(84 days)
No
The summary describes a physical intervertebral cage made of titanium alloy, intended for spinal fusion. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are mechanical tests, not related to data analysis or interpretation.
Yes.
The device is used to treat degenerative disc disease and facilitate intervertebral body fusion in the cervical spine, which directly addresses a medical condition to restore function.
No
The device is an intervertebral cage designed to facilitate spinal fusion in patients with degenerative disc disease, not to diagnose a condition.
No
The device description clearly states it is a physical implant made of Titanium alloy and is supplied with dedicated surgical instruments.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (an intervertebral cage) intended to be placed in the cervical spine to facilitate bone fusion. It is a physical device used in the body, not a test performed on samples from the body.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, analysis of biological samples, or any other characteristics associated with IVD devices.
This device is a surgical implant used in a surgical procedure.
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
No design changes have been made to the Scarlet® AC-T cage. Same as the previously cleared devices (K141314, K141314), the Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled with 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. SCARLET® AC-T is 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing in compliance with: FDA's "Class II Special Controls Guidance
Document: Intervertebral Body Fusion Device" was performed for the Scarlet® AC-T.
The following mechanical tests were performed: Static and dynamic axial compression
(per ASTM F2077), Static and dynamic shear compression (per ASTM F2077), Static
torsion (per ASTM F2077), subsidence (per ASTM F2267) and expulsion (per internal
protocol).
The result of these studies shows that the Scarlet® AC-T meets or exceeds the
performance of the predicate devices and does not introduce any new risks. Therefore
the Scarlet® AC-T is substantially equivalent to its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K143214, K141314, K122366, K091873, K153373
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
Image /page/0/Picture/12 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN" is partially visible around the logo.
SPINEART Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan Les Ouates, Geneva Switzerland
Re: K172065
Trade/Device Name: SCARLET® AC-T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE Dated: July 5, 2017 Received: July 7, 2017
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Katherine D. Kavlock -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)
Device Name SCARLET® AC-T
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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510(k) SUMMARY
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | Expanded Indications |
| 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 | September 18, 2017 |
| Common Name | Intervertebral body fusion device |
| Trade Name | SCARLET AC-T |
| 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 (K143214) manufactured by SPINEART |
| Additional predicates: SCARLET AC-T Secured Anterior Cervical Cage And Associated Instrumentation (K141314) manufactured by SPINEART; TRYPTIK CC Anterior Intersomatic Cervical Cage (K122366) manufactured by SPINEART; TRYPTIK CA Anterior Intersomatic Cervical Cage (K091873) manufactured by SPINEART and PERIMETER® C Spinal System manufactured by Medtronic Sofamor Danek (K153373) | |
| 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 the device | No design changes have been made to the Scarlet® AC-T cage. Same as the previously cleared devices (K141314, K141314), the Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled with 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. SCARLET® AC-T is 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 | As was established in this submission Scarlet® AC-T is substantially equivalent and has |
| the same technological characteristics to its predicate devices in areas including | |
| function, material composition, design, range of sizes and mechanical performance. | |
| Scarlet® AC-T included within this submission differs from Scarlet® AC-T previously | |
| cleared devices by its use without the two bone screws and with supplemental fixation. | |
| Nonclinical testing was performed to demonstrate that the Scarlet® AC-T is | |
| substantially equivalent to its predicate devices. | |
| Discussion of Testing | Mechanical testing in compliance with: FDA's "Class II Special Controls Guidance |
| Document: Intervertebral Body Fusion Device" was performed for the Scarlet® AC-T. | |
| The following mechanical tests were performed: Static and dynamic axial compression | |
| (per ASTM F2077), Static and dynamic shear compression (per ASTM F2077), Static | |
| torsion (per ASTM F2077), subsidence (per ASTM F2267) and expulsion (per internal | |
| protocol). | |
| The result of these studies shows that the Scarlet® AC-T meets or exceeds the | |
| performance of the predicate devices and does not introduce any new risks. Therefore | |
| the Scarlet® AC-T is substantially equivalent to its predicate devices. | |
| 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. |
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K172065
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