(259 days)
Not Found
No
The summary describes navigated surgical instruments that work with a separate navigation system (Medtronic StealthStation® System). The description focuses on the instruments themselves and their compatibility with the navigation system, which uses standard imaging modalities and positional tracking. There is no mention of AI or ML being incorporated into the instruments or the described functionality.
No.
The device is described as surgical instruments and is indicated for use during spinal surgery to assist the surgeon, not to treat a medical condition directly.
No
The device is intended to assist surgeons in precisely locating anatomical structures during spinal surgery, functioning as a navigation tool rather than providing a diagnosis of a patient's medical condition.
No
The device description explicitly states the instruments are manufactured from stainless steel and are non-sterile, reusable instruments, indicating a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these instruments are used during spinal surgery to assist the surgeon in precisely locating anatomical structures and placing screws. They are physical tools used directly on the patient's anatomy, not for analyzing samples taken from the body.
- Intended Use: The intended use is to aid in surgical procedures, not to diagnose a condition based on laboratory analysis.
- Device Description: The device is described as non-sterile, reusable instruments made of stainless steel, designed to function with a surgical navigation system. This aligns with surgical tools, not diagnostic tests.
The information provided strongly indicates that this is a surgical instrument designed for use with a surgical navigation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Spinal Elements Navigated Instruments are intended to be used during the preparation and placements screws (Overwatch®, Savannah® and Mercury® Fixation Systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Product codes
OLO
Device Description
Spinal Elements Navigated instruments are non-sterile, reusable instruments designed to function with the the the Medtronic StealthStation® System. Spinal v Elements Navigated instruments are for use with Spinal Elements pedicle screw systems, specifically, Overwatch®, Mercury® and Savannah® pedicle screw systems. Instruments are manufactured from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, spinal surgery
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)
Spinal Elements Navigated Instruments have been tested per ASTM F2554 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". The results of this non-clinical testing show that performance of the Spinal Elements Navigated instruments is sufficient for its intended use and is substantially equivalent to legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
December 19, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Spinal Elements Inc. Julie Lamothe Vice President Regulatory Affairs 3115 Melrose Dr. Suite 200 Carlsbad, California 92010
Re: K190881
Trade/Device Name: Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 18, 2019 Received: November 20, 2019
Dear Julie Lamothe:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190881
Device Name Spinal Elements Navigated Instruments
Indications for Use (Describe)
Spinal Elements Navigated Instruments are intended to be used during the preparation and placements screws (Overwatch®, Savannah® and Mercury® Fixation Systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of 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 Navigated Instruments
510(k) Number: K190881
| Manufacturer Identification
Submitted by: | Spinal Elements, Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
760-607-0121 |
|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Julie Lamothe
Vice President, Regulatory Affairs/Quality Assurance
Spinal Elements, Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
760-607-1816
jlamothe@spinalelements.com |
| Date Prepared: | December 16, 2019 |
| Proprietary Device
Common Name
Classification Name
Regulation Number
Regulatory Class
Product Code | Spinal Elements Navigated Instruments
Stereotaxic Instrument
Orthopedic Stereotaxic Instrument
21 CFR 882.4560
Class II
OLO |
Device Description
Spinal Elements Navigated instruments are non-sterile, reusable instruments designed to function with the the the Medtronic StealthStation® System. Spinal v Elements Navigated instruments are for use with Spinal Elements pedicle screw systems, specifically, Overwatch®, Mercury® and Savannah® pedicle screw systems. Instruments are manufactured from stainless steel.
Indications for Use
Spinal Elements Navigated Instruments are intended to be used during the preparation and placement of Spinal Elements screws (Overwatch®, Savannah® and Mercury® Fixation Systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
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Substantial Equivalence
The subject devices are substantially equivalent to the primary predicate devices cleared in K140454 and the additional predicates cleared in K143375 and K143628.
Technological Characteristics
The subject device has equivalent technological characteristics to its predicates presented below through comparison in areas including labeling/indications for use, general design features, function, material, manufacturing process and principle of operation:
- Medtronic Navigated Horizon screwdriver/Taps. K140454 Primary .
Performance Data
Spinal Elements Navigated Instruments have been tested per ASTM F2554 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". The results of this non-clinical testing show that performance of the Spinal Elements Navigated instruments is sufficient for its intended use and is substantially equivalent to legally marketed devices.
Conclusion
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to the aforementioned predicate devices cleared by FDA for commercial distribution in the United States.