(342 days)
The Synthes XRL device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synthes XRL device is intended to be used with Synthes supplemental internal fixation systems (e.g., USS, including Matrix and Pangea, and TSLP). The interior of Synthes XRL can be packed with bone (i. e., autograft or allograft). The Synthes XRL device is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Synthes XRL System is an addition to Synthes' existing thoracolumbar vertebral body replacement systems. These implants are designed to replace a collapsed, damaged or unstable vertebral body and provide anterior spinal column support. These additional implants include telescoping cylindrical components with spiked endplates to grip the adjacent vertebral bodies. These devices are manufactured from PEEK (ASTM F1579-02e1 and ASTM D 6262) with titanium (ASTM F 1295) locking rings and stop pins and tantalum (ASTM F 560) radiopaque markers.
Here's a breakdown of the acceptance criteria and study information for the Synthes XRL System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Outcome) |
|---|---|
| Static Axial Compression | Substantially equivalent to predicate devices |
| Dynamic Axial Compression | Substantially equivalent to predicate devices |
| Static Axial Torsion | Substantially equivalent to predicate devices |
| Dynamic Axial Torsion | Substantially equivalent to predicate devices |
| Expulsion | Substantially equivalent to predicate devices |
| VBR Height-Locking Test | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set. It mentions "bench testing results," which implies laboratory-based tests of the device itself rather than patient data. Therefore, the data provenance is likely in-vitro testing and not retrospective or prospective patient data. No country of origin for the data is specified beyond it being performed by Synthes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The testing involved bench testing against established ASTM standards (ASTM F2077 and ASTM F1717). The "ground truth" would be the performance requirements set forth in these standards. The individuals conducting and analyzing these engineering tests would be qualified engineers or technicians, but their specific number and detailed qualifications are not provided.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation. Since this was bench testing, no such adjudication method would have been used. The results would be objectively measured against the ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical data and conclusions were not needed for this device." Therefore, an MRMC comparative effectiveness study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not relevant as the device is a physical vertebral body replacement system, not a software algorithm. The "performance" refers to the mechanical integrity and function of the implant itself.
7. Type of Ground Truth Used
The ground truth used for the device's performance assessment was based on ASTM standards (ASTM F2077 and ASTM F1717), which define the mechanical properties and performance requirements for spinal implants.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here. This device underwent bench testing, not machine learning algorithm development.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, a training set is not relevant for this type of device and study.
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K IO3320
PAGE 1 OF 2
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes USA1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Heather GuerinSr. Regulatory Affairs SpecialistTelephone: 610-719-5432Facsimile: 610-719-5102Email: guerin.heather@synthes.com |
| Date Prepared: | September 6, 2011 |
| Trade Name: | Synthes XRL System |
| Classification: | 21 CFR 888.3060-Spinal intervertebral body fixation orthosisClass IIOrthopedic and Rehabilitation Devices PanelProduct Code: MQP |
| Predicates: | Synthes SynMesh Spacer System (K003275)Synthes Synex System (K003836)Synthes Contoured SynMesh (K041389)Alphatec NOVEL VBR Spinal System (K050553)Synthes Oracle Spacer System (K062933) |
| DeviceDescription: | The Synthes XRL System is an addition to Synthes' existingthoracolumbar vertebral body replacement systems. These implants aredesigned to replace a collapsed, damaged or unstable vertebral bodyand provide anterior spinal column support. These additional implantsinclude telescoping cylindrical components with spiked endplates to gripthe adjacent vertebral bodies. These devices are manufactured fromPEEK (ASTM F1579-02e1 and ASTM D 6262) with titanium (ASTM F1295) locking rings and stop pins and tantalum (ASTM F 560) radiopaquemarkers. |
| Intended Use/Indications forUse: | The Synthes XRL device is a vertebral body replacement device intendedfor use in the thoracolumbar spine (T1-L5) to replace a collapsed,damaged or unstable vertebral body due to tumor or trauma (i.e.,fracture). The Synthes XRL device is intended to be used with Synthessupplemental internal fixation systems (e.g., USS, including Matrix andPangea, and TSLP). The interior of Synthes XRL can be packed withbone (i. e., autograft or allograft).The Synthes XRL device is designed to provide anterior spinal columnsupport even in the absence of fusion for a prolonged period. |
| 510(k) Summary | |
| Comparison ofthe device topredicatedevice(s): | The Synthes XRL System is a result of design modifications to predicatedevices. It is substantially equivalent to the predicates in design, function,material and intended use. |
| PerformanceData | Synthes performed the following testing based on ASTM F2077 andASTM F1717:• Static and Dynamic Axial Compression• Static and Dynamic Axial Torsion• Expulsion• VBR Height-Locking TestBench testing results demonstrate that the Synthes XRL System issubstantially equivalent to the predicate devices. Clinical data andconclusions were not needed for this device. |
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K103320 PAGE 2 OF 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three curved lines representing snakes or streams, and a base element that could be interpreted as a staff or a bowl.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Synthes USA % Ms. Heather Guerin Sr. Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K103320
Trade/Device Name: Synthes XRL System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 14, 2011 Received: October 17, 2011
Dear Ms. Guerin:
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 cranbe 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 not the Act
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Page 2 - Ms. Heather Guerin
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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 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 Statement 4
510(k) Number: K103320 ______________________________________________________________________________________________________________________________________________________________________ (if known)
Device Name: Synthes Synthes XRL System
Indications for Use:
The Synthes XRL device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synthes XRL device is intended to be used with Synthes supplemental internal fixation systems (e.g., USS, including Matrix and Pangea, and TSLP). The interior of Synthes XRL can be packed with bone (i. e., autograft or allograft).
The Synthes XRL device is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
| Prescription Use | X |
|---|---|
| (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
KIO3320 510(k) Number___
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.