(182 days)
Medtronic StealthStation S7, Medtronic StealthStation S8
No
The summary describes reusable surgical instruments designed for use with existing navigation systems (Medtronic StealthStation). It focuses on compatibility and positional accuracy, with no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself might incorporate AI/ML, but the submitted device (the instruments) does not.
No.
The device is intended to assist in the precise location of anatomical structures during surgery, not to treat or cure a disease or condition. It is a navigational tool for surgical placement, not a therapeutic agent itself.
No
Explanation: The device is described as reusable instruments intended to assist a surgeon in precisely locating anatomical structures during spinal surgery, functioning in conjunction with
Medtronic StealthStation systems. It is not depicted as diagnosing medical conditions.
No
The device description explicitly states "The ChoiceSpine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System." This indicates the device is a physical instrument, not solely software.
Based on the provided text, 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 ChoiceSpine Navigation reusable instruments are described as surgical instruments used during surgery to assist the surgeon in locating anatomical structures and placing implants. They interact directly with the patient's body during a procedure, not with samples taken from the body.
- Intended Use: The intended use clearly states the instruments are used "during preparation and placement of ChoiceSpine system implants during spinal surgery."
- Device Description: The description reinforces that these are "reusable instruments designed to function with the Medtronic® StealthStation® System" for use with ChoiceSpine systems.
The device is a surgical navigation instrument, which is a type of medical device used to guide surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OLO
Device Description
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®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks
Anatomical Site
rigid anatomical structure, such as a skull, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
The ChoiceSpine Navigation system dimensional analysis and positional accuracy (per ASTM F2554) validations were performed in side-by-side testing of the Medtronic® StealthStation® system and predicate device. The test results demonstrate that the ChoiceSpine Navigation system performance is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic, Navigated CD Horizon Solera Screwdriver/Taps (K140454), SI-BONE, Inc. IFuse Implant System- IFuse Navigation (K203110), ChoiceSpine Navigation System (K203561), Medtronic Navigated VERTEX SELECT® Instruments (K143628)
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/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
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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) 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)
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510(k) Summary
| Date: | May 6, 2022 |
|---|---|
| Sponsor: | ChoiceSpine, LLC |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-243-3969 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed Proprietary | |
| Trade 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 Navigation |
| system instruments to be compatible with the Medtronic® StealthStation® | |
| Navigation System. | |
| Device Description: | 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®. | |
| Indications for Use: | 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. | |
| Materials: | The instruments are manufactured from previously cleared materials for |
| surgical 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 positional |
| accuracy (per ASTM F2554) validations were performed in side-by-side | |
| testing of the Medtronic® StealthStation® system and predicate device. | |
| The test results demonstrate that the ChoiceSpine Navigation system | |
| performance is substantially equivalent to the predicate. | |
| Technological | |
| Characteristics: | The ChoiceSpine Navigation System has the same technological |
| characteristics as the predicate device. Therefore, the fundamental | |
| scientific technology of the ChoiceSpine Navigation System is the same as | |
| previously cleared devices. | |
| Conclusion: | The overall technological characteristics, performance data, and intended |
| use of the ChoiceSpine Navigation System are the same which lead to the | |
| conclusion that the Navigation System is substantially equivalent to the | |
| predicate devices. |
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K220024
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