Who is the manufacturer of Black Diamond Navigation Instruments?

Osseus Fusion Systems filed the 510(k) submission for Black Diamond Navigation Instruments (K192495).

What is the FDA product code for Black Diamond Navigation Instruments?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Black Diamond Navigation Instruments?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Black Diamond Navigation Instruments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Black Diamond Navigation Instruments

K192495 · Osseus Fusion Systems · OLO · Jan 17, 2020 · Neurology

Device Facts

Record ID	K192495
Device Name	Black Diamond Navigation Instruments
Applicant	Osseus Fusion Systems
Product Code	OLO · Neurology
Decision Date	Jan 17, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended 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.

Device Story

Black Diamond Navigation Instruments consist of manual, reusable surgical tools including probes, bone taps, and inserters; used in spinal surgery for pedicle screw placement. Instruments interface with Medtronic StealthStation System (S7 v2.1.0) to provide real-time, multi-plane 3D/2D image guidance. Surgeon operates instruments manually to locate anatomical structures; navigation system tracks instrument position relative to patient anatomy (CT/MR/fluoroscopy). Output provides visual confirmation of hardware placement to surgeon; aids in precise screw positioning; potentially improves surgical accuracy and patient outcomes in open or minimally invasive procedures.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including accuracy, compatibility, and performance testing.

Technological Characteristics

Non-sterile, reusable manual instruments (probes, taps, inserters). Materials: Stainless steel per ASTM F899. Operates via manual manipulation in conjunction with Medtronic StealthStation System for image-guided navigation. No internal energy source; connectivity provided by integration with external navigation platform.

Indications for Use

Indicated for use during spinal surgery for preparation and placement of Black Diamond pedicle screws in open or minimally invasive procedures, specifically for use with the Medtronic Stealth Station System in patients requiring stereotactic surgery where anatomical structures can be referenced via CT, MR, fluoroscopy, or digitized landmarks.

Regulatory Classification

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.

Predicate Devices

Navigated CD Horizon Solera Screwdrivers and Taps, Medtronic Sofamor Danek, USA Inc. (K140454)
Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems, DePuy Spine, Inc (K140927)
SeaSpine Navigation System, SeaSpine Orthopedics Corporation (K172517)

Reference Devices

Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810)

Related Devices

K182345 — Spineology Navigation Instruments · Spineology, Inc. · Sep 21, 2018
K172517 — SeaSpine Navigation System · SeaSpine Orthopedics Corporation · May 11, 2018
K162921 — Navigated Instrument System · Orthofix, Inc. · Mar 13, 2017
K172115 — Navigated Instrument System · Orthofix, Inc. · Mar 8, 2018
K180796 — Spineology Navigation Instruments · Spineology, Inc. · May 2, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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, 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. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | ### 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}------------------------------------------------ ## 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 {4}------------------------------------------------