(105 days)
Not Found
No
The summary describes a physical intervertebral body fusion cage and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "intervertebral body fusion cage" intended for the treatment of "cervical degenerative disc disease" to "facilitate fusion," which clearly indicates a therapeutic purpose.
No
The device is an intervertebral body fusion cage intended for treatment of cervical degenerative disc disease by facilitating fusion, not for diagnosing a condition.
No
The device description explicitly states it is an "intervertebral body fusion cage" and includes "two bone screws provided," indicating it is a physical implant and not software-only.
No, 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 an implantable medical device designed to be surgically inserted into the body to facilitate bone fusion in the spine. It is a physical structure (a cage and screws) used to stabilize the spine, not to analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating a physical condition (degenerative disc disease) by implanting a device. It does not involve testing or analyzing samples from the body.
Therefore, based on the provided information, the SCARLET®AC-T 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®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET®AC-T is intended to be level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
Similar to the previously cleared Scarlet® AC-T Spinal System (K141314), the added Scarlet® AC-T implant is a cervical Intervertebral Body Fusion device with integrated Fixation. It consists of an interbody cage intended to be used with the two bone screws provided as a stand-alone system and requires no additional supplementary fixation system. Similar to the previously cleared Scarlet® AC-T Spinal System (K141314), the added Scarlet® AC-T implant is a box-shaped spacer with a central cavity that can be filled with bone graft (autograft) to facilitate fusion and with two cancellous bone screws that pass through screw holes within its body. The added Scarlet® AC-T intervertebral body fusion spacer comes in various sizes in order to accommodate different patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, levels C2 to T1
Indicated Patient Age Range
Skeletally mature
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: Static and dynamic axial compression, Static and dynamic shear compression, Static and dynamic torsion testing according to ASTM F2077, subsidence testing according to ASTM F2267, and expulsion testing according to ASTM Draft F04-25.02.02. Results demonstrate comparable mechanical properties to the predicate devices.
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.
K141314, K120819, K111439, K112459, K102606
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2015
SPINEART Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20 Route De Pre-bois-CP 1813 1215 Geneva Switzerland
Re: K143214
Trade/Device Name: SCARLET® AC-T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: February 23, 2015 Received: February 23, 2015
Dear Mr. Pennesi:
This letter corrects our substantially equivalent letter of February 23, 2015.
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
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Page 2 - Mr. Franck Pennesi
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 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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" (21CFR 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 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 yours,
Mark N. Melkerson -S
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) K143214
Device Name SCARLET®AC-T
Indications for Use (Describe)
The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET®AC-T is intended to be level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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Traditional 510k SCARLET® AC-T Secured Anterior Cervical Cage
Image /page/3/Picture/1 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a butterfly above the word. The "ea" in "spineart" are purple, while the rest of the letters are black.
510(k) SUMMARY
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | Extension of the range of SCARLET® AC-T devices cleared under K141314 |
| Submitted by | SPINEART |
| International Center Cointrin | |
| 20 route de pré-bois | |
| CP1813 | |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Franck PENNESI Director of Industry & Quality | |
| Contacts | Phone : +41 22 799 40 25 Fax : +41 22 799 40 26 |
| Mail : fpennesi@spineart.com | |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | |
| Date Prepared | February 23rd 2015 |
| Common Name | Intervertebral body fusion device |
| Trade Name | SCARLET® AC-T |
| Classification Name | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Class | II |
| Product Code | OVE |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed | |
| predicate devices | Primary Predicate device: SCARLET® AC-T (K141314) manufactured by SPINEART |
| Additional predicates include: STALIF® C Cervical Intervertebral Body Fusion Cage | |
| (K120819) manufactured by CENTINEL SPINE, INC; Chesapeake® cervical-Ti Stabilization | |
| system (K111439) manufactured by K2M, INC; Zero-P anterior cervical interbody fusion | |
| device (K112459) manufactured by SYNTHES SPINE; AVS® Anchor-C Cervical Cage | |
| System (K102606) manufactured by STRYKER SPINE | |
| Description of the device | Similar to the previously cleared Scarlet® AC-T Spinal System (K141314), the added |
| Scarlet® AC-T implant is a cervical Intervertebral Body Fusion device with integrated | |
| Fixation. It consists of an interbody cage intended to be used with the two bone screws | |
| provided as a stand-alone system and requires no additional supplementary fixation | |
| system. Similar to the previously cleared Scarlet® AC-T Spinal System (K141314), the | |
| added Scarlet® AC-T implant is a box-shaped spacer with a central cavity that can be | |
| filled with bone graft (autograft) to facilitate fusion and with two cancellous bone | |
| screws that pass through screw holes within its body. The added Scarlet® AC-T | |
| intervertebral body fusion spacer comes in various sizes in order to accommodate | |
| different patient anatomies. | |
| Indications for use | The SCARLET® AC-T is intended to be used as an intervertebral body fusion cage as a |
| standalone system used with the two bone screws provided and requires no additional | |
| supplementary fixation systems. It is inserted between the vertebral bodies into the | |
| disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease | |
| (defined as neck pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies). The device system is designed for use with autograft | |
| bone to facilitate fusion. SCARLET® AC-T is intended to be used at one level. The cervical | |
| cage is to be used in a skeletally mature patient who has had six weeks of non- | |
| operative treatment prior to implantation of the cage. | |
| Technological | |
| Characteristics | The added SCARLET® AC-T cervical spacers are available in two footprints (small and |
| large) and six heights (from 5 to 10 mm). The added SCARLET® AC-T cervical spacers are | |
| all made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. The | |
| SCARLET® AC-T cancellous bone screws are available in two diameters (3 and 3.5 mm) | |
| and four lengths (from 12 to 18 mm). The SCARLET® AC-T cancellous bone Screws are all | |
| made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. | |
| SCARLET® AC-T (spacer and screw) is single-use device provided sterile and supplied | |
| with dedicated surgical instruments. | |
| Discussion of Testing | The following non-clinical tests were conducted: Static and dynamic axial compression, |
| Static and dynamic shear compression, Static and dynamic torsion testing according to | |
| ASTM F2077, subsidence testing according to ASTM F2267, and expulsion testing | |
| according to ASTM Draft F04-25.02.02. Results demonstrate comparable mechanical | |
| properties to the predicate devices. | |
| Conclusion | Non clinical performance testing demonstrate that the added SCARLET® AC-T spacer is |
| substantially equivalent to its predicate devices in terms of intended use, material, | |
| design, mechanical properties and function. |
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