(90 days)
No
The description focuses on reusable surgical instruments used with a navigation system, with no mention of AI or ML capabilities in the instruments themselves or the navigation system's function as described.
No
The device is a system of surgical instruments intended to assist surgeons in precisely locating anatomical structures during spinal surgery, rather than directly treating a medical condition itself.
No
The device is an instrument system used during spinal surgery to assist in the placement of screws by precisely locating anatomical structures, not to diagnose a medical condition.
No
The device description explicitly states that the system consists of "reusable surgical instruments" made from stainless steel, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Dark Star Navigated Instrument System is a set of surgical instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures. It is used in conjunction with a navigation system and imaging data.
- Lack of Sample Testing: The device does not perform any tests on biological samples. Its function is to aid in the physical manipulation and placement of surgical instruments based on imaging and navigation data.
Therefore, the Dark Star Navigated Instrument System falls under the category of surgical instruments and navigation aids, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Dark Star Navigated Instrument System is intended to be used during the preparation and placement of Dark Star screws 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 (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Republic Spine, LLC Dark Star Navigation Instrument System consists of reusable surgical instruments intended for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.
The Dark Star Navigation Instrument System includes taps, awls, probes, and drivers. The Dark Star Navigation Instrument System is to be used with the Dark Star Spinal System.
The instruments are made from stainless steel. The Dark Star Navigation Instrument System is not compatible with implants from other manufacturers and is 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, or digitized landmarks of the anatomy.
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)
The Dark Star Navigation Instrument System has been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems."
The results of this non-clinical testing show that performance of the Dark Star Navigation Instrument System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
September 27, 2021
Image /page/0/Picture/1 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Republic Spine, LLC James Doulgeris Director of Product Development and Quality Systems 2424 N Federal HW, Suite 257 Boca Raton, Florida 33431
Re: K212028
Trade/Device Name: Dark Star Navigation Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 28, 2021 Received: June 29, 2021
Dear James Doulgeris:
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,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |
|---|---|---|
| Food and Drug Administration | ||
| Expiration Date: 06/30/2020 | ||
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number (if known) | K212028 |
|---|---|
| Device Name | Dark Star Navigation Instrument System |
| Indications for Use (Describe) | Dark Star Navigated Instrument System is intended to be used during the preparation and placement of Dark Star screws 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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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
3
510(K) SUMMARY
| Submitter's Name: | Republic Spine, LLC |
|---|---|
| Submitter's Address: | 2424 North Federal Hwy, Suite 257 |
| Boca Raton, FL 33431 | |
| Submitter's Telephone: | 561-334-2421 |
| Contact Person: | James Doulgeris |
| 727-512-5461 | |
| James@rspine.com | |
| Date Summary was Prepared: | 06/28/2021 |
| Trade or Proprietary Name: | Dark Star Navigation Instrument System |
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Republic Spine, LLC Dark Star Navigation Instrument System consists of reusable surgical instruments intended for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.
The Dark Star Navigation Instrument System includes taps, awls, probes, and drivers. The Dark Star Navigation Instrument System is to be used with the Dark Star Spinal System.
The instruments are made from stainless steel. The Dark Star Navigation Instrument System is not compatible with implants from other manufacturers and is designed for use only with Medtronic StealthStation Navigation System hardware and software.
INDICATIONS FOR USE
Dark Star Navigated Instrument System is intended to be used during the preparation and placement of Dark Star screws 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.
TECHNOLOGICAL CHARACTERISTICS
Republic Spine, LLC Dark Star Navigation Instrument System
4
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specially, the following characteristics are identical between the subject and predicates:
- Indications for Use ●
- Materials of manufacture ●
- Principles of Operation ●
- Sizes ●
Table 5-1 Predicate Devices
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Product
Code | Predicate
Type |
|----------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------|-------------------|
| K161210 | Medtronic Navigated Reusable Manual
Instruments for Use with the StealthStation™
and IPCT™ Powerease™ Systems | Medtronic
Sofamor
Danek | OLO | Primary |
| K201420 | Dark Star Spinal System | Republic
Spine, LLC | NKB,
KWP | Reference |
PERFORMANCE DATA
The Dark Star Navigation Instrument System has been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems."
The results of this non-clinical testing show that performance of the Dark Star 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 Dark Star Navigation Instrument System is substantially equivalent to the predicate device.