Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
This device is an implant designed for intervertebral body fusion procedures to treat degenerative disc disease, which clearly falls under the definition of a therapeutic device as it directly treats a medical condition.

Diagnostic

No

Explanation: The EL CAPITAN device is an implantable interbody fusion device used for treatment, not for diagnosing conditions. Its purpose is to facilitate bone fusion in patients with degenerative disc disease.

SaMD (Software as a Medical Device)

No

The device description clearly states that the EL CAPITAN Anterior Lumbar Interbody Fusion devices are implants, which are physical hardware components. The summary also details mechanical performance studies (Static Compression, Dynamic Compression, etc.) which are relevant to physical implants, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical implant for spinal fusion, not a test performed on biological samples outside the body to diagnose a condition.
Device Description: The description details a physical implant designed to replace bone graft and provide structural support in the spine.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
Performance Studies: The performance studies focus on mechanical properties and clinical outcomes related to the implant's function within the body, not the accuracy or reliability of a diagnostic test.

Therefore, the EL CAPITAN Anterior Lumbar Interbody Fusion device is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EL CAPITAN Anterior Lumbar Interbody Fusion 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 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 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), Oblique interbody devices and EL CAPITAN X 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 X spacer may only be used with titanium alloy screws.

Product codes (comma separated list FDA assigned to the subject device)

OVD

Device Description

The EL CAPITAN Anterior Lumbar Interbody Fusion 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 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)

The following analyses were conducted:
Static Compression ASTM F2077
Dynamic Compression ASTM F2077
Static Compression Shear ASTM F2077
Dynamic Compression Shear ASTM F2077
Subsidence ASTM F2267
Expulsion

The results of these evaluations indicate that the EL CAPITAN X implants are equivalent to predicate devices.

Clinical data were provided as ancillary evidence of substantial equivalence.

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.

K192492, K163481, K182877, K192006

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

Regulation Number and Section

§ 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.

Summary

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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 19, 2023

Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063

Re: K222554

Trade/Device Name: EL CAPITAN Anterior Lumbar Interbody Fusion Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: December 20, 2022 Received: December 20, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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 -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222554

Device Name

EL CAPITAN Anterior Lumbar Interbody Fusion

Indications for Use (Describe)

The EL CAPITAN Anterior Lumbar Interbody Fusion 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 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 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), Oblique interbody devices and EL CAPITAN X 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 X spacer may only be used with titanium alloy screws.

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)

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510(k) Summary: EL CAPITAN Anterior Lumbar Interbody Fusion

Date Prepared	August 23, 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
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
Device(s)	Half Dome (K163481, K182877)
SIRION (K192006)
Device Description	The EL CAPITAN Anterior Lumbar Interbody Fusion 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 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	Tantalum per ASTM F560
Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136
Nitinol #1 per ASTM E2063
Substantial Equivalence
Claimed to Predicate
Devices	The EL CAPITAN X device 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 Fusion 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), Oblique interbody devices
and EL CAPITAN X 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 X spacer may only be used with titanium alloy screws. |
| Non-clinical Test
Summary | The following analyses were conducted:
Static Compression ASTM F2077Dynamic Compression ASTM F2077Static Compression Shear ASTM F2077Dynamic Compression Shear ASTM F2077Subsidence ASTM F2267Expulsion |
| | The results of these evaluations indicate that the EL CAPITAN X implants
are equivalent to predicate devices. |
| Clinical Test Summary | Clinical data were provided as ancillary evidence of substantial
equivalence. |
| Conclusions: Non-Clinical
and Clinical | Astura Medical considers the EL CAPITAN Anterior Lumbar Interbody
Fusion 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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