(90 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and its intended use for creating a void in bone. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on mechanical properties and functional testing.
Yes
The device is used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, which directly treats a medical condition.
No
The device is described as a system for the reduction of fractures and creation of a void in cancellous bone for vertebral augmentation, using an inflatable balloon catheter. This is a surgical tool, not a device used for diagnosing medical conditions.
No
The device description clearly states it is a balloon catheter, which is a physical hardware component.
Based on the provided information, the Stryker® iVAS Inflatable Vertebral Augmentation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's spine to reduce fractures and create voids in bone. This is an in vivo procedure, meaning it takes place within a living organism.
- Device Description: The device is a bone tamp with an inflatable balloon, designed for physical manipulation within the vertebral body. This is a surgical tool, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic testing performed in vitro.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The Stryker® iVAS system is a surgical device used for treatment.
N/A
Intended Use / 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 and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Product codes (comma separated list FDA assigned to the subject device)
HRX, NDN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The testing which was conducted included functional testing, such as insertion and retraction force, force to puncture, burst and stimulated use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Stryker® iVAS Balloon Catheter (K103807), Stryker® iVAS Balloon Catheter (K093419), Kyphx Xpander Inflatable Bone Tamps (K041454)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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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
Image /page/0/Picture/2 description: The image shows the text "K113154 PAGE 1 OF 2" in a handwritten-like font at the top. Below that is the word "stryker" in a bold, stylized font. The text at the top appears to be a document identifier and page number, while the word "stryker" likely indicates a brand or company name.
Instruments
| 510(k) Summary | |
|---|---|
| 510(k) Owner: | Stryker Instruments |
| 4100 E. Milham Avenue | |
| Kalamazoo, 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: | Arthroscope |
| Cement, Bone, Vertebroplasty | |
| Regulation Number: | §888.1100 |
| §888.3027 | |
| Product Code: | HRX |
| NDN | |
| 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 the | |
| vertebral body. | |
| 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 and Cortoss® Bone | |
| Augmentation Material indicated for use during percutaneous vertebral | |
| augmentation procedures, such as kyphoplasty. | |
| Testing | 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: | 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 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
4
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