(90 days)
No
The summary 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 indicated for stereotactic surgery based on imaging or digitized landmarks, which is a standard navigation approach and does not inherently imply AI/ML.
No.
The device facilitates surgical procedures (discectomy, bony resection, implant selection) but does not directly treat or prevent a disease, nor does it restore, modify, or correct body function or structure. It is a surgical instrument.
No
Explanation: The device is described as surgical instruments intended to facilitate discectomy, bony resection, and implant selection during spinal surgery. Its function is interventional (preparatory to surgery and during surgery), not diagnostic.
No
The device description explicitly states that the device is a set of "surgical instruments" which are physical hardware components. While they are designed to be compatible with a navigation system (which likely includes software), the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ATEC Posterior Navigated Disc Prep Instruments are surgical instruments used during spinal surgery to facilitate procedures like discectomy and bony resection. They are used in vivo (within the living body) and are guided by a navigation system.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples. The device interacts directly with the patient's anatomy during surgery.
- Input Modality: The input modalities (CT, MR, fluoroscopy, digitized landmarks) are imaging and anatomical data, not biological sample data.
Therefore, the ATEC Posterior Navigated Disc Prep Instruments fall under the category of surgical instruments and are not IVDs.
N/A
Intended Use / Indications for Use
The ATEC Posterior Navigated Disc Prep Instruments are indicated to facilitate discectomy, bony 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.
Product codes
OLO
Device Description
The ATEC Posterior Navigated Disc Prep Instruments are surgical instruments that are designed to be compatible with the Medtronic® StealthStation™ Surgical Navigation System. The navigated disc preparation instruments are intended to facilitate discectomy, and bony resection. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable and are offered non-sterile to be cleaned and steam sterilized by the end user.
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 Posterior Navigated Disc Prep 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 Posterior Navigated Disc Prep Instruments are substantially equivalent when compared to other legally marketed devices cleared by FDA.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K161363, K203056, K200719, K223765
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
November 2, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
Alphatec Spine, Inc. Sandv Gill Sr. Regulatory Affairs Specialist 1950 Camina Vida Roble Carlsbad, California 92008
Re: K232345
Trade/Device Name: ATEC Posterior Navigated Disc Prep Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 4. 2023 Received: August 4, 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 (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.
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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" (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 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,
Tejen D. Soni -S
For Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair
2
and Trauma 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) K232345
Device Name
ATEC Posterior Navigated Disc Prep Instruments
Indications for Use (Describe)
The ATEC Posterior Navigated Disc Prep Instruments are indicated to facilitate discectorny, bony 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K232345 510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for a company called "atec". The "a" is green and the "tec" is dark blue. There is a trademark symbol in the upper right corner of the logo. There is a black line underneath the logo.
Traditional 510(k) Premarket Notification ATEC Posterior Navigated Disc Prep Instruments
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 |
Sandy Gill Manager, Regulatory Affairs
Date Summary Prepared:
November 1, 2023
II. DEVICE
| Trade or Proprietary Name: | ATEC Posterior Navigated Disc Prep Instruments |
|---|---|
| Common Name: | Navigation Instruments |
| Classification Name: | Orthopedic Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Classification: | Class II |
| Product Code: | OLO |
III. LEGALLY MARKETED PREDICATE DEVICES
Primary Predicate Device:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K201267 | Adaptix Interbody System with Titan | |
| nanoLOCK Surface Technology | ||
| Navigated Disc Prep Instruments including | ||
| Navigated Rotating Shavers | August 26, 2020 |
Additional Predicate Device:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K211441 | Navigated Anterolateral Disc Prep | |
| Instruments | June 09, 2021 |
Reference Devices:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K161363 | Arsenal Spinal Fixation System | June 10, 2016 |
| K203056 | Invictus Spinal Fixation System | November 23, 2020 |
| K200719 | NuVasive Navigation.S Instruments | December 02, 2020 |
| K223765 | ATEC Lateral Navigation Instruments | March 23, 2023 |
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Image /page/5/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are dark blue. There is a trademark symbol in the upper right corner of the logo. There is a black line underneath the logo.
DEVICE DESCRIPTION IV.
The ATEC Posterior Navigated Disc Prep Instruments are surgical instruments that are designed to be compatible with the Medtronic® StealthStation™ Surgical Navigation System. The navigated disc preparation instruments are intended to facilitate discectomy, and bony resection. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable and are offered non-sterile to be cleaned and steam sterilized by the end user.
V. INDICATIONS FOR USE
The ATEC Posterior Navigated Disc Prep Instruments are indicated to facilitate discectomy, bony resection, and implant selection 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.
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 Posterior Navigated Disc Prep 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 Posterior Navigated Disc Prep Instruments are substantially equivalent when compared to other legally marketed devices cleared by FDA.
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Image /page/6/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
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.