(98 days)
Not Found
No
The document describes surgical instruments used with a navigation system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself is mentioned, but its specific technology is not detailed as AI/ML.
No.
This device is a surgical instrument intended to facilitate discectomy, bone resection, implant selection, and access during spinal surgery. It does not exert a therapeutic effect on the patient.
No
The device description and intended use state that the instruments are for facilitating surgical procedures (discectomy, bony resection, implant selection, access, nerve location), not for diagnosing a medical condition.
No
The device description explicitly states the device is comprised of "surgical instruments" which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The ATEC Lateral Navigation Instruments are surgical instruments used during spinal surgery to facilitate procedures like discectomy, boney resection, implant selection, and access. They are used directly on the patient's anatomy, not on specimens taken from the body.
- Intended Use: The intended use clearly describes their role in surgical procedures and their compatibility with a surgical navigation system. There is no mention of analyzing biological samples.
Therefore, the ATEC Lateral Navigation Instruments fall under the category of surgical instruments and are not IVDs.
N/A
Intended Use / Indications for Use
The ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® 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. The Stimulating Initial Dilator may also be utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
Product codes
OLO
Device Description
The ATEC Lateral Navigation Instruments are surgical instruments that are designed to be compatible with Medtronic's StealthStation Surgical Navigation System. The navigated disc preparation and dilator instruments are intended to facilitate discectomy, boney resection, access, and nerve location during spinal surgery. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable or single-use and are offered either nonsterile to be cleaned and steam sterilized by the end user or sterile packaged.
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
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
The following performance testing was conducted on the subject ATEC Lateral Navigation Instruments:
- Dimensional analysis of the instruments compared to Medtronic instruments
- . Testing to confirm performance and safety of the subject instruments when used with Medtronic StealthStation System.
Testing results demonstrated the subject ATEC Lateral Navigation Instruments are substantially equivalent when compared to other legally marketed devices cleared by FDA.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 23, 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.
Alphatee Spine, Inc. Sandy Gill Sr. Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K223765
Trade/Device Name: ATEC Lateral Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 17, 2023 Received: February 21, 2023
Dear Sandy Gill:
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
510(k) Number (if known) K223765
Device Name
ATEC Lateral Navigation Instruments
Indications for Use (Describe)
The ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® 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 Stimulating Initial Dilator may also be utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
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
Image /page/3/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the right of the "c". A black line is underneath the word.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|----|------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Sandy Gill
Sr. Regulatory Affairs Specialist |
| | Date Summary Prepared: | March 23, 2023 |
II. DEVICE
Trade or Proprietary Name: | ATEC Lateral Navigation Instruments |
---|---|
Common Name: | Navigation Instruments |
Classification Name: | Orthopedic Stereotaxic Instrument |
Regulation Number: | 21 CFR 882.4560 |
Classification: | Class II |
Product Code: | OLO |
LEGALLY MARKETED PREDICATE DEVICES III.
Primary Predicate Device:
510(k) | Product Name | Clearance Date |
---|---|---|
K192336 | Navigated Anterolateral Disc Prep Instruments | November 22, 2019 |
Additional Predicate Devices:
510(k) | Product Name | Clearance Date |
---|---|---|
K221821 | ATEC IOM Accessory Instruments | September 23, 2022 |
K200719 | NuVasive Navigation Instruments | December 2, 2020 |
IV. DEVICE DESCRIPTION
The ATEC Lateral Navigation Instruments are surgical instruments that are designed to be compatible with Medtronic's StealthStation Surgical Navigation System. The navigated disc preparation and dilator instruments are intended to facilitate discectomy, boney resection, access, and nerve location during spinal surgery. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable or single-use and are offered either nonsterile to be cleaned and steam sterilized by the end user or sterile packaged.
4
Image /page/4/Picture/0 description: The image shows the "atec" logo. The "a" is green, and the "tec" is dark blue. There is a trademark symbol next to the "c". There is a black line underneath the logo.
V. INDICATIONS FOR USE
The ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® 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. The Stimulating Initial Dilator may also be utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject instruments were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VII. PERFORMANCE DATA
The following performance testing was conducted on the subject ATEC Lateral Navigation Instruments:
- Dimensional analysis of the instruments compared to Medtronic instruments
- . Testing to confirm performance and safety of the subject instruments when used with Medtronic StealthStation System.
Testing results demonstrated the subject ATEC Lateral Navigation Instruments are substantially equivalent when compared to other legally marketed devices cleared by FDA.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.