(128 days)
Not Found
No
The description focuses on manual, reusable instruments used with a navigation system, with no mention of AI/ML terms or capabilities.
No
The device is a surgical instrument intended to assist surgeons in precisely locating anatomical structures during spinal surgery, rather than directly treating a condition or restoring a function.
No
The device is described as surgical instruments used to assist in the placement of screws during spinal surgery, focusing on navigation and precise location of anatomical structures rather than diagnosing a condition or disease.
No
The device description explicitly states the Spine Wave® Navigated Instruments are "reusable, manual, surgical instruments made from stainless steel," indicating they are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instruments are used during spinal surgery to assist the surgeon in precisely locating anatomical structures for screw placement. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description confirms they are reusable, manual, surgical instruments used with a navigation system during surgery.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD device.
Therefore, the Spine Wave® Navigated Instruments are surgical instruments used for navigation during spinal surgery, not an in vitro diagnostic device.
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, or Proficient® Posterior Cervical 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, cervicothoracic and thoracolumbosacral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, during 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
Spine Wave, Inc. tested the subject devices in accordance with ASTM F2554 to demonstrate that the Spine Wave® Navigated Instruments are substantially equivalent to the predicates.
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).
0
October 24, 2018
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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Spine Wave, Inc. Amy Noccioli Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K181596
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 26, 2018 Received: September 27, 2018
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S 2018.10.24 13:12:14 -04'00'
For:
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K181596
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, or Proficient® Posterior Cervical 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.
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."
3
Image /page/3/Picture/1 description: The image shows the logo for Spine Wave. The text "Spine Wave" is written in a bold, sans-serif font. A blue wave design is underneath the text, adding a visual element to the logo.
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: | June 15, 2018 |
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 Spine Wave® Navigated Instruments.
4. Predicate Device Information
The Spine Wave® Navigated Instruments described in this submission are substantially equivalent to the following predicates:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Navigated Screwdrivers and Taps | Medtronic | K124004 |
| Additional Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Navigated Vertex Select Instruments | Medtronic | K143628 |
4
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.
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, or Proficient® Posterior Cervical 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 devices, including intended use, performance, design, and material composition.
8. Performance Data
Spine Wave, Inc. tested the subject devices in accordance with ASTM F2554 to demonstrate that the Spine Wave® Navigated Instruments are substantially equivalent to the predicates.
9. Conclusion
The indications for use, technological characteristics, and performance testing show that the Spine Wave® Navigated Instruments are substantially equivalent to the predicate devices identified in this submission and do not present any new issues of safety or effectiveness.