(57 days)
No
The device description focuses on the mechanical properties, materials, and design of a cervical intervertebral body fusion device. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is indicated for use in degenerative disc disease of the cervical spine to facilitate intervertebral body fusion, which directly treats a medical condition.
No
Explanation: The SCARLET® AC-Ti system is an intervertebral body fusion device intended to provide mechanical support and stabilization to the cervical spine and facilitate fusion, not diagnose a condition.
No
The device description clearly states it is a physical intervertebral body fusion device made from titanium alloy, including spacers, screws, and anchors. It also mentions dedicated surgical instruments. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the SCARLET® AC-Ti cages are implants intended for surgical use in the cervical spine to facilitate fusion. They are physical devices inserted into the body, not used to analyze samples outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes related to analyzing bodily fluids or tissues.
Therefore, the SCARLET® AC-Ti system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SCARLET® AC-Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. SCARLET® AC-Ti cages are intended to be used at one or two contiguous levels from C2-T1 to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used with two bone screws, the SCARLET® AC-Ti Secured Anterior Cervical Cage is intended to be used as a standalone system and requires no additional supplementary fixation systems. When used with two anchors or without two bone screws, the SCARLET® AC-Ti cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine. The SCARLET® AC-Ti hyperlordotic (12° lordosis) cages are to be used with bone screws and/or anchors and additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine.
Product codes
OVE, ODP
Device Description
Spineart SCARLET® AC-Ti system is a Cervical Intervertebral Body Fusion device with integrated fixation intended to provide mechanical support and stabilization to the cervical spine and maintain adequate disc space until fusion occurs. The system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints, and lordosis to adapt individual pathology and different patients' anatomical conditions. The interbody device is a box-shaped spacer with a central cavity that can receive bone graft, which is intended to promote intervertebral fusion. It has a monolithic design and is crossed by two tunnels that guide the bone screws and/or the anchors insertion into the vertebral endplates. Moreover, SCARLET® AC-Ti comprises integrated fixation by the mean of bone screws and/or anchors that come in various diameters and lengths. The SCARLET® AC-Ti spacers are all made from medical grade titanium alloy conforming to ASTM F136 and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is polished and thread tapping is machined. The screws and anchors are made from Ti-6AI-4V ELI conforming to ASTM F136. The SCARLET® AC-Ti spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile). Bacterial endotoxin testing on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-T1
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)
Mechanical testing: Static and dynamic Axial Compression, Static and dynamic Shear-compression and Static and dynamic Torsion according to ASTM F2077-22 and Subsidence according to ASTM F2267-22 were conducted. Results demonstrate comparable mechanical properties to the identified predicate devices. Mass loss was measured on post-test run out SCARLET® AC-Ti worst-case specimens dynamically tested. Expulsion characterization was conducted.
MRI Safety Evaluation: In accordance with the FDA guidance “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment” (Issued October 2023), testing has been completed on the worst-case implants. The following testing has been completed and provided a determination that the subject Spineart SCARLET® AC-Ti in this 510(k) submission has been determined to be MR conditional:
- ASTM F2052-2021: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2182-19e2: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance
- ASTM F2503-23e1:"Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment"
Human cadaveric testing: Cadaver lab trials were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SCARLET® AC-T Secured Anterior Cervical Cage manufactured by Spineart (K141314, K143214, K172065, K190322)
Reference Device(s)
TRYPTIK® Ti manufactured by Spineart (K200312, K230583), ChoiceSpine Blackhawk Ti Cervical Spacer System manufactured by ChoiceSpine LLC (K203311, K223869), Atlas Spine Expandable Cervical Standalone Interbody System manufactured by Atlas Spine, Inc. (K192570)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
May 10, 2024
SPINEART SA Estelle Lefeuvre Regulatory & Market Access Manager Chemin du Pré-Fleuri 3 Plan-les-Ouates, 1228 Switzerland
Re: K240699
Trade/Device Name: SCARLET® AC-Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: March 12, 2024 Received: March 14, 2024
Dear Estelle Lefeuvre:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
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
2
Indications for Use
510(k) Number (if known) K240699
Device Name SCARLET® AC-Ti
Indications for Use (Describe)
SCARLET® AC-Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. SCARLET® AC-Ti cages are intended to be used at one or two contiguous levels from C2-T1 to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used with two bone screws, the SCARLET® AC-Ti Secured Anterior Cervical Cage is intended to be used as a standalone system and requires no additional supplementary fixation systems.
When used with two anchors or without two bone screws, the SCARLET® AC-Ti cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.
The SCARLET® AC-Ti hyperlordotic (12° lordosis) cages are to be used with bone screws and/or anchors and additional supplemental fixation system that has been cleared by the FDA for use in the cervical 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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3
Traditional 510k SCARLET® AC-Ti
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510(k) SUMMARY
| 510k | Traditional | |
|---|---|---|
| Basis for submission | New devices | |
| Submitted by | SPINEART SA | |
| 3 Chemin du Pré Fleuri | ||
| 1228 Plan-les-Ouates | ||
| SWITZERLAND | ||
| Contacts | Max LOK, EVP RAQA | |
| Phone : +41 22 570 1200 Fax : +41 22 594 8306 | ||
| Mail : mlok@spineart.com | ||
| Regulatory contact : Estelle LEFEUVRE (elefeuvre@spineart.com) | ||
| Date Prepared | May 2nd, 2024 | |
| Common Name | Intervertebral body fusion device | |
| Trade Name | SCARLET® AC-Ti | |
| Classification Name | Intervertebral Fusion Device With Integrated Fixation, Cervical | |
| Class | II | |
| Product Code | OVE, ODP | |
| CFR section | 888.3080 | |
| Device panel | Orthopedic | |
| Legally marketed predicate devices | Primary predicate: SCARLET® AC-T Secured Anterior Cervical Cage manufactured by Spineart (K141314, K143214, K172065, K190322) | |
| Additional predicates: |
- TRYPTIK® Ti manufactured by Spineart (K200312, K230583)
- ChoiceSpine Blackhawk Ti Cervical Spacer System manufactured by ChoiceSpine LLC (K203311, K223869)
- Atlas Spine Expandable Cervical Standalone Interbody System manufactured by Atlas Spine, Inc. (K192570) | |
4
| Indications for use | SCARLET® AC-Ti cages are indicated for use in skeletally mature
patients with degenerative disc disease (defined as neck pain of
discogenic origin with degeneration of the disc confirmed by history and
radiographic studies) of the cervical spine. Patients should have at least
six (6) weeks of non-operative treatment prior to treatment with an
intervertebral cage. SCARLET® AC-Ti cages are intended to be used at
one or two contiguous levels from C2-T1 to facilitate intervertebral body
fusion with autogenous bone graft and/or allogenic bone graft comprised
of cancellous and/or corticocancellous bone graft. When used with two
bone screws, the SCARLET® AC-Ti Secured Anterior Cervical Cage is
intended to be used as a standalone system and requires no additional
supplementary fixation systems.
When used with two anchors or without two bone screws, the
SCARLET® AC-Ti cages are to be used with supplemental fixation which
has been cleared by the FDA for use in the cervical spine.
The SCARLET® AC-Ti hyperlordotic (12° lordosis) cages are to be used
with bone screws and/or anchors and additional supplemental fixation
system that has been cleared by the FDA for use in the cervical spine. |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of the device | Spineart SCARLET® AC-Ti system is a Cervical Intervertebral Body
Fusion device with integrated fixation intended to provide mechanical
support and stabilization to the cervical spine and maintain adequate
disc space until fusion occurs. The system comprises a range of
intervertebral spacers implanted via an anterior approach, and having
various sizes, heights, footprints, and lordosis to adapt individual
pathology and different patients' anatomical conditions. The interbody
device is a box-shaped spacer with a central cavity that can receive bone
graft, which is intended to promote intervertebral fusion. It has a
monolithic design and is crossed by two tunnels that guide the bone
screws and/or the anchors insertion into the vertebral endplates.
Moreover, SCARLET® AC-Ti comprises integrated fixation by the mean
of bone screws and/or anchors that come in various diameters and
lengths.
The SCARLET® AC-Ti spacers are all made from medical grade titanium
alloy conforming to ASTM F136 and are produced by additive
manufacturing (SLM) according to ASTM F3001. Subsequently the
spacer is polished and thread tapping is machined. The screws and
anchors are made from Ti-6AI-4V ELI conforming to ASTM F136.
The SCARLET® AC-Ti spinal implants are delivered sterile (gamma
sterilization) and supplied with dedicated surgical instruments (reusable
– provided non-sterile). Bacterial endotoxin testing on final, finished
devices as specified in USP standard is used for pyrogenicity testing to
achieve the Endotoxin limit of 20 EU / device. |
| Technological
characteristics
compared to the
predicate devices | The SCARLET® AC-Ti spinal implants are manufactured using the same
manufacturing technology, i.e. additive manufacturing (SLM) as
predicate device TRYPTIK® Ti. The characterization of the chemical,
physical and mechanical properties of the material was performed in
accordance with ASTM F3001.
The SCARLET® AC-Ti implants are available in various sizes, heights,
footprints and lordosis so as to adapt individual pathology and different
patient's anatomical conditions. The SCARLET® AC-Ti implants are
implanted via an anterior approach. These features are similar to those
of the predicate devices (K141314, K143214, K172065, K190322,
K200312, K230583, K223869, K203311, K192570) |
| Mechanical testing: | Static and dynamic Axial Compression, Static and dynamic Shear-
compression and Static and dynamic Torsion according to ASTM F2077-
22 and Subsidence according to ASTM F2267-22 were conducted.
Results demonstrate comparable mechanical properties to the identified
predicate devices. Mass loss was measured on post-test run out
SCARLET® AC-Ti worst-case specimens dynamically tested.
Expulsion characterization was conducted. |
| Discussion of Testing | MRI Safety Evaluation:
In accordance with the FDA guidance “Testing and Labeling Medical
Devices for Safety in the Magnetic Resonance (MR) Environment”
(Issued October 2023), testing has been completed on the worst-case
implants. The following testing has been completed and provided a
determination that the subject Spineart SCARLET® AC-Ti in this 510(k)
submission has been determined to be MR conditional:
- ASTM F2052-2021: Standard Test Method for Measurement of
Magnetically Induced Displacement Force on Medical Devices in the
Magnetic Resonance Environment - ASTM F2213-17: Standard Test Method for Measurement of
Magnetically Induced Torque on Medical Devices in the Magnetic
Resonance Environment - ASTM F2119-07: Standard Test Method for Evaluation of MR Image
Artifacts from Passive Implants - ASTM F2182-19e2: Standard Test Method for Measurement of Radio
Frequency Induced Heating On or Near Passive Implants During
Magnetic Resonance - ASTM F2503-23e1:"Standard Practice for Marking Medical Devices
and Other Items for Safety in the Magnetic Resonance Environment" |
| | Human cadaveric testing:
Cadaver lab trials were conducted. |
| Conclusion | Based on the design features, technological characteristics, feature
comparisons, indications for use, and non-clinical performance testing,
the SCARLET® AC-Ti implants have demonstrated substantial
equivalence to the identified predicate devices |
5