(120 days)
The TiWAVE-C™ Porous Titanium Cervical Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the device. The devices 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 when used as an adjunct to fusion.
The TiWAVE-C™ Porous Titanium Cervical Cages are 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.
This is a medical device, specifically an intervertebral body fusion device, not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI, standalone algorithm performance, sample size for training sets, and adjudication methods for experts) are not applicable.
However, based on the provided text, I can extract information regarding the device's non-clinical acceptance criteria and the study performed to prove it:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TiWAVE-C™ Porous Titanium Cervical Cage are based on demonstrating safety and performance equivalence to predicate devices through various mechanical and sterilization tests, adhering to industry standards.
| Acceptance Criteria Category | Specific Tests Performed (Industry Standards) | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Safety | Static and dynamic axial compression (per ASTM F2077) | Results of these evaluations indicate that the device is equivalent to the predicate device. |
| Static and dynamic torsion (per ASTM F2077) | ||
| Static compression shear (per ASTM F2077) | ||
| Subsidence (per ASTM F2267) | ||
| Static Expulsion | ||
| Sterilization Effectiveness | Effectiveness of gamma irradiation validated using AAMI/ANSI/ISO 11137-2 – method VDmax25, including: Bioburden recovery factor testing, Bacteriostasis and fungistasis, Bioburden, Verification dose, Sterility testing of the verification dose sample. | Results indicate satisfactory validation of the sterilization process. (Implicit, as the conclusion states no new safety/efficacy issues and equivalence to predicate) |
| Cleaning Procedure | Effectiveness of final ultrasonic cleaning procedure for gamma sterilization, including: Visual verification, Bioburden testing, Cytotoxicity testing, UV/Vis testing, Total organic carbon (TOC), Bacterial Endotoxin (LAL). | Results indicate satisfactory validation of the cleaning procedure. (Implicit, as the conclusion states no new safety/efficacy issues and equivalence to predicate) |
| Packaging & Shipping | Effectiveness of packaging and shipping of sterile product, including: Shipping testing, Peel strength testing, Bubble emission testing, Integrity inspections. | Results indicate satisfactory validation of packaging and shipping. (Implicit, as the conclusion states no new safety/efficacy issues and equivalence to predicate) |
| Overall Conclusion | Substantial equivalence to predicate devices in terms of intended use, design, materials used, mechanical safety, and performances. | Kalitec Direct, LLC considers the TiWAVE-C™ Porous Titanium Cervical Cage to be equivalent to the predicate devices. Based on the testing performed, it can be concluded that there are no new issues of safety or efficacy when comparing the subject device to the predicates. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes (e.g., number of individual cages) used for each mechanical and sterilization test. However, it indicates that "the following tests were independently performed on the device," implying that multiple device samples were subjected to these tests to meet the relevant ASTM or ISO standards.
- Data Provenance: The tests were "independently performed on the device," suggesting that the testing was conducted in a laboratory setting (likely by the manufacturer or a contracted third-party lab) to evaluate the physical characteristics and performance of the TiWAVE-C™ Porous Titanium Cervical Cages themselves, rather than collecting data from human subjects or existing patient records. Therefore, it is prospective data generation from device testing, not retrospective. Country of origin for data is not explicitly stated but implied to be related to the submitter (Kalitec Direct, LLC in Orlando, FL, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this type of device submission. There were no human experts establishing ground truth for a test set in the context of diagnostic accuracy or clinical interpretation. The "ground truth" for the device's performance is established by its compliance with recognized mechanical, material, and sterilization standards (ASTM, ISO).
4. Adjudication Method for the Test Set
This question is not applicable. No human adjudication was involved in evaluating the technical performance and safety of an intervertebral body fusion device based on mechanical and sterilization testing. The results are based on objective measurements against predefined standards.
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
This question is not applicable. The device is a physical intervertebral body fusion cage, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical intervertebral body fusion cage, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is based on:
- Engineering Standards: Compliance with established mechanical testing standards (e.g., ASTM F2077, ASTM F2267) for intervertebral body fusion devices. These standards define the expected performance characteristics (e.g., strength, durability).
- Material Specifications: Conformance to material standards (e.g., ASTM F3001 for Titanium Grade 23).
- Sterilization and Biocompatibility Standards: Compliance with standards for sterilization methods (e.g., AAMI/ANSI/ISO 11137-2) and cleanliness (e.g., cytotoxicity, bioburden, bacterial endotoxin).
- Predicate Device Equivalence: The primary ground truth is also the demonstration of "substantial equivalence" to legally marketed predicate devices through comparative testing and analysis of design, materials, and intended use. The performance of the predicate devices, which are already deemed safe and effective, serves as the benchmark.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device.
9. How the ground truth for the training set was established
This question is not applicable. There is no "training set" for this physical medical device.
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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 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.
Kalitec Direct, LLC % Teresa Cherry Cherry Tree Consulting 1230 Show Drive Orlando, Florida 32828
Re: K180401
Trade/Device Name: TiWAVE-C™ Porous Titanium Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: May 15, 2018 Received: May 16, 2018
Dear Ms. Cherry:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
June 14, 2018
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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,
Digitally signed by 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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration.
Indications for Use
510(k) Number (if known) K180401
Device Name
TiWAVE-CTM Porous Titanium Cervical Cage
Indications for Use (Describe)
The TiWAVE-C™ Porous Titanium Cervical Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices 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 when used as an adjunct to fusion.
| 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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for the TiWAVE-C ™ Porous Titanium Cervical Cage
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | Dec 15, 2017 |
|---|---|
| Submitted by | Scott WinnKalitec Direct, LLC618 E. South Street, Suite 500Orlando, FL 32801407-545-2063 Tele407-358-5441 Fax |
| Primary Contact | Teresa CherryCherry Tree Consulting1230 Show DriveOrlando, FL 32828407-252-3295e-mail: Teresa@cherrytreequality.com |
| Secondary Contact | Keith Cannan1890 W. CR 419, Suite 2000Oviedo, FL 32765407-545-2063 Tele407-358-5441 Faxe-mail: quality@kalitecdirect.com |
| Trade Name | TiWAVE-C™ Porous Titanium Cervical Cage |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate Device | NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody K170318 |
| Secondary Predicate Devices | Cascadia™ Interbody System K160125 |
| Device Description | The TiWAVE-C™ Porous Titanium Cervical Cages are intervertebral bodyfusion devices made from additive manufactured (AM) Titanium Grade 23per ASTM F3001. The implants are available in various heights andlengths to accommodate patients' anatomy. The implants are providedsterile. |
| Materials | Implants are made from additive manufactured (AM) Titanium Grade 23per ASTM F3001.System specific instruments are made from either 17-4 H900 SS or 465SS H950 conforming to ASTM F899 |
| Intended Use | Intervertebral body fusion devices indicated for use with autograft and/orallogenic bone graft comprised of cancellous and/or corticocancellousbone graft when used as an adjunct to fusion. |
| Substantial EquivalenceClaimed to Predicate Devices | The TiWAVE-C™ Porous Titanium Cervical Cage is substantiallyequivalent to the predicate devices in terms of intended use, design,materials used, mechanical safety and performances. |
| Indications for Use | The TiWAVE-C™ Porous Titanium Cervical Cage is intended for use inskeletally mature patients with cervical degenerative disc disease (DDD)at one level or two contiguous levels from C2 to T1. DDD is defined asdiscogenic back pain with degeneration of the disc confirmed by patienthistory and radiographic studies. Patients should have received six (6)weeks of prior non-operative treatment prior to treatment with the device.The devices must be used with supplemental fixation and must be usedwith autograft and/or allogenic bone graft comprised of cancellous and/orcorticocancellous bone graft when used as an adjunct to fusion. |
| Non-clinical Test Summary | The following tests were independently performed on the device to demonstrate safety based on current industry standards:Static and dynamic axial compression (per ASTM F2077) Static and dynamic torsion (per ASTM F2077) Static compression shear (per ASTM F2077) Subsidence (per ASTM F2267) Static Expulsion The effectiveness of the gamma irradiation as a means of sterilization was validated using AAMI/ANSI/ISO 11137-2 – method VDmax25. This included: Bioburden recovery factor testing Bacteriostasis and fungistasis Bioburden Verification dose Sterility testing of the verification dose sample The effectiveness of the final ultrasonic cleaning procedure for gamma sterilization included the following process qualifications: Visual verification Bioburden testing Cytotoxicity testing UV/Vis testing Total organic carbon (TOC) Bacterial Endotoxin (LAL) The effectiveness of the packaging and shipping of sterile product included the following process qualifications: Shipping testing Peel strength testing Bubble emission testing Integrity inspections The results of these evaluations indicate that the TiWAVE-C™ Porous Titanium Cervical Cage is equivalent to predicate device. |
| Clinical Test Summary | No clinical studies were performed. |
| Conclusions: Non-clinical and Clinical | Kalitec Direct, LLC considers the TiWAVE-C™ Porous Titanium Cervical Cage to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. Based on the testing performed, it can be concluded that there are no new issues of safety or efficacy when comparing the subject device to the predicates. |
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T
§ 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.