(134 days)
No
The summary describes manual surgical instruments used with a navigation system. There is no mention of AI or ML in the intended use, device description, or performance studies. The navigation system itself is described as providing visualization and real-time images, which is typical of traditional navigation technology, not necessarily AI/ML.
No
The device is a surgical instrument used to assist in the placement of screws during spinal surgery, which is an interventional rather than a therapeutic use.
No
The device is described as surgical instruments used to assist surgeons in precisely locating anatomical structures during spinal surgery for the placement of screws. While it works with a navigation system that provides imaging, the instruments themselves are not performing a diagnostic function; they are tools for surgical guidance and execution.
No
The device description explicitly states "manual, surgical instruments" and describes "dimensional measurements" and "interface compatibility and functionality" testing, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist surgeons in precisely locating anatomical structures during spinal surgery using a navigation system. This is a surgical tool used during a procedure, not a test performed on a sample (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- Device Description: The device is described as "manual, surgical instruments" used with a navigation system to aid in surgical procedures. This aligns with surgical tools, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on guiding surgical procedures.
N/A
Intended Use / Indications for Use
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
The purpose of this Traditional 510(k) Premarket Notification is to clear for market Alphatec NAV Instruments which are additions to the Arsenal™ Spinal Fixation System (K133221, K143149, K152968) and the Illico MIS® Posterior Fixation System (K123623) for use with the Medronic StealthStation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
rigid anatomical structure, such as a skull, along bone, or vertebra
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, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis and performance data demonstrate that the subject Alphatec Spine Navigation Instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance. Engineering analysis includes dimensional measurements of both predicate and subject devices. Verification testing includes interface compatibility and functionality of the subject device. Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.
Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject Alphatec NAV Instruments are substantially equivalent to the predicate Medtronic navigation instruments when used with the StealthStation System and NavLock Tracker.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K133221, K143149, K152968, K123623
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Alphatec Spine, Incorporated Ms. Renée Murphy Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K153603
Trade/Device Name: Alphatec Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 15, 2015 Received: December 17, 2015
Dear Ms. Murphy:
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 (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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic 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) K153603
Device Name Alphatec Navigation Surgical Instruments
Indications for Use (Describe)
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
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
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Phone: (760) 431-9286 Fax: (760) 431-0289
Contact Person: Renée L. Murphy Date Prepared: March 24, 2016
II. DEVICE
Name of Device: Alphatec Spine Navigation Instruments Common or Usual Name: Stereotaxic instruments Classification Name: Stereotaxic instruments (21 CFR 882.4560) Regulatory Class: II Product Code: OLO
III. PREDICATE DEVICE
K140454, Medtronic Navigation, Inc., Navigated CD Horizon Solera Screwdrivers and Taps
IV. DEVICE DESCRIPTION
The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
The purpose of this Traditional 510(k) Premarket Notification is to clear for market Alphatec NAV Instruments which are additions to the Arsenal™ Spinal Fixation System (K133221, K143149, K152968) and the Illico MIS® Posterior Fixation System (K123623) for use with the Medronic StealthStation System.
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V. INDICATIONS FOR USE
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
TECHNOLOGICAL COMPARISON TO PREDICATES VI.
The technological design features of the subject Alphatec Spine Navigation Instruments were compared to the predicate in indications for use, intended use, design, technology, materials, function, and performance. It was demonstrated that the subject Alphatec NAV Instrument technology is substantially equivalent to the predicate.
VII. PERFORMANCE DATA
Engineering analysis and performance data demonstrate that the subject Alphatec Spine Navigation Instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance. Engineering analysis includes dimensional measurements of both predicate and subject devices. Verification testing includes interface compatibility and functionality of the subject device. Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.
Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject Alphatec NAV Instruments are substantially equivalent to the predicate Medtronic navigation instruments when used with the StealthStation System and NavLock Tracker.
VIII. CONCLUSION
Based upon the information provided in this Traditional 510(k) submission, it has been demonstrated that the subject Alphatec Spine Navigation Instruments are substantially equivalent to legally marketed predicate devices in regards to indications for use, intended use, design, technology, functionality, and performance.