(266 days)
No
The summary describes reusable surgical instruments designed for compatibility with a navigation system (Medtronic StealthStation® System S8). The focus is on the physical instruments and their interaction with the navigation system, which uses pre-existing imaging data (CT, MR, fluoroscopy) and digitized landmarks for guidance. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on dimensional analysis and positional accuracy testing, not on algorithmic performance related to AI/ML.
No
The device consists of navigated reusable surgical instruments (awls, probes, drill bits, taps, and screwdrivers) that assist surgeons in precisely locating anatomical structures for the preparation and placement of spinal screws. It is a surgical tool, not a device directly performing therapy.
No
The device is described as "reusable surgical instruments" used during spinal surgery to assist the surgeon in precisely locating anatomical structures for "preparation and placement of SpineCraft ASTRA Spine system pedicle screws." Its purpose is to guide the placement of implants, not to diagnose a medical condition.
No
The device description explicitly states that the ASTRA, AVANT, and ASTRA-OCT Navigation instruments are "non-sterile, reusable surgical instruments" manufactured from "medical grade stainless steel." This indicates the device includes physical hardware components, not just software.
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 Intended Use: The intended use of the ASTRA, AVANT, and ASTRA-OCT Navigated Reusable Instruments is to assist surgeons in precisely locating anatomical structures during spinal surgery for the preparation and placement of pedicle screws. This is a surgical tool used during a procedure on the patient's body, not for testing specimens outside the body.
- Device Description: The device is described as non-sterile, reusable surgical instruments made from medical grade stainless steel. This aligns with surgical tools, not diagnostic devices.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples, providing diagnostic information, or being used for testing purposes.
Therefore, the ASTRA, AVANT, and ASTRA-OCT Navigated Reusable Instruments fall under the category of surgical instruments used for navigation and placement during spinal procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ASTRA and AVANT Navigated Reusable Instruments are indicated for preparation and placement of SpineCraft ASTRA Spine system pedicle screws during thoracolumbar sacroiliac spinal surgery to assist surgeon in precisely locating anatomical structures in either open, minimally invasive procedures, or percutaneous, procedures. ASTRA and AVANT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the ASTRA and AVANT Navigated Reusable Instruments is limited to use only with ASTRA Spine System implants.
ASTRA-OCT Navigated Reusable instruments are indicated for preparation and placement of SpineCraft ASTRA-OCT Spine screws during cervico-thoracic spinal surgery to assist surgeon in precisely locating anatomical structures in open procedures. ASTRA-OCT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the ASTRA-OCT Navigated Reusable Instruments is limited to use only with ASTRA-OCT Spine System implants.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The ASTRA, AVANT and ASTRA-OCT Navigation instruments are non-sterile, reusable surgical instruments designed for compatibility with the Medtronic NavLock Trackers and to ultimately provide seamless interaction with the Medtronic StealthStation® System. The ASTRA and AVANT Navigation instruments are for use with ASTRA Spine System pedicle screws and the ASTRA-OCT Navigation instruments are for use with ASTRA-OCT Spine System pedicle screws. The instruments are manufactured from medical grade stainless steel. The ASTRA-OCT navigation instruments are available in same or similar diameters and lengths as the corresponding predicate Medtronic navigated instruments. This includes awls, probes, drill bits, taps and screwdrivers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
thoracolumbar sacroiliac spinal, cervico-thoracic spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, medical condition in which the use of stereotactic surgery may be appropriate
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)
Non-clinical Test Summary:
A detailed dimensional analysis and one-to-one comparison has been conducted for subject and predicate device to support the substantial equivalence.
Additionally, the ASTRA, AVANT and ASTRA-OCT Navigation instruments Systems have been tested per ASTM F2554-18 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems".
- I Single point measurement accuracy per ASTM F2554-18
- . Instrument axis rotation measurement accuracy per ASTM F2554-18
- l Instrument angular position perpendicular to the system camera measurement accuracy per ASTM F2554-18
- l Instrument angular position parallel to the system camera measurement accuracy per ASTM F2554-18
- Distance between points measurement accuracy per ASTM F2554-18
The results of this non-clinical testing together with the dimensional analysis and comparison show that performance of the ASTRA, AVANT and ASTRA-OCT Navigation Instruments Systems is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K153442, K150417, K211323, K181350
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
July 20, 2023
SpineCraft, LLC Ami Akallal-Asaad Vice President of Regulatory Affairs & Quality Assurance 777 Oakmont Lane, Suite 200 Westmont, Illinois 60559
Re: K223301
Trade/Device Name: ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 12, 2023 Received: June 14, 2023
Dear Ami Akallal-Asaad:
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.
1
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 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 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-S
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)
Device Name
ASTRA and AVANT Navigation Instruments System And
ASTRA-OCT Navigation Instruments System
Indications for Use (Describe)
ASTRA and AVANT Navigated Reusable Instruments are indicated for preparation and placement of SpineCraft ASTRA Spine system pedicle screws during thoracolumbar sacroiliac spinal surgery to assist surgeon in precisely locating anatomical structures in either open, minimally invasive procedures, or percutaneous, procedures.
ASTRA and AVANT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the ASTRA and AVANT Navigated Reusable Instruments is limited to use only with ASTRA Spine System implants.
ASTRA-OCT Navigated Reusable instruments are indicated for preparation and placement of SpineCraft ASTRA-OCT Spine system screws during cervico-thoracic spinal surgery to assist surgeon in precisely locating anatomical structures in open procedures.
ASTRA-OCT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® SystemS8 (V1.2.0), which is indical 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the ASTRA-OCT Navigated Reusable Instruments is limited to use only with ASTRA-OCT Spine System implants.
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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3
510(k) Summary for the ASTRA, AVANT and ASTRA-OCT Navigation Instruments Systems
In accordance with 21 CFR 807.92 of the Federal Code of Requlations The following 510(k) Summary is submitted for the ASTRA, AVANT and ASTRA-OCT Navigation Instruments Systems
Date Prepared: July 20, 2023
| 1. Submitter: | Contact Person: |
|---|---|
| SpineCraft, LLC | Ami Akallal-Asaad |
| 777 Oakmont Lane | VP, Regulatory Affairs & QA |
| Westmont, IL 60559 USA | SpineCraft, LLC |
| Tel: 1 630-920-7300. | a.asaad@spinecraft.com |
| Fax: 1 630-920-7310. |
| 2. Trade name: | ASTRA & AVANT Navigation Instruments System |
|---|---|
| ASTRA-OCT Navigation Instruments System | |
| Common Name: | Computer Assisted Surgery System |
| Regulation Number: | 21 CFR 882.4560 |
| Regulation Name: | |
| Device Class | |
| Product Code: | Stereotaxic instrument |
| Class II | |
| OLO |
3. Primary predicate or legally marketed device which is substantially equivalent:
ASTRA & AVANT Navigation
- Navigated CD Horizon Solera (Medtronic) cleared in 510(k): K140454 ●
ASTRA-OCT Navigation
- . Navigated Infinity Instruments (Medtronic) cleared in 510(k): K173338
-
- Reference devices:
5. Description of the device:
The ASTRA, AVANT and ASTRA-OCT Navigation instruments are non-sterile, reusable surgical instruments designed for compatibility with the Medtronic NavLock Trackers and to ultimately provide seamless interaction with the Medtronic StealthStation® System. The ASTRA and AVANT Navigation instruments are for use with ASTRA Spine System pedicle screws and the ASTRA-OCT Navigation instruments are for use with ASTRA-OCT Spine System pedicle screws. The instruments are manufactured from medical grade stainless steel. The ASTRA-OCT navigation instruments are available in same or similar diameters and lengths as the corresponding predicate Medtronic navigated instruments. This includes awls, probes, drill bits, taps and screwdrivers.
6. Materials:
Medical grade stainless steel per ASTM F899
4
7. Substantial equivalence claimed to predicate devices
ASTRA & AVANT Navigation Instruments System is substantially equivalent to the Navigated CD Horizon Solera system (K140454) and Navigated Manual Reusable Instruments (K153442) in terms of intended use, design, materials used, mechanical safety and/or performances.
ASTRA-OCT Navigation Instruments System is substantially equivalent to the Navigated Infinity Instruments system (K173338) in terms of intended use, design, materials used, mechanical safety and/or performances.
8. Indications for Use:
ASTRA and AVANT Navigated Reusable Instruments are indicated for preparation and placement of SpineCraft ASTRA Spine system pedicle screws during thoracolumbar sacroiliac spinal surgery to assist surgeon in precisely locating anatomical structures in either open, minimally invasive procedures, or percutaneous, procedures.
ASTRA and AVANT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the ASTRA and AVANT Navigated Reusable Instruments is limited to use only with ASTRA Spine System implants.
ASTRA-OCT Navigated Reusable instruments are indicated for preparation and placement of SpineCraft ASTRA-OCT Spine screws during cervico-thoracic spinal surgery to assist surgeon in precisely locating anatomical structures in open procedures.
ASTRA-OCT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the ASTRA-OCT Navigated Reusable Instruments is limited to use only with ASTRA-OCT Spine System implants.
9. Summary of the technological characteristics compared to predicate
Intended Use
The ASTRA. AVANT and ASTRA-OCT Navigation instruments Systems and all the corresponding predicates have similar intended uses.
Materials
The ASTRA, AVANT and ASTRA-OCT Navigation instruments System are fabricated from the same material as the corresponding predicate devices.
Design Features/Functions
The ASTRA, AVANT and ASTRA-OCT Navigation instruments Systems and the cited corresponding predicate devices share similar basic design features and functions.
Dimensions
The ASTRA, AVANT and ASTRA-OCT Navigation instruments Systems are dimensionally similar to the cited corresponding predicate devices.
5
Sterilization
The ASTRA, AVANT and ASTRA-OCT Navigation instruments Systems are reusable provided non-sterile and the cited corresponding predicate devices are reusable and non-sterile.
Performance Specification
Performance testing conducted on the ASTRA, AVANT and ASTRA-OCT Navigation instruments Systems demonstrated that they perform as designed, are suitable for their intended use and are substantially equivalent to the cited corresponding predicate devices under the same test conditions.
10. Non-clinical Test Summary:
A detailed dimensional analysis and one-to-one comparison has been conducted for subject and predicate device to support the substantial equivalence.
Additionally, the ASTRA, AVANT and ASTRA-OCT Navigation instruments Systems have been tested per ASTM F2554-18 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems".
- I Single point measurement accuracy per ASTM F2554-18
- . Instrument axis rotation measurement accuracy per ASTM F2554-18
- l Instrument angular position perpendicular to the system camera measurement accuracy per ASTM F2554-18
- l Instrument angular position parallel to the system camera measurement accuracy per ASTM F2554-18
- Distance between points measurement accuracy per ASTM F2554-18
The results of this non-clinical testing together with the dimensional analysis and comparison show that performance of the ASTRA, AVANT and ASTRA-OCT Navigation Instruments Systems is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices
11. Clinical Test Summary
No clinical studies were performed
12. Conclusion Nonclinical and Clinical
The overall technology characteristics and performance data lead to the conclusion that the ASTRA, AVANT and ASTRA-OCT Navigation Instruments Systems are substantially equivalent to the cited corresponding predicate devices in terms of indications for use, design, material, performance and function.