(166 days)
No
The document describes surgical instruments used with a navigation system, but there is no mention of AI or ML in the intended use, device description, or performance studies. The navigation system itself (Medtronic StealthStation) is mentioned, but its specific technology is not detailed in this summary, and the focus is on the instruments' compatibility and accuracy.
No.
This device is a surgical instrument system used to assist surgeons in precisely locating anatomical structures during spinal surgery for the placement of screws, rather than directly treating a medical condition.
No
This device is a surgical navigation instrument system, not a diagnostic device. Its purpose is to assist surgeons in precisely locating anatomical structures during spinal surgery for the placement of screws, rather than to identify or determine the nature of a disease or condition. It is used with a navigation system (Medtronic StealthStation), which does use imaging data, but the instruments themselves are tools for surgical guidance.
No
The device description explicitly lists physical instruments (Screwdrivers, Taps, Drills, and Drill Guides) made of stainless steel, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical 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 SPINEART® Navigation Instrument System is a set of surgical instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures and placing screws. It interacts directly with the patient's body during a surgical procedure.
- Intended Use: The intended use clearly states it's for use during spinal surgery to assist in the preparation and placement of screws. It does not involve the analysis of specimens taken from the body.
The device is a surgical navigation instrument system, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Product codes
OLO
Device Description
The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic® StealthStation® 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.
The SPINEART® Navigation Instrument System includes the following: Screwdrivers, Taps, Drills, and Drill Guides.
The SPINEART® Navigation Instrument System are to be used with the following Spineart Systems:
- ■Romeo® 2
▪Romeo® 2 MIS
▪Perla® Cervico-thoracic Fixation System
All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4mm to Ø7.5mm for the Romeo® 2 systems and from Ø3mm to Ø4mm for the Perla system.
The SPINEART® Navigation Instruments are not compatible with implants from other manufacturers.
The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation Navigation System hardware and software.
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, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons / 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
Design validation testing including connection, registration, simulated use, and accuracy was conducted to ensure that the SPINEART® Navigation Instrument System instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation®, and to demonstrate substantial equivalence to the predicate instruments.
Connection testing evaluated the connection between the NavLock Tracker and the instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation®. Simulated use testing was completed to verify successful implantation of Spineart screws by the SPINEART® Navigation Instrument System. Accuracy testing per ASTM F2554-10, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems," was completed for comparison to the predicate instruments. The results of this non-clinical testing show that the performance of the SPINEART® Navigation Instrument System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K143628/K140454/K143375, K172517, K153203
Reference Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 06, 2019
Spineart SA % Meredith May Vice President Empirical Consulting LLC 4628 Northpark Dr Colorado Springs, Colorado 80918
Re: K183630
Trade/Device Name: SPINEART Navigation Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 3, 2019 Received: May 6, 2019
Dear Meredith May:
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
1
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 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 (QS) 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 medical devices and radiation-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,
For: Shumaya Ali 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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K183630
Device Name
SPINEART® Navigation Instrument System
Indications for Use (Describe)
The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System 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, a long 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) |
| 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 |
| PRAStaff@fda.hhs.gov |
| "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." |
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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5.510(K) SUMMARY
| Submitter's Name: | Spineart SA |
|---|---|
| Submitter's Address: | Chemin du Pré- Fleuri 3 |
| 1228 Plan-les-Ouates | |
| Switzerland | |
| Submitter's Telephone: | +41 22 570 1200 |
| Contact Person: | Meredith Lee May MS, RAC |
| Empirical Consulting | |
| 719.337.7579 | |
| MMay@EmpiricalConsulting.com | |
| Date Summary was Prepared: | 21-Dec-18 |
| Trade or Proprietary Name: | SPINEART® Navigation Instrument System |
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification: | Class II per 21 CFR §882.4260 |
| Product Code: | OLO |
| Classification Panel: | Division of Orthopedic Devices |
Description of the Device Subject to Premarket Notification:
The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic® StealthStation® 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.
The SPINEART® Navigation Instrument System includes the following: Screwdrivers, Taps, Drills, and Drill Guides.
The SPINEART® Navigation Instrument System are to be used with the following Spineart Systems:
- ■Romeo® 2
▪Romeo® 2 MIS
▪Perla® Cervico-thoracic Fixation System
All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4mm to Ø7.5mm for the Romeo® 2 systems and from Ø3mm to Ø4mm for the Perla system.
The SPINEART® Navigation Instruments are not compatible with implants from other manufacturers.
The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation Navigation System hardware and software.
4
INDICATIONS FOR USE
The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for use
- Materials of manufacture
- Principle of operation
- Device technology ●
- Sizes ●
- Mechanical performance
- Packaging (materials and processes) ●
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-----------------------------|---------------------------------------------------------|--------------------------------------|-------------------|
| K143628/K140454/
K143375 | Medtronic Navigated
Instruments | Medtronic Sofamor
Danek USA, Inc. | Primary |
| K172517 | SeaSpine Navigation
System | SeaSpine Orthopedics
Corporation | Additional |
| K153203 | Navigation Instruments | Globus Medical, Inc. | Additional |
| K140948 | ROMEO® Posterior
Osteosynthesis System | Spineart | Reference |
| K153386 | PERLA® Posterior
Cervico-Thoracic Fixation
System | Spineart | Reference |
Performance Data
Design validation testing including connection, registration, simulated use, and accuracy was conducted to ensure that the SPINEART® Navigation Instrument System instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation®, and to demonstrate substantial equivalence to the predicate instruments.
5
Connection testing evaluated the connection between the NavLock Tracker and the instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation®. Simulated use testing was completed to verify successful implantation of Spineart screws by the SPINEART® Navigation Instrument System. Accuracy testing per ASTM F2554-10, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems," was completed for comparison to the predicate instruments. The results of this non-clinical testing show that the performance of the SPINEART® Navigation Instrument System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the SPINEART® Navigation Instrument System is substantially equivalent to the predicate device.