What is the FDA product code for NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER?

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

What is the regulatory pathway for NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER?

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

Who can help prepare an FDA 510(k) submission like NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER?

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.

NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER

Q: Who is the manufacturer of NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER?

Medtronic Navigation, Inc. filed the 510(k) submission for NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER (K131425).

K131425 · Medtronic Navigation, Inc. · OLO · Aug 14, 2013 · Neurology

Device Facts

Record ID	K131425
Device Name	NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
Applicant	Medtronic Navigation, Inc.
Product Code	OLO · Neurology
Decision Date	Aug 14, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Indications for Use

The Navigated Inserter is intended to be use during implant placement of Medtronic intervertebral body fusion devices during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. The navigated instruments are specifically designed for use with the 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Story

Navigated Trials and Inserters are non-sterile, reusable surgical instruments used during spinal surgery to assist in sizing and placing Medtronic intervertebral body fusion devices. Instruments integrate with the StealthStation® System via optical (infra-red) trackers; system provides real-time navigation by referencing instruments against patient anatomy (CT/MR/fluoroscopy). Surgeons use the system to visualize instrument position relative to anatomical structures, facilitating precise implant placement. Benefits include improved accuracy in implant sizing and positioning during fusion procedures.

Clinical Evidence

Bench testing only. Testing included accuracy verification in 2D/3D space, environmental/life/shipping testing, simulated use, CAD model verification, cleaning verification, and implant/instrument mating validation. No clinical data presented.

Technological Characteristics

Reusable surgical instruments; materials include 17-4 SS, 465 SS, 6061 Aluminum, 303 SS, and Silicon. Optical (infra-red) tracking principle. Steam sterilization. Designed for use with StealthStation® System. Software interface via Spine Tools package.

Indications for Use

Indicated for use during spinal surgery to facilitate implant size selection and placement of Medtronic intervertebral body fusion devices. Designed for use with the StealthStation® System in patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced against 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, Taps, Iliac Taps, LEGACY Taps (K124004)
CAPSTONE® Spinal System (K073291, K103731)
CLYDESDALE® Spinal System (K083026, K112405)

Submission Summary (Full Text)

{0}------------------------------------------------ # 510(k) Summary # K131425 Page 1 of 5 # May 2013 - I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500 AUG 1 4 2013 - Regina Holmes Contact: Sr. Regulatory Affairs Specialist Telephone: (901) 396-3133 Fax: (901) 346-9738 - Proprietary Trade Name: Navigated CAPSTONE® Trials, CLYDESDALE® II. Trials, and CAPSTONE® & CLYDESDALE® Inserter - Common Name: Stereotaxic Instrument, Implant Trial, Implant Inserter III. - Classification Name: Stereotaxic Instrument (21 CFR 882.4560) IV. - ﺮ ﺍ V. Classification: Class II - VI. Product Code: OLO, MAX #### VII. Product Description: The Navigated Trials and Inserter are non-sterile, reusable surgical instruments intended to be used to facilitate implant sizing and placement of Medtronic intervertebral body fusion devices, respectively, during spinal surgery and are specifically designed for use with the StealthStation® System. These navigated interbody devices are used in conjunction with system Trackers, which allows for optical navigation of the surgical instrument, and are also designed for use with the Medtronic CAPSTONE® and CLYDESDALE® Spinal Systems. ### VIII. Indications for Use: The Navigated Inserter is intended to be use during implant placement of Medtronic intervertebral body fusion devices during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. The navigated instruments are specifically designed for use with the 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 {1}------------------------------------------------ anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. ## Identification of Legally Marketing Devices (Predicate Devices) IX. - NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC . TAPS, LEGACY TAPS (K124004) - CAPSTONE® SPINAL SYSTEM (K073291, K103731) . - CLYDESDALE® SPINAL SYSTEM (K083026, K112405) . | Item | Subject Devices | Predicate Devices | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Navigated Inserter is intended to be used during implant placement of Medtronic intervertebral body fusion devices during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. The navigated instruments are specifically designed for use with the 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | Navigated CD HORIZON® SOLERA™ Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps - K124004 The Navigated Taps and Screwdrivers are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the 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 the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | | Item | Subject Devices | Predicate Devices | | Intended Use | The Navigated Inserter is intended to be used during implant placement of Medtronic intervertebral body fusion devices during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. The navigated instruments are specifically designed for use with the StealthStation® System. | CAPSTONE® Spinal System - K073291, K103731 The trials and inserter are intended to be used during sizing and placement of the CAPSTONE implant devices, respectively. CLYDESDALE® Spinal System - K083026, K112405 The trials and inserter are intended to be used during sizing and placement of the CLYDESDALE implant devices, respectively. | | | | Navigated CD HORIZON® SOLERATM Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps - K124004 The Navigated Taps and Screwdrivers are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the StealthStation® System. | | Operating Principle (Tracking Method) | Identical | Navigated CD HORIZON® SOLERATM Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps - K124004 Optical (infra-red) | | Materials - Trials | Identical | Navigated CD HORIZON® SOLERATM Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps - K124004 CAPSTONE® Spinal System - K073291 CLYDESDALE® Spinal System - K083026 | ### Comparison of the Technological Characteristics: X {2}------------------------------------------------ K131425 Page 3 of 5 {3}------------------------------------------------ # K131425 | Page | 4 | of | 5 | |------|---|----|---| |------|---|----|---| | Item | Subject Devices | Predicate Devices | |---------------------------------|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Materials - Inserter | Identical | CAPSTONE® Spinal System - K103731 17-4SS, 465 SS, Silicon CLYDESDALE® Spinal System - K112405 17-4 SS, Silicon | | Materials - Inserter Tracker | Identical | Navigated CD HORIZON® SOLERATM Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps - K124004 Tracker: 6061 Aluminum, 303 SS | | Sterilization Method | Identical | Navigated CD HORIZON® SOLERATM Screwdrivers, CD HORIZON® SOLERA™ Taps, CD HORIZON® SOLERA™ Iliac Taps and CD HORIZON® LEGACY™ Taps - K124004 CAPSTONE® Spinal System - K073291, K103731 CLYDESDALE® Spinal System - K083026, K112405 Method: Steam Sterilization | The subject devices have the same intended use and technological characteristics as the predicate devices. ## Discussion of the Performance Testing XI. Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed: | Test | Description | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Accuracy | Tested navigated instruments accuracy in both 2D and 3D space. | | Environmental, Life, and Shipping | Tested navigated instrument functionality after multiple reprocessing cycles (cleaning and sterilization), simulating environmental exposure under expected use conditions and shipping. | | Simulated Use | Tested navigated instruments according to the user's needs and intended use. | {4}------------------------------------------------ # K131425 K131425 Of Pa | of 5 5 a de | |----------------------| |----------------------| | Test | Description | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | CAD Model | Verified that the CAD models are accurately reflected in the application software. | | Cleaning Verification | Verified that the product can be effectively cleaned using automated and manual methods. | | Implant/Instrument Mating | Verified that the instruments can be attached and mated with the appropriate instrument and/or implant devices according to their intended use. | | Spine Tools (Toolcards) | Verified that the Spine Tools package has met the required interface needs of the spine application software. | ## XII. Conclusions The Navigated Trials and Inserter have been shown through comparison and testing to be substantially equivalent to the identified predicate devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, positioned to the right. Encircling the symbol are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 14, 2013 Regina Holmes Schior Regulatory Affairs Specialist Medtronic Navigation, Incorporated 826 Coal Creek Circle Louisville, Colorado 80027 USA Re: K131425 Trade/Device Name: Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE®& CLYDESDALE™ Inserter Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Codc: OLO, MAX Dated: June 3, 2013 Received: June 5, 2013 Dear Ms. Holmes: 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. 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 11 (Special Controls) or class 111 (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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Regina Holmes forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## FOR Peter D. Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## 510(k) Number (if known): Device Name: Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE® & CLYDESDALE® Inserter ## Indications for Use: The Navigated Inserter is intended to be use during implant placement of Medironic intervertebral body fusion devices during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. The navigated instruments are specifically designed for use with the 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (2) CFR Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF · NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | DSD—DIVISION SIGN-OFF | Joshua C. Nipper | |------------------------------|------------------| | Division of Surgical Devices | -S | | 510(k) Number: | K131425 |

NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER

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NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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