(132 days)
Not Found
No
The description focuses on the mechanical design and intended use of a physical implant (intervertebral body fusion cage) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of 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," indicating its use in treating a medical condition and restoring normal function.
No
The SCARLET®AC-T is an intervertebral body fusion cage and is used for treatment (fusion) of discs, not for diagnosing conditions.
No
The device description clearly states it is a physical intervertebral body fusion cage with bone screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SCARLET®AC-T Function: The SCARLET®AC-T is a surgical implant (an intervertebral body fusion cage) designed to be placed inside the body to facilitate bone fusion in the spine. It does not analyze specimens taken from the body.
The provided text clearly describes a medical device used for surgical implantation, not for in vitro testing.
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 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
Product codes
OVE
Device Description
The SCARLET®AC-T Spinal System is a Cervical Intervertebral Body Fusion device with integrated fixation. It consists of an interbody cage intended to be used with the bone screws provided as a stand-alone system and requires no additional supplementary fixation system. SCARLET®AC-T is a box-shaped spacer with two cancellous bone screws that pass through screw holes within its body. It is intended to be used as a stand-alone interbody fusion device with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. SCARLET®AC-T intervertebral body fusion spacer comes in various sizes and footprints in order to accommodate different patient anatomies. It receives two cancellous bone screws that come in various diameters and lengths so as to better fulfill surgeon's needs and to accommodate anatomical variations.
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 patient
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.
Non clinical performance testing demonstrate that The SCARLET®AC-T is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120819, K111439, K112459, K102606
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The profiles are arranged in a way that suggests unity and forward movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2014
Spineart Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de Pré-Bois - CP 1813 1215 Geneva - SWITZERLAND
Re: K141314
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: OVE Dated: August 26, 2014 Received: August 28, 2014
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
1
Page 2 - Mr. Franck Pennesi
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 you 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/Resourcesfor You/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 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,
Ronald和Nean -S for
Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | Indications for Use | |
| 510(k) Number (if known) | K141314 | |
| Device Name | SCARLET®AC-T Secured Anterior Cervical Cage | |
| 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 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 | |
| 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) |
| | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| | FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| | This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| | Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov | |
| | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
3
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 "t". The butterfly and the "t" are purple, while the rest of the word is black.
510(k) SUMMARY
| Submitted by | SPINEART
International Center Cointrin
20 route de pré-bois
CP1813
1215 GENEVA 15
SWITZERLAND |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PENNESI Director of Industry & Quality
Phone : +41 22 799 40 25 Fax : +41 22 799 40 26
e-mail : fpennesi@spineart.com
Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)
e-mail : idrubaix@nordnet.fr |
| Date Prepared | September 24th 2014 |
| 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 | STALIF C® Cervical Intervertebral Body Fusion Cage (K120819) manufactured by CENTINEL SPINE, INC;
Additional predicates include: 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 | The SCARLET®AC-T Spinal System is a Cervical Intervertebral Body Fusion device with integrated fixation. It consists of an interbody cage intended to be used with the bone screws provided as a stand-alone system and requires no additional supplementary fixation system. SCARLET®AC-T is a box-shaped spacer with two cancellous bone screws that pass through screw holes within its body. It is intended to be used as a stand-alone interbody fusion device with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. SCARLET®AC-T intervertebral body fusion spacer comes in various sizes and footprints in order to accommodate different patient anatomies. It receives two cancellous bone screws that come in various diameters and lengths so as to better fulfill surgeon's needs and to accommodate anatomical variations. |
4
| Indications for use | The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage
as a stand-alone 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 SCARLET®AC-T cervical spacers SCARLET®AC-T are available in two
footprints (small and large) and six heights (from 5 to 10 mm). The
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 cervical spacers
SCARLET®AC-T 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 SCARLET®AC-T is
substantially equivalent to its predicate devices in terms of intended use,
material, design, mechanical properties and function. |