(172 days)
No
The document describes a mechanical device (balloon catheter) and its intended use in vertebral augmentation. There is no mention of AI, ML, or any software-driven analysis or decision-making process. The input imaging modality (fluoroscopy) is used for visualization, not for AI/ML processing.
Yes
The device is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine, 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 or surgical intervention, not a diagnostic one. It does not identify or determine the nature of a disease or condition.
No
The device description clearly details a physical balloon catheter with an inflatable component, radiopaque markers, and silicone coating, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Stryker IVAS® Elite Inflatable Vertebral Augmentation System is a surgical device used within the body to treat vertebral fractures. It physically manipulates bone tissue.
- Intended Use: The intended use clearly describes a surgical procedure (reduction of fractures, creation of a void in bone) and not a diagnostic test performed on a sample.
- Device Description: The description details a physical tool (balloon catheter, bone tamp) used for mechanical action within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory analysis.
This device falls under the category of a surgical device or implantable device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker IVAS® Elite 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
HRX, NDN
Device Description
The Stryker iVAS ® Elite Balloon Catheter is a bone tamp with an inflatable component at the distal end. The balloon is inflated to create a void within the vertebral body. It is used with various accessories during vertebral augmentation.
When the balloon is inflated with radiopaque fluid, the balloon expands axially and radially. Two radiopaque markers are fixed near the distal end of the balloon to show the location of the balloon during placement. The balloon is coated with silicone to assist with insertion of the catheter into the access needle.
The patient contacting components of the device such as the balloon, catheter coating, lubricant and radiopaque material are externally communicating tissue/bone/dentin-limited contact ≤24 hrs.
Associated Accessories include:
- Access cannula/stylet
- Syringe
- Inflator
- Hand Drill
- Cement Tube
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic visualization
Anatomical Site
spine, vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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
Bench Testing: Risk Management File (RMF) in compliance with EN ISO 14971:2012 was completed. Verification and validation testing was performed. All bench testing pertaining to the subject device modifications met their respective acceptance criteria. Testing included Constrained Burst, Un-Constrained Burst, Length to Diameter, One-way Valve Torque, Insert, Retract, Sheath Removal, Assembly Strength, Tensile Force, Sheath shipping test, and Real-time packaging testing.
Cadaveric Testing: Cadaveric testing was completed to provide evidence that the use of the subject balloon with a high inflation pressure of 808psi would not cause any new concerns regarding safety and effectiveness. This cadaveric testing was completed by a physician using the subject device in a manner as similar as possible to how the balloon would be used in the clinical setting. The subject balloon was inflated under fluoroscopic guidance. Following the inflation of the balloon, the physician evaluated nearby anatomical structures for adverse events related to the high-pressure balloon inflations. There were no adverse events following the inflations with the subject balloon catheter. This testing confirms that the modifications to the subject device do not raise new questions of safety and effectiveness.
Biocompatibility Testing: Biocompatibility testing, adopted per K172116, was performed following the recommendations of ISO 10993-1 and FDA Guidance (Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" June 2016) as appropriate for limited exposure (
§ 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
December 21, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Corporation Kristi Ashton Sr. Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K181752
Trade/Device Name: Stryker iVAS ® Elite Inflatable Vertebral Augmentation System (Stryker iVAS ® Elite Balloon Catheter) Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, NDN Dated: November 20, 2018 Received: November 21, 2018
Dear Ms. Ashton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sarah B. Nelson -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Stryker iVAS ® Elite Inflatable Vertebral Augmentation System (Stryker iVAS ® Elite Balloon Catheter)
Indications for Use (Describe)
The Stryker IVAS® Elite 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
1. Submitter
a. 510(k) Owner: Stryker Instruments 4100 E. Milham Avenue Kalamazoo, Michigan 49001 USA Ph: +1-269-323-7700 Fax: +1-269-324-5412 b. FDA Establishment 1811755 Registration Number: Contact Person: Kristi Ashton ﻦ Ph: +1-269-389-5929 Fax: +1-269-389-5412 Kristi.Ashton@Stryker.com
d. Date Submitted: December 14, 2018
2. Subject Device Name
Trade Name: Stryker iVAS® Elite Balloon Catheter Common Name: Inflatable Bone Tamp Product Codes: HRX, NDN Regulation: 888.1100, 888.3027
3. Legally Marketed Predicate Devices
Table 1 Predicate Device Table
| Predicate Devices | ||
|---|---|---|
| Stryker iVAS ® Elite Balloon Catheter | K172116 | Primary Predicate |
| Stryker iVAS® Elite Balloon Catheter | ||
| Stryker iVAS® Balloon Catheter | K123942 | Secondary Predicate |
| Stryker iVAS® Balloon Catheter |
4. Device Description
The Stryker iVAS ® Elite Balloon Catheter is a bone tamp with an inflatable component at the distal end. The balloon is inflated to create a void within the vertebral body. It is used with various accessories during vertebral augmentation.
When the balloon is inflated with radiopaque fluid, the balloon expands axially and radially. Two radiopaque markers are fixed near the distal end of the balloon to show the
4
location of the balloon during placement. The balloon is coated with silicone to assist with insertion of the catheter into the access needle.
The patient contacting components of the device such as the balloon, catheter coating, lubricant and radiopaque material are externally communicating tissue/bone/dentin-limited contact ≤24 hrs.
Associated Accessories include:
- Access cannula/stylet ●
- Syringe
- Inflator ●
- Hand Drill ●
- Cement Tube ●
5. Principles of Operation / Mechanism of Action
The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon is designed to create a cavity by compressing cancellous bone and/or moving cortical bone as it inflates. After manufacturing, the balloon is covered with a protector called a sheath that the physician will remove prior to performing a procedure. Radiopaque markers provide for fluoroscopic visualization of the vertebral balloon prior to filling it with contrast media. The radiopaque balloon markers are located within the balloon.
After placing the access cannula into the fractured vertebral body, the physician places the access cannula and stylet in the desired location within the vertebral body, creating a channel for the balloon. The stylet is then removed, leaving the cannula in place. The deflated balloon is inserted through the access cannula. Contrast medium is injected into the balloon to inflate it. As the balloon inflates, it moves and compresses the cancellous bone, creating a void. The balloon is deflated and removed before cement injection takes place. Cement is then injected through the access cannula into this space.
6. Intended Use/Indications for use
The Stryker iVAS® Elite 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.
5
7. Comparison of Technological Characteristics with the Predicate Devices
The subject and primary predicate devices are identical in the following ways:
- Indications for use
- Design intent ●
- Classification ●
- FDA product codes and regulation ●
- Intended use
- Regulation medical specialty
- Placed percutaneously under fluoroscopy
- Uses syringe for inflation ●
- Balloon diameter
- Balloon wall thickness ●
- Sheath material ●
- Radiopaque balloon markers ●
- Radiopaque balloon material
- Sliding pin material ●
- Catheter material ●
- Balloon material ●
- Balloon lubricant
- Depth markers
- Color of shaft
- Color of distal tip ●
- Color of hub
- Sterilization method ●
- SAL ●
- Single use ●
- Maximum inflation pressure ●
The subject and primary predicate devices differ in the following ways:
- Sheath color
- Tamp size
- Maximum recommended inflation volume ●
The subject and secondary predicate devices are identical in the following ways:
- . Tamp size
- Maximum recommended inflation volume
8. Non-Clinical
8.1 Biocompatibility
Biocompatibility testing, adopted per K172116, was performed following the recommendations of ISO 10993-1 and FDA Guidance (Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" June 2016) as appropriate for limited exposure (