(161 days)
Not Found
No
The summary describes a navigation system that uses image-based models and acquired images (CT, MR, 2D/3D fluoroscopy) for surgical guidance, but there is no mention of AI or ML being used for image processing, analysis, or any other function. The performance studies focus on accuracy and functionality of the navigation system and instruments, not on AI/ML performance metrics.
Yes.
The device is used to assist in the placement of spinal screws, which are therapeutic implants. Therefore, the instrument itself is a therapeutic device.
No
The device is described as "Navigation Instruments" intended to assist the surgeon during spinal surgery by locating anatomical structures. It is used with a navigation system that references acquired images but does not itself provide a diagnosis.
No
The device description explicitly states "The Innovasis® Excella® Navigation Instruments used for the preparation and insertion of Excella III , Excella 3° & Excella MIS® screws... These instruments are with the Medtronic® StealthStation® System or as standalone, unnavigated instruments." This indicates the device includes physical instruments, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Excella® Navigation Instruments are surgical instruments used during spinal surgery to assist the surgeon in locating anatomical structures and placing screws. They are used directly on the patient's body, not on specimens taken from the body.
- Intended Use: The intended use clearly states their purpose is to assist in surgical procedures, not to perform diagnostic tests on biological samples.
- Device Description: The description confirms they are instruments used for preparing and inserting screws during surgery.
- Performance Studies: The performance studies focus on the accuracy of the navigation system and the functionality of the instruments in a surgical context, not on the accuracy of diagnostic results from biological samples.
Therefore, based on the provided information, the Excella® Navigation Instruments fall under the category of surgical instruments or navigation systems, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
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.
Mentions image processing
Acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model of the anatomy.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D/3D fluoroscopic image reconstruction
Anatomical Site
Vertebra / Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, During 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Not Found
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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
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-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
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.
-
Technology is substantially equivalent.
-
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.
-
Indications for use and intended use are substantially equivalent.
-
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.