(255 days)
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.
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 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 provided text is a 510(k) summary for the Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System. It states that "PERFORMANCE DATA - Not Required." and describes the rationale for this. Therefore, it does not include information about acceptance criteria or a study demonstrating the device meets such criteria in the way a clinical or performance study would typically generate.
Here's a breakdown of why the requested information cannot be extracted from the provided text, and what is stated about performance:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The submission explicitly states "Performance Data - Not Required." and therefore does not list pre-defined acceptance criteria or report device performance against them.
2. Sample size used for the test set and the data provenance:
- Not Applicable. No test set or associated data provenance (e.g., country of origin, retrospective/prospective) is mentioned because performance data was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth establishment occurred as performance data was not required.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication process is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a physical interbody fusion system, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No ground truth was established, as no performance study was conducted.
8. The sample size for the training set:
- Not Applicable. This is a physical medical implant; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set or ground truth in this context.
What the document does say about meeting regulatory requirements/equivalence:
Instead of performance studies, the rationale for substantial equivalence is based on technical characteristics and mechanical analysis:
- Technical Characteristics: The device is made of polyether ether ketone (PEEK Optima LT, ASTM F2026) with tantalum markers (ASTM F560), which are standard materials. Its technological characteristics are similar to the currently cleared predicate device (K103034).
- Performance Data (Mechanical): While clinical performance data was "Not Required," the submission states:
- "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 drawn by the submitter:
"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."
FDA's finding:
The FDA letter confirms that based on the provided information, the device is "substantially equivalent" to legally marketed predicate devices. This means that, for the purpose of this 510(k) submission, the device was deemed to meet the required safety and effectiveness standards (by being similar enough to एक already approved device) without needing new, extensive performance data or clinical trials.
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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 SouthBuilding Three, Suite 600Austin, Texas 78746 |
| Submitter's Telephone: | 512-381-7080 |
| Submitter's Fax: | 800-817-4938 |
| Contact Name: | William W. Sowers |
| Date Summary wasPrepared: | 1-Apr-13 |
| Trade or Proprietary Name: | Genesys Spine Apache™ Lateral Lumbar InterbodyFusion 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.
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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
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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
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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
§ 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.