(93 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 radiosraphic 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 (0) months of non-operative weatment 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 only the zero plate may be used and 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) and the Oblique interbody devices 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).
The provided text is a 510(k) Summary for the EL CAPITAN Anterior Lumbar Interbody Fusion System. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by non-clinical testing. It explicitly states that no clinical studies were performed. Therefore, information regarding acceptance criteria derived from a clinical study, sample sizes for test/training sets, expert qualifications, or adjudication methods cannot be extracted from this document.
However, the document does list non-clinical tests that were conducted to establish substantial equivalence. These tests serve as the basis for the device meeting performance acceptance criteria in a non-clinical context.
Here's a breakdown of the requested information based on the provided text, with explicit notes about what is not available:
1. A table of acceptance criteria and the reported device performance
The document lists the types of non-clinical tests performed, and states that the results "indicate that the El Capitan implants are equivalent to predicate devices." This implies that the acceptance criteria for these tests were met by demonstrating equivalence to the legally marketed predicate devices. Specific quantitative acceptance criteria or detailed numerical performance results are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Properties: | |
| Equivalent biological response and mechanical properties to predicate devices made of PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy (Ti6-AL4-V ELI), and Nitinol #1. | Device materials (PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy, Nitinol #1) are similar to predicate devices, indicating equivalent performance. |
| Mechanical Performance: | |
| Static Compression (per ASTM F2077) performance equivalent to predicate devices. | Results of static compression testing indicate equivalence to predicate devices. |
| Dynamic Compression (per ASTM F1717) performance equivalent to predicate devices. | Results of dynamic compression testing indicate equivalence to predicate devices. |
| Static Compression Shear (per ASTM F2077) performance equivalent to predicate devices. | Results of static compression shear testing indicate equivalence to predicate devices. |
| Dynamic Compression Shear (per ASTM F1717) performance equivalent to predicate devices. | Results of dynamic compression shear testing indicate equivalence to predicate devices. |
| Subsidence (per ASTM F2267) performance equivalent to predicate devices. | Results of subsidence testing indicate equivalence to predicate devices. |
| Expulsion performance equivalent to predicate devices. | Results of expulsion testing indicate equivalence to predicate devices. |
| Overall Equivalence: | |
| Substantially equivalent to predicate devices in terms of intended use, design, materials used, mechanical safety, and performances. | Astura Medical concluded the device is substantially equivalent to predicate devices based on similarities in principles of operation, technology, materials, and indications for use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available as the summary explicitly states "No clinical studies were performed." The non-clinical tests would involve physical device samples, but the number of samples used for each test is not specified. The provenance of the test data would be the laboratory where the non-clinical mechanical testing was performed, but this is not mentioned.
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)
This information is not applicable as no clinical studies were performed and thus no human expert-established ground truth was required for the presented non-clinical equivalence testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies involving human interpretation or adjudication were performed.
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
This information is not applicable as no clinical studies, especially those involving AI assistance or human readers, were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device described is a physical interbody fusion system, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is established by adherence to recognized ASTM standards (e.g., F2077, F1717, F2267) and by comparing the performance results to established performance characteristics of the predicate devices. This represents a laboratory-based, standard-driven performance benchmark rather than a medical ground truth (like pathology or outcomes data).
8. The sample size for the training set
This information is not applicable as no clinical studies were performed, and therefore, no training set for a clinical algorithm was used.
9. How the ground truth for the training set was established
This information is not applicable as no clinical studies were performed, and therefore, no training set for a clinical algorithm was used.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 30, 2022
Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063
Re: K214047
Trade/Device Name: EL CAPITAN Anterior Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 17, 2022 Received: March 17, 2022
Dear Parker 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
{1}------------------------------------------------
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 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 medical devices and radiation-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,
for
Brent Showalter, Ph.D. 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
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 sketally 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 radiosraphic 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 (0) months of non-operative weatment 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 only the zero plate may be used and 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) and the Oblique interbody devices 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary: EL CAPITAN Anterior Lumbar Interbody Fusion
| Date Prepared | March 16, 2022 |
|---|---|
| Submitted By | Astura Medical |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Contact | Parker Kelch |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Phone: 469-501-5530 x503 | |
| Email: quality@asturamedical.com | |
| Trade Name | EL CAPITAN Anterior Lumbar Interbody Fusion System |
| 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 | EL CAPITAN Anterior Lumbar Interbody Fusion (K192492) |
| Additional Predicate | Half Dome (K152512, K182877) |
| Device(s) | Spinal Elements Lucent Magnum (K083475) |
| Device Description | 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 topromote contact of the bone graft with the vertebral end plates, allowing | |
| bone growth (arthrodesis). | |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 |
| Tantalum per ASTM F560 | |
| Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136 | |
| Nitinol #1 (ASTM E2063) | |
| 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 I spondylolisthesisor retrolisthesis at the involved level(s). El Capitan System implants are tobe used with autogenous bone graft and supplemental fixation. Patientsshould have at least six (6) months of non-operative treatment prior totreatment 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 only the zero plate may be usedand the assembly is intended for use with additional supplementalfixation that has been cleared by the FDA for use in the lumbar spine.Hyperlordotic interbody devices (>20° lordosis) and the Oblique interbodydevices must be used with supplemental fixation (e.g. posterior fixation)that has been cleared by the 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 Expulsion The results of these evaluations indicate that the El Capitan implants areequivalent 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. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
{4}------------------------------------------------
§ 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.