(93 days)
Not Found
No
The document describes a physical interbody fusion device and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is indicated for intervertebral body fusion procedures to treat degenerative disc disease, which involves addressing a medical condition.
No
Explanation: This device is an implantable medical device used for spinal fusion, specifically an intervertebral body fusion device. It is designed to physically replace bone graft and provide support for fusion, rather than to diagnose a medical condition.
No
The device description clearly describes physical implants (spacers, plates, screws, anchors) made of titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The El Capitan Anterior Lumbar Interbody System is an implantable medical device designed for surgical use in the lumbar spine. It is a physical structure intended to be placed within the body to facilitate bone fusion.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by implanting the device. It does not involve testing biological samples.
Therefore, based on the provided information, the El Capitan Anterior Lumbar Interbody System falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OVD
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 to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L1-L2 to L5-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Summary: 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 are equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EL CAPITAN Anterior Lumbar Interbody Fusion (K192492), Half Dome (K152512, K182877), Spinal Elements Lucent Magnum (K083475)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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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) |
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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 to | |
| promote 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 Equivalence | |
| Claimed to Predicate | |
| Devices | The El Capitan Anterior Lumbar Interbody System is substantially |
| equivalent 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 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 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. |
| Non-clinical Test
Summary | 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 are
equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical
and Clinical | Astura Medical considers the El Capitan Anterior Lumbar Interbody
System to be equivalent to the predicate devices listed above. This
conclusion is based upon the devices' similarities in principles of
operation, technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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