(92 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) for vertebral augmentation and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is intended for "reduction of fractures and/or creation of a void in cancellous bone in the spine" using a balloon catheter, which directly addresses a pathological condition (fractures) and modifies the body structure (creating a void).
No
The device is described as an "Inflatable Vertebral Augmentation System" intended for "reduction of fractures and/or creation of a void in cancellous bone in the spine." This describes a therapeutic, rather than a diagnostic, function.
No
The device description explicitly states it is a "balloon catheter," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description and intended use of the Stryker® iVAS system clearly indicate it is a surgical device used within the body (in vivo) to treat vertebral fractures. It is used to create a void in bone and is part of a procedure involving bone cement.
Therefore, based on the provided information, 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) 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
NDN, HRX
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 hody.
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
No clinical testing was deemed necessary for this 510(k).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
MAY 2 3 2013
4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 269 324 5412 www.stryker.com
stryker
Instruments
510(k) Summary
1. Contact Details
Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 (p) 269-323-7700 (f) 269-389-5412
Christina McKee Christina.McKee@Stryker.com
February 13, 2013
2. Device Name
Trade Name: Stryker Inflatable Vertebral Augmentation System (iVAS)
Common Name: Inflatable Bone Tamp
Classification Name: Arthroscope Cement, Bone, Vertebroplasty
3. Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K113477 | HRX | Stryker® iVAS 20mm (10 Gauge) Balloon Catheter | Stryker Instruments |
| NDN | |||
| K103807 | HRX | Stryker® iVAS 10mm (10 Gauge) Balloon Catheter | Stryker Instruments |
| NDN | |||
| K093419 | HRX | Stryker® iVAS 15mm (10 Gauge) Balloon Catheter | Stryker Instruments |
| NDN |
1
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 hody.
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. 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.
6. Substantial Equivalence Comparison
The Stryker® iVAS 11 Gauge Balloon Catheter has the same intended use/indications for use as the predicate Stryker® iVAS 10 Gauge Balloon Catheter.
Although the device incorporates modifications to the balloon wall thickness, the spiral cut on the stainless steel catheter tube, and the color of the proximal reflow and luer hub, the modifications do not alter the intended use, indications for use, or the fundamental scientific technology of the predicate devices.
Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971. Stryker has determined that the modifications to the predicate device raise no new questions of safety or effectiveness.
7. Non-clinical Testing
The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. The modified device is not technologically different than the predicate device.
8. Clinical Testing
No clinical testing was deemed necessary for this 510(k).
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9. Conclusions
The Stryker® iVAS (10mm and 15mm) 11 Gauge balloon catheters are substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker® iVAS Balloon Catheters 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® (10mm and 15mm) 11 Gauge iVAS balloon catheters are equivalent to the existing predicate `devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: May 23, 2013
Stryker Corporation % Ms. Christina McKee Regulatory Affairs Associate Analyst 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K130430
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, HRX Dated: April 15, 2013 Received: April 19, 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
4
Page 2 - Ms. Christina McKee -
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Nimelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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 Polymethylmethacrylate (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)
Laurence D! (Soyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130430