(111 days)
The Sterispine™M CC is intended to be used as an intervertebral body fusion cage as a standalone system used with 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 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. Sterispine™ CC 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.
Sterispine™ CC system includes one cervical cage and four cervical fixations (two cervical fixations screws and two rescue screws) but only two screws are used within the cervical cage. Implantable components of Sterispine™ CC are made of Titanium Ta6V Eli grade conforming to ASTM F136 for screws and the cervical cage is made of VESTAKEEP i4R (PEEK) conforming to the ASTM F2026 with one Tantalum marker conforming to ASTM F560 to visualize the position of the cervical cage in the disc space. The Sterispine™ CC range of products is supplied sterile with a sterile single-use set of surgical instruments.
This document describes the 510(k) premarket notification for the Sterispine™ CC intervertebral body fusion device. It does not contain information about an AI/ML medical device, human readers, or AI assistance. Therefore, it is impossible to describe the acceptance criteria and study proving device performance as requested in the format of the prompt.
The document primarily focuses on demonstrating substantial equivalence of the Sterispine™ CC to predicate devices through technical characteristics, indications for use, and a series of mechanical tests.
The information provided in the document pertains to a medical device (intervertebral body fusion device) and not an AI or imaging-based diagnostic device. Therefore, the questions related to AI/ML device performance, human readers, ground truth, and training/test sets are not applicable.
However, I can extract the information relevant to this specific device from the provided text:
Acceptance Criteria & Device Performance (Based on Mechanical Testing for Substantial Equivalence):
The document implicitly states that acceptance criteria were met by demonstrating "substantially equivalent performance to the identified predicate devices" through various mechanical tests. The specific numerical acceptance criteria (e.g., minimum load, maximum displacement) for each test are not explicitly provided in the text, only that the device met the requirements.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance (per FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and ASTM Standards) | The Sterispine™ CC demonstrated substantially equivalent performance to the identified predicate devices in the following tests: |
| Static Compression | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Static Compression Shear | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Static Torsion | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Dynamic Compression | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Dynamic Compression Shear | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Dynamic Torsion | Performance compliant with ASTM F2077. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Subsidence | Performance compliant with ASTM F2267. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Expulsion | Performance compliant with an "in-house protocol". Specific values for the Sterispine™ CC are not provided, only that it met the protocol. |
| Wear testing | Performance compliant with ASTM F1877. Specific values for the Sterispine™ CC are not provided, only that it met the standard. |
| Material Conformance | Implantable components are made of Titanium Ta6V Eli grade conforming to ASTM F136 (screws) and VESTAKEEP i4R (PEEK) conforming to ASTM F2026 (cervical cage). Tantalum marker conforms to ASTM F560. |
| Sterility | Supplied sterile for single-use. |
Information Not Applicable to This Device (as it's not an AI/ML medical device):
- Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices for mechanical testing, not a dataset of patient images or clinical data. The provenance of the physical test units is not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods, not clinical expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 imaging or AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the requirements of the ASTM standards and the FDA guidance document for intervertebral body fusion devices. This is a physical "truth" established by engineering metrology and material science, not clinical or image-based ground truth.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2016
Safe Orthopaedics Sophie Rehault OA/RA Director Parc des Bellevues Allée R. Luxemburg - Bat. Californie 95610 Eragny sur Oise, France
Re: K162531
Trade/Device Name: Sterispine™ CC Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: November 30, 2016 Received: December 2, 2016
Dear Ms. Rehault:
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 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
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the quality systems (OS) 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/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 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.
Caroline Rhim -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name STERISPINETM CC
Indications for Use (Describe)
The Sterispine™M CC is intended to be used as an intervertebral body fusion cage as a standalone system used with 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 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. Sterispine™ CC 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) |
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Image /page/3/Picture/1 description: The image shows the logo for SafeOrthopaedics. The logo features a stylized letter 'S' in a light green color, with a small dot to the right of the 'S'. Below the 'S', the words 'SafeOrthopaedics' are written in a smaller font size, with the 'e' in 'Safe' also in light green.
5.510(k) summary
510(k) Summary
| 510k | Traditional |
|---|---|
| Submitted by | Safe Orthopaedics |
| Parc des Bellevues | |
| Allée R. Luxemburg - Bat. Californie95610 Eragny sur Oise - FRANCE | |
| Contacts | |
| s.rehault@safeorthopaedics.com | |
| +33 (0) 1 34 21 50 00 | |
| Isabelle DRUBAIX Regulatory contact | |
| idee-consulting@nordnet.fr | |
| +33 (0)3 21 05 64 23 | |
| Date Prepared | 1st September 2016 |
| Common Name | Intervertebral body fusion device |
| Trade Name | SteriSpine™ CC |
| Classification Name | Intervertebral body fusion device |
| Class | II |
| Product Code | OVE |
| CFR section | 888.3080 |
| Device panel | Orthopedic |
| Legally marketedpredicate devices | Primary predicate: Stalif-C manufactured by Centinel |
| Spine cleared under K120819 | |
| Other predicate: PEEK PREVAIL CERVICAL INTERBODY | |
| DEVICE manufactured by Medtronic Sofamor Danek | |
| cleared under K073285. | |
| STERISPINET™ CC | |
| Indications for use | The Sterispine™ CC is intended to be used as anintervertebral body fusion cage as a standalone systemused with bone screws provided and requires noadditional supplementary fixation systems. It is insertedbetween the vertebral bodies into the disc space fromlevels C2 to T1 for the treatment of cervical degenerativedisc disease (defined as neck pain of discogenic originwith degeneration of the disc confirmed by history andradiographic studies). The device system is designed foruse with autograft bone to facilitate fusion. Sterispine™CC is intended to be used at one level. |
| The cervical cage is to be used in a skeletally maturepatient who has had six weeks of non-operativetreatment prior to implantation of the cage | |
| Description of the device | Sterispine™ CC system includes one cervical cage andfour cervical fixations (two cervical fixations screws andtwo rescue screws) but only two screws are used withinthe cervical cage. Implantable components ofSterispine™ CC are made of Titanium Ta6V Eli gradeconforming to ASTM F136 for screws and the cervicalcage is made of VESTAKEEP i4R (PEEK) conforming to theASTM F2026 with one Tantalum marker conforming toASTM F560 to visualize the position of the cervical cagein the disc space. The Sterispine™ CC range of productsis supplied sterile with a sterile single-use set of surgicalinstruments. |
| Summary ofTechnologicalCharacteristics | The purpose of this 510(k) submission is to obtainclearance for cervical cages available in 6 heights (from5mm to 10mm) and 2 diameters (12 & 14mm). Thewidth is 14.5mm for a diameter of 12mm and for a heightfrom 5 to 8mm. The width is 16mm for a diameter of14mm and heights from 5 to 10mm. |
| Discussion of Testing | Testing in compliance with: FDA's "Class II SpecialControls Guidance Document: Intervertebral Body FusionDevice" was performed for the Sterispine™ CC anddemonstrated substantially equivalent performance tothe identified predicate devices. The following non-clinicaltests were conducted on Sterispine™ CC: Staticcompression, Static compression shear, Static torsion,Dynamic compression, Dynamic compression shear,Dynamic torsion according to ASTM F2077, Subsidenceaccording to ASTM F2267, Expulsion according to in-house protocol and wear testing according to ASTMF1877 |
| Conclusion | Based on the design features, the use of established well known materials, feature comparisons, indications for use, and results of the mechanical testing, the Sterispine™ CC has demonstrated substantial equivalence to the identified predicate devices. |
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Traditional 510k STERISPINE™ CC
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Traditional 510k STERISPINE™ CC
§ 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.