(366 days)
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No
The document describes a physical implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "Anchored Cervical Interbody Fusion System" indicated for treating degenerative disc disease and facilitating fusion, which is a therapeutic intervention.
No
This device is a surgical implant designed to facilitate spinal fusion in patients with degenerative disc disease. It is used for treatment, not for diagnosing conditions.
No
The device description clearly states that the device includes physical components made of PEEK and titanium alloy, which are implanted into the patient. This is a hardware medical device, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- This device is an implantable medical device used in surgery to fuse vertebrae in the cervical spine. It is physically placed within the patient's body.
The description clearly states its intended use is for surgical implantation in the cervical spine to treat degenerative disc disease. This is a therapeutic and structural device, not a diagnostic one that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Genesys Spine Apache® Anchored Cervical Interbody Fusion 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 device 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 Apache® Anchored Cervical Interbody Fusion System includes a PEEK interbody that is implanted with two (2) titanium bone nails. The Apache® Anchored Cervical Interbody Fusion System 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
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Input Imaging Modality
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Anatomical Site
cervical spine at one disc level from C2-T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System was tested in static and dynamic axial compression 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 for bone nail back-out under worst-case conditions.
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System was evaluated in a cadaveric validation study.
Key results: The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine Apache® Anchored Cervical Interbody Fusion System is substantially equivalent to the LDR Spine Cervical Interbody Fusion System – ROI-C (K091088, K113559) and the Exactech Acapella One Cervical Spacer System (K132582).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LDR Spine Cervical Interbody Fusion System – ROI-C (K091088, K113559), Exactech Acapella One Cervical Spacer System (K132582)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2016
Genesys Spine Mr. Benjamin V. Keller Product Development Engineer 1250 Capital of Texas Highway South Building Three. Suite 600 Austin, Texas 78746
Re: K152099
Trade/Device Name: Genesys Spine Apache® Anchored Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion Device Regulatory Class: Class II Product Code: OVE Dated: July 19, 2016 Received: July 21, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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" (21CFR 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,
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) K152099
Device Name
Genesys Spine Apache® Anchored Cervical Interbody Fusion System
Indications for Use (Describe)
The Genesys Spine Apache® Anchored Cervical Interbody Fusion 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 device 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
| Submitter's Name: | Genesys Spine |
|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway South |
| Building Three, Suite 600 | |
| Austin, Texas 78746 | |
| Submitter's Telephone: | 512-381-7093 |
| Submitter's Fax: | 512-381-7076 |
| Submitter's E-mail: | Ben.Keller@genesysspine.com |
| Contact Name: | Ben Keller |
| Date Summary was | |
| Prepared: | 07/25/16 |
| Trade or Proprietary Name: | Genesys Spine Apache® Anchored Cervical Interbody |
| Fusion System | |
| Common or Usual Name: | Intervertebral Fusion Device With Integrated Fixation, |
| Cervical | |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Codes: | OVE |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate (unmodified) | |
| devices to Which Substantial | |
| Equivalence is Claimed: | LDR Spine Cervical Interbody Fusion System – ROI-C |
| (K091088, K113559) [Primary Predicate], Exactech | |
| Acapella One Cervical Spacer System (K132582) |
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| Question | YES | NO |
|---|---|---|
| Is the device intended for prescription use (21 CFR 801 Subpart | ||
| D)? | X | |
| Is the device intended for over-the-counter use (21 CFR 807 | ||
| Subpart C)? | X | |
| Does the device contain components derived for a tissue or other | ||
| biologic source? | X | |
| Is the device provided sterile? | X | |
| Is the device intended for single use? | X | |
| Is the device a reprocessed single use device? | X | |
| Does the device contain a drug? | X | |
| Does the device contain a biologic? | X | |
| Does the device use software? | X | |
| Does the submission include clinical information? | X | |
| Is the device implanted? | X |
Genesys Spine regards information provided in support of this premarket notification to be confidential and proprietary and afforded such protection under 21CFR 807.95 and other applicable statutes. In accordance with the Safe Medical Devices Act of 1990, a 510(k) Summary of Safety and Effectiveness is included in this notification.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System includes a PEEK interbody that is implanted with two (2) titanium bone nails. The Apache® Anchored Cervical Interbody Fusion System was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.
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INDICATIONS FOR USE:
The Genesys Spine Apache® Anchored Cervical Interbody Fusion 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 device 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:
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System implants are comprised of two components; 1) PEEK interbodies with tantalum markers and 2) titanium alloy cervical bone nails. Both the interbodies and the cervical bone nails are offered in various sizes. The bone nails are inserted through the channels in the PEEK interbody and into the adjacent cervical vertebrae. The device is inserted after a discectomy and the integrated fixation provides additional stabilization to the spine during fusion.
The 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 disc space. The bone nail components are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F-136.
NON-CLINICAL PERFORMANCE DATA:
The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine Apache® Anchored Cervical Interbody Fusion System be equivalent to (or greater than) previously cleared interbody fusion systems. Prior to performing mechanical testing, all possible configurations of the Apache® Anchored Cervical Interbody Fusion System constructs were analyzed in order to determine the worst case to be used for testing.
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System was tested in static and dynamic axial compression 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 for bone nail back-out under worst-case conditions.
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System was evaluated in a cadaveric validation study.
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CONCLUSION OF NON-CLINICAL TESTS:
The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine Apache® Anchored Cervical Interbody Fusion System is substantially equivalent to the LDR Spine Cervical Interbody Fusion System – ROI-C (K091088, K113559) and the Exactech Acapella One Cervical Spacer System (K132582).
Bez. V. Kella
Ben Keller Genesys Spine 07/25/16