(28 days)
The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine Lancer", Thunderbolt", and Blackbird™ system during spinal surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The ChoiceSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System (V2.1.0), 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, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The ChoiceSpine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use. The ChoiceSpine Navigation instruments are for use with ChoiceSpine screw systems, specifically, Lancer™, Thunderbolt™, and Blackbird™ Spinal Systems.
The provided text is a 510(k) Summary for the ChoiceSpine Navigation System. It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it explicitly states that no new testing was performed for this specific submission to add Blackbird instruments. Instead, it relies on the previous testing of the predicate device.
Therefore, the following information cannot be fully extracted based on the provided text for the current submission:
- A table of acceptance criteria and reported device performance (for the current submission).
- Sample size used for the current test set.
- Data provenance for the current test set.
- Number of experts used to establish ground truth for the current test set and their qualifications.
- Adjudication method for the current test set.
- Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done for the current submission.
- Whether a standalone performance study was done for the current submission.
- The type of ground truth used for the current test.
- Sample size for the current training set.
- How ground truth for the current training set was established.
Based on the provided text, here is what can be inferred about the original testing that established "substantial equivalence" for the predicate device, which this submission leverages:
1. A table of acceptance criteria and the reported device performance
The text does not explicitly state acceptance criteria in a table format. It only mentions that the "Navigation System has been tested per ASTM F2554-10, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems'." It concludes that "The results of this non-clinical testing show that performance of the Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Without the actual report of the ASTM F2554-10 testing, specific numerical acceptance criteria and reported performance values cannot be provided here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text for either the predicate device's testing or the current submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The testing mentioned (ASTM F2554-10) is a standard for positional accuracy of computer-assisted surgical systems, which is typically an engineering performance test and may not involve expert review in the same way clinical studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not performed for this submission, as no new testing was conducted. The text describes an engineering performance test (ASTM F2554-10) for positional accuracy, not a comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The submission states that the "ChoiceSpine Navigation System" was tested per ASTM F2554-10. This is a standard for evaluating the accuracy of computer-assisted surgical systems. This would be considered a standalone performance test of the device's accuracy, as it measures the system's ability to precisely locate anatomical structures. However, it's not an "algorithm only" test in the sense of an AI/ML algorithm being evaluated in isolation, but rather the integrated navigation system's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the ASTM F2554-10 test would likely be based on physical measurements and precise anatomical models used to assess the positional accuracy of the surgical system. It would not typically involve expert consensus, pathology, or outcomes data in the traditional sense of clinical ground truth.
8. The sample size for the training set
This information is not provided as the submission refers to an engineering performance test, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not provided as no machine learning training set is relevant to the described testing.
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January 4th, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K203561
Trade/Device Name: ChoiceSpine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 2, 2020 Received: December 7, 2020
Dear Kim Finch:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 medical devices and radiation-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,
For: 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203561
Device Name
ChoiceSpine Navigation System
Indications for Use (Describe)
The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine Lancer", Thunderbolt", and Blackbird™ system during spinal surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The ChoiceSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System (V2.1.0), 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, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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7. 510(k) Summary
| Date: | December 2, 2020 |
|---|---|
| Sponsor: | ChoiceSpine, LLC400 Erin DriveKnoxville, TN 37919 |
| Phone: | 865-243-3969 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| ProposedProprietary TradeName: | ChoiceSpine Navigation System |
| Product Class: | Class II |
| ClassificationName: | ChoiceSpine Navigation System• 882.4560 Neurological Stereotaxic Instrument |
| Device ProductCode: | ChoiceSpine Navigation System• OLO |
| Purpose of Submission: | The purpose of this submission is to add Blackbird instruments to theChoiceSpine Navigation system. |
| Device Description: | The ChoiceSpine Navigation instruments are non-sterile, reusable instrumentsdesigned to function with the Medtronic® StealthStation® System and SureTrak®II System. Refer to the appropriate navigation system Instructions for Useand/or Surgical Technique Guide for details regarding navigation system use.The ChoiceSpine Navigation instruments are for use with ChoiceSpine screwsystems, specifically, Lancer™, Thunderbolt™, and Blackbird™ Spinal Systems. |
| Indications for Use: | The ChoiceSpine Navigation reusable instruments are intended to be usedduring preparation and placement of ChoiceSpine Lancer™, Thunderbolt™, andBlackbird™ system during spinal surgery to assist the surgeon in preciselylocating anatomical structures in either open or minimally invasive procedures.The ChoiceSpine Navigation reusable instruments are specifically designed foruse with the Medtronic Stealth Station System (V2.1.0), which is indicated forany medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure, such as askull, along bone, or vertebra, can be identified relative to a CT or MR basedmodel, fluoroscopy images, or digitized landmarks for the anatomy. |
| Materials: | The instruments are manufactured from medical grade titanium and stainlesssteel. |
| Non-clinical Testing: | Addition of Blackbird to Choicespine Navigation does not require testing. Thesubject and predicate devices have nearly identical technological characteristicsthe minor difference does not raise any new issues of safety and effectiveness.Specifically, the following characteristics are identical between the subject and |
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predicate; Principle of operation and technical characteristics such as design, sterility, and interfacing. The only difference between the subject and predicate device is anatomical location of surgical use. The predicate submission names system used in the thoracic lumbar region of the spine (Lancer™)Thunderbolt™) whereas this subject submission will add usage in the cervical region (Blackbird™) as well as the thoracic lumbar region of the spine (Lancer™/Thunderbolt™). The Choice Spine Navigation instruments are specifically 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 a skull, a long bone, or vertebra. Thus the Medtronic® StealthStation® System inherently has the ability for stereotactic surgery of the cervical spine, such as the proposed usage of the ChoiceSpine Blackbird™ system in an identical or similar registration, calibration and application to that of the existing ChoiceSpine Navigation system. Testing is not required since the subject device has identical and unchanged technological characteristics and function as the predicate which was tested per ASTM F2554-10, "Standard Practice for Measurement of Positional Accuracy of Computer assisted Surgical Systems" as part of the original submission.
- Predicate Devices: Primary Predicate: Navigation System (K182721) Additional Predicates: Blackbird™ Spinal System (K133214) Medtronic Navigated Disc Prep Instruments and CAPSTONE Trials (K150231)
Substantial Equivalence
Conclusion: The addition of Blackbird to Navigation is within scope of the primary and secondary predicates. The Primary predicate submission names system used in the thoracic lumbar region of the spine (Lancer™/Thunderbolt™) whereas this subject submission will add usage in the cervical region (Blackbird™) as well as the thoracic lumbar region of the spine (Lancer™/Thunderbolt™). The secondary predicate (K150231) includes usage in both the Cervical and thoracic lumbar region. So, subject submission is within scope of both the primary and secondary predicates. This subject submission has identical and unchanged technological characteristics and function as the primary predicate.
PERFORMANCE DATA:
The Navigation System has been tested per ASTM F2554-10, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". The results of this non-clinical testing show that performance of the Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION:
The overall technology characteristics and performance data lead to the conclusion that the Navigation System is substantially equivalent to the predicate device.
§ 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).