(136 days)
No
The summary describes a mechanical device (inflatable bone tamp) and its intended use. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes.
The device is used for the reduction of fractures in the spine and the creation of a void in cancellous bone in the spine, particularly during percutaneous vertebral augmentation procedures like kyphoplasty, which are therapeutic interventions.
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 is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a "bone tamp with an inflatable component (balloon) at the distal end," indicating it is a physical medical device, not software only.
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 to reduce fractures and create a void in bone. This is an in-vivo procedure, not an in-vitro test performed on samples outside the body.
- Device Description: The device is described as a bone tamp with an inflatable balloon used within the vertebral body. This is a surgical tool, not a diagnostic reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. 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 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
cancellous bone in the 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 ft: 269 324 5412
www.stryker.com
MAR 1 8 2010
stryker
。 ::
·
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: | Becky Ditty |
| 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: | 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. | |
| Substantial Equivalence | |
| (SE) Rational: | The Stryker® IVAS balloon catheter is equivalent in intended use, technological |
| characteristics, safety, and effectiveness to the Kyphx Xpander Inflatable Bone | |
| Tamp. | |
| 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 | |
| device. |
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stryker®
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Submitted by:
ﻟﺰ
ﻜﺮ ﻣ
Becky E. Ditty Regulatory Analyst ﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍ signature
3 17 : 2010
Date Submitted:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 emblem resembling an eagle or bird in flight, composed of three curved lines that suggest movement and dynamism. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Instruments % Ms. Becky Ditty 4100 East Milham Avenue Kalamazoo, Michigan 49001
MAR 1 8 2010
Re: K093419
Trade/Device Name: Stryker iVAS Inflatable Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, HRX Dated: March 11, 2010 Received: March 12, 2010
Dear Ms. Ditty:
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 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.
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Page 2 - Ms. Becky Ditty
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/CDRHVCDRHOffices/uccr11158001/phm fast 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" (21) 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.
Ronbar Bremp
Mark N. Melker 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): _K093419
Device Name: Stryker iVAS Inflatable Vertebral Augmentation System
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
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)
FOR M. MELKERSON
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093419