(89 days)
No
The summary describes a physical spinal implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for intervertebral body fusion procedures in patients with degenerative disc disease, facilitating fusion until fusion occurs. This function is inherently therapeutic.
No
Explanation: The Scarlet® AL-T system is described as an anterior lumbar interbody fusion device designed to provide mechanical support and facilitate fusion, not to diagnose medical conditions. Its intended use is for surgical fusion procedures, not for detecting or identifying diseases.
No
The device description clearly states that the Scarlet® AL-T system comprises physical intervertebral spacers made from titanium alloy, bone screws, and surgical instruments. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Scarlet® AL-T System Function: The Scarlet® AL-T system is a surgical implant designed to provide mechanical support and facilitate fusion in the lumbar spine. It is physically implanted into the patient's body.
- Lack of Diagnostic Testing: The description focuses on the device's mechanical properties, surgical use, and materials. There is no mention of it being used to test or analyze biological samples for diagnostic purposes.
Therefore, the Scarlet® AL-T system falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 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 fusion device (i.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 Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the bone screws provided and ALSO additional supplemental fixation system that has been cleared by the FDA for use in the lumbosacral spine.
Product codes
OVD, MAX
Device Description
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 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). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
The subject product line extension consists of an extended range of titanium alloy spacers intended to be used with the three unicortical cancellous bone screws previously approved (K181818).
Scarlet® AL-T product line extension comprises a range of hyperlordotic 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 Scarlet® AL-T Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the bone screws provided and ALSO additional supplemental fixation system that has been cleared by the FDA for use in the lumbosacral spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2-S1, lumbosacral 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 non-clinical tests were conducted on the Scarlet® AL-T hyperlordotic cages: Static Axial Compression according to ASTM F2077-18, Static Shear-compression according to ASTM F2077-18; Static Torsion according to ASTM F2077-18, Subsidence according to ASTM F2267-04 and Expulsion according to ASTM Draft F-04.25.02.02. Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818).
Based on the static testing results and engineering analysis it has been determined that dynamic testing was not necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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January 22, 2020
Spineart Franck Pennesi Chief Technical Officer 3 Chemin du Pre Fleuri 1228 Plan Les Ouates, Geneva SWITZERLAND
Re: K192993
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: October 22, 2019 Received: October 25, 2019
Dear Mr. 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 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,
for
Brent Showalter, PhD 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
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Indications for Use
510(k) Number (if known) K192993
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 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 fusion device (i.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 Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the bone screws provided and ALSO additional supplemental 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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K192993 510(k) SUMMARY
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | New devices - Product Line Extension |
| Submitted by | SPINEART |
| 3 Chemin du Pré Fleuri | |
| 1228 PLAN LES OUATES | |
| GENEVA 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 | December 19, 2019 |
| Common Name | Intervertebral body fusion device |
| Trade Name | Scarlet® AL-T |
| Classification Name | Intervertebral Fusion Device with Integrated Fixation Lumbar |
| Class | II |
| Product Code | OVD |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed | |
| predicate devices | Primary predicate: Scarlet® Al-T manufactured by Spineart (K181818) |
| Additional predicate: NuVasive BASE Interfixated Titanium System manufactured by NuVasive, | |
| Incorporated (K170592) | |
| Indications for use | 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 | |
| prior to 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 fusion device (i.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 Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by | |
| the mean of the bone screws provided and ALSO additional supplemental fixation system that has | |
| been cleared by the FDA for use in the lumbosacral spine. | |
| Description | |
| of | |
| the | |
| device | 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 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). Bacterial endotoxin testing as | |
| specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / | |
| device. | |
| The subject product line extension consists of an extended range of titanium alloy spacers intended | |
| to be used with the three unicortical cancellous bone screws previously approved (K181818). | |
| Scarlet® AL-T product line extension comprises a range of hyperlordotic 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 Scarlet® AL-T | |
| Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the | |
| Technological | |
| characteristics | |
| compared to | |
| the | bone screws provided and ALSO additional supplemental fixation system that has been cleared by |
| predicate devices | the FDA for use in the lumbosacral spine. |
| Except for the lordosis, the Scarlet® AL-T hyperlordotic implants present the same design features, | |
| anti-backout mechanism, integrated fixation and bone screws as the cleared Scarlet® AL-T devices | |
| (K181818). The Scarlet® AL-T hyperlordotic implants are manufactured using the same | |
| manufacturing technology, i.e. additive manufacturing (SLM) as predicate device Scarlet® AL-T | |
| (K181818). Except for the dedicated trial devices and implant holder, the Scarlet® AL-T | |
| hyperlordotic implants share the same surgical instrumentation as predicate device Scarlet® AL-T | |
| (K181818). | |
| Discussion of Testing | The following non-clinical tests were conducted on the Scarlet® AL-T hyperlordotic cages: Static |
| Axial Compression according to ASTM F2077-18, Static Shear-compression according to ASTM | |
| F2077-18; Static Torsion according to ASTM F2077-18, Subsidence according to ASTM F2267-04 and | |
| Expulsion according to ASTM Draft F-04.25.02.02. Results demonstrate comparable mechanical | |
| properties to the predicate device Scarlet® AL-T (K181818). | |
| Based on the static testing results and engineering analysis it has been determined that dynamic | |
| testing was not necessary. | |
| Conclusion | Based on the design features, technological characteristics, feature comparisons, indications for |
| use, and non-clinical performance testing, the Scarlet® AL-T hyperlordotic cages have | |
| demonstrated substantial equivalence to the identified predicate devices. |
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