(119 days)
The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DDD patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is made from a titanium alloy (Ti-6Al-4V ELI per ASTM F3001 and TI-6Al-4V ELI per ASTM F136) 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: PLIF (Lordotic; 3°, 6°, and 15°, Convex) and TLIF (Straight, Curved Lordotic and Curved Parallel)
This document describes the regulatory clearance for a medical device and, as such, does not contain information about acceptance criteria or a study proving a device meets them in the way described in your request.
The provided text is a 510(k) summary for the TirboLOX-L™ Lumbar IBFD, an intervertebral body fusion device. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish performance against acceptance criteria in the context of an AI/software as a medical device (SaMD) evaluation.
Therefore, I cannot extract the following information as it is not present in the provided document:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
What the document does describe in terms of "performance data" is the results of non-clinical, mechanical testing to ensure the structural integrity and biocompatibility of the physical implant.
Here's the relevant section from the document concerning "Performance Data":
Performance Data:
The TirboLOX-L™ Lumbar IBFD has been tested in the following test modes:
- ASTM F2177-14 Static Axial Compression
- Static Shear
- Dynamic Axial Compression
- Dynamic Shear
- ASTM 3267-04 Static Subsidence
- AAMI ST72 Bacterial Endotoxin Testing
Additionally, expulsion testing was performed. The results of this non-clinical testing show that the strength of the TirboLOX-L™ Lumbar IBFD is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
This information relates to the physical characteristics and safety of the implant itself, not to the performance of a diagnostic or therapeutic algorithm.
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August 13, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Captiva Spine, Inc. Jackie Ferro VP Quality Assurance & Regulatory Affairs 967 N. Alternate A1A. Suite 1 Jupiter, Florida 33477
Re: K180990
Trade/Device Name: TirboLOX-L™ Lumbar IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 11, 2018 Received: July 13, 2018
Dear Ms. 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) K180990
Device Name TirboLOX-LTM Lumbar IBFD
Indications for Use (Describe)
The Captiva Spine TirboLOX-L™ Lumbar IBFD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DDD patients may also have up to a Grade I spondylolisthesis at the involved level(s).
| 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/1 description: The image contains the logo for Captiva Spine. The logo features a blue, stylized "S" shape enclosed in a partial circle on the left. To the right of the symbol, the words "CAPTIVA" and "SPINE" are stacked on top of each other in a bold, sans-serif font. Below "SPINE", the website address "captivaspine.com" is printed in a smaller font.
| 510(k) Summary: TirboLOX-L™ Lumbar 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 | July 11, 2018 |
| Trade Name | TirboLOX-L™ Lumbar IBFD |
| Common Name | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Proposed Class | Class II |
| ClassificationName | Intervertebral Body Fusion Device (21 CFR §888.3080) |
| Product Code | MAX |
| ClassificationPanel | Division of Orthopedic Devices |
| PredicateDevices | Primary Predicate:• K171351 Posterior Spine Truss System (PSTS) Interbody FusionDevice, 4WEB, Inc.Additional Predicates:• K122956 FuseLOX® Lumbar Interbody System, Captiva Spine, Inc.• K150481 Cascadia Interbody System, K2M• K172888 EIT Cellular Titanium PLIF Cages, EIT Emerging ImplantTechnologies GmbH• K170341 Medussa-PL Cage, Medyssey USA, Inc.• K153400 ProLift® Expandable System, Life 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 called TirboLOX-L™ Lumbar IBFD. |
| DeviceDescription | The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is made from a titanium alloy(Ti-6Al-4V ELI per ASTM F3001 and TI-6Al-4V ELI per ASTM F136) and iscreated using 3D printing technologies. The implants are available in variousfootprints to accommodate a variety of patient anatomies and is provided sterile. Thedevice has a window in the center of device to accept autogenous bone and/orallogenic bone graft. The implant is available in the following configurations: PLIF(Lordotic; 3°, 6°, and 15°, Convex) and TLIF (Straight, Curved Lordotic and CurvedParallel) |
| Indications forUse | The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is indicated for use inskeletally mature patients with Degenerative Disc Disease (DDD) at one ortwo contiguous levels from L2-S1. DDD is defined as discogenic back painwith degeneration of the disc confirmed by patient history and radiographicstudies. Patients should have received 6 months of non-operative treatmentprior to treatment with the devices. The device must be used withsupplemental fixation and must be used with autograft and/or allogenic bonegraft comprised of cancellous and/or corticocancellous bone graft. The DDDpatients may also have up to a Grade I spondylolisthesis or retrolisthesis atthe involved level(s). |
| Summary of theTechnologicalCharacteristics | The TirboLOX-L™ Lumbar 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-L™ Lumbar IBFD has been tested in the following test modes:ASTM F2177-14 Static Axial Compression Static Shear Dynamic Axial Compression Dynamic Shear ASTM 3267-04 Static Subsidence AAMI ST72 Bacterial Endotoxin Testing Additionally, expulsion testing was performed. The results of this non-clinical testing show that the strength of the TirboLOX-L™ Lumbar 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-L™ Lumbar IBFD is substantiallyequivalent to the predicate devices. |
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Image /page/4/Picture/1 description: The image contains the logo for Captiva Spine. The logo features a blue circular icon with a white curved line inside, resembling a spine. To the right of the icon, 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", the website address "captivaspine.com" is written in a smaller, lighter 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.