(255 days)
Not Found
No
The document describes a physical implant and surgical system, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is an interbody fusion system designed to facilitate spinal fusion in patients with degenerative disc disease, not to treat or cure a disease itself, but rather to provide mechanical support for fusion.
No
The device is an interbody fusion system designed to treat degenerative disc disease and is implanted to facilitate fusion. It does not perform diagnostic functions.
No
The device description explicitly states the system consists of implant components made of PEEK and tantalum markers, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (an interbody fusion system) designed to be placed within the lumbar spine to facilitate fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
The information provided focuses on the device's material, dimensions, intended anatomical site, and surgical application, all of which are characteristic of a medical device used in vivo (within the living body), not an IVD.
N/A
Intended Use / Indications for Use
The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine lumbar interbody fusion device, which may be implanted as a single device via a lateral approach.
The Genesys Spine Apache™ Lateral Lumbar 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 LT)) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to SI
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)
Not Required. FEA analysis and projected area calculations show that a new worst-case device was not created. This analysis tool was validated (calibrated) 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 Lateral Lumbar Interbody Fusion System implants fall within the scope of devices already cleared per K103034.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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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K130913 page 1 of 2
DEC 1 3 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: | 1-Apr-13 |
| Trade or Proprietary Name: | Genesys Spine Apache™ Lateral Lumbar Interbody |
| Fusion System | |
| Common or Usual Name: | Intervertebral Fusion Device, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Codes: | MAX |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Legally Marketed | |
| (unmodified) device: | Genesys Spine Apache™ Interbody Fusion System, |
| Lumbar (K103034) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine lumbar interbody fusion device, which may be implanted as a single device via a lateral approach.
INDICATIONS FOR USE
The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin 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.
1
TECHNICAL CHARACTERISTICS
The Genesys Spine Apache™ Lateral Lumbar 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 LT)) 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
Not Required. FEA analysis and projected area calculations show that a new worst-case device was not created. This analysis tool was validated (calibrated) 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 Lateral Lumbar Interbody Fusion System implants fall within the scope of devices already cleared per K103034.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System is substantially equivalent to the Genesys Spine Apache™ Lumbar Interbody System
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K130913
Trade/Device Name: Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 14, 2013 Received: November 15, 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 (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 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/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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.
You may obtain other general information on vour 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.
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedie 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™ Lateral Lumbar Interbody Fusion System
The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin 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.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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