(134 days)
Not Found
No
The summary describes manual surgical instruments and trials used in conjunction with a navigation system. There is no mention of AI or ML in the device description, intended use, or performance testing. The navigation system itself is mentioned, but its description does not indicate AI/ML capabilities, focusing on stereotactic surgery based on anatomical references and imaging.
No.
The device facilitates discectomy and implant selection during spinal surgery but does not directly treat a disease or condition itself.
No
Explanation: The device is described as surgical instruments (e.g., Cobb Elevator, Curette, Osteotome, Rotating Shaver) and trials used to facilitate a discectomy and implant size selection during spinal surgery. While it uses navigation with imaging, its primary function is not to diagnose a condition but to assist in performing a surgical procedure.
No
The device description explicitly details physical instruments made of stainless steel (Cobb Elevator, Combo Tool, Curette, Osteotome, Rotating Shaver, and Trials) that are manual accessories to the StealthStation System. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described devices (Navigated Disc Preparation Instruments and Navigated Trials) are surgical instruments and trials used during spinal surgery to facilitate procedures and select implant sizes. They are used directly on the patient's anatomy, not on specimens taken from the body.
- Intended Use: The intended use clearly states their purpose is to "facilitate a discectomy during spinal surgery" and "facilitate implant size selection... during spinal surgery." This is a surgical, not a diagnostic, function.
- Device Description: The description details surgical instruments (Cobb Elevator, Combo Tool, Curette, Osteotome, Rotating Shaver) and trials, all designed for use within the surgical field.
- Input: The input is based on imaging modalities (CT, MR, fluoroscopy, digitized landmarks) of the patient's anatomy, not laboratory analysis of biological specimens.
Therefore, the function and intended use of these devices fall squarely within the realm of surgical tools and navigation systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy 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.
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
OLO
Device Description
The Cobb Elevator. Combo Tool, Curette, Osteotome, and Rotating Shaver are instruments that are manual accessories to the StealthStation System. These instruments can be used to facilitate a discectomy during a spinal surgery procedure. These devices are offered in non-sterile form and are reusable. The stainless steel material used in the Disc Prep Instruments conforms to ASTM F899, ASTM A693 and ASTM A564 standards.
Implant size and placement is determined by selecting the trial which provides the most satisfactory fit in the prepared disc space. Once trialing is complete, the implant of corresponding size is positioned. The new trials are designed specifically to be used with CAPSTONE and are also compatible with StealthStation. The trials will be provided non-sterile and are reusable. The stainless steel material used in the CAPSTONE Trials conforms to ASTM F899, ASTM A693 and ASTM A564 standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
rigid anatomical structure, such as a 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: Performance Testing
Tests:
- Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
- Anatomical Simulated Use: Confirmed instrument functionality under expected use conditions.
- Navigation Simulated Use: Confirmed navigation system functionality under expected use conditions.
- CAD Model Evaluation: Verified that the CAD models are accurately reflected in the application software.
- Implant/Instrument Mating Conditions: Verified that the instruments can be assembled with the appropriate devices according to their intended use.
- Spine Tools Package Functional Testing: Verified that the Spine Tools package has met the required interface needs of the spine application software.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Mr. Nicholas Tabrizi Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
June 16, 2015
Re: K150231
Trade/Device Name: Navigated Disc Prep Instruments and CAPSTONE Trials Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: May 13, 2015 Received: May 14, 2015
Dear Mr. Tabrizi:
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 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 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
1
Page 2 - Mr. Nicholas Tabrizi
forth in the quality systems (QS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150231
Device Name
Navigated Disc Prep Instruments and CAPSTONE Trials
Indications for Use (Describe)
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy 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.
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.
| 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
June 2015
| I. | Company: | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone Number: (901) 396-3133 |
| ---- | ---------- | ------------------------------------------------------------------------------------------------------------------ |
|---|
- Contact: Nicholas Tabrizi Principal Regulatory Affairs Specialist Telephone: (901) 344-1463 Fax: (901) 346-9738
- II. Proprietary Trade Name: Navigated Disc Prep Instruments and CAPSTONE Trials
Common Name: Stereotaxic Instrument, Navigated Instruments
Classification Name: Stereotaxic Instruments (21 CFR 882.4560)
Classification: Class II
Product Code: OLO
III. Product Description:
The Cobb Elevator. Combo Tool, Curette, Osteotome, and Rotating Shaver are instruments that are manual accessories to the StealthStation System. These instruments can be used to facilitate a discectomy during a spinal surgery procedure. These devices are offered in non-sterile form and are reusable.
The stainless steel material used in the Disc Prep Instruments conforms to ASTM F899, ASTM A693 and ASTM A564 standards.
CAPSTONE Trials
Implant size and placement is determined by selecting the trial which provides the most satisfactory fit in the prepared disc space. Once trialing is complete, the implant of corresponding size is positioned. The new trials are designed specifically to be used with CAPSTONE and are also compatible with StealthStation. The trials will be provided non-sterile and are reusable.
The stainless steel material used in the CAPSTONE Trials conforms to ASTM F899, ASTM A693 and ASTM A564 standards.
4
IV. Indications for Use:
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy 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.
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.
V. Identification of Legally Marketing Devices (Predicate Devices)
- Navigated CD HORIZON® SOLERA® Instruments (K140454) ● This predicate has not been subject to a design-related recall. This predicate is the primary predicate for this submission.
- Navigated CAPSTONE Trials, CLYDESDALE Trials, CAPSTONE & . CLYDESDALE Inserter (K131425) This predicate has not been subject to a design-related recall. This predicate is an additional predicate for this submission.
VI. Comparison of the Technological Characteristics:
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy 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. These instruments are specifically designed for use with the StealthStation® System, which allows for optical navigation of the surgical instruments. These devices have similar designs as the predicate devices and incorporate the same design features to enable navigation capabilities. Like the predicate devices, the subject Navigated Taps and Screwdrivers are also made from stainless steel.
The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing instruments or the StealthStation® System.
VII. Discussion of the Performance Testing
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:
| Test | Description |
|---|---|
| ------ | ------------- |
5
| Test | Description |
|---|---|
| Navigation | |
| Accuracy Analysis | Confirmed navigated instrument accuracy. |
| Anatomical | |
| Simulated Use | Confirmed instrument functionality under expected use conditions. |
| Navigation | |
| Simulated Use | Confirmed navigation system functionality under expected use |
| conditions. | |
| CAD Model | |
| Evaluation | Verified that the CAD models are accurately reflected in the |
| application software. | |
| Implant/Instrument | |
| Mating Conditions | Verified that the instruments can be assembled with the appropriate |
| devices according to their intended use. | |
| Spine Tools | |
| Package | |
| Functional Testing | Verified that the Spine Tools package has met the required interface |
| needs of the spine application software. |
VIII. Conclusions
The Navigated Disc Prep Instruments and CAPSTONE Trials have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.