(59 days)
The SynFixTM-LR is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFixTM-LR can be packed with autograft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Synthes SynFixTM-LR is a combination radiolucent and radiopaque intervertebral body fusion device. Four screws are inserted through the anteriorly-located plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism. The Synthes SynFixTM-LR is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
The provided text describes a 510(k) premarket notification for the Synthes SynFixTM-LR intervertebral body fusion device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study with acceptance criteria and performance metrics in the same way an AI/ML device would.
Therefore, many of the requested fields regarding acceptance criteria, study details, expert involvement, and ground truth establishment are not applicable. The information provided focuses on non-clinical (bench) testing to demonstrate mechanical equivalence.
Here's a breakdown of the available information:
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Table of acceptance criteria and the reported device performance:
Not applicable (N/A). The submission is for an intervertebral body fusion device, not an AI/ML device. The "Performance Date (Nonclinical and/or Clinical)" section states: "Bench testing results demonstrate that the Synthes SynFix™-LR is substantially equivalent to the predicate devices." No specific numerical acceptance criteria or performance metrics are provided in the summary. -
Sample size used for the test set and the data provenance:
N/A. No test set for an AI/ML algorithm is mentioned. The testing was "bench testing." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. Ground truth establishment by experts is not relevant for bench testing of a physical medical device. -
Adjudication method for the test set:
N/A. Not relevant for bench testing of a physical medical device. -
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:
N/A. This is not an AI/ML device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This is not an AI/ML device. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
N/A. The "ground truth" for this device would be its mechanical and material properties meeting established standards or being equivalent to the predicate device's properties as determined through bench testing. -
The sample size for the training set:
N/A. There is no training set for a physical medical device. -
How the ground truth for the training set was established:
N/A. There is no training set for a physical medical device.
Summary of available information:
- Acceptance Criteria/Performance: The device met the "substantial equivalence" criteria through bench testing. No specific numerical values or acceptance ranges are provided in the summary.
- Study Type: Non-clinical bench testing.
- Clinical Data: "Clinical data and conclusions were not needed for this device." This statement clarifies that no human clinical trials were required for this 510(k) submission.
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007 1 2 2007
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Susan LewandowskiManager, Spine Regulatory AffairsTelephone: 610-719-5712 Facsimile: 610-719-5102Email: lewandowski.susan@synthes.com |
| Date Prepared: | September 14, 2007 |
| Trade Name: | Synthes SynFixTM-LR |
| Classification: | 21 CFR 888.3080 - Intervertebral body fusion deviceClass II (special controls)Orthopaedic and Rehabilitation Devices Panel (87)Product Code MAX (orthosis, spinal intervertebral fusion) |
| Predicates: | K062083 Synthes SynFixTM-LRP950002 BAK Intervertebral Body Fusion Device |
| Device Description: | The Synthes SynFixTM-LR is a combination radiolucent and radiopaqueintervertebral body fusion device. Four screws are inserted through theanteriorly-located plate into the adjacent vertebral bodies. The screws locksecurely to the plate using a tapered-thread locking mechanism.The Synthes SynFixTM-LR is available as assembled components invarious heights and geometries to suit individual pathology and anatomicalconditions. |
| Intended Use/Indications for Use: | The Synthes SynFixTM-LR is a stand-alone anterior interbody fusiondevice indicated for use in patients with degenerative disc disease (DDD)at one or two contiguous levels from L2 to S1. These DDD patients mayalso have up to Grade I spondylolisthesis at the involved level(s). Theinterior of the spacer component of the SynFixTM-LR can be packed withautograft.DDD is defined as back pain of discogenic origin with degeneration of thedisc confirmed by history and radiographic studies. These patients shouldbe skeletally mature and have had six months of non-operative treatment. |
| Comparison of thedevice to predicatedevice(s): | The Synthes SynFixTM-LR is substantially equivalent to the predicates indesign, function, material, and intended use. |
| Performance Date(Nonclinical and/or | Non-Clinical Performance and Conclusions: |
| Clinical): | Bench testing results demonstrate that the Synthes SynFix™-LR issubstantially equivalent to the predicate devices. |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
.
5 510(k) Summary – Revised 09/2007
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes Spine % Ms. Susan Lewandowski Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, PA 19380
SEP 1 2 2011
Re: K072253
Trade/Device Name: SynFix™-LR Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 17, 2007 Received: September 18, 2007
Dear Ms. Lewandowski:
This letter corrects our substantially equivalent letter of October 12, 2007.
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.
Sincerely yours,
Mark A. Mulkerson
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): K072253
Device Name: SynFix™-LR
Indications For Use:
The SynFix-LR device is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from 12 to Sl. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix-LR can be packed with autograft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Prescription Use AND/OR Over-The-Counter Use ਮ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bucklin
Restorative. and Neurological Devices
510(k) Number K072253
§ 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.