(252 days)
No
The summary describes a physical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for intervertebral body fusion of the lumbar spine to treat degenerative disc disease, which is a therapeutic intervention.
No
The device description indicates it is a fusion system consisting of implants for intervertebral body fusion, which is a therapeutic treatment. It is not described as diagnosing a condition.
No
The device description explicitly states that the system consists of instruments and VESTAKEEP PEEK implants, which are physical hardware components.
Based on the provided information, 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, a procedure performed in vivo (within the living body). IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose diseases or conditions.
- Device Description: The device is described as implants made of PEEK material, designed for surgical insertion into the lumbar spine. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes
MAX
Device Description
The Lumbar Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) implants which will be offered in four (4) configurations of various sizes to accommodate individual patient anatomy. The configurations are designed pursuant to a specific surgical approach, and consist of the following: 1) Anterior Lumbar Approach (ALIF); 2) Posterior Lumbar Approach (PLIF); 3) Lateral Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Static and dynamic axial compression, static and dynamic compression shear and static and dynamic torsion following ASTM F2077-14. Subsidence was tested following ASTM F2267-04. Expulsion was tested using a widely accepted and validated methodology. The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to it predicate device(s).
Key Metrics
Not Found
Predicate Device(s)
Primary: Python, manufactured by Eminent Spine (K090064)
Reference Device(s)
Cottonmouth, manufactured by Eminent Spine (K090064); K7 Lumbar Spacers, manufactured by K7, LLC (K133126); Opal Spacer, manufactured by Synthes (K072791)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2016
Evolution Spine, LLC % John Siegel Chief Operating Officer LeoNine, LLC 819 S. 5th Street. Suite B Temple, Texas 76504
Re: K160663
Trade/Device Name: Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 18, 2016 Received: October 19, 2016
Dear Mr. Siegel:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160663
Device Name
Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
Indications for Use (Describe)
This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate 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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Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) Premarket Notification 510(k) Summary
| DATE PREPARED | November 10, 2016 |
|---|---|
| MANUFACTURER | Evolution Spine, LLC |
| 4225 Office Parkway | |
| Dallas, TX 75204 | |
| CONTACT PERSON | Ashton Kouzbari |
| President | |
| 214-682-8536 | |
| mak@strategicancillaryservices.com | |
| PREPARED BY | John Siegel |
| COO | |
| LeoNine, LLC | |
| 819 South 5th Street, Suite B | |
| Temple, TX 76504 | |
| 610-457-5324 | |
| john@leoninellc.com | |
| PANEL CODE | Orthopaedics/87 |
| CLASSIFICATION NAME | 21 CFR 888.3080 - Intervertebral Fusion Device with Bone |
| Graft, Lumbar | |
| CLASS | Class II |
| COMMON NAME | Intervertebral Body Fusion Device, Lumbar (MAX) |
| TRADE NAME | Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, |
| TPLIF) | |
| PREDICATE DEVICES | Primary: Python, manufactured by Eminent Spine |
| (K090064) | |
| Reference: Cottonmouth, manufactured by Eminent Spine | |
| (K090064); K7 Lumbar Spacers, manufactured by K7, LLC | |
| (K133126); Opal Spacer, manufactured by Synthes | |
| (K072791) |
DEVICE DESCRIPTION
The Lumbar Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) implants which will be offered in four (4) configurations of various sizes to accommodate individual patient anatomy. The configurations are designed pursuant to a specific surgical approach, and consist of the following: 1) Anterior Lumbar Approach (ALIF); 2) Posterior Lumbar Approach (PLIF); 3) Lateral
4
Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.
INDICATIONS and INTENDED USE
Intervertebral Body Fusion Device:
This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Documentation was provided to demonstrate that the Subject Lumbar Interbody Fusion is substantially equivalent to the predicate device: Python Interbody Fusion Device (K090064). The Subject device is substantially equivalent to the predicate devices in intended use, indications for use, materials, technological characteristics, and labelling.
PERFORMANCE DATA
Static and dynamic axial compression, static and dynamic compression shear and static and dynamic torsion following ASTM F2077-14. Subsidence was tested following ASTM F2267-04. Expulsion was tested using a widely accepted and validated methodology. The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to it predicate device(s).
CONCLUSION
The Lumbar Interbody Fusion System and its predicate(s) have the same intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Subject device are identical to those of the predicate device. Minor differences between the Subject and predicate devices do not raise any new questions of safety or efficacy. Bench testing demonstrated that the differences do not adversely impact device mechanical performance. Based on the intended use, indications for use, technological characteristics, materials, and comparison to the predicate devices, the Subject Lumbar Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices.