(132 days)
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
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.
The provided document is a 510(k) premarket notification for a medical device called the SCARLET® AC-T Secured Anterior Cervical Cage. This document describes the device, its intended use, and provides a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices. It does not present acceptance criteria or the results of a study designed to prove the device meets specific acceptance criteria in the way one might find for a diagnostic or AI-driven device.
Instead, the document focuses on demonstrating that the SCARLET® AC-T device is substantially equivalent to other legally marketed predicate devices, primarily through mechanical performance testing. The "acceptance criteria" here are implicitly tied to demonstrating comparable mechanical properties to these predicate devices.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable or available in this type of submission. This document is for a physical implantable device, not a diagnostic or AI-based system.
However, I can extract information related to the device and the mechanical tests performed:
1. Table of "Acceptance Criteria" (Implicitly, comparability to predicates) and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties: Demonstrate comparable performance to predicate devices (STALIF C®, Chesapeake®, Zero-P, AVS® Anchor-C) in terms of: | 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. |
| - Static and dynamic axial compression strength | Results demonstrate comparable mechanical properties to the predicate devices. |
| - Static and dynamic shear compression strength | Results demonstrate comparable mechanical properties to the predicate devices. |
| - Static and dynamic torsion strength | Results demonstrate comparable mechanical properties to the predicate devices. |
| - Subsidence resistance | Results demonstrate comparable mechanical properties to the predicate devices. |
| - Expulsion resistance | Results demonstrate comparable mechanical properties to the predicate devices. |
| Materials: Use of biocompatible and industry-standard materials. | SCARLET®AC-T cervical spacers and cancellous bone screws are all made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. |
| Intended Use: Match the intended use of predicate devices. | The SCARLET®AC-T has an identical intended use to the predicate devices, as an intervertebral body fusion cage for cervical degenerative disc disease with autograft. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. These were non-clinical, in-vitro mechanical tests, not clinical studies with patient data. No "test set" in the sense of patient data was used. The document does not specify the number of devices or test repetitions for each mechanical test.
- Data Provenance: Not applicable. These are laboratory-based mechanical test results, not originating from a country or being retrospective/prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" established by experts for mechanical performance testing of a physical device in this context. The "truth" is determined by the physical properties and performance measured against engineering standards and a comparison to known predicate devices.
4. Adjudication method for the test set:
- Not applicable. There was no "test set" requiring adjudication in the context of clinical outcomes or expert review.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-driven or diagnostic device. No human reader studies or MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For mechanical testing, the "ground truth" (or reference for evaluation) is established by adherence to recognized ASTM and ISO standards for spinal implants and by comparing measured mechanical properties against those of legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI-driven device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set or ground truth in the context of machine learning.
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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
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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 ONLYConcurrence 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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@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." |
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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 "t". The butterfly and the "t" are purple, while the rest of the word is black.
510(k) SUMMARY
| Submitted by | SPINEARTInternational Center Cointrin20 route de pré-boisCP18131215 GENEVA 15SWITZERLAND |
|---|---|
| Contacts | Franck PENNESI Director of Industry & QualityPhone : +41 22 799 40 25 Fax : +41 22 799 40 26e-mail : fpennesi@spineart.comRegulatory 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. |
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| Indications for use | The SCARLET®AC-T is intended to be used as an intervertebral body fusion cageas a stand-alone system used with the two bone screws provided and requiresno additional supplementary fixation systems. It is inserted between thevertebral bodies into the disc space from levels C2 to T1 for the treatment ofcervical degenerative disc disease (defined as neck pain of discogenic originwith 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 beused in a skeletally mature patient who has had six weeks of non-operativetreatment prior to implantation of the cage. |
|---|---|
| TechnologicalCharacteristics | The SCARLET®AC-T cervical spacers SCARLET®AC-T are available in twofootprints (small and large) and six heights (from 5 to 10 mm). TheSCARLET®AC-T cervical spacers are all made of Titanium alloy Ti6Al4V ELIconforming to ISO 5832.3 and ASTM F136. The SCARLET®AC-T cervical spacersSCARLET®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 madeof Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136.SCARLET®AC-T (spacer and screw) is single-use device provided sterile andsupplied with dedicated surgical instruments. |
| Discussion of Testing | The following non-clinical tests were conducted: Static and dynamic axialcompression, Static and dynamic shear compression, Static and dynamic torsiontesting according to ASTM F2077, subsidence testing according to ASTM F2267,and expulsion testing according to ASTM Draft F04-25.02.02. Resultsdemonstrate comparable mechanical properties to the predicate devices. |
| Conclusion | Non clinical performance testing demonstrate that The SCARLET®AC-T issubstantially equivalent to its predicate devices in terms of intended use,material, design, mechanical properties and function. |
§ 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.