(111 days)
When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
For all the above indications the Zavation Ti 3Z Cervical Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Cervical Plate System.
The Zavation Ti 3Z Cervical Interbody implants offer a variety of heights, widths and lengths in the CIF configuration. The implants are additively manufactured from medical grade Titanium Ti64ELI powder by way of laser sintering.
The Zavation Ti 3Z Cervical Interbody implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of the implants have a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. Both porous and solid aspects of each implant are printed simultaneously.
The provided text is a 510(k) summary for a medical device called the "Ti 3Z Cervical Interbody System." This document describes the device, its intended use, materials, and testing conducted to demonstrate its substantial equivalence to previously cleared predicate devices.
However, this document does not contain any information about a study that proves the device meets acceptance criteria related to AI/algorithm performance, human-in-the-loop studies (MRMC), or a comprehensive evaluation against specific diagnostic performance metrics (like sensitivity, specificity, etc.).
The "Performance Data" section of the document solely focuses on:
- Mechanical Testing: Demonstrating structural integrity and durability in accordance with ASTM F2077 (Static/Dynamic Axial Compression, Torsion, Subsidence, Expulsion). This is standard for implantable devices to ensure they can withstand physiological loads.
- Process Validation Testing: Ensuring the manufacturing process results in clean, sterile implants (ASTM F 2847-10, Gravimetric Analysis, Cytotoxicity, TOC, LAL). This is crucial for patient safety regarding biocompatibility and infection control.
The device described is a physical implant (intervertebral body fusion device) and not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool. Therefore, the questions related to AI/algorithm performance, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training/test set details are not applicable to this specific 510(k) submission.
In summary, based on the provided document, there is no information available to answer the specific questions about acceptance criteria and study designs related to an AI/algorithm-driven device. The document is for a physical medical implant, and its "acceptance criteria" are based on mechanical and material biocompatibility standards, not diagnostic or AI performance.
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September 9, 2019
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Zavation Medical Products, LLC Katie Motley Design Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
Re: K191354
Trade/Device Name: Ti3Z Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 31, 2019 Received: August 1, 2019
Dear Katie Motley:
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/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 531-542 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K191354
Device Name Ti 3Z Cervical Interbody System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
For all the above indications the Zavation Ti 3Z Cervical Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Cervical Plate System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary
| Date: | August 1, 2019 |
|---|---|
| Submitter: | Zavation Medical Products, LLC220 Lakeland PkwyFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302 |
| Contact person: | Katie Motley |
| Type of 510(k) submission: | Traditional |
| Trade name: | Ti 3Z Cervical Interbody System |
| Common name: | Intervertebral Body Fusion Device |
| Classification regulation: | 21 CFR 888.3080 Intervertebral body fusion device |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | ODP |
Device Description:
The Zavation Ti 3Z Cervical Interbody implants offer a variety of heights, widths and lengths in the CIF configuration. The implants are additively manufactured from medical grade Titanium Ti64ELI powder by way of laser sintering.
The Zavation Ti 3Z Cervical Interbody implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of the implants have a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. Both porous and solid aspects of each implant are printed simultaneously.
Purpose of 510K:
New Interbody Device.
Indications for Use:
When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with
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degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
For all the above indications the Zavation Ti 3Z Cervical Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Cervical Plate System.
Materials:
The devices are manufactured from medical grade Titanium Ti64ELI (ASTM F3001-14).
Predicate Device:
Primary -Zavation IBF System, Zavation LLC (K181246) Additional - LDR Spine Cervical Interbody Fusion System (K091088) Additional - K2M CASCADIA Interbody System (K172941) Reference Predicate – Zavation Ti 3Z Interbody System (K180076)
Technological Characteristics:
The Zavation Ti 3Z Cervical Interbody System possesses similar technological characteristics as the predicates. These include: basic design (material, rectangular shape with bulleted nose, and graft windows for packing autogenous bone); sizes (similar heights, widths, lengths, and lordotic angles); and intended use (as described above).
Performance Data:
Mechanical test results demonstrated that the Zavation Ti 3Z Interbody System is substantially equivalent to the predicate devices. Testing was performed in accordance with:
- ASTM F2077, Test Methods for Intervertebral Body Fusion Devices .
- O Static Axial Compression
- O Dynamic Axial Compression
- O Static Torsion
- O Dynamic Torsion
- Subsidence O
- Expulsion O
Process Validation test results demonstrate that the Zavation Ti 3Z Interbody System (K180076) is free from any possible contaminants and the cleaning process is adequate for implants to be provided sterile. The Zavation Ti 3Z Cervical Interbody System manufacturing, post processing, cleaning, sterilization, and packaging is identical to that of Zavation Ti 3Z Interbody System (K180076). Testing was performed in accordance with:
- . ASTM F 2847-10, Standard Practice for Reporting Assessment of Residues on Single Use Implants
- O Gravimetric Analysis, ASTM F 2459-12
- O Cytotoxicity, ISO 10993-5: 2009
- Total Organic Carbon O
- Limulus Amebocyte Lysate (LAL) (Endotoxin) o
Basis for Substantial Equivalence:
The Zavation Ti 3Z Cervical Interbody devices are similar to the predicate systems with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacers to the predicate devices and is therefore safe and effective for its intended use.
§ 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.