(162 days)
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.
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).
Here's a breakdown of the acceptance criteria and the study details for the Streamline Navigated Instruments, as extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance |
|---|---|
| Positional Accuracy | Tested per ASTM F2554-18 |
| Compatibility with Medtronic StealthStation System | Ensured through dimensional comparison and tolerance analysis |
| Functionality | Ensured through dimensional comparison and tolerance analysis |
(Note: The document doesn't provide specific numerical thresholds for acceptance, only that the device was tested against the standard and deemed sufficient.)
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the traditional sense of a clinical or observational study with human participants. The performance evaluation was based on non-clinical testing.
- Sample Size: Not applicable in the context of a clinical test set. The evaluation involved testing the instruments themselves according to a standard.
- Data Provenance: Not applicable. The "data" comes from engineering and laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This is not applicable as the evaluation was based on non-clinical testing of device accuracy and compatibility with a navigation system, not on medical image interpretation or clinical outcomes requiring human expert ground truth.
4. Adjudication Method for the Test Set
None. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where discrepancies might arise. This non-clinical performance evaluation does not involve such a process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The study described is a non-clinical performance evaluation of device accuracy and compatibility, not a comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable as the device (Streamline Navigated Instruments) is a physical surgical instrument designed to be used with a navigation system and by a human surgeon. It is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was defined by:
- ASTM F2554-18 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems": This standard serves as the benchmark for evaluating positional accuracy.
- Dimensional comparison and tolerance analysis: This establishes whether the instruments meet the required specifications for functionality and compatibility with the Medtronic StealthStation System.
8. The Sample Size for the Training Set
Not applicable. The Streamline Navigated Instruments are physical instruments, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI model, there is no training set or associated ground truth for it.
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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 CircleMarquette, MI 49855 USAPhone: (906) 226-9909Fax: (906) 225-5868 | |
| Contact Information: | Kurtis HunsbergerPrincipal Regulatory Affairs SpecialistRTI Surgical, Inc.khunsberger@rtix.com952-698-9931 |
| 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, reusableinstruments for use with the Medtronic StealthStation NavigationSystem to assist surgeons in precisely locating anatomical structuresin either open or minimally invasive (MIS) procedures for preparationand placement of screws from the Streamline TL Spinal FixationSystem and Streamline MIS Spinal Fixation System and preparationof screws from the Streamline OCT Occipito-Cervico-ThoracicSystem. |
| The Streamline Navigated Instruments include pedicle finders,modular handle, taps, drills, and screw inserters designed for use withStreamline TL, Streamline MIS, and Streamline OCT Systems. Theinstruments are manufactured from stainless steel (ASTM F899). | |
| Indications for Use: | Streamline Navigated Instruments are intended to be used during thepreparation and placement of screws from the Streamline TL and MISSystems and preparation of screws from the Streamline OCT Systemduring spinal surgery to assist the surgeon in precisely locatinganatomical structures in either open or minimally invasive procedures.These instruments are designed for use with the MedtronicStealthStation System, which is indicated for any medical condition inwhich the use of stereotactic surgery may be appropriate, and wherereference to a rigid anatomical structure, such as vertebra, can beidentified relative to a CT- or MR-based model, fluoroscopy images,or digitized landmarks of the anatomy. |
| Comparison ofTechnologicalCharacteristics withthe Predicate Device: | Both the subject and predicate devices are stereotactic instrumentsdesigned for use with optical navigation. At a high level, the subjectand predicate devices are based on the following same technologicalelements. 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 andpredicate devices. However, there are minor dimensional differencesinherent to the instruments in the respective spinal fixation systemssuch as instrument/implant interface features and tap threading.These minor dimensional differences do not affect the criticaldimensions of the instrument and do not affect performance withnavigation. | |
| Performance Data: | Streamline Navigated Instruments have been tested per ASTMF2554-18 "Standard Practice for Measurement of Positional Accuracyof Computer Assisted Surgical Systems." Dimensional comparisonand tolerance analysis of the Streamline Navigated Instruments to thepredicate Medtronic Navigated Instruments was conducted to ensurethe Streamline Navigated Instruments are acceptable for their |
| intended use, ensure functionality and compatibility with theMedtronic StealthStation® System. The results of this non-clinicaltesting show that performance of the Streamline NavigatedInstruments is sufficient for their intended use and demonstratesubstantial equivalence to legally marketed predicate devices. | |
| Conclusion: | The supporting evidence in this submission concludes the subjectStreamline Navigated Instruments are substantially equivalent to thepredicate devices. |
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§ 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).