SCARLET AC-T

{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) K172065 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ ## 510(k) SUMMARY | 510k | TRADITIONAL | |-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Basis for submission | Expanded Indications | | Submitted by | SPINEART<br>3 Chemin du Pré Fleuri<br>1228 PLAN LES OUATES<br>GENEVA SWITZERLAND | | Contacts | Franck PENNESI Chief Technical Officer<br>Phone : +41 22 570 1200 Fax : +41 22 594 8306<br>Mail : fpennesi@spineart.com<br>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<br>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.<br>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.<br>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.<br>Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device | | Technological<br>characteristics compared<br>to the predicate devices | As was established in this submission Scarlet® AC-T is substantially equivalent and has<br>the same technological characteristics to its predicate devices in areas including<br>function, material composition, design, range of sizes and mechanical performance.<br>Scarlet® AC-T included within this submission differs from Scarlet® AC-T previously<br>cleared devices by its use without the two bone screws and with supplemental fixation.<br>Nonclinical testing was performed to demonstrate that the Scarlet® AC-T is<br>substantially equivalent to its predicate devices. | | Discussion of Testing | Mechanical testing in compliance with: FDA's "Class II Special Controls Guidance<br>Document: Intervertebral Body Fusion Device" was performed for the Scarlet® AC-T.<br>The following mechanical tests were performed: Static and dynamic axial compression<br>(per ASTM F2077), Static and dynamic shear compression (per ASTM F2077), Static<br>torsion (per ASTM F2077), subsidence (per ASTM F2267) and expulsion (per internal<br>protocol).<br>The result of these studies shows that the Scarlet® AC-T meets or exceeds the<br>performance of the predicate devices and does not introduce any new risks. Therefore<br>the Scarlet® AC-T is substantially equivalent to its predicate devices. | | Conclusion | Based on the design features, technological characteristics, feature comparisons,<br>indications for use, and non-clinical performance testing, the Scarlet® AC-T has<br>demonstrated substantial equivalence to the identified predicate devices. | {4}------------------------------------------------ K172065 Page 2 of 2