(161 days)
The Excella® Navigation Instruments are intended to be used during the preparation and placement of Excella II®, Excella 3® & Excella MIS® screws during spinal surgery to assist the surgeon in locating anatomical structures in either open or percutaneous spinal procedures. The Excella Navigation Instruments are specifically designed for use with the Medtronic® StealthStation® System S8 and associated tracking arrays, 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 an acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model of the anatomy.
The Innovasis® Excella® Navigation Instruments used for the preparation and insertion of Excella III , Excella 3° & Excella MIS® screws, in either open or percutaneous procedures. These instruments are with the Medtronic® StealthStation® System or as standalone, unnavigated instruments.
The FDA document concerns the Excella Navigation Instruments and its 510(k) premarket notification (K223511), which determined the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does NOT describe a study that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, accuracy, or any performance related to an AI/algorithm-driven diagnostic or assistive system.
Instead, the document details engineering and functional testing for a stereotaxic instrument (navigation instruments for spinal surgery). The acceptance criteria and "study" described are focused on the physical and functional performance of the navigation instruments themselves, not on an algorithm's diagnostic or predictive capabilities and their impact on human reader performance.
Therefore, I cannot fulfill the request as it pertains to an AI/algorithm-driven device performance study, because the provided document does not contain that information. The device in question is a physical instrument for navigation during surgery, and the "tests" described are for its mechanical and operational accuracy and compatibility.
Summary of Available Information (related to engineering/functional testing, not AI performance):
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (High-Level) Reported Device Performance Positional Accuracy All measurements were within specifications and comparable to the predicate product (ASTM F2554-18) Navigated Instrument Accuracy Confirmed Navigation System Functionality Confirmed under expected use conditions CAD Model Accuracy Verified that CAD models are accurately reflected in the application software Implant/Instrument Mating Verified that instruments can be assembled with appropriate devices according to intended use Spine Tools Package Functionality Verified that the Spine Tools package has met the required interface needs of the spine application software -
Sample size used for the test set and data provenance:
This information is not provided in the document. The testing described (e.g., positional accuracy, simulated use) would likely involve a sample of the instruments themselves, but the exact number or data provenance (e.g., specific images or patient data) is not detailed. -
Number of experts used to establish ground truth and qualifications:
This information is not provided. The testing appears to be engineering-focused (e.g., comparing measurements to specifications or CAD models), not dependent on human expert interpretation of medical images. -
Adjudication method for the test set:
This information is not applicable/provided. The testing appears to be quantitative measurements and functional checks, not requiring adjudication of human interpretations. -
Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size:
No MRMC study was done or reported. The device is a navigation instrument, not an AI model assisting image interpretation, so such a study would not be the primary means of validation for this type of device. -
Stand-alone (algorithm-only) performance:
Not applicable. The device is a physical instrument, not a standalone algorithm. While it needs to interface with a navigation system (Medtronic StealthStation S8), the performance described is for the instrument itself. -
Type of ground truth used:
The "ground truth" for these tests appears to be engineering specifications, CAD model data, and predefined functional requirements. For positional accuracy, it would be the true physical position as measured by a highly accurate reference system. -
Sample size for the training set:
Not applicable. This is a hardware device undergoing functional and performance testing, not a machine learning model requiring a training set. -
How the ground truth for the training set was established:
Not applicable. See point 8.
In conclusion, the provided FDA document details the regulatory clearance for a medical instrument based on engineering and functional performance tests tied to physical accuracy and compatibility, not an AI-driven device requiring clinical performance metrics like sensitivity, specificity, or human reader studies.
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May 2, 2023
Innovasis, Inc. Michael Thomas Regulatory Affairs Manager 614 E 3900 S Salt Lake City, Utah 84107
Re: K223511
Trade/Device Name: Excella Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: [NOTE: Use date of most recent supplement] Received: May 5, 2023
Dear Michael Thomas:
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-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
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Indications for Use
Submission Number (if known)
Device Name
Excella Navigation Instruments
Indications for Use (Describe)
The Excella® Navigation Instruments are intended to be used during the preparation and placement of Excella II®, Excella 3® & Excella MIS® screws during spinal surgery to assist the surgeon in locating anatomical structures in either open or percutaneous spinal procedures. The Excella Navigation Instruments are specifically designed for use with the Medtronic® StealthStation® System S8 and associated tracking arrays, 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 an acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model 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)
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510(k) Summary
Prepared on: 2022-11-18
Contact Details
| Applicant Name | Innovasis, Inc. |
|---|---|
| Applicant Address | 614 E 3900 S Salt Lake City UT 84107 United States |
| Applicant Contact Telephone | 8012612236 |
| Applicant Contact | Mr. Michael Thomas |
| Applicant Contact Email | mthomas@innovasis.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | Excella Navigation Instruments |
|---|---|
| Common Name | Stereotaxic instrument |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Regulation Number | 882.4560 |
| Product Code | OLO |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | K140454 |
|---|---|
| Predicate Trade Name (Primary Predicate is listed first) | Medtronic Navigated CD Horizon Solera Screwdrivers and Taps |
| Product Code | OLO |
Device Description Summary 21 CFR 807.92(a)(4)The Innovasis® Excella® Navigation Instruments used for the preparation and insertion of Excella III , Excella 3° & Excella MIS® screws, in either open or percutaneous procedures. These instruments are with the Medtronic® StealthStation® System or as standalone, unnavigated instruments.
Intended Use/Indications for Use
The Excella® Navigation Instruments are intended to be used during the preparation and placement of Excella 3° & Excella MIS® screws during spinal surgery to assist the surgeon in locating anatomical structures in either open or percutaneous spinal procedures. The Excella Navigation Instruments are specifically designed for use with the Medtronice StealthStation® System S8 and associated tracking arrays, which is indical 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 an acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model of the anatomy.
Indications for Use Comparison
Indications for use are substantially equivalent. The subject Innovasis indications are a subset of the predications (i.e., specifically spinal procedures).
Technological Comparison
The subject device has the same technological characteristics as the as the predicate device.
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Technology is substantially equivalent.
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Design is substantially equivalent.
K223511, Page 1 of 2
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
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Size is substantially equivalent.
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Indications for use and intended use are substantially equivalent.
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Materials (biocompatibility profile) are substantially equivalent.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Testing was conducted in accordance with "ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Systems". The data shows all measurements were within specifications and comparable to the predicate product.
Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
Navigation Simulated Use: Confirmed navigation system functionality under expected use conditions.
CAD Model Evaluation: Verified that the CAD models are accurately reflected in the application software.
lmplant/Instrument Mating Conditions: Verified that the instruments can be assembled with the appropriate devices according to their intended use.
Spine Tools Package Functional Testing: Verified that the Spine Tools package has met the required interface needs of the spine application software.
§ 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).