(146 days)
The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:
Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.
This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
The screws and washers that are the subject components of this submission are modified DISCOVERY® System screws and washers that are available in various geometries and sizes. Manufactured from ASTM F 136 implant grade titanium alloy.
The provided text describes the 510(k) summary for the VIPER® F2 Facet Fixation System. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical mechanical testing, rather than device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from this document in the typical sense of AI/medical device performance evaluation.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way a diagnostic AI device summary would. Instead, the "device performance" is demonstrated through nonclinical mechanical testing and comparison to predicate devices, implying that if the device performs comparably to legally marketed devices, it meets the unstated "acceptance criteria" for safety and effectiveness.
Nonclinical Test Summary and Implied Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity under static compression bending (similar to predicate) | Device underwent static compression bending in accordance with ASTM F1798. (Performance results not explicitly stated, but deemed substantially equivalent to predicates.) |
| Mechanical integrity under dynamic compression bending (similar to predicate) | Device underwent dynamic compression bending in accordance with ASTM F1798. (Performance results not explicitly stated, but deemed substantially equivalent to predicates.) |
| Mechanical integrity under static three-point bending (similar to predicate) | Device underwent static three-point bending in accordance with ASTM F1798. (Performance results not explicitly stated, but deemed substantially equivalent to predicates.) |
| Mechanical integrity under dynamic three-point bending (similar to predicate) | Device underwent dynamic three-point bending in accordance with ASTM F1798. (Performance results not explicitly stated, but deemed substantially equivalent to predicates.) |
| Equivalence in materials, manufacturing methods, sterility, biocompatibility, safety, and packaging design to predicate devices. | Stated as a basis for substantial equivalence comparison. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the study did not involve a test set of data points (e.g., medical images, patient records) for evaluation of the device's diagnostic or predictive performance. The "testing" involved mechanical benchmarks of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is an implantable medical device, not an AI or diagnostic tool requiring ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1798).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There was no clinical test set or human interpretation involved that would require an adjudication method.
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
There was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the nonclinical mechanical testing was based on engineering standards (ASTM F1798) for evaluating spinal arthrodesis implants.
8. The sample size for the training set
This information is not applicable. There was no training set involved as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable. There was no training set.
Summary of the Study:
The study proving the device meets acceptance criteria was a nonclinical mechanical testing program involving static and dynamic compression bending, and static and dynamic three-point bending, all conducted in accordance with ASTM F1798. The intent was to demonstrate that the modified components of the VIPER® F2 Facet Fixation System perform mechanically comparably to its predicate devices. No clinical tests were performed. The FDA's substantial equivalence determination was based on this nonclinical testing and comparison of intended use, design, materials, manufacturing methods, performance, sterility, biocompatibility, safety, and packaging design to legally marketed predicate devices.
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K101762
5. 510(K) SUMMARY
.
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767NOV 15 2010 |
|---|---|
| Contact Person: | Frank JurczakSr. Regulatory Affairs AssociateVoice: (508) 828-3288Fax: (508) 828-3797E-Mail: fjurczak@its.jnj.com |
| Date Prepared: | October 21, 2010 |
| Device Class: | Unclassified |
| Classification Name: | N/A |
| Classification Panel: | Orthopedics |
| FDA Panel Number: | 87 |
| Product Code(s): | MRW |
| Proprietary Name: | VIPER® F2 Facet Fixation System |
| Predicate Devices: | DISCOVERY Facet Screw Fixation System (K012773)PERPOS FCD-2 System (K090767)Capture Facet Screw System (K092464)Facet Fixation System (K061041)Triad Facet Screw System (K020411)Chameleon Fixation System (K071420)VIPER System (K041801) |
| Device Description: | The screws and washers that are the subject components of thissubmission are modified DISCOVERY® System screws andwashers that are available in various geometries and sizes. |
| Intended Use: | The VIPER® F2 Facet Fixation System is intended to stabilize thespine as an aid to fusion by the transfacet fixation method only: |
| Transfacet fixation: - The screws are inserted bilaterally throughthe superior side of the facet, across the facet joint and into theinferior pedicle. | |
| This system is indicated for the posterior surgical treatment of anyor all of the following at the L1 to S1 (inclusive) spinal levels: 1) |
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K101 762
Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis: 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
Manufactured from ASTM F 136 implant grade titanium alloy. Materials:
Comparison to
The substantial equivalence of the subject devices to the predicates Predicate Device: identified above is based upon the equivalence of intended use, design (fundamental scientific technology), materials, manufacturing methods, performance, sterility, biocompatibility, safety and packaging design.
Nonclinical Test Summary:
The following mechanical tests were conducted:
- Static compression bending in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
- Dynamic compression bending in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
- Static Three-Point bending in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
- Dynamic Three-Point bending in accordance with ASTM . F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants".
Clinical Test Summary:
No clinical tests were performed.
Conclusion:
Based on the predicate comparison and testing, the subject modified components of the DISCOVERY® System (marketed as the VIPER® F2 Facet Fixation System) are substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
DePuy Spine, Inc. % Mr. Frank Jurczak Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K101762
Trade/Device Name: VIPER®F2 Facet Fixation System Regulatory Class: Unclassified Product Code: MR W Dated: October 21, 2010 Received: October 22, 2010
Dear Mr. Jurczak:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
NOV 1 5 2010
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Page 2 – Mr. Frank Jurczak
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.
Barbara Buchm
Mark N. Melkerso 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 1.
NOV 1 5 2010
510(k) Number (if known): K101762
Device Name: VIPER® F2 Facet Fixation System
Indications For Use:
The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:
Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.
This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
x Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
_
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
N/A