(248 days)
Not Found
No
The summary describes a physical implant device (spacer and plate) for spinal fusion and its mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is indicated for intervertebral body fusion procedures for degenerative disc disease and spine instability, aiming to restore stability and function. This directly addresses health conditions through a medical intervention, classifying it as a therapeutic device.
No
This device is an implant designed for intervertebral body fusion procedures. Its purpose is to substitute bone graft blocks and provide stability, not to diagnose medical conditions.
No
The device description clearly states that the device is an implant (spacers and plates) made of physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The SIRION Lateral Lumbar Interbody System is described as an implant used for intervertebral body fusion procedures. It is a physical device inserted into the body to replace bone graft blocks and provide structural support.
- Intended Use: The intended use clearly states it is for surgical procedures to treat degenerative disc disease and spinal instability. This involves direct intervention within the body, not testing samples outside the body.
The information provided focuses on the mechanical properties, surgical application, and anatomical placement of the implant, which are characteristic of a surgical device, not an IVD.
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
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 spacer may also be used with an integrated plate component. The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation. 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 F2063)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L1-L2 to L5-S1), Thoracolumbar (T1-L5), Lumbar and lumbosacral (L1-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:
• FEA
• Static Compression Bending (ASTM F1717)
• Dynamic Compression Bending (ASTM F1717)
• Static Torsion (ASTM F1717)
• Static Cantilever Bending Testing
• Spacer and Plate Dissociation Testing
The results of these evaluations indicate that the Sirion 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.
K152512, K163481, K172947, K182877, K141791, K163543, K182746, K130868, K133911
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.
0
Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
April 2, 2020
Astura Medical, LLC Mr. Parker Kelch Quality Manager 3168 Lionshead Ave, Suite 100 Carlsbad, California 92010
Re: K192006
Trade/Device Name: SIRION Lateral Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD, KWQ Dated: March 5, 2020 Received: March 5, 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
1
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,
Brent L. Showalter, Ph.D. Assistant Director (Acting) 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)
K192006
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 Postem. 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 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 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, 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
| 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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------- |
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
"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."
PRAStaff @fda.hhs.gov
3
510(k) Summary: SIRION Lateral Lumbar Interbody Fusion
Date Prepared March 31, 2020 Submitted By Astura Medical 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 Phone: 760-814-8047 Contact Parker Kelch 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 Phone: 760-814-8047 x413 Email: quality@asturamedical.com Trade Name SIRION Lateral Lumbar Interbody Fusion System Common Name Intervertebral body fusion device Classification Name Intervertebral body fusion device - lumbar Class ll MAX, OVD, KWQ Product Code CFR Section 21 CFR section 888.3080 21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate Device HALF DOME Posterior Lumbar Interbody System (K152512) Additional Predicate Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543); Alphatec Spine ATEC ALIF and LLIF Spacer System (K182746) NuVasive Decade Lateral Plate System (K130868) Genesys Spine Anterior Buttress Plate System (K133911) 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 spacer may also be used with an integrated plate component. The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation. Materials PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 Tantalum per ASTM F560 Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
4
| Nitinol #1 (ASTM F2063) | |
|---|---|
| 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 | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • FEA | |
| • Static Compression Bending (ASTM F1717) | |
| • Dynamic Compression Bending (ASTM F1717) | |
| • Static Torsion (ASTM F1717) | |
| • Static Cantilever Bending Testing | |
| • Spacer and Plate Dissociation Testing | |
| The results of these evaluations indicate that the Sirion implants are | |
| equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical | |
| and Clinical | Astura Medical considers the Sirion Lateral Lumbar Interbody System to |
| be substantially equivalent to the predicate devices listed above. This |
5
conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.