(101 days)
Not Found
No
The summary describes a physical intervertebral body fusion device made of PEEK, with no mention of software, algorithms, or any AI/ML capabilities.
Yes
The device is an implant used in spinal fusion procedures to treat cervical disc disease and degenerative disc disease, which are medical conditions. Its purpose is to facilitate healing and alleviate symptoms, thereby contributing to the patient's well-being.
No
Explanation: The device is an intervertebral body fusion implant used for spinal fusion procedures, not for diagnosing medical conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is an implant manufactured from medical grade PEEK and includes physical components like tantalum beads or pins and machined teeth. This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Zavation IBF implants are physical devices made of PEEK, designed to be surgically implanted into the spine for fusion procedures.
- Intended Use: The intended use is for spinal fusion procedures, which is a surgical intervention, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Activity: The device itself does not perform any diagnostic function on biological samples. While radiographic studies are mentioned as part of the patient evaluation, the device itself is not involved in the diagnostic process.
Therefore, the Zavation IBF implants are a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. 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 (definded 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.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.
Product codes
MAX, ODP
Device Description
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled · implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
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; Lumbar spine, from L2 to S1
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 IBF System is substantially equivalent to the predicate devices. Testing was performed in accordance with ASTM F2077 and ASTM F2267. Static and Dynamic axial compression, subsidence and expulsion tests were completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Lumbar I/F Cage, Depuy Spine (P960025), Aleutian IBF System, K2M (K110843), LDR Spine Cervical Interbody Fusion System (K091088), Spinal Elements, Crystal, Interbody Fusion Device (K073351), Synthes Spine, Oracle, OPAL Spacer (K072791), Synthes Spine, T-PAL Spacer (K100089), Globus Medical, Patriot Spacers (K072970)
Reference Device(s)
Not Found
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
KII2664
DEC 2 3 2011
510K Summary
| Date: | September 12, 2011 |
|---|---|
| Submitter: | Zavation LLC |
| 501 Avalon Way | |
| Brandon, MS 39047 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact person: | John Walker |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation IBF System |
| Common name: | Intervertebral Body Fusion Device |
| Classification regulation: | 888.3080 (MAX, ODP) |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | MAX, ODP |
| Basis for submission: | New device |
Device Description:
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled · implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
1
Intended Use:
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. 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 (definded 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.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.
Materials:
The devices are manufactured from medical grade PEEK Zeniva ZA-500(ASTM F2026) with Tantalum alloy position markers (ASTM F560).
Predicate Device:
Lumbar I/F Cage, Depuy Spine (P960025) Aleutian IBF System, K2M (K110843) LDR Spine Cervical Interbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusion Device (K073351) Synthes Spine, Oracle, OPAL Spacer (K072791) Synthes Spine, T-PAL Spacer (K100089) Globus Medical, Patriot Spacers (K072970)
Technological Characteristics:
The Zavation IBF System possesses the same technological characteristics as the predicates. These include similar heights, widths, lengths, and intended use.
Performance Data:
Mechanical test results demonstrated that the Zavation IBF System is substantially equivalent to the predicate devices. Testing was performed in accordance with ASTM F2077 and ASTM F2267. Static and Dynamic axial compression, subsidence and expulsion tests were completed.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 3 2011
Zavation LLC % Mr. John Walker 501 Avalon Way Brandon, Mississippi 39047
Re: K112664
Trade/Device Name: Zavation IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: December 13, 2011 Received: December 13, 2011
Dear Mr. Walker:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. John Walker
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice tor your avrites offices/CDRH/CDRHOffices/ucm115809.htm for go to mtd.io.it www.ida.gover.item.ith's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radionanding by reference to premarket notification" (21CFR Part note the regulations 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I ou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Peter
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K112664
Device Name: Zavation IBF System
Indications For Use:
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. 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 (definded 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.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
Prescription Use _ X _________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
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ivision of Surgical, Orthopedic, and Restorative Devices
K112664 510(k) Number ___