(30 days)
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.
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. All instruments are reusable instruments provided not sterile.
The SPINEART® Navigation Instrument System instruments are not compatible with implants from other manufacturers.
The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation® System (V2.1.0) and the Medtronic NavLock® Tracker System.
The provided text is a 510(k) summary for a medical device (SPINEART Navigation Instrument System) seeking FDA clearance for a device modification (addition of new instruments). It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The key statement regarding testing is: "Addition of navigated instruments to SPINEART Navigation Instrument System (K183630) does not require testing." This implies that the modification is considered minor enough that the performance data from the predicate device (SPINEART Navigation Instrument System K183630) is deemed sufficient. The submission relies on the "substantial equivalence" argument, stating that the new instruments have the "same technological characteristics" and "accuracy performance" as the previously cleared predicate.
Therefore, I cannot provide the requested information from the given text because the document explicitly states that no new testing was required for this specific submission.
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March 19, 2021
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Spineart Franck Pennesi Chief Technical Officer 3 chemin du pré Fleuri Plan Les Ouates, Geneva 1228 Switzerland
Re: K210472
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: February 11, 2021 Received: February 17, 2021
Dear Franck Pennesi:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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,
For; Shumaya Ali, MPH 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K210472
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)
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FORM FDA 3881 (6/20)
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Special 510k - Device Modification SPINEART NAVIGATION Instrument System
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510(k) SUMMARY
| 510k | Special 510(k): Device Modification |
|---|---|
| Basis for submission | Product Line Extension of the SPINEART Navigation Instrument System (K183630) |
| Submitted by | SPINEART3 Chemin du Pré Fleuri1228 PLAN LES OUATESGENEVA SWITZERLAND |
| Contacts | Franck PENNESI Chief Technical OfficerPhone: +41 22 570 1200 Fax: +41 22 594 8306Mail: fpennesi@spineart.comRegulatory contact: Dr Isabelle DRUBAIX (PhD) idee-consulting@bbox.fr |
| Date Prepared | February 8, 2021 |
| Common Name | Orthopedic Stereotaxic Instrument |
| Trade Name | SPINEART Navigation Instrument System |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Class | II |
| Product Code | OLO |
| CFR section | 882.4560 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate device(s) | Primary predicate: SPINEART Navigation Instrument System manufactured bySPINEART (K183630) |
| 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. |
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| Description of the device | The SPINEART® Navigation Instrument System reusable instruments are surgicalinstruments for use with the Medtronic StealthStation® Navigation System toassist surgeons in precisely locating anatomical structures in either open,minimally invasive, or percutaneous procedures for preparation and placement ofpedicle 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 followingSpineart Systems:- Romeo® 2- Romeo® 2 MIS- Perla® Cervico-thoracic Fixation SystemAll instruments are made of stainless steel per ASTM F899. All instruments arereusable instruments provided not sterile.The SPINEART® Navigation Instrument System instruments are not compatiblewith implants from other manufacturers.The SPINEART® Navigation Instrument System are designed for use only withMedtronic StealthStation® System (V2.1.0) and the Medtronic NavLock® TrackerSystem. |
|---|---|
| Technologicalcharacteristicscompared to thepredicate devices | The subject product line extension of the SPINEART Navigation Instrument System(K183630) consists of addition of taps, drill and screwdrivers for the Perla TL andPerla TL MIS Posterior Osteosynthesis Systems.As was established in this submission, the SPINEART Navigation added instrumentsare substantially equivalent and have the same technological characteristics topredicate devices in areas including indications for use, function, materialcomposition, design, range of sizes and accuracy performance. Verification andvalidation activities conducted on the added navigated instruments demonstratethat these navigated instruments are suitable to be used with the Medtronic®StealthStation® System (V2.1.0) and the Medtronic® NavLock Tracker Systemwhen implanting screws part of the Perla TL and Perla TL MIS PosteriorOsteosynthesis Systems. |
| Discussion of Testing | Addition of navigated instruments to SPINEART Navigation Instrument System(K183630) does not require testing. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons,indications for use, and dimensional and tolerance stack-up analysis, the addedSPINEART Navigation Instruments have demonstrated substantial equivalence to |
§ 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).