(79 days)
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as addressing degenerative disc disease to facilitate fusion and provide biomechanical strength, which directly aims to treat a medical condition.
No.
The device is an interbody fusion system designed to facilitate fusion in patients with degenerative disc disease, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it includes PEEK and titanium interbodies and titanium alloy bone anchors, which are physical hardware components.
No, 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 provided information describes a surgical implant (interbody system) used to facilitate fusion in the cervical spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for surgical treatment of degenerative disc disease, not for diagnosing a condition using a sample.
The information clearly indicates this is a medical device used in a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
Product codes
OVE
Device Description
The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, specific disc level from C2-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)
The Genesys Spine AIS-C Cervical Anchored Interbody System was tested in static and dynamic axial compression, compressive-shear, and torsion per ASTM F2077-11, static subsidence per ASTM F2267-04, and expulsion testing per ASTM draft standard F-04.25.02.02. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions.
The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine AIS-C Cervical Anchored Interbody System be equivalent to (or greater than) previously cleared interbody fusion systems. Prior to performing mechanical testing, all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing.
The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine AIS-C Cervical Anchored Interbody System is substantially equivalent to the Genesys Spine Apache Anchored Cervical Interbody Fusion System (K152099), the LDR Spine Cervical Interbody Fusion System - ROI-C (K091088, K113559), and the Exactech Acapella One Cervical Spacer System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical Cage (K141314), Genesys Spine Apache® IBFD System, (K103034).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K152099, K091088, K113559, K132582, K141314, K103034
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 28, 2018
Genesys Spine Benjamin Keller Product Development Engineer 1250 Capital of Texas Highway South Building 3 Suite 600 Austin, Texas 78746
Re: K180056
Trade/Device Name: Genesys Spine AIS-C Cervical Anchored Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: January 4, 2018 Received: January 8, 2018
Dear Mr. Keller:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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1000-1050.
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S
for
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)
K180056
Device Name
Genesys Spine AIS-C Cervical Anchored Interbody System
Indications for Use (Describe)
The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
| 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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4. 510(K) SUMMARY
| Submitter's Name: | Genesys Spine |
|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway South |
| Building Three, Suite 600 | |
| Austin, Texas 78746 | |
| Contact Name: | Benjamin V. Keller (Primary) William W. Sowers (Secondary) |
| Submitter's Telephone: | 512-381-7093 512-381-7080 |
| Submitter's Fax: | 800-817-4938 800-817-4938 |
| Date Summary was Prepared: | March 15, 2018 |
| Trade or Proprietary Name: | Genesys Spine AIS-C Cervical Anchored Interbody System |
| Common or Usual Name: | Intervertebral Body Fusion Device, Cervical |
| Classification Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Regulation Number: | 21 CFR 888.3080 |
| Product Codes: | OVE |
| Classification Panel: | Orthopedic Devices Panel |
| Legally Marketed (unmodified) devices to Which Substantial Equivalence is Claimed: | Primary Predicate: Genesys Spine Apache® Anchored Cervical |
| Interbody Fusion System (K152099) |
Additional Predicates: LDR Spine Cervical Interbody Fusion System –
ROI-C (K091088, K113559), Exactech Acapella One Cervical Spacer
System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical
Cage (K141314), Genesys Spine Apache® IBFD System, (K103034) |
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DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine AIS-C Cervical Anchored Interbody System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium allov bone anchors. The Cervical Anchored Interbody System (AIS-C) was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.
INDICATIONS FOR USE
The Genesys Spine AIS-C Cervical Anchored Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Genesys Spine AIS-C Cervical Anchored Interbody System is comprised of two versions of interbodies, each of which are secured by integrated fixation Anchors. The interbodies are available in a PEEK configuration with tantalum markers or in a titanium alloy version. Both versions use the same integrated titanium alloy locking mechanism. The interbodies are to be available in several footprints, configurations, and heights. The titanium alloy cervical bone Anchors provide integrated fixation for the system and are to be offered in various lengths. The bone Anchors are deployed through the channels in the interbody and embed into the adjacent cervical vertebrae. The system is to be inserted after cervical discectomy and the integrated fixation provides additional stabilization to the spine during fusion.
The PEEK interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disk space. The titanium alloy interbody devices, anchor locking mechanism, and the bone anchor components are manufactured from medical grade Ti6Al-4V ELI titanium alloy per ASTM F136.
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The subject and predicate devices are based on the following same technological elements:
- Integrated fixation Anchors provide additional biomechanical support to the interbody
- . Devices are offered in the same sizes and shapes (parallel, lordotic, and convex) which provide surgeons options to suit the patient's anatomy
- . Implants materials are identical: PEEK, Titanium 6Al-4V ELI allov, and Tantalum
- Use of a single inserter instrument to position the interbodies and deploy the Anchors ●
The following technological differences exist between the subject and predicate devices:
- Integrated titanium locking mechanism that provides visual feedback of Anchor securement
PERFORMANCE DATA
The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine AIS-C Cervical Anchored Interbody System be equivalent to (or greater than) previously cleared interbody fusion systems. Prior to performing mechanical testing, all possible configurations of the AIS-C System constructs were analyzed in order to determine the worst case to be used for testing.
The Genesys Spine AIS-C Cervical Anchored Interbody System was tested in static and dynamic axial compression, compressive-shear, and torsion per ASTM F2077-11, static subsidence per ASTM F2267-04, and expulsion testing per ASTM draft standard F-04.25.02.02. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions.
CONCLUSION OF NON-CLINICAL TESTS:
The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine AIS-C Cervical Anchored Interbody System is substantially equivalent to the Genesys Spine Apache Anchored Cervical Interbody Fusion System (K152099), the LDR Spine Cervical Interbody Fusion System - ROI-C (K091088, K113559), and the Exactech Acapella One Cervical Spacer System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical Cage (K141314), Genesys Spine Apache® IBFD System, (K103034) .