(181 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) for vertebral augmentation and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine, specifically during percutaneous vertebral augmentation procedures like kyphoplasty, which are therapeutic interventions.
No
The device is described as a system for the reduction of fractures and/or creation of a void in cancellous bone in the spine using an inflatable balloon catheter. This is a therapeutic or surgical tool, not a diagnostic one.
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:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's spine (reduction of fractures, creation of a void, vertebral augmentation). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- 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 diagnostic test.
- No mention of analyzing biological samples: The description and intended use do not involve the analysis of any biological samples from the patient.
Therefore, the Stryker® iVAS Inflatable Vertebral Augmentation System is a surgical device, not an In Vitro Diagnostic 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
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 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.
Key Metrics
Not Found
Predicate Device(s)
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.”
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l of 2
4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 ff: 269 324 5412
www.stryker.com
JUN 2 8 2011
stryker
్రామ్నా
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: | Melissa Kann |
| 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 (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. |
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Image /page/1/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '103807'. The numbers are written in a simple, clear style, and the image appears to be a close-up of the sequence.
Image /page/1/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and the letter "y" has a long, curved tail. There is a registered trademark symbol to the right of the letter "r". The word is likely a logo or brand name.
Instruments
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:
Melissa Kann Regulatory Affairs Supervisor
10-June-2011
eussa kanu
Signature
Signature
Date Submitted:
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Corporation % Ms. Melissa Kann Regulatory Affairs Supervisor 4100 E. Milham Ave Kalamazoo, Michigan 49001
JUN 2 8 2011
Re: K103807
Trade Name: iVAS 2-10mm (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: June 06, 2011 Received: June 08, 2011
Dear Ms. Kann:
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
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Page 2 - Ms. Melissa Kann
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
E.L. Keith
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 (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 Polymethacrylate (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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103807