(223 days)
The EL CAPITAN Anterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors, the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the Lumbar spine.
The EL CAPITAN Anterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The Spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis)
This document is a 510(k) summary for the EL CAPITAN Anterior Lumbar Interbody System, a medical device for spinal fusion. This device is not an AI/ML-enabled device, and therefore, the requested information about acceptance criteria and studies demonstrating AI performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) is not applicable.
The document explicitly states: "No clinical studies were performed." This indicates that the device's substantial equivalence to predicate devices was based on non-clinical tests (mechanical and material properties), rather than clinical performance data. Therefore, there are no acceptance criteria related to AI/ML performance metrics, nor any studies proving such performance.
The non-clinical tests conducted establish the device's mechanical safety and performance, demonstrating equivalence to predicate devices. The acceptance criteria for these non-clinical tests would be the established ASTM standards mentioned (e.g., ASTM F2077, ASTM F1717, ASTM F2267).
To summarize why the specific points of your request cannot be answered from this document:
- Acceptance Criteria & Reported Device Performance (Table): Not applicable for AI/ML performance. The device's performance is shown through compliance with mechanical testing standards.
- Sample sizes & Data Provenance (Test/Training Sets): Not applicable as there is no AI/ML component. Mechanical tests have their own sample size requirements per ASTM standards.
- Number of experts & Qualifications: Not applicable as there is no AI/ML component and no clinical studies were performed requiring expert reading.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable.
- Standalone Performance: Not applicable.
- Type of ground truth: Not applicable for AI/ML. The "ground truth" for this device's safety and efficacy is derived from its mechanical properties, material biocompatibility, and demonstrated equivalence to previously cleared predicate devices through non-clinical testing.
- Sample size for training set & How ground truth established: Not applicable.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:
- Intended Use
- Design
- Materials Used (PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy, Nitinol)
- Mechanical Safety and Performance (Non-clinical tests: Static/Dynamic Compression, Static/Dynamic Compression Shear, Subsidence, Expulsion per ASTM standards).
Therefore, this document does not contain the information required to answer your prompt, as it pertains to a traditional medical device, not an AI/ML-enabled one.
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April 21, 2020
Astura Medical, LLC Mr. Parker Kelch Quality Manager 3186 Lionshead Ave, Suite 100 Carlsbad, California 92010
Re: K192492
Trade/Device Name: EL CAPITAN Anterior Lumber Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: April 10, 2020 Received: April 13, 2020
Dear Mr. Kelch:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192492
Device Name
EL CAPITAN Anterior Lumbar Interbody System
Indications for Use (Describe)
The EL CAPITAN Anterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). EL CAPITAN System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When anchors, the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the Lumbar spine.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | April 10, 2020 |
|---|---|
| Submitted By | Astura Medical3186 Lionshead Ave, Suite 100Carlsbad, CA 92010Phone: 760-814-8047 |
| Contact | Parker Kelch3186 Lionshead Ave, Suite 100Carlsbad, CA 92010Phone: 760-814-8047 x413Email: quality@asturamedical.com |
| Trade Name | EL CAPITAN Anterior Lumbar Interbody Fusion |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | OVD |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate Device | HALF DOME Posterior Lumbar Interbody System (K152512) |
| Additional Predicate Device(s) | Half Dome (K163481, K172947, K182877)Biomet Fusion System (K141791, K163543)Medtronic Pyramid Fixation System (K013665)NuVasive BASE Interfixated System (K170592)Stryker AVS (K143163)Core-Link M3 (K180814) |
| Device Description | The EL CAPITAN Anterior Lumbar Interbody devices are implantsdeveloped for the substitution of the classical autogenous bone graftblocks. The cages assist to avoid complications related to the bone graftdonation site (chronic pain, hematoma, infection, bone removal from thedonor site making it impossible to remove bone again, quality of the iliacbone, accessing a healthy donor site that may become an unhealthy site,hernias by the incision). The Spacers are a 2-piece modular design whichallows for interchangeable plate and spacer components. The plate andspacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior toimplantation. The spacer components are available in a range offootprints and heights, and the plates are offered in multiple fixationtypes and sizes to suit the individual pathology and anatomical conditionsof the patient. The implants have a hollow center to allow placement ofautogenous bone graft. The superior and inferior surfaces are open topromote contact of the bone graft with the vertebral end plates, allowingbone growth (arthrodesis) |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227Tantalum per ASTM F560Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136Nitinol #1 (ASTM F2063) |
| Substantial EquivalenceClaimed to PredicateDevices | The EL CAPITAN Anterior Lumbar Interbody System is substantiallyequivalent to the predicate devices in terms of intended use, design,materials used, mechanical safety and performances. |
| Indications for Use | The EL CAPITAN Anterior Lumbar Interbody System is indicated forintervertebral body fusion procedures in skeletally mature patients withdegenerative disc disease (DDD) of the lumbar spine at one or twocontiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic painwith degeneration of the disc confirmed by history and radiographicstudies. These DDD patients may also have up to Grade Ispondylolisthesis or retrolisthesis at the involved level(s). EL CAPITANSystem implants are to be used with autogenous bone graft andsupplemental fixation. Patients should have at least six (6) months ofnon-operative treatment prior to treatment with an intervertebral cage.The EL CAPITAN Spacer and Plate assembly are an integrated interbodyfusion device intended for stand-alone use when used with all titaniumalloy screws. When used with anchors, the assembly is intended for usewith additional supplemental fixation that has been cleared by the FDAfor use in the lumbar spine.Hyperlordotic interbody devices (>20° lordosis) must be used withsupplemental fixation (e.g. posterior fixation) that has been cleared bythe FDA for use in the Lumbar spine. |
| Non-clinical TestSummary | The following analyses were conducted:• Static Compression ASTM F2077• Dynamic Compression ASTM F1717• Static Compression Shear ASTM F2077• Dynamic Compression Shear ASTM F1717• Subsidence ASTM F2267• ExpulsionThe results of these evaluations indicate that the EL CAPITAN implantsare equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinicaland Clinical | Astura Medical considers the EL CAPITAN Anterior Lumbar InterbodySystem to be equivalent to the predicate devices listed above. Thisconclusion is based upon the devices' similarities in principles ofoperation, technology, materials and indications for use. |
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§ 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.