(145 days)
The TiWAVE-L™ Porous Titanium Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). TiWAVE-L Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The TiWAVE-L Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device
The TiWAVE-L Porous Titanium Lumbar Cages are lumbar intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.
The provided text describes a medical device called the TiWAVE-L™ Porous Titanium Lumbar Cage, which is an intervertebral body fusion device. The document is an FDA 510(k) premarket notification summary.
Here's the analysis of the acceptance criteria and the study information based on the provided text, keeping in mind that this document describes a traditional medical device, not a software algorithm or AI model:
1. Table of Acceptance Criteria and Reported Device Performance
For traditional medical devices like the TiWAVE-L™ Porous Titanium Lumbar Cage, "acceptance criteria" and "device performance" are typically defined by engineering and biomechanical specifications rather than diagnostic performance metrics like sensitivity or specificity. The "study" here refers to non-clinical (mechanical and material) testing to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria Category | Specific Tests Conducted (Referenced Standard if applicable) | Reported Device Performance / Conclusion |
|---|---|---|
| Mechanical Performance | Static and dynamic axial compression (ASTM F2077) | Demonstrated equivalent performance to the cited predicate device under the same test conditions. |
| Static torsion (ASTM F2077) | Demonstrated equivalent performance to the cited predicate device under the same test conditions. | |
| Static and dynamic compression shear (ASTM F2077) | Demonstrated equivalent performance to the cited predicate device under the same test conditions. | |
| Subsidence (ASTM F2267) | Demonstrated equivalent performance to the cited predicate device under the same test conditions. | |
| Static Expulsion (ASTM draft standard F04.25.02.02) | Demonstrated equivalent performance to the cited predicate device under the same test conditions. | |
| Material/Biological Safety | Bacterial Endotoxin (BET) | Results indicate substantial equivalence to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the mechanical tests (e.g., number of cages tested for axial compression). It generally refers to "the TiWAVE-L Porous Titanium Lumbar Cage" being tested.
- Data Provenance: Not applicable in the context of this device. The data comes from non-clinical, in-vitro mechanical and material testing of the device itself, not from patient data, clinical trials, or retrospective/prospective studies on humans or animals.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For mechanical and material testing of this nature, "ground truth" is established by adhering to recognized industry standards (e.g., ASTM standards) and performing the tests in a controlled laboratory environment. The "experts" would be the engineers and technicians conducting the tests and interpreting the results according to the specified standards.
- Qualifications: Not specified, but implied to be individuals competent in biomechanical testing and material science, following established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a study requiring human interpretation or consensus. The results are quantitative measurements against predefined mechanical limits or comparison values from predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No MRMC study was done. The device in question is a physical implant, not a diagnostic or AI-assisted interpretation device. The document explicitly states: "No clinical studies were performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical implant, not an algorithm or AI.
7. The Type of Ground Truth Used
- Ground Truth: For this device, the "ground truth" is defined by established engineering and material science standards (e.g., ASTM standards) for intervertebral body fusion devices, and the performance characteristics of legally marketed predicate devices. The testing aims to demonstrate that the new device meets or exceeds these established benchmarks.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this device is not an AI/ML model or algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set or associated ground truth for this type of medical device submission.
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Image /page/0/Picture/0 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.
January 7, 2019
Kalitec Medical, LLC % J.D. Webb Authorized Contact Person The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K182210
Trade/Device Name: TiWAVE-L™ Porous Titanium Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 13, 2018 Received: August 15, 2018
Dear Mr. Webb:
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 mav, 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 avare 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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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.
Melissa Hall -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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Expiration Date: 06/30/2020
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
TiWAVE-L™ Porous Titanium Lumbar Cage
Indications for Use (Describe)
The TiWAVE-L™ Porous Titanium Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). TiWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal approach or an open posterior approach. The TIWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Y Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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for the TiWAVE
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | December 6, 2018 |
|---|---|
| Submitted by | Scott WinnKalitec Medical, LLC618 E. South Street, Suite 500Orlando, FL 32801407-545-2063 Tele407-358-5441 Fax |
| Primary Contact | J.D. WebbOrthoMedix Group1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net |
| Secondary Contact | Keith Cannan1890 W. CR 419, Suite 2000Oviedo, FL 32765407-545-2063 Tele407-358-5441 Faxe-mail: kcannan@kalitecmed.com |
| Trade Name | TiWAVE-L™ Porous Titanium Lumbar Cage |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody, HT Medical, LLC (K170318) |
| Additional PredicateDevices | Cascadia™ Interbody System, K2M, Inc. (K160125/ K162264/ K172009/ K172941/K170318)BAK/L Interbody Fusion System, Zimmer (P950002)Brantigan I/F Cage, DePuy Spine, Inc. (P960025)InTess Lumbar Cage System, Kalitec Direct, LLC (K133815)InTess Cervical Cage System, Kalitec Direct, LLC (K123100) |
| Device Description | The TiWAVE-L Porous Titanium Lumbar Cages are lumbar intervertebral body fusiondevices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001.The implants are available in various heights and lengths to accommodate patients'anatomy. The implants are provided sterile. |
| Materials | Implants are made from additive manufactured (AM) Titanium Grade 23 per ASTMF3001.System specific instruments are made from either stainless steel conforming to ASTMF899 or Ti6Al4V ELI titanium alloy conforming to ASTM F136. |
| Intended Use | Intervertebral body fusion devices indicated for use with autograft and/or allograftcomprised of cancellous and/or corticocancellous bone graft when used as an adjunctto fusion. |
| Substantial EquivalenceClaimed to PredicateDevices | The TiWAVE-L Porous Titanium Lumbar Cage is substantially equivalent to thepredicate devices in terms of intended use, design, materials used, mechanical safetyand performances. |
| Indications for Use | The TiWAVE-L Porous Titanium Lumbar Cage is indicated for intervertebral bodyfusion procedures in skeletally mature patients with degenerative disc disease (DDD)of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative discdisease is defined as discogenic back pain with degeneration of the disc confirmed byhistory and radiographic studies. These DDD patients may have up to Grade 1spondylolisthesis or retrolisthesis at the involved level(s). TiWAVE-L Porous TitaniumLumbar Cage implants are to be used with autogenous bone graft and/or allograftcomprised of cancellous and/or corticocancellous bone graft implanted via atransforaminal approach or an open posterior approach. The TiWAVE-L PorousTitanium Lumbar Cage implants are to be used with supplemental fixation. Patientsshould have at least (6) months of non-operative treatment prior to treatment with anintervertebral cage. Patients with previous non-fusion spinal surgery at involved levelmay be treated with the device |
| Summary of thetechnologicalcharacteristicscompared to predicate | Intended UseThe TiWAVE-L Porous Titanium Lumbar Cage and all the predicates have similarintended uses.MaterialsThe TiWAVE-L Porous Titanium Lumbar Cage is composed of the same material asthe predicate device.Design Features/FunctionsThe TiWAVE-L Porous Titanium Lumbar Cage and cited predicate devices sharesimilar basic design features and functions.DimensionsThe TiWAVE-L Porous Titanium Lumbar Cage is dimensionally similar to citedpredicate devices.SterilizationThe TiWAVE-L Porous Titanium Lumbar Cage is provided sterile and cited predicatedevices are packaged sterile for single use only.Performance SpecificationMechanical testing confirmed the TiWAVE-L Porous Titanium Lumbar Cagedemonstrated equivalent performance to the cited predicate device under the sametest conditions. |
| Non-clinical TestSummary | The following tests were independently performed on the TiWAVE-L PorousTitanium Lumbar Cage to demonstrate substantial equivalence based on currentindustry standards:> Static and dynamic axial compression (per ASTM F2077)> Static torsion (per ASTM F2077)> Static and dynamic compression shear (per ASTM F2077)> Subsidence (per ASTM F2267)> Static Expulsion (per ASTM draft standard F04.25.02.02)> Bacterial Endotoxin (BET)The results of these evaluations indicate that the TiWAVE-L Porous TitaniumLumbar Cage is substantially equivalent to the predicate devices. |
| Clinical Test Summary | No clinical studies were performed. |
| Conclusions: Non-clinical and Clinical | Kalitec Medical considers the TiWAVE-L Porous Titanium Lumbar Cage system tobe substantially equivalent to the predicate devices listed above. This conclusion isbased upon the devices' similarities in principles of operation, technology,materials, and indications for use. Based on the testing performed, it can beconcluded that there are no new issues of safety or efficacy when comparing thesubject device to the predicates. |
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K182210
Page 2 of 2
§ 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.