(27 days)
Not Found
No
The summary describes manual, reusable surgical instruments used with a navigation system, with no mention of AI or ML capabilities. The performance study focuses on dimensional analysis.
No
The device is a set of navigated surgical instruments used for precise screw placement during spinal surgery, not a device that directly treats a medical condition.
No
The device is described as "reusable, manual, surgical instruments" used "to assist the surgeon in precisely locating anatomical structures" during screw placement in spinal surgery. It works with a navigation system but does not itself provide a diagnosis of a patient's condition. Its function is to guide surgical actions, not to identify diseases or conditions.
No
The device description explicitly states the instruments are "reusable, manual, surgical instruments made from stainless steel," indicating they are physical hardware components.
No, 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.
- Device Function: The Spine Wave® Navigated Instruments are surgical instruments used during surgery to assist in the placement of screws. They are used directly on the patient's anatomy, not on samples taken from the patient.
- Intended Use: The intended use clearly states they are used "during spinal surgery to assist the surgeon in precisely locating anatomical structures." This is an in vivo (within the living body) application, not in vitro (in glass/outside the body).
The device description and intended use clearly indicate that this is a surgical navigation system component used for guiding instruments during spinal surgery, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, Proficient® Posterior Cervical Spine System, or the Salvo™ Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.
Product codes
OLO
Device Description
The Spine Wave® Navigated Instruments are reusable, manual, surgical instruments made from stainless steel. These instruments are to be used with the Medtronic StealthStation® System via the Medtronic NavLock™ Tracker to facilitate screw placement during cervicothoracic and thoracolumbosacral surgeries. New instruments are being added to allow use with Salvo™ Spine System screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervicothoracic and thoracolumbosacral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / spinal surgery (clinical setting)
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
A dimensional analysis and characterization was performed for the new components to demonstrate substantial equivalence.
Key Metrics
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).
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October 10, 2019
Image /page/0/Picture/1 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
Spine Wave, Inc. Amy Noccioli Sr. Regulatory Affairs Specialist 3 Enterprise Drive. Suite 210 Shelton, Connecticut 06484
Re: K192526
Trade/Device Name: Spine Wave Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 12, 2019 Received: September 13, 2019
Dear Amy Noccioli:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Spine Wave® Navigated Instruments
Indications for Use (Describe)
The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, Proficient® Posterior Cervical Spine System, or the Salvo™ Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wavigated Instruments are designed for use with the Medtronic StealthStation® System.
| 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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K192526
510(k) Summary Spine Wave® Navigated Instruments
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1842 |
| Telefax: | 203-944-9493 |
| Contact: | Amy Noccioli |
| Date Prepared: | October 9, 2019 |
2. Device Information
| Trade Name: | Spine Wave® Navigated Instruments |
|---|---|
| Common Name: | Orthopedic Stereotaxic Instruments |
| Classification: | Class II per 21 CFR 882.4560 |
| Classification Name: | Stereotaxic Instruments |
| Product Code: | OLO |
3. Purpose of Submission
The purpose of this submission is to gain clearance for the addition of new instruments and to expand the indications to allow use with Salvo™ Spine System screws.
4. Predicate Device Information
The Spine Wave® Navigated Instruments described in this submission are substantially equivalent to the following predicate:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Navigated Instruments | Spine Wave | K181596 |
5. Device Description
The Spine Wave® Navigated Instruments are reusable, manual, surgical instruments made from stainless steel. These instruments are to be used with the Medtronic StealthStation® System via the Medtronic NavLock™ Tracker to facilitate screw placement during cervicothoracic and thoracolumbosacral surgeries. New instruments are being added to allow use with Salvo™ Spine System screws.
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6. Indications for Use
The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, Proficient® Posterior Cervical Spine System, or the Salvo™ Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.
7. Comparison of Technological Characteristics
The Spine Wave® Navigated Instruments have technological characteristics similar to those of the predicate device, including intended use, performance, design, and material composition.
8. Performance Data
A dimensional analysis and characterization was performed for the new components to demonstrate substantial equivalence.
9. Conclusion
The intended use and technological characteristics show that the Spine Wavigated Instruments are substantially equivalent to the predicate devices identified in this submission and do not present any new issues of safety or effectiveness.