(92 days)
The Scarlet® AL-T system 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 L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system.
When used as a lumbar intervertebral fi.e. without the bone screws provided), the Scarlet® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.
The Scarlet® AL-T spinal system is an anterior lumbar interbody fusion device with integrated fixation intended to provide mechanical support to the lumbar spine and maintain adequate disc space until fusion occurs. The Scarlet® AL-T system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints and lordosis so as to adapt individual pathology and different patient's anatomical conditions. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The Scarlet® AL-T spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished.
The Scarlet® AL-T interbody spacer has a monolithic design that incorporates solid, lattice and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant.
When used as a stand-alone system with its integrated fixation, the spacer is crossed by three (3) bone screws protruding into the vertebral endplates. The bone screws are secured by the mean of two (2) cam locks that prevent backing out.
The Scarlet® AL-T spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).
The provided text describes the Scarlet® AL-T intervertebral body fusion device and its substantial equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about a study proving the device meets acceptance criteria related to a machine learning or AI algorithm.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning:
- A table of acceptance criteria and reported device performance (for AI/ML).
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document discusses the mechanical and material testing for a physical medical device (intervertebral body fusion device) to demonstrate its substantial equivalence to previously cleared devices under a 510(k) premarket notification. The tests mentioned are:
- Static and dynamic axial compression (per ASTM F2077-17)
- Static and dynamic Shear compression (per ASTM F2077-17)
- Expulsion (per ASTM Draft F-04.25.02.02)
- Subsidence (per ASTM F2267-04)
- Bacterial endotoxin testing (per USP standard)
The conclusion states that these non-clinical tests demonstrate comparable mechanical properties to the predicate devices and that the Scarlet® AL-T has demonstrated substantial equivalence based on design, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing.
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October 9, 2018
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Spineart Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan Les Ouates Geneva. Switzerland
Re: K181818
Trade/Device Name: Scarlet® AL-T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: September 12, 2018 Received: September 13, 2018
Dear Franck Pennesi:
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 mav, 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181818
Device Name Scarlet® AL-T
Indications for Use (Describe)
The Scarlet® AL-T system 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 L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system.
When used as a lumbar intervertebral fi.e. without the bone screws provided), the Scarlet® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral 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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Traditional 510k SCARLET® AL-T
510(k) SUMMARY
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | NEW DEVICES |
| Submitted by | SPINEART |
| 3 Chemin du Pré Fleuri | |
| 1228 PLAN LES OUATESGENEVA SWITZERLAND | |
| Contacts | Franck PENNESI Chief Technical Officer |
| Phone : +41 22 570 1200 Fax : +41 22 594 8306 | |
| Mail: fpennesi@spineart.com | |
| Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | |
| Date Prepared | July 2, 2018 |
| Common Name | Intervertebral body fusion device |
| Trade Name | Scarlet® AL-T |
| Intervertebral Fusion Device with Integrated Fixation Lumbar / Intervertebral | |
| Classification Name | Fusion Device Lumbar |
| Class | II |
| Product Code | OVD / MAX |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketedpredicate devices | Primary predicate: Renovis S134 Anterior Lumbar Interbody Fusion (ALIF)System manufactured by Renovis Surgical Technologies, Inc (K142095)Additional predicates: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II,MIDLINE II-Ti manufactured by Centinel Spine, Inc (K150643), VU APODIntervertebral Body Fusion Device Manufactured by Theken Spine, LLC(K101310, K121211) and Juliet® Ti manufactured by Spineart (K153621) |
| Indications for use | The Scarlet® AL-T system is indicated for intervertebral body fusion proceduresin skeletally mature patients with degenerative disc disease (DDD) of thelumbar spine at one or two contiguous levels from L2-S1. DDD is defined asdiscogenic back pain with degeneration of the disc confirmed by patient historyand radiographic studies. These DDD patients may also have up to Grade 1spondylolisthesis or retrolisthesis at the involved level(s). These spinal implantsare to be used with autogenous and/or allogeneic bone graft comprised ofcancellous and/or corticocancellous bone graft to facilitate fusion. Patientsshould have at least six (6) months of non-operative treatment prior totreatment with an intervertebral cage.When used with the integrated fixation by the mean of the bone screwsprovided, the Scarlet® AL-T is a stand-alone system and requires no additionalsupplemental fixation system.When used as a lumbar intervertebral fusion device (i.e. without the bonescrews provided), the Scarlet® AL-T interbody device must be used withsupplemental internal spinal fixation system that has been cleared by the FDAfor use in the lumbosacral spine. |
| Description of the device | The Scarlet® AL-T spinal system is an anterior lumbar interbody fusion devicewith integrated fixation intended to provide mechanical support to the lumbarspine and maintain adequate disc space until fusion occurs. The Scarlet® AL-Tsystem comprises a range of intervertebral spacers implanted via an anteriorapproach, and having various sizes, heights, footprints and lordosis so as toadapt individual pathology and different patient's anatomical conditions. Theinterbody device is a box-shaped spacer with a large central cavity that canreceive bone graft intended to promote intervertebral fusion. The Scarlet® AL-T spacers are all made from medical grade titanium alloy conforming to ASTMF136 standard and are produced by additive manufacturing (SLM) according toASTM F3001. Subsequently the spacer is machined (thread tapping) andpolished.The Scarlet® AL-T interbody spacer has a monolithic design that incorporatessolid, lattice and porous structures along with superior and inferior roughsurfaces intended to increase implant stability into the intervertebral space andbony integration throughout the implant.When used as a stand-alone system with its integrated fixation, the spacer iscrossed by three (3) bone screws protruding into the vertebral endplates. Thebone screws are secured by the mean of two (2) cam locks that prevent backingout.The Scarlet® AL-T spinal implants are delivered sterile (gamma sterilization) andsupplied with dedicated surgical instruments (reusable - provided non-sterile). |
| Technological characteristics compared to predicate devices | The Scarlet® AL-T implants are manufactured using the same manufacturingtechnology, i.e. additive manufacturing (SLM) as predicate device Juliet® Ti(K153621). The characterization of the chemical, physical and mechanicalproperties of the material was performed in accordance with ASTM F3001 andthe ASTM E8/E8M. The porous structure featured on titanium alloy implantsadditively manufactured was validated based on the FDA's Guidance forindustry on the testing of metallic plasma sprayed coatings on orthopedicimplants to support reconsideration of postmarket surveillance requirements. |
| Discussion of Testing | The following non-clinical tests were conducted on the Scarlet® AL-T: Static anddynamic axial compression (per ASTM F2077-17), Static and dynamic Shearcompression (per ASTM F2077-17) expulsion (per ASTM Draft F-04.25.02.02)and subsidence (per ASTM F2267-04). Results demonstrate comparablemechanical properties to the predicate devices.Bacterial endotoxin testing as specified in USP standard is used for pyrogenicitytesting to achieve the Endotoxin limit of 20 EU / device. |
| Conclusion | Based on the design features, technological characteristics, featurecomparisons, indications for use, and non-clinical performance testing, theScarlet® AL-T has demonstrated substantial equivalence to the identifiedpredicate devices. |
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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.