(102 days)
No
The summary describes navigation instruments that work with a separate navigation system (Medtronic StealthStation). The instruments themselves are passive and do not contain AI/ML. The summary does not mention AI/ML capabilities within the navigation system either, focusing on positional accuracy and compatibility with imaging modalities.
No.
The device is a non-sterile, reusable instrument intended to assist surgeons in precisely locating anatomical structures during spinal surgery, rather than providing therapy itself.
No.
Explanation: The device is an instrument used during spinal surgery to assist in precisely locating anatomical structures, not to diagnose a condition. It is designed to work with a navigation system that can use imaging modalities, but the instrument itself does not perform diagnostics.
No
The device description explicitly states the instruments are "non-sterile, reusable instruments" manufactured from "medical grade titanium and stainless steel," indicating they are physical hardware components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that these are "reusable instruments intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures". They are tools used during a surgical procedure on the patient's body, not for testing samples outside the body.
- Intended Use: The intended use is to assist in surgical navigation and screw placement, not to diagnose or provide information about a patient's health status based on in vitro testing.
The device is a surgical instrument designed for use with a navigation system during spinal surgery.
N/A
Intended Use / Indications for Use
The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation reusable 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, 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 Choice Spine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. The Choice Spine Navigation instruments are for use with Choice Spine pedicle screw systems, specifically, the Lancer™ and Thunderbolt™ Pedicle Screw Systems. The instruments are manufactured from medical grade titanium and stainless steel.
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 a skull, a long bone, or vertebra, spinal
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
January 8, 2019
Choice Spine, LP. % Meredith May Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K182721
Trade/Device Name: Choice Spine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 19, 2018 Received: December 20, 2018
Dear Meredith May:
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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page. |
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
| Indications for Use | |
|---|---|
| 510(k) Number (if known) | K182721 |
| Device Name | Choice Spine Navigation System |
| Indications for Use (Describe) |
The Choice Spine Navigation reusable instruments are intended to be used during preparation
and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal
surgery to assist the surgeon in precisely locating anatomical structures in either open or
minimally invasive procedures. The Choice Spine Navigation reusable 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, 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) |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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 information unless it displays a currently valid OMB number."
4
| Submitter's Name | Choice Spine, LP. |
|---|---|
| Submitter's Address | 400 Erin Dr. |
| Knoxville, TN 37919 | |
| Submitter's Phone | 865.246.3333 |
| Contact Person | Meredith Lee May |
| Empirical Consulting | |
| 719.337.7579 | |
| mmay@empiricalconsulting.com | |
| Date Summary was | |
| Prepared | 03 January 2019 |
| Trade or Proprietary Name | Choice Spine Navigation System |
| Common or Usual Name | Orthopedic Stereotaxic Instrument |
| Classification | Class II per 21 CFR §882.4560 |
| Product Code | OLO |
| Classification Panel | Orthopedic |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Choice Spine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. The Choice Spine Navigation instruments are for use with Choice Spine pedicle screw systems, specifically, the Lancer™ and Thunderbolt™ Pedicle Screw Systems. The instruments are manufactured from medical grade titanium and stainless steel.
INDICATIONS FOR USE
The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation reusable 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, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The indications for use for the Choice Spine Navigation is similar to that of the predicate devices noted in Table 5-1: Predicate Devices.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
5
- Indications for Use ●
- Principle of Operation ●
- Technical Characteristics
- Sterility o
- Interfacing о
- Sizes O
The only difference between the subject and predicate device is the subject device utilizes different materials than the predicate device, which manufactured only from stainless steels. In addition to stainless steel, the subject device has Radel, Ketaspire KT-820 CF30, Ti-6Al-4V per ASTM F136 and PTFE.
Table 5-1: Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate Type |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------|
| K150231 | Navigated Disc Prep
Instruments | Medtronic | Primary |
| K132049 | Thunderbolt and Lancer
Pedicle Screw System | Choice Spine,
LP | Additional |
| K124004 | Navigated CD HORIZON®
SOLERATM
Screwdrivers, CD
HORIZON® SOLERATM
Taps, CD HORIZON®
SOLERATM
Iliac Taps and CD
HORIZON® LEGACY™
Taps | Medtronic
Navigation, Inc | Reference |
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.