(89 days)
Not Found
No
The summary describes a navigated surgical instrument system that uses optical tracking and pre-existing imaging data (CT, MR, fluoroscopy) for guidance. There is no mention of AI or ML algorithms being used for image processing, decision support, or any other function. The performance testing focuses on accuracy, environmental factors, simulated use, and compatibility, not on the performance metrics typically associated with AI/ML models (e.g., AUC, sensitivity, specificity).
No
The device is described as non-sterile, reusable surgical instruments used to facilitate implant sizing and placement. It does not actively treat or cure a disease but rather aids in surgical procedures.
No
The devices described (Navigated Trials and Inserter) are surgical instruments used for implant sizing and placement, not for diagnosing a medical condition. Their use is in conjunction with a navigation system during surgery, to facilitate the surgical procedure.
No
The device description explicitly states that the Navigated Trials and Inserter are "non-sterile, reusable surgical instruments," indicating they are physical hardware components. The summary also details performance testing related to physical attributes like accuracy, environmental exposure, cleaning, and mating with other instruments/implants.
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 Navigated Inserter and Trials are surgical instruments used during spinal surgery to facilitate implant sizing and placement. They are used in conjunction with a navigation system to guide the surgeon's actions within the body.
- Intended Use: The intended use clearly states their purpose is for implant placement and size selection during spinal surgery.
- Device Description: The description reinforces that they are surgical instruments used in the surgical setting.
The device is a surgical navigation tool and associated instruments, not a device that performs tests on biological samples outside of the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO, MAX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
skull, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Tests:
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.
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.
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.
K124004, K073291, K103731, K083026, K112405
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.
Not Found
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
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 |