(113 days)
No
The description focuses on passive navigation markers and standard image-guided surgery technology, with no mention of AI or ML.
No
The device is described as an access kit for pedicle screws and solely provides access into the pedicle. It is not therapeutic in nature.
No
This device is intended to assist in the accurate placement of pedicle screws during posterior spinal surgery, which is a therapeutic intervention, not a diagnostic one. It helps locate the tip of a needle in space for surgical guidance.
No
The device description clearly states it consists of a physical pedicle access needle with cannula and a handle containing retro-reflective navigation markers. It is a sterile, single-use physical instrument.
Based on the provided information, the Navigated Pedicle Access Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in posterior spinal surgery to assist in the accurate placement of pedicle screws. This is an in vivo procedure (performed within the living body).
- Device Description: The device description details a pedicle access needle with cannula and navigation markers. These are surgical instruments used directly on the patient during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. The Navigated Pedicle Access Kit does not perform any such analysis of specimens.
The device is a surgical instrument designed to be used in conjunction with an image-guided surgery system to facilitate a surgical procedure.
N/A
Intended Use / 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 acurate placement of pedicle screws. The device is sterile and designed for single use.
Product codes (comma separated list FDA assigned to the subject device)
OLO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image guided surgery
Anatomical Site
Spinal, pedicle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
- . ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
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.
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
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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)
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.
Type of Use (Select one or both, as applicable)
| For Activities (Part 2 of STEP 4) Only | For Site Cleanup Only (STEP 5) |
|---|---|
| ----------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------ |
|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
-
- 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
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.
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.
5
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.