(104 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 with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma.
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 K123942 submission for the Stryker® iVAS Balloon Catheter is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared devices rather than prove novel safety and effectiveness through extensive new clinical trials. Therefore, the information typically associated with acceptance criteria and a detailed study proving performance (like in a PMA submission) will be limited. This type of submission relies heavily on non-clinical testing and comparison to predicates.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, "acceptance criteria" are generally based on meeting the performance characteristics demonstrated by the legally marketed predicate devices through bench testing. The "reported device performance" refers to the results of the non-clinical tests that show the new device performs similarly.
| Acceptance Criterion (Based on Predicate Performance) | Reported Device Performance (Stryker® iVAS Balloon Catheter) |
|---|---|
| Material Properties: Equivalent to predicate devices. | Demonstrated through engineering testing, ensuring materials meet specified standards. |
| Functional Performance (Balloon Inflation/Void Creation): Capable of reducing fractures and creating a void in cancellous bone. | Achieved through bench testing, verifying the inflatable component's ability to inflate and create a void as intended. |
| Biocompatibility: Compliant with biocompatibility standards (implied by predicate equivalence). | Addressed in previous 510(k)s (K113477, K103807, K093419) and presumed to be met. |
| Sterility: Sterilized and maintained sterility (implied by predicate equivalence). | Addressed in previous 510(k)s and presumed to be met. |
| Durability/Reliability: Maintains integrity during intended use (implied by predicate equivalence). | Addressed in previous 510(k)s and presumed to be met. |
| Removal of Contraindication "Fractures in which more than 68% of vertebral height is lost": Bench testing to justify this specific change. | Bench testing performed to support the removal of this contraindication. Specific performance metrics are not detailed in this summary but would have been part of the full submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" for clinical evaluation because no clinical testing was deemed necessary for this submission. The "test set" would primarily refer to samples used in non-clinical bench testing. The document states: "Bench testing was performed for the removal of the contraindication 'Fractures in which more than 68% of vertebral height is lost.'" The specific number of devices or scenarios used for this bench testing is not provided in this summary.
- Data Provenance: The data provenance is primarily from non-clinical bench testing performed by Stryker Instruments. The country of origin for the data is implied to be the United States (Stryker Instruments is based in Kalamazoo, Michigan). The data is prospective in the sense that the bench tests were conducted specifically for this submission or its predicate submissions to demonstrate performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For a 510(k) based on substantial equivalence and non-clinical testing, expert-established "ground truth" derived from clinical data is not a primary component. The "ground truth" for non-clinical testing is typically defined by engineering specifications and objective measurements against those specifications.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since no clinical "test set" requiring expert review for ground truth was used, there was no adjudication method employed in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used to assess the impact of a device (often an AI-powered diagnostic tool) on human reader performance, which is not relevant for this medical device (an inflatable bone tamp).
- Effect Size: N/A, as no such study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The Stryker® iVAS Balloon Catheter is a physical medical device, not a standalone algorithm or software. Therefore, the concept of "standalone performance" in this context does not apply.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical testing, the "ground truth" would be established by engineering design specifications, material standards, and objective physical measurements (e.g., balloon inflation pressure, volume, tamp strength, void creation dimensions). For instance, if testing the removal of the contraindication regarding vertebral height loss, the ground truth would be the measurable performance of the device in various simulated fracture scenarios as defined by mechanical engineering principles.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. Since there is no training set, there is no ground truth to establish for it.
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stryker®
Instruments
APR 0 3 2013
510(k) Summary
1. Contact Details
4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 269 324 5412
Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 (p) 269-323-7700 (f) 269-389-5412
Christina McKee Christina.McKee@Stryker.com
December 7, 2012
2. Device Name
Trade Name: Stryker® iVAS Balloon Catheter
Common Name: Inflatable Bone Tamp
Classification Name: Arthroscope Cement, Bone, Vertebroplasty
Regulation Number: 8888.1100 §888.3027
3. Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K113477 | HRX | Stryker® iVAS BalloonCatheter | Stryker Instruments |
| K103807 | HRX | Stryker® iVAS BalloonCatheter | Stryker Instruments |
| K093419 | HRX | Stryker® iVAS BalloonCatheter | Stryker Instruments |
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| K110998 | HRXNDN. | AFFIRM™ VCF System | Algea Therapies |
|---|---|---|---|
| K041454 | HRX | Xpander Inflatable BoneTamps | Kyphon Inc. |
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 body.
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 with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma.
| Stryker® iVASBalloon Catheter | Stryker® iVASBalloon Catheter(Predicates)Indications for Use | AFFIRM™ VCFSystem | XpanderInflatableBone Tamps | Comparison |
|---|---|---|---|---|
| The Stryker® iVASInflatable VertebralAugmentation System(system) is intended tobe used for thereduction of fracturesand/or creation of avoid in cancellousbone in the spine. Thisincludes use duringpercutaneous vertebralaugmentation withCortoss ® and clearedspinal | The Stryker iVASInflatable VertebralAugmentationSystem (system) isintended to be used forthe reduction offractures and/orcreation of a void incancellous bone in thespine. This includes useduring percutaneousvertebral augmentation.The system is to beused with cleared spinalPolymethylmethacrylate (PMMA) bonecements and Cortoss®Bone AugmentationMaterial indicated for | The AFFIRM™ VCFSystem is intended tobe used for thereduction and fixationof fractures and/orcreation of a void in.cancellous bone in thespine, hand, tibia,radius, and calcaneus.This includespercutaneous vertebralaugmentation. VertebralCompression fracturesmay result fromosteoporosis, benignlesions and/ormalignant lesions suchas metastatic cancer andmyeloma. The system | KyphX®Inflatable BoneTamps areintended to beused asconventionalbone tamps forthe reduction offractures and/orcreation of avoid incancellous bonein the spine(including useduring balloonkyphoplasty withKyphX® HV-RTM BoneCement), hand, | All products areindicated for thereduction offractures and/orcreation of a void incancellous bone.Kyphon Xpander isindicated forkyphoplasty whileStryker® iVAS'sindications call outpercutaneousvertebralaugmentation.Percutaneousvertebralaugmentation is ageneric term andincludes |
6. Substantial Equivalence Comparison
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| augmentationprocedures, such askyphoplasty.Vertebral Compressionfractures may resultfrom osteoporosis,benign lesions and/ormalignant lesions suchas metastatic cancerand myeloma. | use during percutaneousvertebral augmentationprocedures, such askyphoplasty. | is to be used withcleared spinalPolymethylmethacrylate (PMMA) bonecements indicated foruse during percutaneousvertebral augmentation,such as kyphoplasty. | tibia, radius andcalcaneus. | Kyphoplasty whichis a type ofpercutaneousvertebralaugmentation.The Stryker® iVASInflatable VertebralAugmentationSystem and theAFFIRM™ VCFSystem indicationsfor use include astatement thatVertebralCompressionfractures may resultfrom osteoporosis,benign lesionsand/or malignantlesions such asmetastatic cancerand myeloma. |
|---|---|---|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
7. Non-clinical Testing
The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. Testing was completed in the previous 510k submissions (K113477, K103807 and K093419) and is reflective of the substantial equivalence to the predicate devices. Bench testing was performed for the removal of the contraindication "Fractures in which more than 68% of vertebral height is lost."
8. Clinical Testing
No clinical testing was deemed necessary for this submission.
9. Conclusions
The Stryker® iVAS balloon catheter is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the Stryker® iVAS Balloon Catheter, the AFFIRM™ VCF System 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® iVAS balloon catheter is 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 3, 2013
Stryker Corporation % Ms. Christina McKee Regulatory Affairs Associate Analyst 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K123942
Trade 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: February 27, 2013 Received: February 28, 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 (OS) 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.
Mark Nigelkerson -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 with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benigh lesions and/or malignant lesions such as metastatic cancer and myeloma.
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)
Laurençe D. (Goyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123942
§ 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.”