(170 days)
No
The summary describes navigated surgical instruments that work with a separate navigation system (Medtronic StealthStation). The instruments themselves are passive tools and the summary does not mention any AI/ML capabilities within the instruments or the overall system described.
No.
The device functions as navigated instruments to assist in precise localization during spinal implant preparation and placement, rather than providing direct therapeutic treatment.
No
Explanation: The device is described as surgical instruments intended to assist a surgeon in precisely locating anatomical structures during spinal surgery, rather than for diagnosing a medical condition.
No
The device description explicitly lists physical instruments (screw drivers, taps, probes, awls) made of stainless steel and Radel, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Integrity Implants Navigated Instruments are surgical instruments used during surgery to assist the surgeon in placing spinal implants. They are used directly on the patient's anatomy, not on samples taken from the patient.
- Intended Use: The intended use clearly states they are for "use during the preparation and placement of Integrity Implants spinal implants during spinal surgery." This is an in-vivo (within the living body) application, not in-vitro (in glass, or outside the body).
The device description and intended use clearly indicate that these are surgical tools used in a surgical setting, not diagnostic tests performed on patient samples.
N/A
Intended Use / Indications for Use
Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's StealthStation System, 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Integrity Implants Navigated Instruments include non-sterile screw drivers, cannulated and solid taps (4.0 - 10.5 mm), probes, and awls designed to function with the Medtronic StealthStation® System and NavLock® Tracker. The subject devices are for use with the Integrity Implants LineSider® Spinal System (K190360 and K203367). The instruments are manufactured from stainless steel and Radel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR-based model, fluoroscopy images
Anatomical Site
Vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Performance testing of the subject devices, including accuracy testing in accordance with ASTM F2554-18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, was completed to ensure the functionality and compatibility of the Integrity Implants Navigated Instruments with the Medtronic StealthStation® Surgical System and the NavLock® Tracker.
Registration testing was performed to ensure the instruments can be registered with the StealthStation System.
A dimensional analysis was conducted to demonstrate that the subject devices are substantially equivalent to the predicate devices.
Cleaning and sterilization validation data from K190360 were leveraged in support of the substantial equivalence determination.
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
Image /page/0/Picture/0 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.
December 23, 2021
Integrity Implants Inc. % Roshana Ahmed Sr. Regulatory Specialist TELOS Partners, LLC 571 Christina Lake Drive Lakeland, Florida 33813
Re: K212088
Trade/Device Name: Integrity Implants Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 22, 2021 Received: November 24, 2021
Dear Roshana Ahmed:
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.
1
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 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.
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
510(k) Number (if known) K212088
Device Name
Integrity Implants Navigated Instruments
Indications for Use (Describe)
Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's StealthStation System, 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 vertebra, can be identified relative to a CT or MR-based model, finages, or digitized landmarks of the anatomy.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-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 Drug 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) Summary
I. Submitter
Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens, FL 33418 Phone: 561-529-3861
Contact Person: Roshana Ahmed, M.A., RAC, Senior Regulatory Specialist, Telos Partners LLC Secondary Contact Person: Lauren Kamer, Sr. Director of Reg Affairs, Integrity Implants Inc.
Date Prepared: December 22, 2021
II. Device
| Device Proprietary Name: | Integrity Implants Navigated Instruments |
|---|---|
| Common or Usual Name: | Navigation Instruments |
| Classification Name: | Stereotaxic Instruments |
| Regulation Number: | 21 CFR 882.4560 |
| Product Code: | OLO |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate devices:
-
Navigated CD Horizon Solera Screwdriver/Taps, K140454, Medtronic Sofamor Danek ● USA, Inc.
The following secondary predicate devices are cited within the submission: -
LineSider® Spinal System, K190360, Integrity Implants, Inc. ●
-
LineSider® Spinal System, K203367, Integrity Implants, Inc. ●
IV. Device Description
The Integrity Implants Navigated Instruments include non-sterile screw drivers, cannulated and solid taps (4.0 - 10.5 mm), probes, and awls designed to function with the Medtronic StealthStation® System and NavLock® Tracker. The subject devices are for use with the Integrity Implants LineSider® Spinal System (K190360 and K203367). The instruments are manufactured from stainless steel and Radel.
4
V. Indications for Use
Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's StealthStation System, 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
VI. Comparison of Technological Characteristics
The navigated instruments are identical to the predicate navigated instruments in that they are both intended to be used during the preparation and placement of implants during spinal surgery. incorporate the same design features to ensure navigation and compatibility with the Medtronic StealthStation® System and NavLock® Tracker to precisely locate anatomical structures, are made from the same materials, and utilize the same sterilization methods. The devices are equivalent in dimensions to the predicate instruments.
The table below compare the indications for use and key technological features between the subject and predicate device.
| Parameter | Subject Device | Navigated CD Horizon
Solera Screwdriver/Taps
(K140454) | Analysis | |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer | Integrity Implants Inc. | Medtronic Sofamor Danek
USA, Inc. | N/A | |
| Indications for Use | Integrity Implants Navigated
Instruments are intended to be
used during the preparation
and placement of Integrity
Implants spinal implants
during spinal surgery to assist
the surgeon in precisely
locating anatomical structures
in either open or minimally
invasive procedures.
Integrity Implants Navigated
Instruments are specifically | Medtronic Navigated
Reusable Instruments are
intended to be used during the
preparation and placement of
Medtronic screws during
spinal surgery to assist the
surgeon in precisely locating
anatomical structures in either
open or minimally invasive
procedures.
Medtronic Navigated
Reusable Instruments are | Substantially
Equivalent | |
| Parameter | Subject Device | | Navigated CD Horizon
Solera Screwdriver/Taps
(K140454) | Analysis |
| Probes and
Awls | | designed for use with
Medtronic's StealthStation
System, 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
vertebra, can be identified
relative to a CT or MR-based
model, fluoroscopy images,
or digitized landmarks of the
anatomy. | specifically designed for use
with the StealthStation®
System, 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 skull, a long bone, or
vertebra, can be identified
relative to a CT or MR based
model, fluoroscopy images,
or digitized landmarks of the
anatomy.
Medtronic Navigated
Reusable Instruments are also
compatible with the IPC®
POWEREASET™ System. | |
| | Tip
Geometry | Trocar tip (Awl)
Tapered Straight Probe
Duckbilled Straight Probe | Trocar tip (Awl),
Tapered (aka Thoracic) Probe
Duckbilled (aka Lumber)
Probe | Substantially
equivalent |
| | Materials | Stainless Steel | Stainless Steel | |
| Taps | Diameter | 4.0 - 8.5 mm | 3.75 - 8.5 mm | Substantially
equivalent |
| | Design | Solid or cannulated
Dual Lead, Quad Lead | Solid or cannulated
Dual Lead | |
| | Materials | Stainless Steel | Stainless Steel | |
| Drivers | Diameter | 5.5 - 6.0 mm | 5.5 - 6.0 mm | Substantially
equivalent |
| | Materials | Stainless Steel and Radel | Stainless Steel | Substantially
equivalent |
| Sterilization | | Non-Sterile | Non-Sterile | Substantially
equivalent |
5
6
VII. Performance Data
Performance testing of the subject devices, including accuracy testing in accordance with ASTM F2554-18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, was completed to ensure the functionality and compatibility of the Integrity Implants Navigated Instruments with the Medtronic StealthStation® Surgical System and the NavLock® Tracker.
Registration testing was performed to ensure the instruments can be registered with the StealthStation System.
A dimensional analysis was conducted to demonstrate that the subject devices are substantially equivalent to the predicate devices.
Cleaning and sterilization validation data from K190360 were leveraged in support of the substantial equivalence determination.
VIII. Conclusion
The information provided above supports that the Integrity Implants Navigated Instruments are as safe and effective as the predicate device. Although minor differences in design and technology exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the Integrity Implants Navigated Instruments are substantially equivalent to the predicate device.