(306 days)
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No
The summary describes a physical interbody fusion device made of PEEK and tantalum markers. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is used for intervertebral body fusion to treat degenerative disc disease and accompanying radicular symptoms, which directly addresses a medical condition in patients.
No
The device is an intervertebral body fusion device (an implant) used in surgical procedures, not for diagnosing conditions. Its purpose is to facilitate fusion, not to determine the presence or nature of a disease.
No
The device description explicitly states that the device components are made of polyether ether ketone (PEEK) and contain tantalum markers, indicating it is a physical implant and not software-only.
Based on the provided information, the Genesys Spine Apache™ IBFD Star Cervical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Genesys Spine Apache™ IBFD Star Cervical System is an implantable medical device. Its purpose is to be surgically placed in the cervical spine to facilitate fusion.
- The intended use and device description clearly state it is for intervertebral body fusion in the cervical spine.
- While radiographic studies are used in the diagnosis of the condition it treats (DDD), the device itself does not perform any diagnostic testing on biological specimens.
Therefore, the device falls under the category of an implantable surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Genesys Spine Apache™ IBFD Star Cervical System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. 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 and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Genesys Spine Apache™ IBFD Star Cervical System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine cervical interbody fusion device, which may be implanted as a single device via an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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
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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™ IBFD Star Cervical 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.
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.
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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DEC 1 1 2013
5.510(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: | 512-381-7080 |
| Submitter's Fax: | 800-817-4938 |
| Contact Name: | William W. Sowers |
| Date Summary was | |
| Prepared: | 4-Feb-13 |
| Trade or Proprietary Name: | Genesys Spine Apache™ IBFD Star Cervical System |
| Common or Usual Name: | Intervertebral Body Fusion Device, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Codes: | ODP |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Legally Marketed | |
| (unmodified) device: | Genesys Spine Apache™ Cervical Interbody System |
| (K103034) | |
| BAK/Cervical Interbody Fusion System (P980048) | |
| Eminent Spine Copperhead IBFD (K090064) |
Description of the Device Subject to Premarket Notification:
The Genesys Spine Apache™ IBFD Star Cervical System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine cervical interbody fusion device, which may be implanted as a single device via an anterior approach.
INDICATIONS FOR USE
The Genesys Spine Apache™ IBFD Star Cervical System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. 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 and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
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TECHNICAL CHARACTERISTICS
The Genesys Spine Apache™ IBFD Star Cervical System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.
The Genesys Spine Interbody Fusion System implant components are made of polyether ether ketone (Invibio PEEK Optima LTI) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line.
Results of non-clinical testing relative to static and dynamic testing per ASTM F2077-03, subsidence testing per ASTM F2267-04, and expulsion testing per ASTM draft standard F-04.25.02.02 were used to determine substantial equivilence.
PERFORMANCE DATA
The Genesys Spine Apache™ IBFD Star Cervical 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.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache™ IBFD Star Cervical System is substantially equivalent to the Genesys Spine Apache™ Cervical Interbody System, the Centerpulse BAK/Cervical Interbody Fusion System, and the Eminent Spine Copperhead IBFD
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its wings forming a distinctive, flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2013
Genesys Spine Mr. William W. Sowers Vice President of Quality and Regulatory 1250 Capital of Texas Highway South, Building Three, Suite 600 Austin, Texas 78746
Re: K130317
Trade/Device Name: Genesys Spine Apache™ IBFD Star Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 25, 2013 Received: November 1. 2013
Dear Mr. Sowers:
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. William W. Sowers
forth in 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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/ReportalProblem/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 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.
Ronaldingean -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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4. INDICATIONS FOR USE STATEMENT
Device Name: Genesys Spine Apache™ IBFD Star Cervical System
The Genesys Spine Apache™ Interbody Fusion Device Star Cervical System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. 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 and with autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
Genesys Spine Apache™ IBFD Star Cervical System