(30 days)
The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
The FuseLOX Lumbar Interbody Fusion System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The device is made from PEEK-Optima with tantalum or titanium markers. The devices are provided in lordotic and convex configurations with heights ranging from 7-14mm in 1mm increments. Each device has a hollow core to receive bone graft. Placement is achieved with a series of device specific instruments provided.
Here's an analysis of the provided 510(k) summary for the Captiva Spine FuseLOX Lumbar Interbody Fusion System, focusing on acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
This 510(k) pertains to a medical device (intervertebral body fusion device), not an AI/software as a medical device (SaMD). Therefore, the "acceptance criteria" and "reported device performance" are based on mechanical testing and substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Method & Result) |
|---|---|
| Mechanical Performance | Subject device was shown to meet the requirements of relevant ASTM standards. - Static Compression: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device. - Dynamic Compression: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device. - Static Compression Shear: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device. - Static Torsion: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device. - Subsidence: Performed according to ASTM F2267. Results were acceptable and comparable to the predicate device. |
| Material Biocompatibility | Not explicitly detailed in this summary, but would refer to the PEEK-Optima material, which is a common and well-established biocompatible material for implantable devices. Assumed to be met by substantial equivalence to predicate devices using similar materials. |
| Design and Features | The changes in design and features (non-pivoting inserter, lordotic/convex configurations) were found not to introduce any new risks. - The design changes were assessed for their impact on mechanical function and safety and found to be substantially equivalent to the predicate. |
| Indications for Use | Identical to predicate device. - The device is indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine (L2-S1) for patients with DDD with up to Grade 1 spondylolisthesis, who are skeletally mature and have had six months of non-operative treatment. Designed for use with autograft and supplemental fixation systems. |
| Clinical Application | Similar to predicate device. Functionally comparable to the predicate device in its intended clinical use. |
Study Proving Acceptance Criteria Met:
The primary study that proves this device meets its acceptance criteria is a mechanical performance testing study conducted according to recognized ASTM standards (ASTM F2077 and ASTM F2267).
This is a Special 510(k) submission, which means the changes introduced (new marketing name, new configurations, new inserter/trial instrument designs, new tray design) are minor and do not significantly alter the fundamental scientific technology of the device or its intended use. Therefore, extensive new clinical trials or highly complex comparative studies are generally not required. The key is to demonstrate that the modified device remains as safe and effective as the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of patient numbers. For mechanical testing, the "test set" would refer to the number of device samples (implants) subjected to each specific mechanical test (e.g., N samples for static compression, N samples for dynamic compression). These numbers are typically defined by the ASTM standards themselves, but are not provided in this summary.
- Data Provenance: The data is generated from laboratory mechanical testing of the device components, not from human patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. For mechanical testing of an intervertebral body fusion device, "ground truth" is established by adherence to standardized testing protocols (e.g., ASTM F2077) and objective measurement of physical properties (e.g., load to failure, displacement). There are no human "experts" establishing a subjective ground truth in this context like there would be for an image classification SaMD.
- Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians performing and supervising the mechanical tests, ensuring adherence to the standards and accurate data collection.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image interpretation studies where there is subjective interpretation or discrepancies in expert opinions. In mechanical testing, results are objective measurements against defined criteria.
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
- MRMC Study: No. This is a physical medical device, not an AI/SaMD.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this device's performance is established by objective mechanical properties (e.g., strength, stiffness, resistance to subsidence) as defined by internationally recognized ASTM standards (ASTM F2077 and ASTM F2267). The "ground truth" for safety and effectiveness is ultimately demonstrated by substantial equivalence to an already cleared predicate device, meaning it performs similarly and presents no new safety risks.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary Specific to this Device:
This 510(k) submission is for a modification to an existing, already-cleared interbody fusion system. The regulatory pathway of a Special 510(k) relies heavily on demonstrating that the changes do not introduce new questions of safety or effectiveness. The core of the "study" proving acceptance criteria here is robust mechanical testing against established ASTM standards and a direct comparison of the modified device's performance to its cleared predicate device(s). The FDA's determination of substantial equivalence (K122956) indicates that these demonstrations were sufficient.
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Captiva Spine FuseLOX Lumbar Interbody Fusion System 510(k)
510(k) Summary according to 807.92(c) FuseLOX Interbody Fusion System
| Date: | August 20, 2012 |
|---|---|
| Submitter Contact: | Dale MitchellCaptiva Spine967 Alternate A1A #1Jupiter, FL 33477877-772-5571866-318-3224 |
| Regulatory Contact: | Rich Jansen, Pharm. D.Silver Pine Consulting, LLC612-281-5505richj@s-pineconsulting.com |
| Trade Name: | FuseLOX Lumbar Interbody Fusion System |
| Product Class: | Class II |
| Classification: | 888.3080 Intervertebral Body Fusion Device |
| Product Codes: | MAX |
| Panel Code: | 87 |
| Predicate Device(s): | Pivotec Lumbar Interbody Fusion System (K092017), AleutianIBF System (K113138), and Lumbar I/F Cage (P960025) |
OCT 2 5 2012Reason for this Submission: This Special 510(k) involves several changes to the previously cleared Pivotec System that allow for:
- The marketing name for this device will be FuseLOX Lumbar. It is a line extension for 1. the Pivotec Lumbar Interbody Fusion Device (K092017). The Pivotec device is inserted using a pivoting insertion tool for implant delivery, while the FuseLOX Lumbar devices will offer a non-pivoting, threaded insertion tool. The reason for the market name change is to distinguish the two insertion options.
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- Offering two new device configurations, the FuseLOX Lumbar Lordotic and the FuseLOX Lumbar Convex.
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- Added new, non-pivoting inserter design to mate with the FuseLOX Lumbar design.
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- New trial instrument design consistent with the FuseLOX Lumbar design.
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- New tray design to accommodate either Pivotec or FuseLOX Lumbar system's inserter and implant/trial caddy, along with all shared instrumentation.
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Indications for Use/Intended Use: The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The FuseLOX Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Device Description: The FuseLOX Lumbar Interbody Fusion System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The device is made from PEEK-Optima with tantalum or titanium markers. The devices are provided in lordotic and convex configurations with heights ranging from 7-14mm in 1mm increments. Each device has a hollow core to receive bone graft. Placement is achieved with a series of device specific instruments provided.
Performance Testing: Mechanical testing of the subject device consisted of static and dynamic compression, static compression shear, static torsion and subsidence according to ASTM F2077 and ASTM F2267.
Conclusion: The documentation provided demonstrates that the FuseLOX Lumbar Interbody Fusion Device is substantially equivalent to the predicate device listed above. This conclusion is based on the devices' similarities in materials, design, indications for use, clinical application and mechanical function. Captiva Spine concludes that the changes to the system do not introduce any new risks and therefore, the system is Substantially Equivalent to the predicate device, Pivotec Lumbar Interbody Fusion Device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Captiva Spine % Silver Pine Consulting, LLC Rich Jansen, Pharm. D. 13540 Guild Avenue Apple Valley, Minnesota 55124
OCT 25 2012
Re: K122956
Trade/Device Name: FuseLOX Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 24, 2012 Received: September 25, 2012
Dear Dr. Jansen:
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 -Rich Jansen, Pharm. D.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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,
Euil Keith
A Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Captiva Spine FuseLOX Lumbar Interbody Fusion System 510(k)
Statement of Indications for Use
510(k) Number (if known): k122295e
The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for interverterral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Prescription Use で (Part 21 CFR 801 Subpart D)
AND/OR
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)
Cal-bp
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K122956 510(k) Number_
§ 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.