K Number
K181818
Device Name
Scarlet AL-T
Manufacturer
Date Cleared
2018-10-09

(92 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
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 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).
More Information

No
The summary describes a physical intervertebral body fusion device made of titanium alloy with integrated fixation. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies are mechanical tests, not evaluations of algorithmic performance.

Yes
The device is an intervertebral body fusion system intended to provide mechanical support and facilitate fusion in the lumbar spine for patients with degenerative disc disease. This aligns with the definition of a therapeutic device as it directly treats a medical condition.

No

The device is an intervertebral body fusion device and is indicated for surgical treatment of degenerative disc disease, not for diagnosing it.

No

The device description clearly states that the Scarlet® AL-T system comprises physical intervertebral spacers made from medical grade titanium alloy, which are implanted surgically. This indicates a hardware component, not a software-only device.

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 Function: The Scarlet® AL-T system is a surgical implant designed to provide mechanical support and facilitate fusion in the lumbar spine. It is a physical device implanted into the body, not used to test samples outside the body.
  • Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by implanting a device, not performing diagnostic tests on patient samples.
  • Device Description: The description details the materials, design, and function of a spinal implant, not a diagnostic testing device.

Therefore, the Scarlet® AL-T system falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.

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 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 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.

Product codes (comma separated list FDA assigned to the subject device)

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 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).

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 L2-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)

The following non-clinical tests were conducted on the Scarlet® AL-T: 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) and subsidence (per ASTM F2267-04). Results demonstrate comparable mechanical properties to the predicate devices.
Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

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.

Renovis S134 Anterior Lumbar Interbody Fusion (ALIF) System manufactured by Renovis Surgical Technologies, Inc (K142095)

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.

Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti manufactured by Centinel Spine, Inc (K150643), VU APOD Intervertebral Body Fusion Device Manufactured by Theken Spine, LLC (K101310, K121211) and Juliet® Ti manufactured by Spineart (K153621)

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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October 9, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

510kTRADITIONAL
Basis for submissionNEW DEVICES
Submitted bySPINEART
3 Chemin du Pré Fleuri
1228 PLAN LES OUATES
GENEVA SWITZERLAND
ContactsFranck 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 PreparedJuly 2, 2018
Common NameIntervertebral body fusion device
Trade NameScarlet® AL-T
Intervertebral Fusion Device with Integrated Fixation Lumbar / Intervertebral
Classification NameFusion Device Lumbar
ClassII
Product CodeOVD / MAX
CFR section888.3080
Device panelORTHOPEDIC
Legally marketed
predicate devicesPrimary 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 APOD
Intervertebral Body Fusion Device Manufactured by Theken Spine, LLC
(K101310, K121211) and Juliet® Ti manufactured by Spineart (K153621)
Indications for useThe 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.
Description of the deviceThe 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).
Technological characteristics compared to predicate devicesThe Scarlet® AL-T implants are manufactured using the same manufacturing
technology, i.e. additive manufacturing (SLM) as predicate device Juliet® Ti
(K153621). The characterization of the chemical, physical and mechanical
properties of the material was performed in accordance with ASTM F3001 and
the ASTM E8/E8M. The porous structure featured on titanium alloy implants
additively manufactured was validated based on the FDA's Guidance for
industry on the testing of metallic plasma sprayed coatings on orthopedic
implants to support reconsideration of postmarket surveillance requirements.
Discussion of TestingThe following non-clinical tests were conducted on the Scarlet® AL-T: 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)
and subsidence (per ASTM F2267-04). Results demonstrate comparable
mechanical properties to the predicate devices.
Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity
testing to achieve the Endotoxin limit of 20 EU / device.
ConclusionBased on the design features, technological characteristics, feature
comparisons, indications for use, and non-clinical performance testing, the
Scarlet® AL-T has demonstrated substantial equivalence to the identified
predicate devices.

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