(162 days)
No
The summary describes navigated surgical instruments that work with a navigation system (StealthStation) to assist surgeons in locating anatomical structures based on pre-operative imaging or digitized landmarks. There is no mention of AI or ML being used for image analysis, decision support, or any other function within the described device or its interaction with the navigation system. The performance testing focuses on positional accuracy and compatibility, not AI/ML performance metrics.
No
The device is described as navigated instruments used during spinal surgery to assist in precisely locating anatomical structures, not to treat a disease or condition itself.
No
This device is a surgical instrument used to assist in the precise placement of screws during spinal surgery, not to diagnose a medical condition. It relies on imaging data (CT/MR/fluoroscopy) provided by other systems (Medtronic StealthStation System) but does not itself perform diagnostic functions.
No
The device description explicitly states that the Streamline Navigated Instruments are non-sterile, reusable instruments manufactured from stainless steel, including components like pedicle finders, modular handles, taps, drills, and screw inserters. 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 Streamline Navigated Instruments are surgical instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures and preparing for and placing screws. They are used directly on the patient's body, not on samples taken from the body.
- Intended Use: The intended use clearly describes a surgical application, not a diagnostic test performed on a sample.
- Device Description: The description details surgical instruments (pedicle finders, taps, drills, screw inserters) made of stainless steel, which are typical surgical tools.
- Input: The input is imaging data (CT, MR, fluoroscopy, digitized landmarks) of the patient's anatomy, not biological samples.
Therefore, the Streamline Navigated Instruments fall under the category of surgical instruments used for guidance and manipulation during a procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic 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 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 Streamline Navigated Instruments are non-sterile, reusable instruments for use with the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive (MIS) procedures for preparation and placement of screws from the Streamline TL Spinal Fixation System and Streamline MIS Spinal Fixation System and preparation of screws from the Streamline OCT Occipito-Cervico-Thoracic System. The Streamline Navigated Instruments include pedicle finders, modular handle, taps, drills, and screw inserters designed for use with Streamline TL, Streamline MIS, and Streamline OCT Systems. The instruments are manufactured from stainless steel (ASTM F899).
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 vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, spinal surgery
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)
Streamline Navigated Instruments have been tested per ASTM F2554-18 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." Dimensional comparison and tolerance analysis of the Streamline Navigated Instruments to the predicate Medtronic Navigated Instruments was conducted to ensure the Streamline Navigated Instruments are acceptable for their intended use, ensure functionality and compatibility with the Medtronic StealthStation® System. The results of this non-clinical testing show that performance of the Streamline Navigated Instruments is sufficient for their intended use and demonstrate substantial equivalence to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K140454 Medtronic Navigated Instruments
Reference Device(s)
K173338 Medtronic Navigated Instruments (Navigated INFINITY™ Instruments)
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).
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June 26, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Kurtis Hunsberger Principal Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
Re: K200095
Trade/Device Name: Streamline Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 19, 2020 Received: June 22, 2020
Dear Kurtis Hunsberger:
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.
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
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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 (OS) 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 mediation-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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200095
Device Name Streamline Navigated Instruments
Indications for Use (Describe)
Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic 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 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
K200095 Streamline Navigated Instruments
As required by 21 CFR 807.92
| Date Prepared: | June 25, 2020 |
|---|---|
| Submitter: | Pioneer Surgical Technology, Inc. |
| DBA RTI Surgical, Inc. | |
| 375 River Park Circle | |
| Marquette, MI 49855 USA | |
| Phone: (906) 226-9909 | |
| Fax: (906) 225-5868 | |
| Contact Information: | Kurtis Hunsberger |
| Principal Regulatory Affairs Specialist | |
| RTI Surgical, Inc. | |
| khunsberger@rtix.com | |
| 952-698-9931 | |
| Name of Device: | Streamline® Navigated Instruments |
| Common Name: | Orthopedic Stereotaxic Instrument |
| Classification Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Regulatory Class: | Class II |
| Product Code: | OLO |
| Panel: | Orthopedic Device Panel, Panel Code 84 |
| Predicate Device: | Primary Predicate: |
| K140454 Medtronic Navigated Instruments | |
| Reference Predicate: | |
| K173338 Medtronic Navigated Instruments (Navigated INFINITY™ | |
| Instruments) | |
| Device Description: | The Streamline Navigated Instruments are non-sterile, reusable |
| instruments for use with the Medtronic StealthStation Navigation | |
| System to assist surgeons in precisely locating anatomical structures | |
| in either open or minimally invasive (MIS) procedures for preparation | |
| and placement of screws from the Streamline TL Spinal Fixation | |
| System and Streamline MIS Spinal Fixation System and preparation | |
| of screws from the Streamline OCT Occipito-Cervico-Thoracic | |
| System. | |
| The Streamline Navigated Instruments include pedicle finders, | |
| modular handle, taps, drills, and screw inserters designed for use with | |
| Streamline TL, Streamline MIS, and Streamline OCT Systems. The | |
| instruments are manufactured from stainless steel (ASTM F899). | |
| Indications for Use: | Streamline Navigated Instruments are intended to be used during the |
| preparation and placement of screws from the Streamline TL and MIS | |
| Systems and preparation of screws from the Streamline OCT System | |
| during spinal surgery to assist the surgeon in precisely locating | |
| anatomical structures in either open or minimally invasive procedures. | |
| These instruments are designed for use with the Medtronic | |
| 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 vertebra, can be | |
| identified relative to a CT- or MR-based model, fluoroscopy images, | |
| or digitized landmarks of the anatomy. | |
| Comparison of | |
| Technological | |
| Characteristics with | |
| the Predicate Device: | Both the subject and predicate devices are stereotactic instruments |
| designed for use with optical navigation. At a high level, the subject | |
| and predicate devices are based on the following same technological | |
| elements. The subject and predicate devices: | |
| Are used with the Medtronic StealthStation Navigation System Are used during preparation and placement of screws during spinal surgery Include the same instrument types (probes, drills, taps, drivers, modular handles) Incorporate a NavLock collar feature designed for connection to the NavLock tracker for use with navigation Have the same/similar critical dimensions of critical length from NavLock tracker to distal tip of instruments Are used with pedicle screws of same diameters and lengths Have accuracy testing performed per ASTM F2554 Are constructed from ASTM F899 stainless steel Are reusable and provided non-sterile Are designed for use with their respective spinal fixation systems | |
| There are no technological differences between the subject and | |
| predicate devices. However, there are minor dimensional differences | |
| inherent to the instruments in the respective spinal fixation systems | |
| such as instrument/implant interface features and tap threading. | |
| These minor dimensional differences do not affect the critical | |
| dimensions of the instrument and do not affect performance with | |
| navigation. | |
| Performance Data: | Streamline Navigated Instruments have been tested per ASTM |
| F2554-18 "Standard Practice for Measurement of Positional Accuracy | |
| of Computer Assisted Surgical Systems." Dimensional comparison | |
| and tolerance analysis of the Streamline Navigated Instruments to the | |
| predicate Medtronic Navigated Instruments was conducted to ensure | |
| the Streamline Navigated Instruments are acceptable for their | |
| intended use, ensure functionality and compatibility with the | |
| Medtronic StealthStation® System. The results of this non-clinical | |
| testing show that performance of the Streamline Navigated | |
| Instruments is sufficient for their intended use and demonstrate | |
| substantial equivalence to legally marketed predicate devices. | |
| Conclusion: | The supporting evidence in this submission concludes the subject |
| Streamline Navigated Instruments are substantially equivalent to the | |
| predicate devices. |
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