(90 days)
The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.
The provided text is a 510(k) summary for the Stryker® iVAS Balloon Catheter, intended for use in vertebral augmentation procedures. It primarily details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the information provided, no specific acceptance criteria or detailed study results proving the device meets these criteria are present in the document in the format you requested.
The document states:
- "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and is substantially equivalent to the predicate devices."
- "The testing which was conducted included functional testing, such as insertion and retraction force, force to puncture, burst and stimulated use."
- "Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1... and is biocompatible."
However, these are high-level statements and do not provide:
- A table of acceptance criteria and reported device performance: While functional tests are mentioned, no specific acceptance values (e.g., minimum or maximum force, burst pressure thresholds) or the actual results achieved (e.g., specific force values, pressure at burst) are provided.
- Sample sizes used for the test set and data provenance: No information is given on the number of devices tested for any of the functional tests.
- Number of experts used to establish the ground truth for the test set and their qualifications: This is not relevant for the type of bench testing described (e.g., insertion force, burst pressure).
- Adjudication method: Not applicable for engineering bench tests.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted, as this is a medical device (catheter) and not an AI or imaging diagnostic tool that would typically involve human readers.
- Standalone performance (algorithm only): Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used: For physical performance tests, the "ground truth" would be the measured physical properties against established engineering specifications. These specifications are not detailed.
- Training set sample size: No training data is applicable for this type of device and testing.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on regulatory submission for substantial equivalence based on bench testing and biocompatibility, rather than a detailed report of clinical or advanced performance study results with specific acceptance criteria and outcome data.
Therefore, I cannot populate the table or provide the requested details using the given text. The text confirms that testing was performed, and the device met its specifications and performance characteristics, thus establishing substantial equivalence to predicate devices, but it does not detail these specifications or results.
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4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 ff: 269 324 5412
www.stryker.com
・・
JAN 2 4 2012
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Instruments
| 510(k) Summary | |
|---|---|
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
| Contact Person: | Meghan Arreaza |
| Registration No.: | 1811755 |
| Trade Name: | Stryker® iVAS Balloon Catheter |
| Common Name: | Inflatable Bone Tamp |
| Classification Name: | ArthroscopeCement, Bone, Vertebroplasty |
| Regulation Number: | §888.1100§888.3027 |
| Product Code: | HRXNDN |
| Predicate Device: | Stryker® iVAS Balloon Catheter (K103807)Stryker® iVAS Balloon Catheter (K093419)Kyphx Xpander Inflatable Bone Tamps (K041454) |
| Device Description: | The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component(balloon) at the distal end. The balloon is inflated to create a void within thevertebral body. |
| Indications for Use: | The Stryker® iVAS Inflatable Vertebral Augmentation System (system) isintended to be used for the reduction of fractures and/or creation of a void incancellous bone in the spine. This includes use during percutaneous vertebralaugmentation. The system is to be used with cleared spinalPolymethylmethacrylate (PMMA) bone cements and Cortoss® BoneAugmentation Material indicated for use during percutaneous vertebralaugmentation procedures, such as kyphoplasty. |
| Testing | The Stryker® iVAS balloon catheter meets the specification and performancecharacteristics and is substantially equivalent to the predicate devices. Thetesting which was conducted included functional testing, such as insertion andretraction force, force to puncture, burst and stimulated use. |
| Biocompatibility: | Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that thedevice meets the applicable requirements of the FDA Blue Book MemorandumG95-1 entitled Use of International Standards ISO 10993 Biological Evaluation ofMedical Devices Part 1: Evaluation of Testing and is biocompatible. |
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Instruments
Substantial Equivalence (SE) Rational:
The Stryker® iVAS balloon catheter is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker® iVAS balloon catheters and the Kyphx Xpander Bone Tamps. The products have the same functional scientific technology, basic design, functional characteristics and the same clinical applications.
Safety and Effectiveness:
The Stryker® iVAS balloon catheter does not raise any new safety and efficacy concerns when compared to a similar devices already legally marketed. Therefore, the Stryker® iVAS balloon catheter is equivalent to the existing devices.
Submitted by:
Meghan Arreaza
21 Oct 2011
Regulatory Affairs Representative
Mlykm Aulaja
Signature
Date Submitted:
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Styker Instruments % Ms. Meghan Arreaza Regulatory Affairs Representative 4100 East Milham Avenue Kalamazoo, Michigan 49001
JAN 2 4 2012
Re: K113154
Trade/Device Name: Stryker Inflatable Vertebral Augmentation System (IVAS) Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: October 21, 2011 Received: October 26, 2011
Dear Ms. Arreaza:
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 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
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Page 2 - Ms. Meghan Arreaza
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 vours,
Mark N. Me 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): ____________________________________________________________________________________________________________________________________________________
Device Name: Stryker Inflatable Vertebral Augmentation System (iVAS)
Indications for Use
The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be The Ourylore NAO Innatable tress and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Android opinal - el indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
and/or
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(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)
Signature (Sign Off)
(Division Sign-Off) (DWision Sign-Only)
Division of Surgical, Orthopedic, Division of Surges and Restorative Devices
510(k) Number K113154
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”