(165 days)
No
The summary describes a physical implant (intervertebral body fusion cage) and its mechanical properties and intended use. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is an intervertebral body fusion cage intended to treat cervical degenerative disc disease, which falls under the scope of therapeutic devices as it aims to alleviate pain and facilitate fusion.
No
The text describes the STALIF C® as an intervertebral body fusion cage intended for treatment of cervical degenerative disc disease. Its purpose is to facilitate fusion, not to diagnose a condition.
No
The device description clearly states it is a physical intervertebral body fusion cage made from PEEK-OPTIMA® LT1 with titanium alloy screws and tantalum marker wires. It is a hardware implant.
Based on the provided text, the STALIF C® device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is an "intervertebral body fusion cage" for the treatment of cervical degenerative disc disease. This is a surgical implant used directly within the body.
- Device Description: The description details the materials and design of a physical implant (cage, screws, marker wires).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVDs are typically tests or systems used outside the body to analyze biological samples. The STALIF C® is a medical device intended for surgical implantation.
N/A
Intended Use / Indications for Use
The STALIF C® 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. STALIF C® 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 nonoperative treatment prior to implantation of the cage.
Product codes
OVE
Device Description
STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central sevity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560).
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)
FEA simulation was performed on the worst case subject STALIF C® and predicate STALIF CTM to show the previous testing in K072415 was adequate. Additional mechanical testing per ASTM F2077 (e.g., static and dynamic compression, static and dynamic compression-shear, and static and dynamic torsion testing) was performed on the worst-case device. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
STALIF CTM (K072415), Stryker Spine Anchor-C Cervical Cage System (K102606), Spinal Elements Mosaic Cage (K071833), Medtronic Affinity Cages (P000028)
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
K12 0819
510(k) Summary
| Device Trade Name: | STALIF C® | AUG 3 1 2012 |
|---|---|---|
| Manufacturer: | Centinel Spine, Inc. | |
| 900 Airport Road, Suite 3B | ||
| West Chester, PA 19380 | ||
| Contact: | Mr. John Parry | |
| Development Manager | ||
| Phone: (484) 887.8813 | ||
| J.Parry@centinelspine.com | ||
| Prepared by: | Mr. Justin Eggleton | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | ||
| 1331 H Street NW, 12th Floor | ||
| Washington, DC 20005 | ||
| Phone: (202) 552-5800 | ||
| Fax: (202) 552-5798 | ||
| Date Prepared: | May 4, 2012 | |
| Classifications: | 21 CFR 888.3080, Intervertebral body fusion device | |
| Class: | II | |
| Product Codes: | OVE |
Indications For Use:
The STALIF C® 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. STALIF C® 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 nonoperative treatment prior to implantation of the cage.
Device Description:
STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central sevity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA®
Page 1 of 2
1
LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560).
Predicate Device:
The subject STALIF C® intervertebral body fusion device is substantially equivalent to predicate STALIF CTM (K072415), Stryker Spine Anchor-C Cervical Cage System (K102606), Spinal Elements Mosaic Cage (K071833), and the Medtronic Affinity Cages (P000028), with respect to indications, design, function, and materials.
Substantial Equivalence:
FEA simulation was performed on the worst case subject STALIF C® and predicate STALIF CTM to show the previous testing in K072415 was adequate. Additional mechanical testing per ASTM F2077 (e.g., static and dynamic compression, static and dynamic compression-shear, and static and dynamic torsion testing) was performed on the worst-case device. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
2
Image /page/2/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 an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 3 1 2012
Centinel Spine, Incorporated % Mr. John Parry Development Manager 900 Airport Road, Suite 3B West Chester, Pennsylvania 19380
Re: K120819
Trade/Device Name: STALIF C® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: August 02, 2012 Received: August 06, 2012
Dear Mr. Parry:
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
3
Page 2 - Mr. John Parry
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known):
Device Name: STALIF C®
The STALIF C® 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. STALIF C® 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.
Prescription Use ج AND/OR (Part 21 CFR 801 Subpart D) .
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carl Rfi
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120819