(125 days)
Not Found
No
The document describes a physical implantable device (cervical spacer system) and its mechanical testing, with no mention of software, algorithms, image processing, or AI/ML terms.
Yes.
The device is a cervical spacer system intended for interbody fusion in patients with degenerative disc disease, explicitly stating its purpose to treat a medical condition.
No
The device is a cervical spacer system intended for interbody fusion procedures, not for diagnosis. It is an implant used for treatment.
No
The device description clearly states it is a "Cervical Spacer System" consisting of physical components made of PEEK, titanium, and tantalum, along with titanium bone screws. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a physical implantable device (a cervical spacer system) used in a surgical procedure to fuse vertebrae in the spine. It is not used to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or laboratory procedures typically associated with IVDs.
This device is a surgical implant used for spinal fusion.
N/A
Intended Use / Indications for Use
The Solitaire -C Cervical Spacer System 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. Cervical degenerative disc disease is defined as intractable radioulopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire -C Cervical Spacer System is to be used with autograft and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The purpose of this submission is to gain market clearance for the Solitaire-C Cervical Spacer System. The Solitaire -C Cervical Spacer System consists of spacers and bone screws for stand-alone cervical intervertebral body fusion. The Solitaire -C spacer will be available in a variety of sizes, angles and footprints. This cervical spacer has a PEEK main body (PEEK-Optima LT1 per ASTM F-2026) with a titanium faccplate and band (Ti-6Al-4V ELI alloy per ASTM F-136), and tantalum markers (unalloyed tantalum per ASTM F-560). This device accepts titanium bone screws that are available in two diameters and multiple lengths.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing recommended in the special controls guidance document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was conducted. The testing conducted, along with the ASTM standard, are listed below:
- Static Axial Compression (ASTM F-2077) l)
-
- Dynamic Axial Compression (ASTM F-2077)
-
- Static Compression-Shear (ASTM F-2077)
-
- Dynamic Compression-Shear (ASTM F-2077)
-
- Static Torsion (ASTM F-2077)
-
- Dynamic Torsion (ASTM F-2077)
- Subsidence (ASTM F-2267 and ASTM F-2077) 7)
-
- Expulsion (ASTM Draft F-04.25.02.02)
Additional mechanical testing was conducted to evaluate screw back out, screw push through, and interconnection testing between the spacer body and the faceplate. Wear debris analysis was also presented.
Mechanical testing shows that the mechanical strength of the subject device is sufficient for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K081395, K093629, K083389, K102606, K072981, K093762, K092336
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K113736
page 1 of 2
APR 2 6 2012
Image /page/0/Picture/2 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR $ 807.92.
| Preparation Date: | April 25, 2012 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Margaret F. Crowe |
| Phone: 973-299-9300, ext. 2260 | |
| Fax: 973-257-0232 | |
| Trade name: | Solitaire®-C Cervical Spacer System |
| Common Name: | Cervical interbody fusion device with integrated fixation |
| Classification Name | |
| (Product Code): | Intervertebral Body Fusion Device (OVE) |
| Device Panel - Regulation No.: | Orthopedics - 21 CFR 888.3080 |
Device Description:
The purpose of this submission is to gain market clearance for the Solitaire-C Cervical Spacer System. The Solitaire -C Cervical Spacer System consists of spacers and bone screws for stand-alone cervical intervertebral body fusion. The Solitaire -C spacer will be available in a variety of sizes, angles and footprints. This cervical spacer has a PEEK main body (PEEK-Optima LT1 per ASTM F-2026) with a titanium faccplate and band (Ti-6Al-4V ELI alloy per ASTM F-136), and tantalum markers (unalloyed tantalum per ASTM F-560). This device accepts titanium bone screws that are available in two diameters and multiple lengths.
Indications for Use:
The Solitaire -C Cervical Spacer System 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. Cervical degenerative disc disease is defined as intractable radior myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire -C Cervical Spacer is to be used with autograft and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Summary of Technologies:
The technological characteristics (material, design and sizing) of the Solitaire-C Cervical Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include:
- Solitaire PEEK Anterior Spinal System (Biomet Spine K081395, K093629) .
- . Coalition Spacer (Globus Medical - K083389)
- A V S-C Spacer (Stryker Spine K 102606) .
- Synthes Zero-P Ccrvical Spacer (Synthes Spine K072981, K093762) .
- C-Thru Spacer System (Biomet Spine K092336) .
1
Performance Data
Mechanical testing recommended in the special controls guidance document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was conducted. The testing conducted, along with the ASTM standard, are listed below:
- Static Axial Compression (ASTM F-2077) l)
-
- Dynamic Axial Compression (ASTM F-2077)
-
- Static Compression-Shear (ASTM F-2077)
-
- Dynamic Compression-Shear (ASTM F-2077)
-
- Static Torsion (ASTM F-2077)
-
- Dynamic Torsion (ASTM F-2077)
- Subsidence (ASTM F-2267 and ASTM F-2077) 7)
-
- Expulsion (ASTM Draft F-04.25.02.02)
Additional mechanical testing was conducted to evaluate screw back out, screw push through, and interconnection testing between the spacer body and the faceplate. Wear debris analysis was also presented.
Mechanical testing shows that the mechanical strength of the subject device is sufficient for its intended use.
Substantial Equivalence:
The Solitaire-C Cervical Spacer System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. The predicates listed above are distributed for similar indications, and/or have similar design features.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 6 2012
Biomet Spine % Ms. Margaret F. Crowe 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K113796
Trade/Device Name: Solitaire -C Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: OVE Dated: March 15, 2012 Received: March 16, 2012
Dear Ms. Crowe:
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
3
Page 2 - Ms. Margaret F. Crowe
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 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 M. Milhiven
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
510(k) Number (if known): ドリ3796
Device Name: Solitaire -C Cervical Spacer System
Indications for Use:
The Solitaire -C Cervical Spacer System 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. Cervical degenerative disc disease is defined as intractable radioulopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire -C Cervical Spacer System is to be used with autograft and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K113796 510(k) Number_