(87 days)
The VLIFT -s system is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectorny procedures due to tumor or trauma (i.e., fracture).
For both corpectorny and vertebrectorny procedures, VLIFT -s system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT -s system include, but are not limited to, Stryker Spine plate or rod systems (e.g., Xia Spinal System, Radius® Spinal System, Mantis® Percutaneous Spinal System, Thore Plating System, Trio +Spinal System). The use of bone graft with VLIFT® -s system is optional.
The VLIFT®-s Distractible In-situ (DIS) Vertebral Body Replacement system is intended for use as an aid in spinal fusion and consists of a single, pre-assembled distractible implant. The hollow cylindrical center may be adjusted continuously via an inner concentric ring. The hollow core of the cage allows for packing bone graft. The use of bone graft with VLIFT®-s is optional. As the implant is distracted via its inner concentric ring, additional, slotted openings appear.
The VLIFT®-s cages are available in various diameters and heights.
Modular end caps snap into each end of the VLIFT®-s implant. Serrated teeth at the rim of the end cap attachments help to anchor the implant to the end plates of the vertebral bodies. The VLIFT®-s end caps are available in both flush and contoured designs and are offered in a variety of angles.
Extension pieces are available for each diameter for the VLIFT®-s implants. Extension pieces may be used to achieve the desired height. The use of extension pieces is optional.
The provided text is a 510(k) summary for the Stryker Spine VLIFT®-s Vertebral Body Replacement System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, primarily based on material, design, indications for use, and mechanical performance.
However, this document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of clinical outcomes or diagnostic accuracy. It is a regulatory submission demonstrating substantial equivalence to previously approved devices for mechanical performance, not a clinical trial report or a diagnostic accuracy study.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated based on the document, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states: "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s issued May 3, 2004 was completed for the Stryker Spine VLIFT®-s Vertebral Body Replacement System." This indicates that mechanical and material testing against established guidance was done, but the specific acceptance criteria (e.g., specific load ultimate strength, fatigue life cycles) and the quantitative results are not included in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The summary mentions "testing... was completed," which refers to mechanical testing of the implants themselves, not a clinical study on human subjects. Therefore, terms like "test set" in the context of clinical data, data provenance, or retrospective/prospective study design are not applicable here.
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)
- Not applicable. This question pertains to clinical or diagnostic studies where expert consensus is used to establish ground truth for human-reviewed data. The provided document concerns a medical device's mechanical substantial equivalence, not a diagnostic algorithm or a clinical trial with human subjects.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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
- Not applicable. This is a physical medical implant, not an AI or diagnostic imaging device. No MRMC study was performed as it's outside the scope of this device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The ground truth for this device's testing would be defined by engineering standards. For example, the "ground truth" for fatigue testing would be the number of cycles to failure under specified loads, and for ultimate strength, it would be the maximum load sustained before failure. This is not clinical ground truth.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary: The provided 510(k) summary is a regulatory document addressing the substantial equivalence of a physical medical implant (Vertebral Body Replacement System) to predicate devices, primarily based on engineering and material characteristics. It explicitly states that "Documentation is provided which demonstrates the Stryker Spine VLIFT®-s Vertebral Body Replacement System to be substantially equivalent to its predicate devices in terms of its material, design, indications for use, and mechanical performance" and that "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k) 's issued May 3, 2004 was completed". This indicates that the "acceptance criteria" and "study" are focused on mechanical engineering and material property testing against FDA guidance, not clinical or diagnostic performance evaluated with human subjects or AI algorithms. The details of these engineering tests (specific criteria, results, sample sizes of test specimens) are not included in this summary.
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Stryker Spine VLIFT®-s System
Traditional 510(k) Premarket Notification
SEP 2 5 2009
ー -
510(k) Summary: Stryker Spine VLIFT -s Vertebral Body Replacement System
| Submitter: | Stryker Spine |
|---|---|
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Ms. Kimberly Lane |
| Regulatory Affairs Specialist | |
| Phone: 201-760-8215 | |
| FAX: 201-760-8415 | |
| Email: Kimberly.lane@stryker.com | |
| Date Prepared | June 26, 2009 |
| Trade Name | Stryker Spine VLIFT®-s Vertebral Body Replacement System |
| Proposed Class | Class II |
| Classification Nameand Number | Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060 |
| Product Code | MQP |
| Predicate Devices | Stryker Spine VLIFT® Vertebral Body Replacement System[K060506], DePuy X-MESHTM Expandable Cage System [K080568],Synthes Spine Synex TM II Spacer [K061891],Surgical Dynamics™ Mesh Cage System, [K003709] andDePuy AcroMed Surgical Titanium Mesh™ [K003043]Product Code MQP, Class II |
| Device Description | The VLIFT®-s Distractible In-situ (DIS) Vertebral Body Replacementsystem is intended for use as an aid in spinal fusion and consists of asingle, pre-assembled distractible implant. The hollow cylindricalcenter may be adjusted continuously via an inner concentric ring. Thehollow core of the cage allows for packing bone graft. The use of bonegraft with VLIFT®-s is optional. As the implant is distracted via itsinner concentric ring, additional, slotted openings appear.The VLIFT®-s cages are available in various diameters and heights. |
| Modular end caps snap into each end of the VLIFT®-s implant. | |
| Serrated teeth at the rim of the end cap attachments help to anchor the | |
| implant to the end plates of the vertebral bodies. The VLIFT®-s end | |
| caps are available in both flush and contoured designs and are offered | |
| in a variety of angles. | |
| Extension pieces are available for each diameter for the VLIFT®-s | |
| implants. Extension pieces may be used to achieve the desired height. | |
| The use of extension pieces is optional. | |
| Intended Use | The VLIFT®-s system is a device intended to replace a vertebral body |
| or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) | |
| to replace a collapsed, damaged, or unstable vertebral body or vertebra | |
| resected or excised during total and partial corpectomy and | |
| vertebrectomy procedures due to tumor or trauma (i.e., fracture). | |
| For both corpectomy and vertebrectomy procedures, VLIFT®-s system | |
| is intended to be used with supplemental internal fixation systems. The | |
| supplemental internal fixation systems that may be used with VLIFT®- | |
| s system include, but are not limited to, Stryker Spine plate or rod | |
| systems (e.g., Xia® Spinal System, Radius® Spinal System, Mantis® | |
| Percutaneous Spinal System, Thor® Plating System, Trio®+Spinal | |
| System). The use of bone graft with VLIFT®-s system is optional. | |
| Summary of the | Documentation is provided which demonstrates the Stryker Spine |
| Technological | VLIFT®-s Vertebral Body Replacement System to be substantially |
| Characteristics | equivalent to its predicate devices in terms of its material, design, |
| indications for use, and mechanical performance. Testing to | |
| demonstrate compliance with FDA's Guidance for Spinal System | |
| 510(k) 's issued May 3, 2004 was completed for the Stryker Spine | |
| VLIFT®-s Vertebral Body Replacement System. |
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Stryker Spine VLIFT®-s System
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 with three curved lines representing its wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Spine % Ms. Kimberly Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
SEP 2 5 2009
Re: K091946
Trade/Device Name: Stryker Spine VLIFT®-s Vertebral Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 26, 2009 Received: June 30, 2009
Dear Ms. Lane:
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.
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 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.
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Page 2 - Ms. Kimberly Lane
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
laubare michm
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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Traditional 510(k) Premarket Notification
Stryker Spine VLIFT -s System
Indications for Use
510(k) Number (if known): K C 9 194 G
Device Name: Stryker Spine VLIFT -s Vertebral Body Replacement System
Indications For Use:
The VLIFT -s system is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectorny procedures due to tumor or trauma (i.e., fracture).
For both corpectorny and vertebrectorny procedures, VLIFT -s system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT -s system include, but are not limited to, Stryker Spine plate or rod systems (e.g., Xia Spinal System, Radius® Spinal System, Mantis® Percutaneous Spinal System, Thore Plating System, Trio +Spinal System). The use of bone graft with VLIFT® -s system is optional.
AND/OR Prescription Use_ (Part 21 CFR 801 Subpart D)
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)
Page 1 of
§ 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.