(19 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a cervical cage and screws for spinal fusion. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Explanation: The device is a cervical cage intended for intervertebral body fusion to treat degenerative disc disease, which falls under the definition of a therapeutic device as it directly treats a medical condition.
No
The device description indicates that the SCARLET® AC-T is an intervertebral cage designed to facilitate spinal fusion, not to diagnose medical conditions.
No
The device description clearly states that the device is a physical implant (box-shaped spacer and screws) made of Titanium alloy. It 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The SCARLET® AC-T is described as a physical implant (a cage and screws made of titanium alloy) intended for surgical insertion into the cervical spine.
- Intended Use: The intended use is to facilitate intervertebral body fusion in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The description clearly indicates a surgically implanted medical device, not a diagnostic tool used with biological samples.
N/A
Intended Use / Indications for Use
SCARLET® AC-T 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-T cages are intended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. When used without the two bone screws, SCARLET AC-T cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.
Product codes
ODP, OVE
Device Description
The Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Scarlet® AC-T is available in convex or lordotic profiles. Scarlet® AC-T comes in two footprints and six heights in order to accommodate different patient anatomies. The Scarlet® AC-T fixation screws are available with diameters 3.0 mm and 3.5 mm and come in various sizes so as to accommodate different patient anatomies. The SCARLET® AC-T spacer and screws are made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. SCARLET® AC-T is single-use device provided sterile (gamma radiation) and supplied with dedicated surgical instruments. Bacterial endotoxin testing 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-C3 disc to the C7-T1 disc
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
No additional testing has been performed for the added Scarlet® AC-T fixation screws. A risk analysis was performed to determine that additional testing was not needed.
Key Metrics
Not Found
Predicate Device(s)
SCARLET® AC-T Secured Anterior Cervical Cage (K172065), SCARLET® AC-T Secured Anterior Cervical Cage (K143214 and K141314)
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.
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 4, 2019
SPINEART Franck Pennesi Chief Technical Officer 3 Chemin du Pre Fleuri Plan Les Ouates CH 1228 Geneva
Re: K190322
Trade/Device Name: SCARLET® AC-T Secured Anterior Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE Dated: February 11, 2019 Received: February 13, 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 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
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/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.
Melissa Hall -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190322
Device Name
SCARLET® AC-T Secured Anterior Cervical Cage
Indications for Use (Describe)
SCARLET® AC-T 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-T cages are intended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. When used without the two bone screws, SCARLET AC-T cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K190322 Page 1 of 2
SPECIAL 510k DEVICE MODIFICATION Scarlet® AC-T
Image /page/3/Picture/2 description: The image shows the word "spineart" in a stylized font. The letters are black, and there is a purple butterfly above the "art" part of the word. There is a registered trademark symbol to the right of the word.
510(k) SUMMARY
| 510k | 510k SPECIAL - DEVICE MODIFICATION |
|---|---|
| Reason for submission | Extension of the range of SCARLET® AC-T screws |
| 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 | February 8, 2019 |
| Common Name | Intervertebral body fusion device |
| Trade Name | SCARLET® AC-T Secured Anterior Cervical Cage |
| Classification Name | Intervertebral fusion device with bone graft, cervical / Intervertebral fusion device |
| with integrated fixation, cervical | |
| Class | II |
| Product Code | ODP / OVE |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed | |
| predicate devices | Primary predicate: SCARLET® AC-T Secured Anterior Cervical Cage (K172065) |
| manufactured by SPINEART | |
| Additional predicates: SCARLET® AC-T Secured Anterior Cervical Cage (K143214 | |
| and K141314) manufactured by SPINEART |
4
| Indications for use | SCARLET® AC-T 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-T cages are
intended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitate
intervertebral body fusion with autogenous bone graft and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone graft. |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as a
standalone system used with the two bone screws provided and requires no
additional supplementary fixation systems.
When used without the two bone screws, SCARLET AC-T cages are to be used with
supplemental fixation which has been cleared by the FDA for use in the cervical
spine. |
| Description
of
device | The Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled with
autogenous bone graft and/or allogenic bone graft comprised of cancellous and/
or corticocancellous bone graft to facilitate fusion. Scarlet® AC-T is available in
convex or lordotic profiles. Scarlet® AC-T comes in two footprints and six heights
in order to accommodate different patient anatomies. The Scarlet® AC-T fixation
screws are available with diameters 3.0 mm and 3.5 mm and come in various
sizes so as to accommodate different patient anatomies.
The SCARLET® AC-T spacer and screws are made of Titanium alloy Ti6Al4V ELI
conforming to ISO 5832.3 and ASTM F136. SCARLET® AC-T is single-use device
provided sterile (gamma radiation) and supplied with dedicated surgical
instruments.
Bacterial endotoxin testing 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 | Added Scarlet® AC-T fixation screws are 3.5 mm in diameter with a core diameter of
2.1 mm for the first-intention screw and 2.6 mm for the revision screw. These added
Scarlet® AC-T fixation screws present a modified distal tip to facilitate the insertion
into the bone.
All other dimensions and features (material, hexalobe imprint, anti-backout
mechanism) are identical.
As was established in this submission added Scarlet® AC-T fixation screws are
substantially equivalent and has the same technological and mechanical characteristics
to predicate devices. |
| Discussion of Testing | No additional testing has been performed for the added Scarlet® AC-T fixation screws.
A risk analysis was performed to determine that additional testing was not needed. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons,
indications for use, and non-clinical performance testing, the Scarlet® AC-T has
demonstrated substantial equivalence to the identified predicate devices. |