(133 days)
The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous bone graft. Patients should have at least six weeks of non-operative to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
The Captiva Spine, Inc. TirboLOX-CTM Cervical IBFD is made from a titanium alloy and is created using 3D printing technologies. The implants are available in various footprints to accommodate a variety of patient anatomies and is provided sterile. The device has a window in the center of device to accept autogenous bone and/or allogenic bone graft. The implant is available in the following configurations: lordotic, anatomically correct and parallel
This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the requested information about acceptance criteria, study data, ground truth, and AI performance metrics is not applicable here.
The document describes the Captiva Spine TirboLOX-C™ Cervical IBFD, an intervertebral body fusion device. It focuses on demonstrating the device's substantial equivalence to legally marketed predicate devices through a series of non-clinical mechanical tests.
Here's a breakdown of the relevant information present in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria alongside performance data. Instead, it states that "The results of this non-clinical testing show that the strength of the TirboLOX-C™ Cervical IBFD is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device's performance in the listed tests met predetermined criteria acceptable for demonstrating equivalence to the predicate devices, but the exact numerical thresholds are not disclosed.
Device Performance (as reported):
- ASTM F2077-14: Static Axial Compression, Static Shear, Static Torsion, Dynamic Axial Compression, Dynamic Shear, Dynamic Torsion
- ASTM 2267-04: Static Subsidence
- ASTM F1978-12: Abrasion Resistance
- ASTM F1877-16: Wear Debris
- Additionally: Expulsion testing was performed.
The reported performance is qualitative: the device's strength is sufficient for its intended use and substantially equivalent to predicate devices. Specific quantitative results are not provided in this summary document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided because it's a mechanical device testing, not a clinical study on human data. The "sample" would refer to the number of devices tested, which is not specified. Data provenance like country of origin or retrospective/prospective is not relevant for this type of non-clinical, in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically defined for AI/medical imaging studies (e.g., expert consensus on diagnoses) is not relevant for mechanical device testing. The "ground truth" for these tests are the established standards and specifications of the ASTM methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical trials or expert reviews to resolve disagreements in interpretations, which is not part of mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a spinal implant, not an AI-powered diagnostic device. No human readers or AI assistance were involved in the testing described in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical performance tests are the established ASTM (American Society for Testing and Materials) standards and test methodologies. These standards define the parameters, procedures, and conditions for evaluating the mechanical properties of medical implants to ensure their safety and effectiveness. The goal is to show the device performs within acceptable limits mandated by these standards and comparably to predicate devices.
8. The sample size for the training set
Not applicable. There is no AI algorithm being described, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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September 19, 2018
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.
Captiva Spine, Inc. Jackie Ferro VP Quality Assurance and Regulatory Affairs 967 N. Alternate A1A. Ste. 1 Jupiter, Florida 33477
Re: K181229
Trade/Device Name: TirboLOX-C™ Cervical IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 17, 2018 Received: August 21, 2018
Dear Jackie Ferro:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name TirboLOX-CTM Cervical IBFD
Indications for Use (Describe)
The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous bone graft. Patients should have at least six weeks of non-operative to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
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 contains the logo for Captiva Spine. The logo features a stylized blue spine graphic on the left. To the right of the spine graphic, the words "CAPTIVA SPINE" are written in a bold, sans-serif font, with "CAPTIVA" on top of "SPINE". Below the company name, the website "captivaspine.com" is written in a smaller font.
| 510(k) Summary: TirboLOX-C TM Cervical IBFD | |
|---|---|
| Manufacturer /Submitter | Captiva Spine, Inc.967 N. Alternate A1A Ste.1Jupiter, FL 33477-3206 |
| Contact Person | Jackie FerroVP Quality Assurance & Regulatory AffairsPhone: (877) 772-5571 x719Fax: (866) 318-3224Email: jackie.ferro@captivaspine.com |
| Date Prepared | September 13, 2018 |
| Trade Name | TirboLOX-CTM Cervical IBFD |
| Common Name | Intervertebral Fusion Device with Bone Graft, Cervical |
| Proposed Class | Class II |
| ClassificationName | Intervertebral Body Fusion Device (21 CFR §888.3080) |
| Product Code | ODP |
| ClassificationPanel | Division of Orthopedic Devices |
| PredicateDevices | Primary Predicate:K110585: FuseLOX Cervical IBF System, Captiva Spine, Inc. Additional Predicates: K180990, TirboLOX-LTM Lumbar IBFD, Captiva Spine Inc. K150765, K1251103, K113559: ROI-C, LDR K153250: Renovis Tesera SC Standalone Anterior Cervical Fusion (ACF) System, Renovis Surgical Technologies, Incorporated K120275: Synthes ACIS, Synthes Spine K170550: Camber Spine Technologies Coveris Cervical Cage System, Camber Spine |
| SubmissionScope | The purpose of this submission is to request market clearance for a newproduct offering of Captiva Spine, Inc. which is an intervertebral bodyfusion device product for the cervical spine called TirboLOX-CTM CervicalIBFD. |
| DeviceDescription | The Captiva Spine, Inc. TirboLOX-CTM Cervical IBFD is made from atitanium alloy and is created using 3D printing technologies. The implantsare available in various footprints to accommodate a variety of patientanatomies and is provided sterile. The device has a window in the center ofdevice to accept autogenous bone and/or allogenic bone graft. The implantis available in the following configurations: lordotic, anatomically correctand parallel |
| Indications forUse | The Captiva Spine TirboLOX-CTM Cervical IBFD is indicated for use inskeletally mature patients with degenerative disc disease (DDD) of thecervical spine at one-disc level. DDD is defined as neck pain ofdiscogenic origin with the degeneration of the disc confirmed by historyand radiographic studies. The Captiva Spine TirboLOX-CTM CervicalIBFD is used to facilitate fusion in the cervical spine and is placed via ananterior approach at the C3 to C7 disc levels with autograft bone and/orallogenic bone graft composed of cancellous and/or corticocancellousbone graft. Patients should have at least six weeks of non-operativetreatment prior to treatment with an intervertebral body fusion device.The device must be used with supplemental fixation. |
| Summary of theTechnologicalCharacteristics | The TirboLOX-CTM Cervical IBFD and its predicate devices have nearlyidentical technological characteristics and the minor differences do not raiseany new issues of safety and effectiveness. Specifically, the followingcharacteristics are identical between the subject and predicates:Indications for use Materials of manufacture Structural support mechanism |
| PerformanceData | The TirboLOX-CTM Cervical IBFD has been tested in the following testmodes:ASTM F2077-14 Static Axial Compression Static Shear Static Torsion Dynamic Axial Compression Dynamic Shear Dynamic Torsion ASTM 2267-04 Static Subsidence ASTM F1978-12 Abrasion Resistance ASTM F1877-16 Wear Debris Additionally, expulsion testing was performed. The results of this non-clinical testing show that the strength of the TirboLOX-CTM Cervical IBFDis sufficient for its intended use and is substantially equivalent to legallymarketed predicate devices. |
| Conclusion | The overall technology characteristics and mechanical performance data leadto the conclusion that the TirboLOX-CTM Cervical IBFD is substantiallyequivalent to the predicate devices. |
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Image /page/4/Picture/0 description: The image contains the logo for Captiva Spine. The logo features a blue, stylized spine graphic on the left. To the right of the graphic, the words "CAPTIVA" and "SPINE" are stacked on top of each other in a bold, sans-serif font, also in blue. Below the word "SPINE" is the website address "captivaspine.com" in a smaller font.
§ 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.