(92 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 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 hody.
Here's an analysis of the provided text regarding the Stryker® iVAS, focusing on acceptance criteria and supporting studies:
This 510(k) submission (K130430) is for a modification to an existing device, the Stryker Inflatable Vertebral Augmentation System (iVAS), specifically an 11 Gauge balloon catheter. It's important to note that this is a submission for substantial equivalence to predicate devices, not a de novo clearance for a completely new device. This means the primary evidence relies on demonstrating that the new device performs as safely and effectively as previously cleared, similar devices, rather than presenting a novel clinical study to establish new performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness to Predicate Devices | Meets the specification and performance characteristics and is substantially equivalent to the predicate devices. The modified device is not technologically different than the predicate device. The modifications do not alter the intended use, indications for use, or the fundamental scientific technology of the predicate devices. Risk assessment (design and use FMEAs) determined no new questions of safety or effectiveness. |
| Intended Use/Indications for Use | Matches the predicate Stryker® iVAS 10 Gauge Balloon Catheter: reduction of fractures and/or creation of a void in cancellous bone in the spine, including during percutaneous vertebral augmentation, with cleared spinal PMMA bone cements. |
| Technological Characteristics | The products have the same fundamental scientific technology, basic design, functional characteristics, and the same clinical applications as predicate devices. |
Key takeaway: The acceptance criteria for this 510(k) are centered around demonstrating that the modified 11-gauge balloon catheter is substantially equivalent to the previously cleared 10-gauge iVAS balloon catheters. This means it must meet the same safety and performance profiles as those already on the market. The reported performance asserts that this substantial equivalence has been met through non-clinical testing and risk assessments.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable. No clinical testing (which would typically involve a "test set" of patients or samples) was deemed necessary for this 510(k) submission. The evaluation was based on non-clinical testing and comparison to predicate devices.
- Data Provenance: Not applicable. Since no clinical testing was performed, there is no patient data provenance (e.g., country of origin, retrospective/prospective). The data primarily comes from non-clinical bench testing conducted by Stryker Instruments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. There was no clinical ground truth established for a test set in this submission, as no clinical testing was performed.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Without a clinical test set requiring human interpretation or assessment, no adjudication method was employed.
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
- MRMC Study: No. This device is a physical medical instrument (an inflatable bone tamp/balloon catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI effect size are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No. As mentioned, this is a physical medical device, not an algorithm. Standalone performance studies are not applicable.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Type of Ground Truth: For the purpose of this 510(k), the "ground truth" is not a clinical diagnosis or outcome, but rather the established performance and safety characteristics of the predicate devices. The new device (11-gauge iVAS balloon catheter) is being compared against these known, legally marketed predicate devices through non-clinical testing. This implicitly relies on the original ground truth (clinical safety and effectiveness) that led to the approval of the predicate devices. The "ground truth" for the current submission is compliance with engineering specifications and performance metrics of the predicate devices based on bench testing and risk assessment.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is non-clinical testing, risk assessment (design and use FMEAs), and a substantial equivalence comparison to legally marketed predicate devices.
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Nature of the Study:
- Non-clinical testing: The document states, "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices." This refers to bench testing to verify material properties, dimensions, inflation characteristics, strength, durability, and other engineering specifications, ensuring the 11-gauge catheter performs identically or acceptably to the 10-gauge predicates.
- Risk Assessment: "Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971. Stryker has determined that the modifications to the predicate device raise no new questions of safety or effectiveness." This analysis demonstrates that the minor design changes (balloon wall thickness, spiral cut, color) do not introduce new risks or affect fundamental performance.
- Substantial Equivalence Comparison: The core of the submission is to demonstrate that the new 11-gauge device is "substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker® iVAS Balloon Catheters and the Kyphx Xpander Inflatable Bone Tamp." This involves a direct comparison of specifications, materials, and intended use.
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Proof: The combination of these non-clinical tests and risk assessments served as the evidence presented to the FDA to demonstrate that the modified device is as safe and effective as the predicate devices, thereby meeting the acceptance criteria for a 510(k) clearance based on substantial equivalence. The FDA's clearance letter (K130430, dated May 23, 2013) confirms their agreement with this assessment.
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MAY 2 3 2013
4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 269 324 5412 www.stryker.com
stryker
Instruments
510(k) Summary
1. Contact Details
Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 (p) 269-323-7700 (f) 269-389-5412
Christina McKee Christina.McKee@Stryker.com
February 13, 2013
2. Device Name
Trade Name: Stryker Inflatable Vertebral Augmentation System (iVAS)
Common Name: Inflatable Bone Tamp
Classification Name: Arthroscope Cement, Bone, Vertebroplasty
3. Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K113477 | HRX | Stryker® iVAS 20mm (10 Gauge) Balloon Catheter | Stryker Instruments |
| NDN | |||
| K103807 | HRX | Stryker® iVAS 10mm (10 Gauge) Balloon Catheter | Stryker Instruments |
| NDN | |||
| K093419 | HRX | Stryker® iVAS 15mm (10 Gauge) Balloon Catheter | Stryker Instruments |
| NDN |
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4. 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 the vertebral hody.
5. Intended Use/Indications for use
The Stryker iVAS Inflatable Vertebral Augmentation 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.
6. Substantial Equivalence Comparison
The Stryker® iVAS 11 Gauge Balloon Catheter has the same intended use/indications for use as the predicate Stryker® iVAS 10 Gauge Balloon Catheter.
Although the device incorporates modifications to the balloon wall thickness, the spiral cut on the stainless steel catheter tube, and the color of the proximal reflow and luer hub, the modifications do not alter the intended use, indications for use, or the fundamental scientific technology of the predicate devices.
Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971. Stryker has determined that the modifications to the predicate device raise no new questions of safety or effectiveness.
7. Non-clinical Testing
The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. The modified device is not technologically different than the predicate device.
8. Clinical Testing
No clinical testing was deemed necessary for this 510(k).
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9. Conclusions
The Stryker® iVAS (10mm and 15mm) 11 Gauge balloon catheters are substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker® iVAS Balloon Catheters and the Kyphx Xpander Inflatable Bone Tamp. The products have the same fundamental scientific technology, basic design, functional characteristics and the same clinical applications. The Stryker® iVAS balloon catheter does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker® (10mm and 15mm) 11 Gauge iVAS balloon catheters are equivalent to the existing predicate `devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: May 23, 2013
Stryker Corporation % Ms. Christina McKee Regulatory Affairs Associate Analyst 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K130430
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, HRX Dated: April 15, 2013 Received: April 19, 2013
Dear Ms. McKee:
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. Christina McKee -
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Mark Nimelkerson -S
Mark N. Melkerson Director Division of Orthopedic 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 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 indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Prescription Use ___________X
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)
Laurence D! (Soyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130430
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.