(111 days)
The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy. Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.
The Kalitec Navigated Instrument System is comprised of nonsterile, reusable instruments, including probes, taps, and drivers that can be operated manually. These instruments are designed to function with the Medtronic StealthStation® S8(v2.0.1-7) System, in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®Il clamps and arrays to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Kalitec polyaxial screws.
Here's a breakdown of the acceptance criteria and study information for the Kalitec Navigated Instrument System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured?) | Reported Device Performance (Result) |
|---|---|
| Dimensional Accuracy (per ASTM F2554) | The Kalitec Navigated Instrument System performance is substantially equivalent to the predicate. (Specific numerical data not provided in text). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "side-by-side testing," but does not specify the sample size for the test set (i.e., how many instruments were tested or how many measurements were taken).
The data provenance is not explicitly stated beyond being part of a non-clinical test conducted by Kalitec Direct, LLC. It is a retrospective study as it's a submission for a 510(k) premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This study appears to be a technical performance validation against a standard (ASTM F2554) and a predicate device, rather than an evaluation requiring expert clinical interpretation to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As this was a technical performance validation, there would not typically be an adjudication method in the sense of resolving discrepancies between expert opinions. The performance was measured against the ASTM standard and the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical performance validation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The study focuses on the "dimensional accuracy" of the "Kalitec Navigated Instrument System" in conjunction with the Medtronic StealthStation® System. This is a technical performance assessment of the device itself, rather than an evaluation of human performance with or without the device. While a human surgeon would ultimately use the instruments, the test described is about the instrument's accuracy, not a surgeon's performance using it.
7. The Type of Ground Truth Used
The "ground truth" for the test set was:
- Dimensional accuracy as defined by ASTM F2554. This is a recognized standard for evaluating dimensional accuracy.
- Performance of the legally marketed predicate device (Medtronic® StealthStation® system and predicate device). The Kalitec system's performance was compared to this established benchmark.
8. The Sample Size for the Training Set
Not applicable. This device is a navigated instrument system, not an AI/ML algorithm that requires a training set in the typical sense. The device's functionality is based on its mechanical design and interaction with the navigation system, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
{0}------------------------------------------------
December 13, 2023
Image /page/0/Picture/1 description: The image contains 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.
Kalitec Direct, LLC doing business as Kalitec Medical % J.D. Webb President The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401
Re: K232572
Trade/Device Name: Kalitec Navigated Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 9, 2023 Received: November 13, 2023
Dear J.D. Webb:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
K232572 - J.D. Webb
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Shumaya Ali-S
Shumaya Ali, MPH
Shumaya Ali, M 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
{2}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
Kalitec Navigated Instrument System
Indications for Use (Describe)
The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy. Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| 510(k) #: K232572 | 510(k) Summary | Prepared on: 2023-11-09 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Kalitec Direct, LLC doing business as Kalitec Medical | ||
| Applicant Address | 618 E. South Street Suite 500 Orlando FL 32801 United States | ||
| Applicant Contact Telephone | 407-545-2063 | ||
| Applicant Contact | Mr. Winn Scott | ||
| Applicant Contact Email | Scott@kalitecmed.com | ||
| Correspondent Name | The OrthoMedix Group, Inc., | ||
| Correspondent Address | 4313 W. 3800 S. West Haven UT 84401 United States | ||
| Correspondent Contact Telephone | 512-590-5810 | ||
| Correspondent Contact | Mr. J.D. Webb | ||
| Correspondent Contact Email | jdwebb@orthomedix.net | ||
| Device Name21 CFR 807.92(a)(2) | |||
| Device Trade Name | Kalitec Navigated Instrument System | ||
| Common Name | Stereotaxic instrument | ||
| Classification Name | Orthopedic Stereotaxic Instrument | ||
| Regulation Number | 882.4560 | ||
| Product Code | OLO | ||
| Legally Marketed Predicate Devices21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K124004/K140454/ | Medtronic Navigated CD Horizon Solera Screwdrivers and Taps | OLO | |
| K140678/K172808 | CosmoLock Pedicle Screw System | MNI | |
| Device Description Summary | 21 CFR 807.92(a)(4) | ||
| The Kalitec Navigated Instrument System is comprised of nonsterile, reusable instruments, including probes, taps, and drivers that canbe operated manually. These instruments are designed to function with the Medtronic StealthStation® S8(v2.0.1-7) System, incombination with the Medtronic NavLock™ tracker and Medtronic SureTrak®Il clamps and arrays to assist surgeons in precisely locatinganatomical structures in open or minimally invasive procedures for preparation and placement of Kalitec polyaxial screws. |
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
{4}------------------------------------------------
The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalited Navigated lnstruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy.
Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.
Indications for Use Comparison
The Kalitec Navigated Instrument System has the same indications for use as the predicate Medtronic device.
Technological Comparison
Indications for Use: no difference Materials: no difference Software & Hardware Compatibility: no difference Navigation Instrument Critical Length Dimension: no difference Operating Principle: no difference Sterility: no difference
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The Kaltec Navigated Instrument System dimensional accuracy (per ASTM F2554) validations were performed in side-by-side testing of the Medtronic® StealthStation® system and predicate device. The test results demonstrate that the Kalitec Navigated Instrument System performance is substantially equivalent to the predicate.
Not Applicable
Kallitec Direct, LLC considers the Kalitec Navigated Instrument System to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
§ 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).