(189 days)
No
The device description and intended use focus on the physical characteristics and surgical application of an interbody fusion system (spacers and plates). There is no mention of any computational or analytical functions, let alone AI/ML. The performance studies are non-clinical mechanical tests.
Yes
Explanation: The device is indicated for intervertebral body fusion procedures to treat conditions like degenerative disc disease, spinal instability due to fracture, tumor, scoliosis, kyphosis, lordosis, and spinal stenosis. These are all therapeutic applications.
No
The device is described as an implant used for intervertebral body fusion procedures and spinal fixation, not for diagnosing conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an implant (cages and plates) made of physical materials, not software.
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 procedures. It is used in the body to treat a physical condition (degenerative disc disease, instability).
- Device Description: The description details a physical implant (spacers and plates) designed to replace bone graft and provide structural support in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is an implantable medical device used inside the body.
N/A
Intended Use / Indications for Use
The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, 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). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications
Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.
SIRION X 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)
MAX, OVD, KWQ
Device Description
The Sirion Lateral 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). They are available in a range of footprints and heights 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 Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.
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.
Thoracic and thoracolumbar (T1-L5) spine
Lumbar and lumbosacral (L1-S1) spine
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 and Dynamic compression per ASTM F2077
• Static and Dynamic Shear per ASTM F2077
• Subsidence per ASTM F2267
• Expulsion
The results of these evaluations indicate that the Sirion X implants are equivalent to predicate devices.
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.
SIRION Lateral Lumbar Interbody Fusion System (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.
Half Dome (K182877, K152512), Spinal Elements Lucent Spacer (K071724, K081968), Globus Medical Rise® Intervertebral Body Fusion Device (K113447), Life Spine ProLift HELO (K210061), Amplify Surgical Dual-X (K211740)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
May 9, 2023
Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063
Re: K223335
Trade/Device Name: SIRION Lateral Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, KWQ, OVD Dated: March 30, 2023 Received: March 30, 2023
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)
K223335
Device Name
SIRION Lateral Lumbar Interbody Fusion System
Indications for Use (Describe)
The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, 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). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior System. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the greatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications
Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.
SIRION X 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) |
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510(k) Summary: SIRION Lateral Lumbar Interbody Fusion
| Date Prepared | October 31st, 2022 |
|---|---|
| Submitted By | Astura Medical |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Phone: 469-501-5530 | |
| Contact | Parker Kelch |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Phone: 469-501-5530 | |
| Email: parker@asturamedical.com | |
| Trade Name | SIRION Lateral Lumbar Interbody Fusion |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device – lumbar |
| Class | II |
| Product Code | MAX, OVD, KWQ |
| CFR Section | 21 CFR section 888.3080 |
| 21 CFR section 888.3060 | |
| Device Panel | Orthopedic |
| Primary Predicate Device | SIRION Lateral Lumbar Interbody Fusion System (K192006) |
| Additional Predicate | |
| Device(s) | Half Dome (K182877, K152512) |
| Spinal Elements Lucent Spacer (K071724, K081968) | |
| Globus Medical Rise® Intervertebral Body Fusion Device (K113447) | |
| Life Spine ProLift HELO (K210061) | |
| Amplify Surgical Dual-X (K211740) | |
| Device Description | The Sirion Lateral 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). They are available in a range of footprints and | |
| heights 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 Sirion cages are designed to be used in | |
| conjunction with supplemental spinal fixation instrumentation. | |
| Materials | Tantalum per ASTM F560 |
| Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136 | |
| Nitinol #1 (ASTM E2063) | |
| Substantial Equivalence | |
| Claimed to Predicate | |
| Devices | The Sirion Lateral 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 SIRION Lateral Lumbar Interbody System Spacer, either used |
| individually or assembled to the SIRION plate, 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). SIRION Spacers are to be used | |
| with autogenous bone graft and supplemental fixation. Approved | |
| supplemental fixation includes the Olympic Posterior Spinal Fixation | |
| System. Patients should have at least six (6) months of non-operative | |
| treatment prior to treatment with an intervertebral cage. |
The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole
configurations, is indicated for use via a lateral or anterolateral surgical
approach above the bifurcation of the great vessels in the treatment of
thoracic and thoracolumbar (T1-L5) spine instability or via the anterior
surgical approach, below the bifurcation of the great vessels in the
treatment of lumbar and lumbosacral (L1-S1) spine instability as a result
of: fracture (including dislocation and subluxation), tumor, degenerative
disc disease (defined as back pain of discogenic origin with degeneration
of the disc confirmed by patient history and radiographic studies),
scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine
surgery.
The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress
configuration is intended for use in conjunction with traditional
supplemental fixation to maintain the relative position of interbody
spacers during spinal fusion. The 1-hole plate is not intended for use in
load-bearing applications
Hyperlordotic interbody devices (>20° lordosis) must be used in
conjunction with the SIRION plate for fixation.
SIRION X 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 and Dynamic compression per ASTM F2077
• Static and Dynamic Shear per ASTM F2077
• Subsidence per ASTM F2267
• Expulsion
The results of these evaluations indicate that the Sirion X implants are
equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical
and Clinical | Astura Medical considers the additional expandable implants for the
Sirion Lateral Lumbar Interbody System to be substantially 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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