(37 days)
The Solitaire™ PEEK-Optima® 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 SI 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 nonoperative treatment.
The Solitaire™ Peek-Optima® Anterior Spinal System consists of a spacer with tantalum radiographic markers and bone screws for intervertebral body fusion. The spacer is PEEK with titanium inserts for the bone screw interface. The Solitaire™ Bone screws will be available in different versions of the the the the the the the types.
I am sorry, but the provided text is a 510(k) summary for a spinal system (Solitaire™ PEEK-Optima Anterior Spinal System). It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical testing. This document does not contain information about acceptance criteria or a study that evaluates device performance in the way typically expected for an AI/ML medical device submission (e.g., diagnostic accuracy, sensitivity, specificity, or reader studies).
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies because the information is not present in the provided text. The document focuses on regulatory equivalence for a physical medical implant, not on the performance metrics of a diagnostic or AI-powered device.
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K 081395
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JUN 2 5 2008
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.
Submitter: Biomet Spine 100 Internace Parkway Parsippany, NJ 07054 Establishment Registration No: 2242816 Contact: Vivian Kelly MS, RAC Regulatory Affairs Project Manager Biomet Spine 100 Interpace Parkway Parsippany, NJ 07054 Tel.: 973-299-9300 Fax: 973-257-0232 Email: Vivian.kelly@ebimed.com Date Prepared: June 16, 2008 Trade/Proprietary Name: Solitaire™ PEEK-Optima Anterior Spinal System Common/Usual Name: Spinal device Classification Name and Reference: Intervertebral body fusion device (21 CFR § 888.3080) Device Classification; 11 Device Panel/Product Code:
Orthopedic (87) MAX
Device Description :
The Solitaire™ Peek-Optima® Anterior Spinal System consists of a spacer with tantalum radiographic markers and bone screws for intervertebral body fusion. The spacer is PEEK with titanium inserts for the bone screw interface. The Solitaire™ Bone screws will be available in different versions of the the the the the the the the types.
Intended Use:
The Solitaire™ PEEK-Optima® 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 SI 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 nonoperative treatment.
Substantial Equivalence:
The Solitaire™ PEEK Optima Anterior Spinal System is substantially equivalent to its predicates for intervertebral body fusion in regards to intended use, design, materials, and operational principles. Examples of other predicate intervertebral body fusion devices distributed for the similar indications include the the Stryiker Spine AVS PL-PEEK Spacers (K073470 and K080758) and Synthes' SynFix™-LR (K072253) while the Solitaire™ Anterior Spinal System from Interpore Cross Intl and EBI LP (K022143 & K062810) and the Interpore Cross Expandable PEEK VBR Implant (K040928) have similar design festures. Based upon the mechanical testing, the Solitaire™ PEEK Optima Anterior Spinal System is substantially equivalent for its intended use to other spacers currently on the market.
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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: K081395
Trade/Device Name: Solitaire™ PEEK-Optima® Anterior Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: May 12, 2008 Received: May 19, 2008
Dear Ms. Kelly:
This letter corrects our substantially equivalent letter of June 25, 2008.
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. Melberm
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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510(k) Number (if known): K081395
Device Name: Solitaire™ PEEK-Optima® Anterior Spinal System
Indications for Use:
The Solitaire™ PEEK-Optima® Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at onc 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 since may since 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)
Sabine Brezin Forman
age 1 of 1
Division of General, Restorative, and Neurological Device
510(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.