(122 days)
Not Found
No
The document describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device, an intervertebral body fusion device, is indicated for the treatment of cervical degenerative disc disease by providing structural stability and facilitating fusion, which aligns with the definition of a therapeutic device.
No
Explanation: The Optio-C™ Anterior Cervical Intervertebral Body Fusion Device is an implantable medical device used for spinal fusion, not for diagnosing medical conditions. It provides structural stability and facilitates fusion rather than identifying or characterizing diseases.
No
The device description explicitly states it is comprised of physical components: an anterior cervical plate, a PEEK IBF spacer, and three bone screws. It also mentions instrumentation for use of the system. This is a hardware medical device.
Based on the provided text, the Optio-C™ Anterior Cervical Intervertebral Body Fusion Device (IBFD) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Optio-C™ Function: The Optio-C™ is an implantable medical device designed to provide structural stability and facilitate fusion in the cervical spine. It is surgically implanted directly into the patient's body.
- Intended Use: The intended use clearly states it's for "stand-alone anterior cervical interbody fusion procedures" in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the physical components (plate, spacer, screws) and how they are used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic testing, or providing information about a patient's health based on laboratory analysis.
Therefore, the Optio-C™ Anterior Cervical Intervertebral Body Fusion Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optio-C™ Anterior Cervical Intervertebral Body Fusion Device (IBFD) is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C™ IBFD is comprised of one Optio-C™PEEK IBF Spacer, one Optio-C™ Anterior Cervical Plate and three Optio-CTM bone screws.
The Optio-C™ IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.
Product codes
OVE
Device Description
The Optio-C™ Anterior Cervical System is comprised of an anterior cervical plate, PEEK IBF spacer and three bone screws and is intended for stand-alone cervical interbody fusion procedures at one level from C2 to T1. The subject device is used to provide structural stability in skeletally mature individuals following discectomy and is offered in multiple contours, lordotic angles, footprints and heights in order to accommodate variations in cervical anatomy.
The plate and PEEK spacer are assembled prior to implantation and placed in the disc space, flush with the adjacent vertebral bodies via an anterior surgical approach. The PEEK spacer is filled with autograft to facilitate fusion. The bone screws pass through the screw holes of the plate and affix to bone to help prevent implant migration.
The plate, with integrated anti-backout locking cap mechanism, is offered in a standard width (16mm)as a one-level configuration in multiple heights (6-12mm). The Diamond Tip bone screws are offered in self-drilling and self-tapping tip design, with a variableangle and have a cortical/cancellous thread design.
The subject device can be implanted in two orientations: Standard orientation- two screws cephalic and one screw caudal or Inverted orientation- one screw cephalic and two screws caudal.
The plate and screws are also made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The PEEK spacer is manufactured from radiolucent Polyetheretherketone (PEEK) per ASTM F2026 and contains radiographic markers comprised of Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136.
The plate and PEEK spacer are supplied sterile; the bone screws and instrumentation are supplied non-sterile and are to be sterilized by the end user.
The Optio-C™ Anterior Cervical System is supplied with the instrumentation necessary for use of the system, e.a. trials, rasps, and inserters that facilitate assembly, insertion and removal of the implants.
The Optio-C Anterior Cervical PEEK Intervertebral Body Fusion Device (IBFD) and the Optio-C Anterior Cervical Plate are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to T1 (Cervical Spine)
Indicated Patient Age Range
Skeletally mature patients
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
Bench Testing for the Intervertebral Body Fusion Device (IBFD) was conducted per ASTM F2077 Static and Dynamic Axial Compression, Static and Dynamic Compression Shear, Static and Dynamic Torsion and Subsidence testing per ASTM F2267; performance is acceptable for its intended use.
Wear Testing for particulate evaluation was conducted per ASTM 1877.
Bench Testing for the cervical plate was conducted per ASTM 1717 for Static . Torsion, Static and Dynamic Compression Bending performance is acceptable for its intended use.
Design Validation / Cadaver Testing will be conducted to ensure the Optio-C™ l Anterior Cervical System performance is acceptable for its intended use and to ensure substantial equivalence to the predicate(s).
Gamma Sterilization will be conducted for sterile implant components under ISO . 11137 and ISO 11737.
Packaging Sterility Testing will be conducted per ISO 11607 to ensure packaging materials maintain a sterile barrier.
Sterilization is conducted for sterilizing at the end user facility under ISO 17665 and AAMI TIR12 to ensure equivalent to the predicate devices. Dry time and cleaning instructions will be assessed and yield similar (substantially Equivalent) to the predicate devices.
Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the Optio-C System materials are biocompatible based with the same type materials to the predicate devices.
The test results conclude the Optio-C™ Anterior Cervical System to be substantially equivalent to the predicate devices listed above.
Key Metrics
Not Found
Predicate Device(s)
K111983, K103033, K111119, K073351, K112388, K120345
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
| 510(k) SUMMARY | JAN 16 2014 | |
|---|---|---|
| Optio-C™ Anterior Cervical System |
| Date of Summary Preparation: | January 13, 2014 |
|---|---|
| Submitter: | Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439 USA |
| Establishment Registration Number: | 2184052 (Minneapolis) |
| Company Contact (Primary): | Donna M. Semlak Senior Regulatory Affairs Specialist Email: Donna.Semlak@zimmer.com Office: 952.857.5643 Email Fax: 952.857.5843 |
| Trade Name(s): | Optio-C™ Anterior Cervical System |
| Device Name (Common Name): | Intervertebral Fusion Device with Integrated Fixation, Cervical |
| Device Classification: | Class II |
| Regulation Number and Product Code(s): | 21 CFR § 888.3080 / OVE |
Predicate Devices:
The Optio-C™ Anterior Cervical System identified several predicates to address theThe Optio-C™ Anterior Cervical System identified several predicates to address the intended uses, mechanical functions and performance attributes of the system. The predicate information is listed in the following table:
・
・
.
.
.
1
| Optio-C Anterior Cervical System
Predicate Device Name | Product Code | FDA 510k Number
Clearance Date |
|-----------------------------------------------------------|----------------------------------|-----------------------------------|
| Vista®-S Device
Zimmer Trabecular Metal | ODP, MQP
21 CFR
§ 888.3080 | K111983
Cleared Nov 18, 2011 |
| Trabecular Metal™ (TM-S)
Zimmer Trabecular Metal | ODP
21 CFR
§ 888.3080 | K103033
Cleared Jan 10, 2011 |
| | | K111119
Cleared Nov 23, 2011 |
| Crystal®
Spinal Elements, Inc. | ODP, MQP
21 CFR
§ 888.3080 | K073351
Cleared Jan 24, 2008 |
| Lanx Cervical SA System
Lanx, Inc. | OVE
21 CFR
§ 888.3080 | K112388
Cleared Dec 16, 2011 |
| HONOUR Spacer System
NEXXT Spine | ODP
21 CFR
§ 888.3080 | K120345
Cleared June 13, 2012 |
General Device Description:
The Optio-C™ Anterior Cervical System is comprised of an anterior cervical plate, PEEK IBF spacer and three bone screws and is intended for stand-alone cervical interbody fusion procedures at one level from C2 to T1. The subject device is used to provide structural stability in skeletally mature individuals following discectomy and is offered in multiple contours, lordotic angles, footprints and heights in order to accommodate variations in cervical anatomy.
The plate and PEEK spacer are assembled prior to implantation and placed in the disc space, flush with the adjacent vertebral bodies via an anterior surgical approach. The PEEK spacer is filled with autograft to facilitate fusion. The bone screws pass through the screw holes of the plate and affix to bone to help prevent implant migration.
The plate, with integrated anti-backout locking cap mechanism, is offered in a standard width (16mm)as a one-level configuration in multiple heights (6-12mm). The Diamond Tip bone screws are offered in self-drilling and self-tapping tip design, with a variableangle and have a cortical/cancellous thread design.
The subject device can be implanted in two orientations: Standard orientation- two screws cephalic and one screw caudal or Inverted orientation- one screw cephalic and two screws caudal.
The plate and screws are also made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The PEEK spacer is manufactured from radiolucent Polyetheretherketone (PEEK) per ASTM F2026 and contains radiographic markers comprised of Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136.
The plate and PEEK spacer are supplied sterile; the bone screws and instrumentation are supplied non-sterile and are to be sterilized by the end user.
The Optio-C™ Anterior Cervical System is supplied with the instrumentation necessary for use of the system, e.a. trials, rasps, and inserters that facilitate assembly, insertion and removal of the implants.
2
The Optio-C Anterior Cervical PEEK Intervertebral Body Fusion Device (IBFD) and the Optio-C Anterior Cervical Plate are for single use only.
Indications for Use:
The Optio-C™ Anterior Cervical System includes the following Indications for Use.
Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD)
The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.
The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.
Summary of Technological Characteristics:
The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) and the Optio-C Anterior Cervical Plate share the same technological characteristics as their predicate devices: Vista-S, Trabecular Metal (TM-S), Crystal, PEEK PREVAIL Cervical Interbody, Lanx Cervical SA System and the HONOUR Spacer. The technological characteristics include similar intended uses, mechanical and functional scientific technology, materials and the substantially equivalent performance characteristics.
The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) and the predicates are intended to provide anterior cervical interbody fusion procedures for various indications for use, as stated in the Section above. TThe IBFD construction consists of a PEEK Spacer connected to a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws (with locking cap) using an anterior surgical approach. Bone screws are available for variable angle implantation. The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) is ' for single use only.
The Optio-C Anterior Cervical Plate is a component of the Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) as described above.
The Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD), Optio-C Anterior Cervical Plate and the predicates, consist of IBFD, bone screws with locking caps, and instrumentation necessary to implant the specific system.
Summary of Performance Testing:
Non-clinical testing of the components comprising each configuration of the subject Optio-C™ Anterior Cervical System were assessed and tested appropriately to design controls; i.e. design verification. The test results conclude the Optio-C™ Anterior Cervical System to be substantially equivalent to the predicate devices listed above.
3
- Bench Testing for the Intervertebral Body Fusion Device (IBFD) was conducted per ASTM F2077 Static and Dynamic Axial Compression, Static and Dynamic Compression Shear, Static and Dynamic Torsion and Subsidence testing per ASTM F2267; performance is acceptable for its intended use.
- Wear Testing for particulate evaluation was conducted per ASTM 1877.
- Bench Testing for the cervical plate was conducted per ASTM 1717 for Static . Torsion, Static and Dynamic Compression Bending performance is acceptable for its intended use.
- Design Validation / Cadaver Testing will be conducted to ensure the Optio-C™ l Anterior Cervical System performance is acceptable for its intended use and to ensure substantial equivalence to the predicate(s).
- Gamma Sterilization will be conducted for sterile implant components under ISO . 11137 and ISO 11737.
- Packaging Sterility Testing will be conducted per ISO 11607 to ensure packaging materials maintain a sterile barrier.
- .. Sterilization is conducted for sterilizing at the end user facility under ISO 17665 and AAMI TIR12 to ensure equivalent to the predicate devices. Dry time and cleaning instructions will be assessed and yield similar (substantially Equivalent) to the predicate devices.
- . Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the Optio-C System materials are biocompatible based with the same type materials to the predicate devices.
The Optio-C™ Anterior Cervical System performance intended use and fundamental scientific technology remain unchanged from the predicate devices. The implant construct design does not change the stabilization of the cervical vertebra found in the predicate devices. The Optio-C™ Anterior Cervical System is substantially equivalent to the predicate devices.
Substantial Equivalence:
Zimmer Spine considers the subject Optio-C™ Anterior Cervical System product performance to be substantially equivalent to the predicate devices because there is no significant difference in intended use, mechanical and functional performance and functional scientific technology. Zimmer believes no new issues of safety and effectiveness are raised due to the similarities between the subject and predicate/commercialized devices, as each are used to treat similar clinical conditions and represent a similar/basic design concept.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2014
Zimmer Spine, Incorporated Ms. Donna Semlak Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K132894
Trade/Device Name: The Optio-CTM Anterior Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 10, 2013 Received: December 11, 2013
Dear Ms. Semlak:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Donna Semlak
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation · Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132894
Device Name The Optio-CTN Anterior Cervical System
Indications for Use (Describe)
Optio-CTM Anterior Cervical Intervertebral Body Fusion Device (IBFD)
The Optio-CM Anterior Cervical Intervertebral Body Fusion Device (IBFD) is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C™ IBFD is comprised of one Optio-C™PEEK IBF Spacer, one Optio-C™ Anterior Cervical Plate and three Optio-CTM bone screws.
The Optio-C™ IBFD is to be used with autografiand implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.
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 ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Pribinting Services { 341} 113-6740
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
7
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 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."