(180 days)
The Genesys Spine Apache@ Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine. from L2 to S1, in skeletally mature patients who 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 1 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.
The Genesys Spine Apache® Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine interbody fusion device, which may be implanted as a single device via:
- Bi-laterally via a posterior (PLIF) approach ■
- As a single device via a transforaminal (TLIF) approach or ■
- I As a single device via an anterior/anterolateral (ALIF) approach.
The system implant components are made of polyether ether ketone (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.
This document is a 510(k) summary for the Genesys Spine Apache® Interbody Fusion System, which is a medical device. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to other legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and study information, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Subsidence (per ASTM F2267-04) | The Genesys Spine Apache® Interbody Fusion System was tested in static subsidence per ASTM F2267-04. The results, combined with Cross-Sectional Area calculations and validated FEA analysis, showed that a new worst-case device was not created when compared to the predicate Genesys Spine Interbody Fusion System (K103034). The performance data were sufficient to allow for a substantial equivalence designation. |
| Static Expulsion (per ASTM draft standard F-04.25.02.02) | The Genesys Spine Apache® Interbody Fusion System was tested in static expulsion per ASTM draft standard F-04.25.02.02. The results, combined with Cross-Sectional Area calculations and validated FEA analysis, showed that a new worst-case device was not created when compared to the predicate Genesys Spine Interbody Fusion System (K103034). The performance data were sufficient to allow for a substantial equivalence designation. |
| (Implied) Equivalent technological characteristics to predicate devices | The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line (predicate devices). The overall technology characteristics lead to the conclusion of substantial equivalence. |
Limitations: The document does not explicitly state numerical acceptance criteria for static subsidence or expulsion. Instead, it relies on a comparative assessment against a predicate device, aiming to demonstrate that a "new worst-case device was not created" and that the performance data were "sufficient to allow for a substantial equivalence designation."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states that the system "was tested" but does not provide details on the number of individual devices or tests conducted for static subsidence and static expulsion.
- Data Provenance: The studies are laboratory-based mechanical performance tests. The country of origin for the data is not explicitly stated but can be inferred as the "Submitter's Address" (Austin, Texas, USA) or the location of the testing facility. The data is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. This submission is for a physical medical device (intervertebral fusion system) and the "ground truth" is established through engineering and mechanical testing standards (ASTM F2267-04, ASTM draft standard F-04.25.02.02, FEA analysis), not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in expert opinions. The presented studies are mechanical tests, governed by standardized protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not relevant to the type of device and studies described in this document. This typically applies to diagnostic devices where the performance of human readers (e.g., radiologists) is evaluated with and without AI assistance. This document describes a surgical implant and its mechanical properties.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. This question is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is based on established engineering and mechanical standards and comparative analysis to predicate devices. Specifically:
- ASTM F2267-04 for static subsidence.
- ASTM draft standard F-04.25.02.02 for static expulsion.
- Cross-Sectional Area calculations.
- Validated FEA (Finite Element Analysis).
- The performance of the legally marketed predicate devices.
There is no "expert consensus," "pathology," or "outcomes data" specifically used to establish the "ground truth" for these mechanical tests in the context of this 510(k) summary.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set." The studies performed are mechanical tests for a physical implant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device submission.
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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 consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
Genesys Spine Mr. Dave Lamb Vice President of Compliance 1250 South Capitol of Texas Highway, Building 3, Suite 600 Austin, Texas 78746
Re: K153123
Trade/Device Name: Genesys Spine Apache® Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 23, 2016 Received: March 29, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/Resourcesfor You/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 yours,
Lori A. Wiggins -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 STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153123
Device Name
Genesys Spine Apache® Interbody Fusion System
Indications for Use (Describe)
The Genesys Spine Apache@ Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine. from L2 to S1, in skeletally mature patients who 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 1 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.
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 SouthBuilding Three, Suite 600Austin, Texas 78746 |
| Submitter's Telephone: | 512-381-7094 |
| Submitter's Fax: | 800-817-4938 |
| Contact Name: | Dave Lamb |
| Date Summary wasPrepared: | April 22, 2016 |
| Trade or Proprietary Name: | Genesys Spine Apache® Interbody Fusion System |
| Common or Usual Name: | Intervertebral Fusion Device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Codes: | MAX |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Legally Marketed(unmodified) device: | Primary Predicate: Genesys Spine Interbody FusionSystem (K103034)Additional Predicates: K2M Aleutian IBF System(K082698); Alphatec Epicage Interbody Fusion System(K130548); Custom Spine, Inc Pathway ELIF (K143143);Medtronic Sofamor Danek Perimeter Interbody FusionDevice (K090353 & K111525); Spine Works AnteriorLumbar Device (K133340); Medtronic Sofamor DanekCAPSTONE Spinal System (K073291) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine Apache® Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine interbody fusion device, which may be implanted as a single device via:
- Bi-laterally via a posterior (PLIF) approach ■
- As a single device via a transforaminal (TLIF) approach or ■
- I As a single device via an anterior/anterolateral (ALIF) approach.
The system implant components are made of polyether ether ketone (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.
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INDICATIONS FOR USE
The Genesys Spine Apache® Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative 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 1 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.
TECHNICAL CHARACTERISTICS
The Genesys Spine Apache® 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 Apache® 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
The Genesys Spine Apache® Interbody Fusion System was tested in static subsidence per ASTM F2267-04 and static expulsion per ASTM draft standard F-04.25.02.02. Confirmatory testing, Cross-Sectional Area calculations, and validated FEA analysis showed that a new worst-case device was not created when compared the predicate Genesys Spine Interbody Fusion System (K103034). The performance data were sufficient to allow for a substantial equivalence designation for the subject device.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache Interbody Fusion System is substantially equivalent to the Genesys Spine Interbody Fusion System (K103034), K2M Aleutian IBF System (K082698), Alphatec Epicage Interbody Fusion System (K130548). Custom Spine, Inc Pathway ELIF (K143143), Medtronic Sofamor Danek Perimeter Interbody Fusion Device (K090353 & K111525), Spine Works Anterior Lumbar Device (K133340), and the Medtronic Sofamor Danek CAPSTONE Spinal System (K073291). As a result of the testing and analysis performed a result of substantially equivalence was determined.
§ 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.