(106 days)
The Solitaire™ and 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.
Additionally, the Solitaire™ Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Solitaire™ Osseotite® Screws are used with the spacers in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System. The screws are fabricated from Titanium alloy and are acid closed to create a roughened surface.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Solitaire™ and Solitaire™ PEEK Anterior Spinal System with Solitaire™ Osteotite® Screws:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantitative acceptance criteria or reporting detailed performance metrics against those criteria in a typical clinical study sense. The "acceptance criteria" here is met by showing that the device is "adequate for its intended use" and "substantially equivalent" to existing, legally marketed devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability (Adequacy for intended use, biomechanical integrity) | "Mechanical testing demonstrates that the Solitaire™ Osseotite® Screws when used with the spacers in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System are substantially equivalent to other spacers currently on the market and is adequate for its intended use." "The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period." |
| Osseointegration & Fixation Strength (Specific to Osteotite® Screws) | "animal testing has demonstrated that the roughened surface area of the screw increases osseointegration and enhances screw fixation strength in the spine in a healthy sheep model." |
| Substantial Equivalence (Overall Safety/Effectiveness) | "The Solitaire™ Osseotite® Screws when used with the spacers in the Solitaire™ PEEK Anterior Spinal System are 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." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for specific quantitative tests on human subjects. The primary "test" for this submission appears to be mechanical testing and animal studies, and comparability to predicate devices.
- Data Provenance:
- Mechanical Testing: Performed on the device itself. No information on location or specifics of the labs.
- Animal Testing: Conducted in a "healthy sheep model." No specific country of origin is mentioned beyond this. This is a pre-clinical/animal study, not a human clinical study. The document explicitly states: "Although animal data is not necessarily indicative of human clinical outcomes..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The study described is primarily mechanical and animal-based, not involving human expert consensus on diagnostic or prognostic performance.
- The FDA review process involves their own experts, but this refers to the study design itself.
4. Adjudication Method for the Test Set:
- Not applicable or not provided. As this is primarily mechanical and animal testing, there wouldn't be an adjudication method in the context of human reader disagreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a spinal implant, not an AI-assisted diagnostic or treatment planning tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical spinal implant, not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used:
- Mechanical Testing: Engineering specifications and ASTM/ISO standards for material properties and device performance serve as the "ground truth" for mechanical integrity.
- Animal Testing: Biological outcomes (osseointegration, screw fixation strength) measured directly in the sheep model constitute the ground truth for that specific pre-clinical study.
- Substantial Equivalence: The ground truth for this aspect is the established safety and effectiveness of the predicate devices that are already legally marketed.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical device, not an AI/machine learning model that requires a training set. The "design" and "technological characteristics" are developed through engineering and manufacturing processes, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, this is not an AI/ML device, so there is no training set or ground truth in that context.
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Image /page/0/Picture/1 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
Preparation Date: November 20, 2009 Applicant/Sponsor: Biomet Spine 100 Interpace Parkway Parsippany, NJ 07054 Contact Person: Vivian Kelly, MS, RAC Phone: 973-299-9300 Fax: 973-257-0232 Trade name: Solitaire™ and Solitaire™ PEEK Anterior Spinal System with Solitaire™ Osteotite® Screws Common Name: Non-cervical spinal spacer Classification Name: Intervertebral fusion device, 21 CFR §888.3080 Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 Device Panel /Product Code: Orthopedic MAX & MQP
Device Description:
The Solitaire™ Ossectite® Screws are used with the spacers in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System. The screws are fabricated from Titanium alloy and are acid closed to create a roughened surface.
Indications for Use:
The Solitaire™ and 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.
Additionally, the Solitaire™ Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Summary of Technologies:
The technological characteristics such as material, design and sizing of the Solitaire™ Osseotite® Screws in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System are the same as, or similar to, the predicate devices.
Performance Testing:
Mechanical testing demonstrates that the Solitaire™ Osseotite® Screws when used with the spacers in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System are substantially equivalent to other spacers currently on the market and is adequate for its intended use. Although animal data is not necessarily indicative of human clinical outcomes, animal testing has demonstrated that the roughened surface area of the screw increases osseointegration and enhances screw fixation strength in the spine in a healthy sheep model.
Image /page/0/Picture/13 description: The image shows a simple line drawing of an abstract shape. The shape appears to be composed of several rectangular forms connected at different angles. Some of the lines are solid, while others are dashed, giving the impression of a three-dimensional object or a blueprint-like representation.
MAR - 9 2010
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Image /page/1/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with the letters connected to each other. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.
MAR - 9 2010
510(k) Summary
| Preparation Date: | November 20, 2009 |
|---|---|
| Applicant/Sponsor: | Biomet Spine100 Interpace ParkwayParsippany, NJ 07054 |
| Contact Person: | Vivian Kelly, MS, RACPhone: 973-299-9300Fax: 973-257-0232 |
| Trade name: | Solitaire™ and Solitaire™ PEEK Anterior Spinal System withSolitaire™ Osteotite® Screws |
| Common Name: | Non-cervical spinal spacer |
| Classification Name: | Intervertebral fusion device, 21 CFR §888.3080Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 |
| Device Panel /Product Code: | Orthopedic MAX & MOP |
Device Description:
The Solitaire™ Osseotite Screws are used with the spacers in the Solitaire™ PEEK Anterior Spinal System. The screws are fabricated from Titanium alloy and are acid etched to create a roughened surface.
Indications for Use:
The Solitaire™ and 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.
Additionally, the Solitaire™ Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e. T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Summary of Technologies:
The technological characteristics such as material, design and sizing of the Solitaire™ Osseotite® Screws in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System are the same as, or similar to, the predicate devices.
Performance Testing:
Mechanical testing demonstrates that the Solitaire™ Osseotite® Screws when used with the spacers in the Solitaire™ and Solitaire™ PEEK Anterior Spinal System are substantially equivalent to other spacers currently on the market and is adequate for its intended use. Although animal data is not necessarily indicative of human clinical outcomes, animal testing has demonstrated that the roughened surface area of the screw increases osseointerration and enhances screw fixation strength in the spine in a healthy sheep model.
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Substantial Equivalence:
The Solitaire™ Osseotite® Screws when used with the spacers in the Solitaire™ PEEK Anterior Spinal System are 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. Examples of predicate intervertebral body fusion devices and vertebral replacement devices include the Solitaire™ PEEK (K022143, K062810, K081501 & K081395) from Biomet Spine as well as Biomet Trauma's Acid Etched Lag Screws (K070955) and the BioDrive® Cannulated Screw System (K082874) as predicates for the proprietary Osseotite process.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. The overall design is simple and professional, conveying the organization's focus on health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Spine % Ms. Vivian Kelly, MS, RAC Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, NJ 07054
SEP 12 2011
Re: K093629
Trade/Device Name: Solitaire™ and Solitaire™ PEEK Anterior Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MOP Dated: February 24, 2010 Received: February 25, 2010
Dear Ms. Kelly:
This letter corrects our substantially equivalent letter of March 9, 2010.
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 (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.
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
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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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Solitaire™ and Solitaire™ PEEK Anterior Spinal System
Indications for Use:
The Solitaire™ and 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.
Additionally, the Solitaire™ Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K093629 5 !! (k) Number_
§ 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.