(128 days)
No
The 510(k) summary describes a physical interbody fusion device and plate. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies are mechanical and FEA, consistent with a physical implant.
Yes
The device is indicated for intervertebral body fusion procedures to treat degenerative disc disease and spinal instability, which are medical conditions that it aims to alleviate or correct.
No
Explanation: This device is an implant for intervertebral body fusion procedures, specifically designed to substitute autogenous bone graft blocks in the treatment of degenerative disc disease and spine instability. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is an implantable medical device (spacers and plates) made of physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (spacers and plates) designed to be placed within the human body to stabilize the spine and promote fusion.
- Intended Use: The intended use is for surgical procedures to treat spinal conditions, not for analyzing biological samples.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
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 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 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.
Hyperlordotic interbody devices (>20 deg lordosis) must be used in conjunction with the SIRION plate for fixation.
Product codes
OVD, MAX
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.
Thoracolumbar (T1-L5) spine, Lumbar and lumbosacral (L1-S1) spine.
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
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:
- FEA
- Static and Dynamic Compression (ASTM F2077)
- Static and Dynamic Shear (ASTM F2077)
- Subsidence (ASTM F2267)
- Mechanical
- Expulsion
The results of these evaluations indicate that the Sirion implants are equivalent to predicate devices.
No clinical studies were performed.
- Expulsion
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sirion Lateral Lumbar Interbody Fusion (K192006)
Reference Device(s)
Half Dome (K152512, K163481, K172947, K182877), ATEC ALIF and LLIF Spacer System (K182746)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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January 6, 2021
Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln Irving, Texas 75063
Re: K202495
Trade/Device Name: SIRION Lateral Lumbar Interbody Fusion Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: December 7, 2020 Received: December 8, 2020
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, 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K202495 Page 1 of 1
Device Name SIRION LATERAL LUMBAR INTERBODY 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 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.
Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.
| 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: SIRION Lateral Lumbar Interbody Fusion
| Date Prepared | August 28, 2020 |
|---|---|
| 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: 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 | OVD, MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Sirion Lateral Lumbar Interbody Fusion (K192006) |
| Additional Predicate | |
| Device(s) | Half Dome (K152512, K163481, K172947, K182877) |
| ATEC ALIF and LLIF Spacer System (K182746) | |
| 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 | 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) | |
| 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. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • FEA | |
| ○ Static and Dynamic Compression (ASTM F2077) | |
| ○ Static and Dynamic Shear (ASTM F2077) | |
| ○ Subsidence (ASTM F2267) | |
| • Mechanical | |
| ○ Expulsion | |
| The results of these evaluations indicate that the Sirion implants are | |
| equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Substantial Equivalence | Astura Medical considers the Sirion Lateral 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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