The Navigated Pedicle Access Kit is intended to be used in image guided surgery with the 7D Surgical System. The Navigated Pedicle Access Kit is intended for use in posterior spinal surgery to assist in the acurate placement of pedicle screws. The device is sterile and designed for single use.

Device Description

The IZI Pedicle Access Kit consists of one pedicle access needle with cannula. The handle contains 4 retro-reflective Navigation Markers (Spherz K022074). The device is sterile and designed for single use. The patient-contacting components are the stainless-steel cannulas and needle. The product is used to gain access to the pedicle in image guided surgeries using the 7D Surgical System. The retro-reflective Navigation Markers (Spherz) that are attached to the handle allows the camera system of 7D Surgical System (K180352) to accurately locate where the tip of the needle is in space.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IZI Navigated Pedicle Access Kit, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format like typical sensitivity/specificity thresholds. Instead, it describes performance based on accuracy testing and conformance to standards. The reported device performance is demonstrated by its compliance with these tests and standards, showing that it performs as safely and effectively as the predicate device.

Test/Standard	Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Performance Surgical Simulations on Phantom Models	The device accurately navigates and assists in pedicle screw placement in a simulated surgical environment with the 7D Surgical System, demonstrating equivalent performance to the predicate.	Performed to verify absolute accuracy, repeatability of accuracy, and navigation accuracy with the 7D Surgical System.
ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems	Compliance with the standard for measuring positional accuracy of computer-assisted surgical systems.	Accuracy testing performed according to this standard to verify absolute accuracy and repeatability of the device and navigation accuracy.
Target Registration Error (TRE) Evaluation	TRE should demonstrate acceptable clinical accuracy of the system on phantom models in a clinical simulated environment.	Used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment.
Biocompatibility Profile	Same biocompatibility profile as the reference device K1423244.	The IZI Pedicle Access Kit has the same biocompatibility profile as the reference device K1423244.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not specify a numerical sample size for the "phantom models" used in the non-clinical performance surgical simulations. It mentions "phantom models" generally.
Data Provenance: The data is based on "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models." This indicates it's retrospective simulation data from a controlled lab environment, not from human patients. The country of origin for the data is not specified, but the applicant (IZI Medical Products LLC) is based in Maryland, USA, and the predicate device manufacturer (7D Surgical Inc.) is in Ontario, Canada, suggesting a North American context for the testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide details on the number or qualifications of experts involved in establishing the ground truth for the non-clinical simulations. The "ground truth" for TRE is described as "measured physically or otherwise," implying objective physical measurements rather than expert consensus on images.

4. Adjudication Method for the Test Set:

No adjudication method is described, as the evaluation appears to be based on objective physical measurements (e.g., TRE) in a simulated environment, not subjective assessment by multiple individuals.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted. This document describes a device (a physical surgical instrument) and its navigation accuracy when used with a surgical system, not an AI diagnostic algorithm that assists human readers in interpreting medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone Performance:

Yes, a standalone performance assessment (algorithm only, without human-in-the-loop performance) was effectively done. The performance metrics (absolute accuracy, repeatability, navigation accuracy, and TRE) are for the device (IZI Navigated Pedicle Access Kit) and its interaction with the 7D Surgical System in a simulated environment. There isn't a "human-in-the-loop" component being evaluated in these specific non-clinical tests.

7. Type of Ground Truth Used:

The ground truth used was objective physical measurements in a phantom model. For TRE, it's defined as "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a gold standard established by precise physical measurement to compare against the system's reported position.

8. Sample Size for the Training Set:

The document does not mention a "training set" or "training data." This submission is for a physical surgical device, not a machine learning or AI algorithm in the context of data training. The "device performance tests" are verification and validation activities, which are akin to testing, not training.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided.

Summary

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August 7, 2019

IZI Medical Products LLC % Mr. Daniel Ziskind Director, Quality & Regulatory 7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto, Ontario, M3B 2R7 Canada

Re: K191012

Trade/Device Name: Navigated Pedicle Access Kit Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: July 29, 2019 Received: July 30, 2019

Dear Mr. Ziskind:

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

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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 medical devices and radiation-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,

Ronald P. Jean, Ph.D. Assistant Director DHT6B: Division of Spinal 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) K191012

Device Name Navigated Pedicle Access Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

For Activities (Part 2 of STEP 4) Only	For Site Cleanup Only (STEP 5)
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|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 IZI Navigated Pedicle Access Kit

This summary is submitted in accordance with 21CFR §807.92.

Submitter's name

Qiang Cao Director of Quality Assurance and Regulatory Affairs Tel (800)231-1499 Email qiang.cao@izimed.com IZI MEDICAL PRODUCTS LLC 5 Easter Ct Ste J Owings Mills, MD 21117

Date prepared: April 12, 2019

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/usual name:	Stereotaxic Instrument
Proprietary name:	Navigated Pedicle Access Kit

These devices are classified as follows:

Classification Name	21 CFR Section	Product Code
Stereotaxic Instrument	21 CFR §882.4560	OLO

2. Predicate Devices

The IZI Pedicle Access Kit is substantially equivalent to the following currently marketed devices:

Product	510(k)
7D Surgical System	K180352 (Primary Predicate)

Reference Devices:

Product	510(k)
Medtronic HORIZON Spinal System	K182928
IZI Medical Disposable Passive Accessory	K142344

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3. Indications for Use

The Navigated Pedicle Access Kit is intended to be used in image guided surgery with the 7D Surgical System. The Navigated Pedicle Access Kit is intended for use in posterior spinal surgery to assist in the accurate placement of pedicle screws. The device is sterile and designed for single use.

4. Device Description

5. Comparison of Technological Characteristic with the Predicate Device

The IZI Navigated Pedicle Access Kit is substantially equivalent to the predicate device in terms of intended use, function, and overall performance.

Biocompatibility Profile – The IZI Pedicle Access Kit has the same biocompatibility profile as the reference device K1423244.

6. Nonclinical Performance Data

Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions.

The following accuracy testing has been performed using the 7D Surgical System to ensure the substantial equivalence of the IZI Navigated Pedicle Access Kit device:

Non-Clinical Performance Surgical Simulations Conducted on Phantom Models
Compliance Conformity Assessments
- . ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

Device performance tests were performed to verify the absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10. In addition, Target Registration Error (TRE) has been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. TRE evaluates the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise.

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7. Conclusion

The IZI Navigated Pedicle Access Kit is substantially equivalent to the predicate devices identified above:

The predicate devices and IZI Navigated Pedicle Access Kit use equivalent technologies.
The predicate devices and IZI Navigated Pedicle Access Kit are designed and manufactured to the similar physical safety standards.

The non-clinical verification and validation performed support the substantial equivalence of the IZI Navigated Pedicle Access Kit compatibility with the 7D Surgical System. The conclusions drawn from the non-clinical tests demonstrate that the IZI Navigated Pedicle Access Kit performs as safely and effectively as the legally marketed device according to the comparison based on the requirements of 21 CFR §882.4560 and the information provided herein. It is concluded that the IZI Navigated Pedicle Access Kit is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics, and performance characteristics.

Regulation Number and Section

§ 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).