(161 days)
No
The summary describes a physical implant device and its mechanical properties and manufacturing process. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as a "cervical intervertebral body fusion device" intended for "treatment of cervical disc disease," which implies a direct therapeutic intervention to alleviate a medical condition.
No.
This device is an interbody fusion device designed to treat cervical disc disease by fusing vertebrae. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implant made from titanium and PEEK, intended for surgical implantation. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, specifically for treating cervical disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an intervertebral body fusion device made of titanium and/or PEEK, designed to be implanted in the spine. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition based on in vitro testing.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The Ti3Z cervical 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.
Product codes
ODP
Device Description
The Zavation Ti3Z Cervical Interbody System implants are offered in two configurations: Ti3Z cervical implants are additively manufactured entirely from medical grade Titanium Ti64ELI powder by way of laser sintering (ASTM F3001); Ti3Z-PEEK cervical implants have an exterior that is manufactured from medical grade PEEK (polyetherketone) with tantalum beads or pins embedded in the implants to allow for radiographic visualization. Ti3Z-PEEK implants also contain an interior titanium insert manufactured by way of laser sintering (ASTM F3001) and a wrought titanium pin (ASTM F136). The ends of the Ti3Z-PEEK implants have machined teeth which are designed to engage with the vertebral body end plates.
The Zavation Ti 3Z Cervical and Ti3Z-PEEK Cervical Interbody implants are available in a range of heights, widths and lengths as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of both constructs 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 the Ti3Z cervical implant are printed simultaneously. This modification seeks clearance for the addition of Ti3Z-PEEK cervical spacers. All implants will be provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C2 to T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical test results demonstrated that the Zavation Ti 3Z- PEEK cervical spacer is substantially equivalent to the predicate devices. Testing was performed in accordance with:
. ASTM F2077
- Static Axial Compression
- Dynamic Axial Compression
- Static Torsion
- Dynamic Torsion
- Static Shear
- Dynamic Shear
. ASTM F2267 - Subsidence
- Expulsion
Process Validation test results demonstrate that the Zavation Ti 3Z Lumbar Interbody System (K180076), Ti3Z Cervical Interbody System (K191354) and Zavation IBF System (K181246) are free from any possible contaminants and the cleaning process is adequate for implants to be provided sterile. The Zavation Ti 3Z-PEEK Cervical spacers' manufacturing, post processing, cleaning, sterilization, and packaging are identical to that of Zavation IBF System (K181246), Zavation Ti3Z Cervical System (K191354), and Zavation Tl3Z Lumbar System (K180076) and fall under current validated procedures. Testing was performed in accordance with:
. ASTM F 2847-10, Standard Practice for Reporting Assessment of Residues on Single Use Implants
- Gravimetric Analysis, ASTM F 2459-12
- Cytotoxicity, ISO 10993-5: 2009
- Total Organic Carbon
- Limulus Amebocyte Lysate (LAL) (Endotoxin)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K181246, K183397, K171075, K191354
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 29, 2021
Zavation Medical Products, LLC Katie Motley Design Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
Re: K202398
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: December 23, 2020 Received: December 28, 2020
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
1
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) 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Page 1 of 1
510(k) Number (if known) K202398
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 intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The Ti3Z cervical 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: | September 9, 2020 |
|---|---|
| Submitter: | Zavation Medical Products, LLC |
| 220 Lakeland Pkwy | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 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 |
| Basis for submission | Addition of Ti3Z-PEEK cervical implant |
Device Description:
The Zavation Ti3Z Cervical Interbody System implants are offered in two configurations: Ti3Z cervical implants are additively manufactured entirely from medical grade Titanium Ti64ELI powder by way of laser sintering (ASTM F3001); Ti3Z-PEEK cervical implants have an exterior that is manufactured from medical grade PEEK (polyetherketone) with tantalum beads or pins embedded in the implants to allow for radiographic visualization. Ti3Z-PEEK implants also contain an interior titanium insert manufactured by way of laser sintering (ASTM F3001) and a wrought titanium pin (ASTM F136). The ends of the Ti3Z-PEEK implants have machined teeth which are designed to engage with the vertebral body end plates.
The Zavation Ti 3Z Cervical and Ti3Z-PEEK Cervical Interbody implants are available in a range of heights, widths and lengths as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of both constructs 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 the Ti3Z cervical implant are printed simultaneously. This modification seeks clearance for the addition of Ti3Z-PEEK cervical spacers. All implants will be provided sterile.
4
Intended Use:
When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The Ti3Z cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc diseans 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.
Materials:
The devices are manufactured from medical grade Titanium Ti6ALV 4ELI alloy (ASTM F3001-14) OR medical grade PEEK (ASTM F560) with Tantalum markers (ASTM F2026) and a medical grade Titanium Ti6ALV 4ELI alloy (ASTM F3001-14) insert and pin (ASTM F136).
Predicate Device:
Primary -Zavation IBF System, Zavation LLC (K181246) Additional – ChoiceSpine Stealth Cervical Spacer System (K183397) Additional - X-Spine Systems, Inc. Calix-C™ Cervical Interbody Spacer (K171075) Additional Predicate - Zavation Ti3Z Cervical Interbody System (K191354) Reference Predicate – Zavation Ti 3Z Lumbar Interbody System (K180076)
Technological Characteristics:
The subject device is identical in surgical technique, and instrumentation to the primary predicate device cleared in (K181246) and additional predicate (K191354). The difference to the Zavation Ti3Z Cervical Interbody System is the addition of a Titanium (ASTM F3001) and PEEK combination implant with the titanium serving as an interior insert. Zavation Ti3Z-PEEK Cervical possesses the same technological characteristics as the primary predicate and reference predicate. These include similar heights, widths, lengths, and intended use.
Performance Data:
Mechanical test results demonstrated that the Zavation Ti 3Z- PEEK cervical spacer is substantially equivalent to the predicate devices. Testing was performed in accordance with:
- . ASTM F2077
- Static Axial Compression o
- Dynamic Axial Compression o
- Static Torsion O
- Dynamic Torsion o
- Static Shear o
- Dynamic Shear O
- . ASTM F2267
- Subsidence o
- Expulsion
5
Process Validation test results demonstrate that the Zavation Ti 3Z Lumbar Interbody System (K180076), Ti3Z Cervical Interbody System (K191354) and Zavation IBF System (K181246) are free from any possible contaminants and the cleaning process is adequate for implants to be provided sterile. The Zavation Ti 3Z-PEEK Cervical spacers' manufacturing, post processing, cleaning, sterilization, and packaging are identical to that of Zavation IBF System (K181246), Zavation Ti3Z Cervical System (K191354), and Zavation Tl3Z Lumbar System (K180076) and fall under current validated procedures. Testing was performed in accordance with:
- . ASTM F 2847-10, Standard Practice for Reporting Assessment of Residues on Single Use Implants
- Gravimetric Analysis, ASTM F 2459-12 o
- o Cytotoxicity, ISO 10993-5: 2009
- o Total Organic Carbon
- o Limulus Amebocyte Lysate (LAL) (Endotoxin)
Basis for Substantial Equivalence:
The Zavation Ti 3Z-PEEK cervical spacer 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.