(128 days)
No
The summary describes navigation instruments used with a stereotactic system that provides real-time imaging for surgeon guidance. There is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on pre-existing imaging data and real-time visualization, not AI/ML-driven analysis or decision support.
No.
The device is a navigation instrument designed to aid surgeons in precisely locating anatomical structures during spinal surgery, rather than directly treating or diagnosing patients.
No
The device is intended to aid the surgeon in precisely locating anatomical structures during spinal surgery and confirm hardware placement, not to diagnose a medical condition.
No
The device description explicitly states that the Black Diamond Navigation Instruments are "non-sterile, reusable instruments; including probes, bone taps, and inserters that are operated manually." These are physical hardware components, not software.
Based on the provided information, 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 Black Diamond Navigation Instruments are surgical instruments used during spinal surgery to aid in the placement of pedicle screws. They are used in conjunction with a navigation system that utilizes imaging data (CT, MR, fluoroscopy) and anatomical landmarks.
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is to provide guidance and aid the surgeon during a surgical procedure based on imaging and anatomical reference.
Therefore, the Black Diamond Navigation Instruments fall under the category of surgical instruments and navigation aids, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
Black Diamond Navigation Instruments are non-sterile, reusable instruments; including probes, bone taps, and inserters that are operated manually. These instruments are intended to be used within the context and limitations of the indications for use for Osseus Fusion System's FDA-cleared Black Diamond system and the Medtronic Synergy Experience StealthStation System S7 (v2.1.0). Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Vertebra / spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / medical condition in which the use of stereotactic surgery may be appropriate
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)
Nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device. The following testing was performed: Accuracy testing Compatibility testing Performance testing The results of these evaluations indicate that the Black Diamond Navigation Instruments are equivalent to predicate devices.
No clinical studies were performed.
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).
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January 17, 2020
Osseus Fusion Systems % J. D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401
Re: K192495
Trade/Device Name: Black Diamond Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 5, 2019 Received: September 11, 2019
Dear J. Webb:
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.
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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 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, M.P.H. 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
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Indications for Use
510(k) Number (if known) K192495
Device Name Black Diamond Navigation Instruments
Indications for Use (Describe)
The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station 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 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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510(k) Summary: Black Diamond Navigation Instruments
| Date Prepared | January 9, 2020 |
|---|---|
| Submitted By | Osseus Fusion Systems, LLC |
| 2703 W. Mockingbird Ln., Ste. #102 | |
| Dallas, TX 75204 | |
| Primary Contact | J.D. Webb |
| 4313 W. 3800 S | |
| West Haven, UT 84401 | |
| 512-590-5810 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Black Diamond Navigation Instruments |
| Common Name | Orthopedic Stereotaxic instrument |
| Classification Name | Stereotaxic Instrument |
| Class | ll |
| Product Code | OLO |
| CFR Section | 21 CFR section 882.4560 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Navigated CD Horizon Solera Screwdrivers and Taps, Medtronic Sofamor Danek, USA |
| Inc. (K140454) | |
| Secondary Predicate | |
| Devices | Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems, |
| DePuy Spine, Inc (K140927) | |
| SeaSpine Navigation System, SeaSpine Orthopedics Corporation (K172517) | |
| Reference Predicate | |
| Devices | Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810) |
| Device Description | Black Diamond Navigation Instruments are non-sterile, reusable instruments; including |
| probes, bone taps, and inserters that are operated manually. These instruments are | |
| intended to be used within the context and limitations of the indications for use for Osseus | |
| Fusion System's FDA-cleared Black Diamond system and the Medtronic Synergy | |
| Experience StealthStation System S7 (v2.1.0). Use of these navigation systems provides | |
| the surgeon access to real-time, multi-plane 3D images (and 2D images) providing | |
| confirmation of hardware placement. | |
| Materials | Stainless steel per ASTM F899 |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Black Diamond Navigation Instruments are substantially equivalent to the |
| predicate devices in terms of intended use, design, materials used, mechanical safety and | |
| performances. | |
| Indications for Use | The Black Diamond Navigation Instruments are intended to be used during the preparation |
| and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon | |
| in precisely locating anatomical structures in either open or minimally invasive procedures. | |
| The Black Diamond Navigation Instruments are specifically designed for use with the | |
| Medtronic Stealth Station 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 vertebra, can be identified relative to a CT or MR based | |
| model, fluoroscopy images, or digitized landmarks for the anatomy. | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to | |
| predicate | When compared to the predicate devices, Black Diamond Navigation Instruments have |
| the same intended use and similar technological characteristics, including: | |
| Design Materials of Construction Function/Performance Fundamental Scientific Technology Principle of Operation | |
| Non-clinical Test | |
| Summary | Nonclinical testing was performed to show that the subject Black Diamond Navigation |
| Instruments are substantially equivalent to the predicate device. The following testing was | |
| performed: | |
| Accuracy testing Compatibility testing Performance testing The results of these evaluations indicate that the Black Diamond Navigation Instruments | |
| are equivalent to predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Osseus Fusion Systems considers the Navigation Instruments to be equivalent to the |
| predicate devices listed above. This conclusion is based upon the devices' similarities in | |
| principles of operation, technology, materials, and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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