(182 days)
The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine system implants during spinal surgery to assist the 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 StealthStation S7 (V2.1.0) and S8 (V1.2.0) systems, which are 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 for the anatomy.
The ChoiceSpine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® 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 any ChoiceSpine systems equipped with the appropriate and necessary features and geometry. These features and geometry have been tested for compatibility with the Medtronic® StealthStation®.
The provided text is a 510(k) summary for the ChoiceSpine Navigation System. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by performance testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance testing described. The study aimed to demonstrate substantial equivalence to the predicate devices. The key performance characteristic assessed was "dimensional analysis and positional accuracy" per ASTM F2554.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional Analysis (compatible with Medtronic StealthStation) | Validated in side-by-side testing of the Medtronic® StealthStation® system and predicate device. |
| Positional Accuracy (per ASTM F2554) | Validated in side-by-side testing of the Medtronic® StealthStation® system and predicate device. |
| Substantial Equivalence to Predicate | "The test results demonstrate that the ChoiceSpine Navigation system performance is substantially equivalent to the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the test set. It mentions "side-by-side testing," which implies that the ChoiceSpine Navigation instruments were tested alongside the Medtronic® StealthStation® system and a predicate device.
- Sample Size: Not explicitly stated as a number of unique cases. It refers to testing of the "ChoiceSpine Navigation system" itself against the predicate system. This suggests a physical testing setup rather than a dataset of patient cases.
- Data Provenance: Not specified in terms of country of origin. The study appears to be a laboratory-based performance validation of the instrument's compatibility and accuracy, rather than a clinical study with patient data. It is a "performance data" section, not a "clinical data" section. The document states it was a "side-by-side testing" with a "predicate device".
- Retrospective/Prospective: Not applicable, as it's a device performance validation, not a clinical data study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for the test set. The ground truth for this type of device (surgical navigation instruments) is typically established through engineering measurements and comparisons to known standards or predicate device performance, not through expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. The study appears to be an engineering performance validation, not one requiring adjudication of clinical interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a technical performance validation of a medical device's accuracy and compatibility, not a study assessing the impact of AI assistance on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of this device. The "ChoiceSpine Navigation System" is a set of instruments designed to work with an existing navigation system (Medtronic StealthStation). It is not an AI algorithm in the traditional sense that would operate "standalone" to produce an interpretation or diagnosis. Its performance is intrinsically linked to its use with the Medtronic system. The performance data focuses on the accuracy and compatibility of the instruments when integrated with the navigation system.
7. The Type of Ground Truth Used
The ground truth used appears to be engineering measurements and direct comparison to a predicate device's performance, specifically for dimensional analysis and positional accuracy as defined by ASTM F2554. This is a technical validation against established engineering standards and existing device performance, not clinical outcomes, pathology, or expert consensus on a clinical condition.
8. The Sample Size for the Training Set
Not applicable. This device is a set of physical surgical instruments, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 6, 2022
ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K220024
Trade/Device Name: ChoiceSpine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 6, 2022 Received: May 10, 2022
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
{1}------------------------------------------------
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K220024
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 system implants during spinal surgery to assist the 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 StealthStation S7 (V2.1.0) and S8 (V1.2.0) systems, which are 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 for the anatomy.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of infonnation unless it displays a currently valid OMB number."
Form Approved: 0MB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
510(k) Summary
| Date: | May 6, 2022 |
|---|---|
| Sponsor: | ChoiceSpine, LLC400 Erin DriveKnoxville, TN 37919 |
| Phone: | 865-243-3969 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed ProprietaryTrade Name: | ChoiceSpine Navigation System |
| Product Class: | Class II |
| Classification Name: | ChoiceSpine Navigation System• 882.4560 Neurological Stereotaxic Instrument |
| Device Product Code: | ChoiceSpine Navigation System• OLO |
| Purpose of Submission: | The purpose of this submission is to allow for ChoiceSpine Navigationsystem instruments to be compatible with the Medtronic® StealthStation®Navigation System. |
| Device Description: | The ChoiceSpine Navigation instruments are non-sterile, reusableinstruments designed to function with the Medtronic® StealthStation®System. Refer to the appropriate navigation system Instructions for Useand/or Surgical Technique Guide for details regarding navigation systemuse. The ChoiceSpine Navigation instruments are for use with anyChoiceSpine systems equipped with the appropriate and necessaryfeatures and geometry. These features and geometry have been testedfor compatibility with the Medtronic® StealthStation®. |
| Indications for Use: | The ChoiceSpine Navigation reusable instruments are intended to be usedduring preparation and placement of ChoiceSpine system implants duringspinal surgery to assist the surgeon in precisely locating anatomicalstructures in either open or minimally invasive procedures. TheChoiceSpine Navigation reusable instruments are specifically designed foruse with the Medtronic StealthStation S7 (V2.1.0) and S8 (V1.2.0) systems,which are indicated for any medical condition in which the use ofstereotactic surgery may be appropriate and where reference to a rigidanatomical structure, such as a skull, a long bone, or vertebra, can beidentified relative to a CT or MR based model, fluoroscopy images, ordigitized landmarks for the anatomy. |
| Materials: | The instruments are manufactured from previously cleared materials forsurgical instruments per ASTM F899 & A564. |
| Predicate Devices: | Primary Predicate:Medtronic, Navigated CD Horizon Solera Screwdriver/Taps (K140454)Additional Predicate:SI-BONE, Inc. IFuse Implant System- IFuse Navigation (K203110)ChoiceSpine Navigation System (K203561)Medtronic Navigated VERTEX SELECT® Instruments (K143628) |
| Performance Data: | The ChoiceSpine Navigation system dimensional analysis and positionalaccuracy (per ASTM F2554) validations were performed in side-by-sidetesting of the Medtronic® StealthStation® system and predicate device.The test results demonstrate that the ChoiceSpine Navigation systemperformance is substantially equivalent to the predicate. |
| TechnologicalCharacteristics: | The ChoiceSpine Navigation System has the same technologicalcharacteristics as the predicate device. Therefore, the fundamentalscientific technology of the ChoiceSpine Navigation System is the same aspreviously cleared devices. |
| Conclusion: | The overall technological characteristics, performance data, and intendeduse of the ChoiceSpine Navigation System are the same which lead to theconclusion that the Navigation System is substantially equivalent to thepredicate devices. |
{4}------------------------------------------------
K220024
Page 2 of 2
§ 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).