(44 days)
No
The summary describes a mechanical device (balloon catheter) for vertebral augmentation and does not mention any software, algorithms, or data processing that would indicate AI/ML use.
Yes
The device is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine, which is a therapeutic intervention for medical conditions.
No
This device is used for the physical reduction of fractures and creation of voids in bone, not for diagnosing conditions.
No
The device description explicitly states it is a "balloon catheter" which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Stryker® iVAS system is a surgical device used within the body to treat vertebral fractures. It physically interacts with bone tissue to create a void and facilitate bone cement injection.
- Intended Use: The intended use clearly describes a surgical procedure for treating spinal fractures, not the analysis of biological samples.
The description focuses on the mechanical function of the device and its use in a surgical setting, which is characteristic of a non-IVD medical device.
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 indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Product codes
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker® iVAS Balloon Catheter (K103807), Stryker® iVAS Balloon Catheter (K093419), Kyphx Xpander Inflatable Bone Tamps (K041454)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
JAN - 6 2012
stryker
-1.
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 Instruments
4100 E. Milham Avenue
Kalamazoo, 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: | 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 indicated for use during
percutaneous vertebral augmentation procedures, such as kyphoplasty. |
| Testing: | 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: | 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. |
| Substantial Equivalence
(SE) Rational: | The Stryker® iVAS balloon catheter is substantially equivalent in intended use,
technological characteristics, safety, and effectiveness to the Stryker® iVAS
Balloon Catheter and the Kyphx Xpander Inflatable Bone Tamp. The products
have the same fundamental 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 device already legally marketed.
Therefore, the Stryker® iVAS balloon catheter is equivalent to the existing
predicate 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
4
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