(111 days)
Not Found
No
The summary describes a physical intervertebral body fusion cage and associated hardware. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on mechanical testing of the device.
Yes
This device is an intervertebral body fusion cage intended for the treatment of cervical degenerative disease, which falls under the definition of a therapeutic device.
No.
The device is an intervertebral body fusion cage intended for treatment, not diagnosis. It is implanted to facilitate fusion after a diagnosis has already been made.
No
The device description explicitly states it includes physical components made of titanium and PEEK, and is supplied with surgical instruments. It is an implantable medical device, not software.
Based on the provided text, the Sterispine™ CC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "intervertebral body fusion cage" for the treatment of cervical degenerative disease. This is a surgical implant used in vivo (within the body) to facilitate bone fusion.
- Device Description: The description details the materials of the implantable components (Titanium and PEEK) and surgical instruments. These are all components of a surgical device, not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition. Its function is purely structural and therapeutic (facilitating fusion).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Sterispine™ CC does not fit this description.
N/A
Intended Use / Indications for Use
The Sterispine™ 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.
Product codes
OVE
Device Description
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.
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)
Testing in compliance with: FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the Sterispine™ CC and demonstrated substantially equivalent performance to the identified predicate devices. The following non-clinical tests were conducted on Sterispine™ CC: Static compression, Static compression shear, Static torsion, Dynamic compression, Dynamic compression shear, Dynamic torsion according to ASTM F2077, Subsidence according to ASTM F2267, Expulsion according to in-house protocol and wear testing according to ASTM F1877.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
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
1
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. Californie | |
| 95610 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 marketed | |
| predicate 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 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 | |
| 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. 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 | |
| Description of the device | 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. | |
| Summary of | |
| Technological | |
| Characteristics | The purpose of this 510(k) submission is to obtain |
| clearance for cervical cages available in 6 heights (from | |
| 5mm to 10mm) and 2 diameters (12 & 14mm). The | |
| width is 14.5mm for a diameter of 12mm and for a height | |
| from 5 to 8mm. The width is 16mm for a diameter of | |
| 14mm and heights from 5 to 10mm. | |
| Discussion of Testing | Testing in compliance with: FDA's "Class II Special |
| Controls Guidance Document: Intervertebral Body Fusion | |
| Device" was performed for the Sterispine™ CC and | |
| demonstrated substantially equivalent performance to | |
| the identified predicate devices. The following non-clinical | |
| tests were conducted on Sterispine™ CC: Static | |
| compression, Static compression shear, Static torsion, | |
| Dynamic compression, Dynamic compression shear, | |
| Dynamic torsion according to ASTM F2077, Subsidence | |
| according to ASTM F2267, Expulsion according to in- | |
| house protocol and wear testing according to ASTM | |
| F1877 | |
| 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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