(24 days)
Not Found
No
The summary focuses on mechanical properties and intended use for spinal fusion, with no mention of AI/ML terms or data analysis.
Yes
The device is indicated for stand-alone intervertebral body fusion to treat degenerative disc disease, which is a therapeutic intervention.
No
The device is an implant for spinal fusion and does not diagnose disease; it treats degenerative disc disease.
No
The device is a physical implant (spinal system) and the submission describes mechanical testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is described as a "spacer" for spinal fusion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted directly into the body for structural support and fusion.
N/A
Intended Use / Indications for Use
The Solitaire PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
This submission is for a line extension to the Solitaire PEEK Anterior Spinal System to add an additional style of spacer with a modified screw angle. This modified device will be marketed as Solitaire-35.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine from L2 to S1
Indicated Patient Age Range
Skeletally mature
Intended User / Care Setting
Prescription Use
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 was conducted in accordance with the special controls guidance document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". The testing conducted, along with the ASTM standard, are listed below:
- . Static Axial Compression (ASTM F-2077)
- Dynamic Axial Compression (ASTM F-2077) .
- Static Compression-Shear (ASTM F-2077) .
- Dynamic Compression-Shear (ASTM F-2077) .
An engineering analysis regarding implant subsidence was presented.
Mechanical testing shows the 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.
Solitaire PEEK-Optima Anterior Spinal System (Biomet Spine K081395), Independence Spacer (Globus Medical K082252), Expandable PEEK Spacer (Biomet Spine K082406)
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
MAR 1 9 2012
Image /page/0/Picture/2 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with each letter connected to the next. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font.
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: | February 23, 2012 |
|---|---|
| Applicant/Sponsor: | Biomet Spine and Bone Healing Technologies |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Margaret F. Crowe |
| Phone: 973-299-9300, ext. 2260 | |
| Fax: 973-257-0232 | |
| Trade name: | Solitaire PEEK Anterior Spinal System Line. |
| Extension (Solitaire 35°) | |
| Common Name: | Lumbar stand-alone intervertebral body fusion |
| device | |
| Classification Name | |
| (Product Code): | Intervertebral Body Fusion Device with Integrated |
| Fixation/Lumbar (OVD) | |
| Device Panel - Regulation No.: | Orthopedic - 21 CFR 888.3080 |
Device Description:
This submission is for a line extension to the Solitaire PEEK Anterior Spinal System to add an additional style of spacer with a modified screw angle. This modified device will be marketed as Solitaire-35.
Indications for Use:
The Solitaire PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
There is no change to the Indications for Use as a result of this design modification.
Summary of Technologies:
The technological characteristics of the new components are the same as, or similar to, the predicate devices. Examples of predicate devices include:
- Solitaire PEEK-Optima Anterior Spinal System (Biomet Spine K081395) .
- Independence Spacer (Globus Medical K082252) .
- Expandable PEEK Spacer (Biomet Spine K082406) .
Page 5-2
1
Performance Data:
Mechanical testing was conducted in accordance with the special controls guidance document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". The testing conducted, along with the ASTM standard, are listed below:
- . Static Axial Compression (ASTM F-2077)
- Dynamic Axial Compression (ASTM F-2077) .
- Static Compression-Shear (ASTM F-2077) .
- Dynamic Compression-Shear (ASTM F-2077) .
An engineering analysis regarding implant subsidence was presented.
Mechanical testing shows the strength of the subject device is sufficient for its intended use.
Substantial Equivalence:
The modified spacers of the Solitaire PEEK Anterior Spinal System are substantially equivalent to the predicate spacers 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 predicate devices listed above are distributed for similar indications, and have similar design features.
Conclusion:
The subject device is substantially equivalent to its predicates when used as an intervertebral body fixation device. The indications for use and fundamental technology of the device remain unchanged. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject device to the other components in the Solitaire PEEK Anterior Spinal System. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Spine and Bone Healing Technologies % Ms. Margaret F. Crowe 100 Interpace Parkway Parsippany, New Jersey 07054
MAR 1 9 2012
Re: K120557
Trade/Device Name: Solitaire® PEEK Anterior Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: February 23, 2012 Received: February 24, 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
3
Page 2 - Ms. Margaret F. Crowe
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 forth in 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 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. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 4-1
Indications for Use Statement
510(k) Number (if known): K120557
Device Name: Solitaire® PEEK Anterior Spinal System
Indications for Use:
The Solitaire® PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months 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
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, Jand Restorative Devices
KI20557 510(k) Number.