(129 days)
Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Keos Lumbar IBFD can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.
The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
Here's an analysis of the provided text regarding the Keos Lumbar IBFD and its acceptance criteria, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static Compression Test (per ASTM F2077) | Met the acceptance criteria. |
| Dynamic Compression Test (per ASTM F2077) | Met the acceptance criteria. |
| Material Characterization (Effects of Cleaning): | |
| X-ray Diffraction (XRD) evaluation | Used to evaluate the effects of cleaning on the implants. The results showed the Keos Lumbar IBFD met the acceptance criteria. (Implies no detrimental alterations from cleaning based on XRD). |
| Fourier Transform Infrared Spectroscopy (FTIR) | Used to evaluate the effects of cleaning on the implants. The results showed the Keos Lumbar IBFD met the acceptance criteria. (Implies no detrimental alterations from cleaning based on FTIR). |
| X-ray Photoelectron Spectroscopy (XPS) | Used to evaluate the effects of cleaning on the implants. The results showed the Keos Lumbar IBFD met the acceptance criteria. (Implies no detrimental alterations from cleaning based on XPS). |
| Sterilization: | |
| Sterility Assurance Level (SAL) of 10⁻⁶ (implants) | Validation testing of the autoclave process (half-cycle method) conducted per ISO 17665 achieved a SAL of 10⁻⁶ for implants. (Implies the device can be effectively sterilized to this level). |
| Sterility Assurance Level (SAL) of 10⁻⁶ (instruments/case) | Validation testing of the autoclave process (half-cycle method) conducted per ISO 17665 achieved a SAL of 10⁻⁶ for instruments and case. (Implies the associated instruments and case can be effectively sterilized to this level). |
2. Sample Size for the Test Set and Data Provenance
The document does not provide specific sample sizes for the mechanical tests (Static and Dynamic Compression Tests) or the material characterization tests (XRD, FTIR, XPS). It only states that these tests were performed and the device met the acceptance criteria.
The data provenance is not specified (e.g., country of origin). Since these are material and mechanical bench tests, the concept of "retrospective or prospective" data provenance, as it typically applies to clinical studies, is not directly relevant here. These are laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for these tests (mechanical and material characterization) is the established standard (e.g., ASTM F2077 for compression, ISO 17665 for sterilization) and the objective measurements derived from the tests themselves, rather than expert consensus on a clinical outcome.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation where there's subjectivity and disagreement among human reviewers to establish a consensus ground truth. The tests mentioned are objective laboratory tests.
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
An MRMC study was not conducted. This device is an Intervertebral Body Fusion Device (implantable medical device), not an AI-powered diagnostic or assistive tool for human readers. No mention of AI or human reader improvement is present.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm. Therefore, no standalone algorithm performance study was performed.
7. The Type of Ground Truth Used
The ground truth used for the nonclinical tests was primarily:
- Standardized Test Methods: Adherence to established industry standards like ASTM F2077 for mechanical testing and ISO 17665 for sterilization validation.
- Objective Measurement Data: The results of the laboratory tests (e.g., force, displacement, spectral data) compared against defined pass/fail criteria within those standards.
- Material Specifications: Compliance with material standards (e.g., ASTM F2026 for PEEK-OPTIMA and ASTM F560 for tantalum x-ray markers).
8. The Sample Size for the Training Set
No training set is mentioned or applicable. This device is a physical implant for which safety and effectiveness are shown through nonclinical (bench) testing and substantial equivalence to a predicate device, not through machine learning model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there was no training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a stacked, flowing manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2017
Keos Mark Schenk Director of QA/RA 1824 Colonial Village Lane Lancaster, Pennsylvania 17601
Re: K163386
Trade/Device Name: Keos Lumbar IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 15, 2017 Received: March 17, 2017
Dear Mr. Schenk:
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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,
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) K163386
Device Name Keos Lumbar IBFD
Indications for Use (Describe)
Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Keos Lumbar IBFD can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.
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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Traditional 510(k) Summary
as required by section 807.92(c).
| Submitter: | Keos1824 Colonial Village LaneLancaster, PA 17601 |
|---|---|
| Contact Person | Mark F Schenk |
| Director of QA/RA | |
| Phone: 610-507-8255 | |
| Email: mfschenk@lokconsulting.net | |
| Date Updated | 4/7/17 |
| Trade Name | Keos Lumbar IBFD |
|---|---|
| Common Name | Intervertebral body fusion device |
| Device Class | Class II |
| Classification Nameand Number | Intervertebral Fusion Device With Bone Graft, Lumbarintervertebral fusion device with bone graft, cervical21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | MAX |
| Reason for 510k | Update Cleaning Instructions |
| Predicate Devices | K160631, Keos Lumbar IBFD |
| Device Description | |
|---|---|
| Device Description | The series of intervertebral body fusion devices are used to maintaindisc space distraction in skeletally mature adults requiringintervertebral body fusion. They are designed to be used inconjunction with supplemental spinal fixation instrumentation. Theseries is comprised of cages of various fixed heights and shapes forplacement in the spine. There are different cages designed forspecific regions of the spine and approaches to the spine. Each cagehas a hollow center to allow placement of graft material inside of thecage. Ridges on the superior and inferior surfaces of the device helpto grip the endplates and prevent expulsion. |
| The series of intervertebral body fusion devices are made from thePEEK radiolucent material and HA enhanced PEEK with embeddedtantalum x-ray markers as specified in ASTM F2026 and ASTM F560,respectively. |
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| Indications for Use | Keos Lumbar IBFD is indicated for spinal fusion procedure at oneor two contiguous levels (L2-S1) in skeletally mature patientswith degenerative disc disease (DDD). DDD is defined asdiscogenic pain with degeneration of the disc confirmed bypatient history and radiographic studies. DDD may also have up |
|---|---|
| The Keos Lumbar IBFD is intended to be used with supplementalspinal fixation systems that have been cleared for lumbosacralspine (i.e. posterior pedicle screws and rod systems, anteriorplate systems, and anterior screw and rod systems). Thedevice(s) is intended to be used with autogenous bone graft. | |
| Patients should have at least six (6) months of non-operativetreatment prior to treatment with an intervertebral cage. | |
| The Keos Lumbar IBFD can be used in one of two methods: | |
| Transforaminal Lumbar Interbody Fusion (TLIF)Used as a TLIF, a single device is implanted in the appropriatelocation (L2-S1) to provide support for a transforaminalapproached surgery. | |
| Posterior Lumbar Interbody Fusion (PLIF)Used as a PLIF, two devices are implanted in the appropriatelocations (L2-S1) to provided support to the spine for a posteriorsurgery. |
| Materials: | The implant is manufactured from ASTM F2026 implant grade PEEK-OPTIMA and PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced). | |
|---|---|---|
| -- | ------------ | ------------------------------------------------------------------------------------------------------------------------------ |
| Statement ofTechnologicalComparison | Keos Lumbar IBFD and its predicate devices have the same indications for use, same design, and test results. The purpose of this submission is to document the cleaning validation for the previously cleared devices. |
|---|---|
| --------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| Nonclinical TestSummary | The following tests were performed to demonstrate that the Keos Lumbar IBFD issubstantially equivalent to other predicate devices.Static and Dynamic Compression Test per ASTM F2077 X-ray Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), and X-ray photoelectron Spectroscopy (XPS) were used to evaluate the effects ofcleaning on the implants. The results of these studies showed that the Keos Lumbar IBFD met the acceptancecriteria. |
|---|---|
| Clinical TestSummary | No clinical tests were performed. |
| Sterilization Information | |
|---|---|
| Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing of the process was conducted (using the half-cycle method) to a Sterility Assurance Level (SAL) of 10-6 per ISO 17665. |
| Instruments and Case | The instrument and case will be shipped non-sterile and will be autoclaveable, validation testing of the process was conducted (using the half-cycle method) to a Sterility Assurance Level (SAL) of 10-6 per ISO 17665. |
| The Keos Lumbar IBFD is substantially equivalent to its predicate devices. This | |
|---|---|
| Conclusion | conclusion is based upon the fact the Keos Cage and its predicate devices have the |
| same indications for use, have a same design and technical characteristics, similar test | |
| results, and any differences do not raise question of safety and effectiveness. |
§ 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.