(128 days)
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.
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.
Here's an analysis of the provided text regarding the SIRION Lateral Lumbar Interbody Fusion device:
The provided document is a 510(k) summary for the SIRION Lateral Lumbar Interbody Fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance.
Based on the provided text, a table of acceptance criteria and reported device performance for a clinical study to prove performance against specific metrics is not available. The document explicitly states: "No clinical studies were performed."
Instead, the submission relies on non-clinical testing and a comparison to predicate devices to establish substantial equivalence.
Here's what can be extracted from the document regarding testing and comparisons:
1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Equivalence):
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Non-Clinical) |
|---|---|
| Material Properties: | |
| Biocompatibility (PEEK, Tantalum, Titanium, Nitinol) | Complies with ASTM standards |
| Mechanical Properties (Implied Equivalence to Predicate): | |
| Static Compression (ASTM F2077) | Meets or comparable to predicate devices |
| Dynamic Compression (ASTM F2077) | Meets or comparable to predicate devices |
| Static Shear (ASTM F2077) | Meets or comparable to predicate devices |
| Dynamic Shear (ASTM F2077) | Meets or comparable to predicate devices |
| Subsidence (ASTM F2267) | Meets or comparable to predicate devices |
| Expulsion Testing | Meets or comparable to predicate devices |
| Functional Equivalence: | |
| Principles of Operation | Similar to predicate devices |
| Technology | Similar to predicate devices |
| Indications for Use | Similar to predicate devices |
Note: The document only states "The results of these evaluations indicate that the Sirion implants are equivalent to predicate devices." It does not provide specific numerical acceptance criteria or detailed results from these non-clinical tests.
2. Sample Size for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No clinical test set was used, as "No clinical studies were performed."
- Data Provenance: The non-clinical testing (FEA and Mechanical) was conducted internally or by a contracted lab for Astura Medical. The data provenance details (e.g., country of origin, retrospective/prospective) are not specified in the summary but would be part of the full 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. No clinical test set was used, and therefore no ground truth established by experts for performance evaluation.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No MRMC comparative effectiveness study was done. The document explicitly states "No clinical studies were performed."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" would be established by validated engineering standards (ASTM F2077, ASTM F2267, etc.) and direct physical measurements and observations during testing (e.g., expulsion force, deformation under load). This is a technical ground truth based on established engineering principles and standardized test methods.
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm, as this is a physical medical device. The "training" for this type of device development involves established engineering design principles, material science, and manufacturing processes.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as no training set for an AI/ML algorithm is mentioned.
Summary of the K202495 Submission:
This 510(k) clearance for the SIRION Lateral Lumbar Interbody Fusion device is based on demonstrating substantial equivalence to previously cleared predicate devices (Sirion Lateral Lumbar Interbody Fusion K192006, Half Dome K152512, K163481, K172947, K182877, and ATEC ALIF and LLIF Spacer System K182746). The equivalence is supported by non-clinical testing (FEA for static/dynamic compression and shear, subsidence, and mechanical expulsion testing) which showed the new device to be comparable. No clinical studies were performed or required for this 510(k) clearance. The acceptance criteria are therefore implicit in the demonstrated equivalence to existing legally marketed devices and adherence to relevant ASTM standards for mechanical performance.
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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
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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
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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 Medical4949 W Royal Ln.Irving, TX 75063 |
| Contact | Parker Kelch4949 W Royal Ln.Irving, TX 75063Phone: 469-501-5530 x503Email: 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 PredicateDevice(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 forthe substitution of the classical autogenous bone graft blocks. The cagesassist to avoid complications related to the bone graft donation site(chronic pain, hematoma, infection, bone removal from the donor sitemaking 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 andheights to suit the individual pathology and anatomical conditions of thepatient. The implants have a hollow center to allow placement ofautogenous bone graft. The superior and inferior surfaces are open topromote contact of the bone graft with the vertebral end plates, allowingbone growth (arthrodesis). The Sirion cages are designed to be used inconjunction with supplemental spinal fixation instrumentation. |
| Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227Tantalum per ASTM F560Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136Nitinol #1 (ASTM F2063) |
| Indications for Use | The SIRION Lateral Lumbar Interbody System Spacer, either usedindividually or assembled to the SIRION plate, is indicated forintervertebral body fusion procedures in skeletally mature patients withdegenerative disc disease (DDD) of the lumbar spine at one or twocontiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain |
| with degeneration of the disc confirmed by history and radiographicstudies. These DDD patients may also have up to Grade I spondylolisthesisor retrolisthesis at the involved level(s). SIRION Spacers are to be usedwith autogenous bone graft and supplemental fixation. Approvedsupplemental fixation includes the Olympic Posterior Spinal FixationSystem. Patients should have at least six (6) months of non-operativetreatment prior to treatment with an intervertebral cage. | |
| The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-holeconfigurations, is indicated for use via a lateral or anterolateral surgicalapproach above the bifurcation of the great vessels in the treatment ofthoracic and thoracolumbar (T1-L5) spine instability or via the anteriorsurgical approach, below the bifurcation of the great vessels in thetreatment of lumbar and lumbosacral (L1-S1) spine instability as a resultof: fracture (including dislocation and subluxation), tumor, degenerativedisc disease (defined as back pain of discogenic origin with degenerationof the disc confirmed by patient history and radiographic studies),scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spinesurgery. | |
| The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttressconfiguration is intended for use in conjunction with traditionalsupplemental fixation to maintain the relative position of interbodyspacers during spinal fusion. The 1-hole plate is not intended for use inload-bearing applications | |
| Hyperlordotic interbody devices (>20° lordosis) must be used inconjunction with the SIRION plate for fixation. | |
| Non-clinical TestSummary | 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 areequivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Substantial Equivalence | Astura Medical considers the Sirion Lateral Lumbar Interbody System tobe equivalent to the predicate devices listed above. This conclusion isbased 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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§ 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.