mm and larger. |
| Sterility | Provided non-sterile
Steam Sterilization
Reusable | Provided sterile
ETO Sterilization
Single Use | Provided sterile
ETO Sterilization
Single Use |
| Number of Lumens | 1 | 5 | 1 |
| Lumen Diameter | 1.7mm, 3.2mm, 4.0mm | 2.2mm | 1mm, 2mm, 3mm, 5mm |
| MR Compatibility | No | Yes | Yes |
| Patient-Contacting
Material | Stainless Steel | SABIC ValoxTM Resin | Polycarbonate |
| Guide for instruments
and devices | Yes | Yes | Yes |
| Trajectory aligned by
Image Guided
Workstations (IGW) | Yes | Yes | No |
| Able to interface
stereotactic navigation
tool for guidance | Yes, optical tracking | Yes, optical tracking | No |
| Navigational
Performance | Mean Error ≤2.00 mm and ≤2.00° | Value not available | Delivery of devices or instruments to target
sites ≥3mm |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
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For comparison of the technological characteristics between the subject and predicate devices, the attribute of navigational performance for the subject device value was presented as mean navigational error and the predicate device presented as a minimum target size. Although these values cannot be directly compared, the safety and efficacy for navigational accuracy of the subject device was demonstrated in bench testing.
PERFORMANCE DATA VII.
Testing was completed to ensure the functionality and compatibility with the identified Medtronic navigation systems and instruments. The following table summarizes the performance testing completed:
| Test | Results | Conclusions |
|---|---|---|
| System Accuracy | The CRTs when used with compatible accessories | |
| and the StealthStation system have demonstrated | ||
| accuracy with a mean positional error of |