(161 days)
Not Found
No
The summary describes a physical intervertebral body 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 focus on mechanical testing and FEA analysis, not algorithmic performance.
Yes.
The device is an intervertebral body fusion device used to facilitate fusion in patients with degenerative disc disease of the cervical spine, which is a treatment for a medical condition.
No.
This device is an implantable intervertebral body fusion device, designed to facilitate fusion in patients with degenerative disc disease. Its purpose is therapeutic (fusion), not diagnostic.
No
The device description explicitly states the device components are made of polyether ether ketone (PEEK) and contain tantalum markers, indicating it is a physical implant, not software.
Based on the provided text, 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. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is described as an implant made of PEEK and tantalum markers, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a therapeutic implant placed within the body.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Genesys Spine Apache™ Interbody Fusion 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-TI 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 (i.e. cleared cervical plating system) and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Product codes
ODP
Device Description
The Genesys Spine Apache™ Cervical Interbody Fusion 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.
The Genesys Spine Apache™ Cervical Interbody Fusion 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 LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-C3 disc to the C7-TI disc.
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
Expulsion testing was conducted. Cross-Sectional Area calculations, FEA analysis, and projected area calculations show that a new worst-case device was not created. This Finite Element analysis tool was validated by the predicate system's mechanical test data and is sufficient to allow for a substantial equivalence designation for the subject device. In addition, the length, width, and height of the Cervical Interbody Fusion System implants fall within the scope of predicate devices already cleared.
Key Metrics
Not Found
Predicate Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle image. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
Genesys Spine Mr. Dave Lamb Vice President of Compliance 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746
Re: K150812
Trade/Device Name: Genesys Spine Apache™ Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 28, 2015 Received: July 30, 2015
Dear Mr. Lamb:
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
1
Page 2 - Mr. Dave Lamb
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" (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) K150812
Device Name
Genesys Spine Apache™ Cervical Interbody Fusion System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Genesys Spine Apache™ Interbody Fusion 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-TI 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 (i.e. cleared cervical plating system) and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Type of Use (Select one or both, as applicable) | |
---|---|
X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart 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: | 512-381-7070 |
Submitter's Fax: | 800-817-4938 |
Contact Name: | Dave Lamb |
Date Summary was | |
Prepared: | August 31, 2015 |
Trade or Proprietary Name: | Genesys Spine Apache™ Cervical Interbody Fusion |
System | |
Common or Usual Name: | Intervertebral Fusion Device, Cervical |
Classification: | Class II per 21 CFR §888.3080 |
Product Codes: | ODP |
Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
Primary Predicate | Genesys Spine Apache™ Interbody Fusion System |
(K103034) | |
Additional predicate | Eminent Spine Copperhead (K090064) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine Apache™ Cervical Interbody Fusion 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
When used as a cervical intervertebral body fusion device, the Genesys Spine Apache™ Interbody Fusion 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-TI 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 (i.e cleared cervical plating system) 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™ Cervical Interbody Fusion 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 LT1) 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.
PERFORMANCE DATA
Expulsion testing was conducted. Cross-Sectional Area calculations, FEA analysis, and projected area calculations show that a new worst-case device was not created. This Finite Element analysis tool was validated by the predicate system's mechanical test data and is sufficient to allow for a substantial equivalence designation for the subject device. In addition, the length, width, and height of the Cervical Interbody Fusion System implants fall within the scope of predicate devices already cleared.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache™ Cervical Interbody Fusion System is substantially equivalent to the legally marketed predicate devices.