(472 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural stability of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to treat degenerative disc disease and provide structural stability in the cervical spine, which are therapeutic functions.
No
The device is an interbody fusion device designed to provide structural stability and promote fusion in the cervical spine; it does not diagnose a condition.
No
The device description clearly states it is a spinal system of Interbody Fusion (IBF) devices made of titanium, which are physical implants. It does not describe any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a physical implant (an interbody fusion device) that is surgically placed into the cervical spine. It is used to provide structural stability and promote bone fusion.
- Intended Use: The intended use is to treat degenerative disc disease in the cervical spine by providing structural support and facilitating fusion, not by analyzing biological samples.
The device is a surgical implant used in a surgical procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Titus Titanium Cervical by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T ). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Titus Titanium Cervical by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The Titus Titanium Cervical by SAGICO is designed in a manner to be used with additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The Titus Titanium Cervical by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The Titanium Cervical by SAGICO, is intended to be used at one disc level from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Titus Titanium Cervical by SAGICO incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The Titus Titanium Cervical by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device. The Titus Titanium Cervical by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.
MATERIALS: The Titus Titanium Cervical by SAGICO are additively manufactured implants from titanium alloy Ti-6Al-4V ELI. The Titus Titanium Cervical by SAGICO includes additively manufactured spacer, integrated fixation anchors per ASTM F3001 and traditionally machined titanium alloy anchors lock per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
Indicated Patient Age Range
skeletally mature patients
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)
Non-clinical performance data testing conducted to support substantial equivalence for the Titus Titanium Cervical by SAGICO includes:
ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices Static and Dynamic Compression Test Static and Dynamic Torsion Test
ASTM F2267-04 Subsidence - Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression
ASTM F04.25.02.02 Static Axial Pullout Test, Strength of Cage with Blade, Expulsion Static Push-Out test, Strength of Deployment of Spin Blade, Effect of Anchors Deployment
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.
Not Found
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
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August 4, 2023
SAGICO VA USA, LLC James J. Gibson, Jr., Ph.D., CPA Project Manager 2189 West Busch Blvd Tampa, Florida 33612
Re: K221138
Trade/Device Name: Titus Titanium Cervical by SAGICO Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: June 8, 2023 Received: June 9, 2023
Dear Dr. Gibson:
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
1
542 of the Act); 21 CFR 1000-1050.
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-
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,
Brent Showalter -S
Brent Showalter, 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) K221138
Device Name Titus Titanium Cervical by SAGICO
Indications for Use (Describe)
The Titus Titanium Cervical by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T ). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Titus Titanium Cervical by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The Titus Titanium Cervical by SAGICO is designed in a manner to be used with additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.
| 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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Image /page/3/Picture/0 description: The image is a logo for SAGICO, which stands for United States of America Government Affairs. The logo is a hexagon shape with a stylized American flag inside. The top of the flag has blue stars, and the rest of the flag has red and white stripes. The text "SAGICO" is in bold blue letters above the flag, and the text "UNITED STATES OF AMERICA" is in smaller blue letters below the text "SAGICO". The words "GOVERNMENT" and "AFFAIRS" are in blue letters at the bottom of the hexagon.
510(k) Summary As required by section 807.92(c)
| Device Trade Name(s): | Titus Titanium Cervical by SAGICO |
|---|---|
| Classification Panel: | Orthopedics |
| Class and Reference: | Class II (21 CFR Section 890.5900) |
| Product Code(s): | OVE |
| Classification Name(s): | Intervertebral Fusion Device with Bone Graft |
| Regulation Number(s): | 21 CFR 888.3080 |
| Applicant/Official Contact Person: | James J. Gibson, Jr., PHD, CPA |
| SAGICO Project Manager | |
| Email: JG@SAGICOUSA.com | |
| Tel. (813) 815-0613 / Fax (813) 433-5586 | |
| Submitter /Manufacturer: | SAGICO VA USA, LLC |
| 2189 West Busch Blvd | |
| Tampa, Florida 33612 | |
| Tel. (813) 815-0613 / Fax (813) 433-5586 | |
| Preparation Date: | June 13th, 2023 |
Substantial Equivalence and Predicate Devices***:
SAGICO VA USA, LLC is making the claim that Titus Titanium Cervical by SAGICO, is a system that is substantially equivalent to legally marketed predicate devices that are distributed for similar indications, and/or have similar design features.
The Titus Titanium Cervical by SAGICO, is a system that is substantially equivalent with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness.
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Image /page/4/Picture/0 description: The image is a logo for SAGICO UNITED STATES OF AMERICA GOVERNMENT AFFAIRS. The logo is a hexagon with a stylized American flag design. The top of the hexagon has blue stars on a white background, and the rest of the hexagon has red and white stripes. The text "SAGICO" is in bold, blue letters above the text "UNITED STATES OF AMERICA" which is in smaller, black letters. The text "GOVERNMENT AFFAIRS" is in red letters at the bottom of the hexagon.
SAGICO Spinal System Traditional 510(k) Premarket Notification
The predicates are listed below:
| Legally Marketed | Distributor/Manufacture | Regulatory Class and | 510(K) Registration |
|---|---|---|---|
| Predicate Device | Name | Product Code | Number |
| SAGICO IBF System | Spinal Analytics & | ||
| Geometrical Implant Co | OVE | K161710 | |
| LDR Spine Cervical | |||
| Interbody Fusion | |||
| System | LDR Spine | OVE | K091088 |
| TiWAVE-C Porous | |||
| Titanium Cervical Cage | Kalitec Direct, LLC | ODP | K180401 |
DEVICE DESCRIPTION:
The Titus Titanium Cervical by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The Titanium Cervical by SAGICO, is intended to be used at one disc level from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Titus Titanium Cervical by SAGICO incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The Titus Titanium Cervical by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device. The Titus Titanium Cervical by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.
MATERIALS: The Titus Titanium Cervical by SAGICO are additively manufactured implants from titanium alloy Ti-6Al-4V ELI. The Titus Titanium Cervical by SAGICO includes additively manufactured spacer, integrated fixation anchors per ASTM F3001 and traditionally machined titanium alloy anchors lock per ASTM F136.
FUNCTION: The Titus Titanium Cervical by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical region.
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Image /page/5/Picture/0 description: The image is a logo for SAGICO, which stands for United States of America Government Affairs. The logo is a hexagon with a stylized American flag inside. The top of the hexagon has blue stars, and the rest of the flag has red and white stripes. The text "SAGICO" is in bold, black letters above the flag, and the words "UNITED STATES OF AMERICA" are in smaller, black letters below it. The words "GOVERNMENT AFFAIRS" are in red letters around the bottom of the hexagon.
INDICATIONS FOR USE:
The Titus Titanium Cervical by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Titanium Cervical by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The Titanium Cervical by SAGICO is designed in a manner to be used with additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.
NON-CLINICAL PERFORMANCE DATA:
Non-clinical performance data testing conducted to support substantial equivalence for the Titus Titanium Cervical by SAGICO includes:
ASTM F2077
Standard Test Methods for Intervertebral Body Fusion Devices Static and Dynamic Compression Test Static and Dynamic Torsion Test
ASTM F2267-04
Subsidence - Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression
ASTM F04.25.02.02
Static Axial Pullout Test, Strength of Cage with Blade, Expulsion Static Push-Out test, Strength of Deployment of Spin Blade, Effect of Anchors Deployment
SUBSTANTIAL EQUIVALENCE CONCLUSION:
The Titus Titanium Cervical by SAGICO implants are similar to legally marketed and FDA 510(k) Cleared predicate devices with respect to design, indication for use, performance and technical characteristics. The information provided within this premarket notification supports substantial equivalence of the Titus Titanium Cervical by SAGICO implants to the cited predicate devices.