(44 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 body.
This document, K113477, is a 510(k) summary for the Stryker® iVAS Balloon Catheter, seeking clearance for a modification to a previously cleared device. As such, the study described is primarily focused on demonstrating substantial equivalence to predicate devices through functional and biocompatibility testing, rather than a clinical trial with acceptance criteria for disease detection or diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for each test or detailed performance metrics in a table format as might be seen for a diagnostic device. Instead, it makes a general statement of compliance and equivalence.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Testing (e.g., Insertion and Retraction Force, Force to Puncture, Burst, Simulated Use) | Meets specified performance characteristics and is substantially equivalent to predicate devices. (Implies meeting established engineering specifications for safety and effectiveness, and performing comparably to the predicate devices). | "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are 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 simulated use." |
| Biocompatibility | Meets applicable requirements of FDA Blue Book Memorandum G95-1 and ISO-10993 Part -1. (Implies no unacceptable biological reactions and safe for contact with the body). | "Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing and are biocompatible." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the tests (functional or biocompatibility). It also does not discuss data provenance in terms of country of origin or whether it was retrospective or prospective, as these are typically not relevant for benchtop and biocompatibility testing for medical device clearance of this nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of testing described. The document pertains to engineering performance and biocompatibility of a medical device, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 medical device clearance for a physical catheter, not an AI or imaging diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used
For functional testing, the "ground truth" would be established engineering specifications, safety standards, and performance benchmarks derived from the predicate devices. For biocompatibility, the ground truth is defined by the requirements of the FDA Blue Book Memorandum G95-1 and ISO-10993.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not an AI/machine learning model that undergoes training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
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JAN - 6 2012
stryker
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4100 E. Milham Avenue Kalamazoo. MI 49001
t: 269 323 7700 f: 269 324 5412 www.stryker.com
ﺗ
Instruments
510(k) Summary
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
|---|---|
| Contact Person: | Christina McKee |
| 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 indicated for use duringpercutaneous vertebral augmentation procedures, such as kyphoplasty. |
| Testing: | The Stryker® iVAS balloon catheter meets the specification and performancecharacteristics and are substantially equivalent to the predicate devices. Thetesting which was conducted included functional testing, such as insertion andretraction force, force to puncture, burst and simulated 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 and Testing and are biocompatible. |
| Substantial Equivalence(SE) Rational: | The Stryker® iVAS balloon catheter is substantially equivalent in intended use,technological characteristics, safety, and effectiveness to the Stryker® iVASBalloon Catheter and the Kyphx Xpander Inflatable Bone Tamp. The productshave the same fundamental scientific technology, basic design, functionalcharacteristics and the same clinical applications. |
| Safety and Effectiveness: | The Stryker® iVAS balloon catheter does not raise any new safety and efficacyconcerns when compared to a similar device already legally marketed.Therefore, the Stryker® iVAS balloon catheter is equivalent to the existingpredicate devices. |
| Submitted by: | Christina McKee |
| Regulatory Affairs Associate Analyst | |
| Signature |
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Instruments
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Date Submitted:
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 6 2012
Stryker Instruments % Ms. Christina McKee Regulatory Affairs Supervisor 4100 E. Milham Ave Kalamazoo, Michigan 49001
Re: K113477
Trade Name: iVAS 20mm (10 Gauge) Balloon Catheter Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: November 22, 2011 Received: November 23, 2011
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
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Page 2 - Ms. Christina McKee
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.
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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510(K) Number (if known):
Device Name: Stryker Inflatable Vertebral Augmentation System (iVAS)
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. assed for the rouation of necessor overtebral augmentation. The system is to be used with cleared spinal Polymethacrylate (PMMA) bone cements 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)
Division Sign-Off)
(DK43 Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113477
§ 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.”