(98 days)
No
The summary describes a mechanical device (balloon catheter) and its intended use with bone cements. There is no mention of AI, ML, or any software components that would suggest the use of such technologies. The submission is for a labeling modification only, with no changes to the device design or performance.
Yes
The device is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine, which directly treats a medical condition.
No
The device is intended for "reduction of fractures and/or creation of a void in cancellous bone in the spine" and "percutaneous vertebral augmentation," which are therapeutic procedures, not diagnostic ones. Although it uses fluoroscopic visualization, this is for guidance during the procedure, not for diagnosing a condition.
No
The device description clearly outlines physical components like balloon catheters, needles, wires, and introducers, indicating it is a hardware-based medical device used in a surgical procedure. The 510(k) is for a labeling modification, not a new software device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reduction of fractures and/or creation of a void in cancellous bone in the spine, specifically during percutaneous vertebral augmentation procedures. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a balloon system designed to create a cavity within the vertebral body. This is a physical manipulation of tissue within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or modify the body itself. This device is clearly designed for a therapeutic procedure performed in vivo.
N/A
Intended Use / Indications for Use
The AVAmax Vertebral Balloon System (system) is intended 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.
The AVAflex Vertebral Balloon System (system) is intended 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 (comma separated list FDA assigned to the subject device)
HRX, NDN
Device Description
The Stryker AVAmax and AVAflex Vertebral Balloon Systems are designed for use in percutaneous vertebral augmentation procedures. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter.
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.
The AVAflex includes a curved needle or a curved wire assembly. The introducer is a flexible radiopaque tube that retains its shape within the vertebral body when used in conjunction with the curved vertebral augmentation needle or wire assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic
Anatomical Site
cancellous bone in the spine / vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
As there were no changes to the device that effect its performance specifications, no new performance testing is required to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AVAmax Vertebral Balloon (K150523), AVAflex Vertebral Balloon (K151125)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2016
Stryker Corporation Ms. Becky Ditty Principal Regulatory Affairs Specialist 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K162062
Trade/Device Name: AVAmax Vertebral Balloon System, AVAflex Vertebral Balloon System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, NDN Dated: September 30, 2016 Received: October 3, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162062
Device Name
AVAmax Vertebral Balloon System
Indications for Use (Describe)
The AV Amax Vertebral Balloon System (system) is intended 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."
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162062
Device Name AVAflex Vertebral Balloon System
Indications for Use (Describe)
The AVAflex Vertebral Balloon System) is intended 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.
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."
4
510(k) Summary
| Device Common Name: | Inflatable Balloon Tamp (IBT) / Vertebral Balloon System |
|---|---|
| Device Proprietary Name: | AVAmax Vertebral Balloon |
| AVAflex Vertebral Balloon | |
| Applicant: | Stryker Instruments |
| 4100 E. Milham Ave | |
| Kalamazoo, MI 49001 | |
| Contact: | Becky Ditty |
| Principal Regulatory Affairs Specialist | |
| Stryker Instruments | |
| 4100 E. Milham Ave | |
| Kalamazoo, MI 49001 | |
| Phone: 269 389 3434 | |
| becky.ditty@stryker.com | |
| Date Prepared: | July 25, 2016 |
| Classification Regulation: | 21 CFR 888.1100, Class II, Arthroscope |
| 21 CFR 888.3027, Class II, Polymethylmethacrylate | |
| (PMMA) bone cement | |
| Panel: | Orthopedics |
| Primary Product Code: | HRX – Arthroscope |
| Secondary Product Code: | NDN – Cement, Bone, Vertebroplasty |
| Predicate Devices: | AVAmax Vertebral Balloon (K150523) |
| AVAflex Vertebral Balloon (K151125) |
Indication for Use:
The AVAmax Vertebral Balloon System (system) is intended 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.
The AVAflex Vertebral Balloon System (system) is intended 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.
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Device Description:
The Stryker AVAmax and AVAflex Vertebral Balloon Systems are designed for use in percutaneous vertebral augmentation procedures. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter.
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.
The AVAflex includes a curved needle or a curved wire assembly. The introducer is a flexible radiopaque tube that retains its shape within the vertebral body when used in conjunction with the curved vertebral augmentation needle or wire assembly.
This 510(k) is being submitted for a labeling modification to the AVAmax and AVAflex devices as cleared in K150523 and K151125. Specifically, the purpose of this 510(k) is to modify the indications for use of the devices to include their use with all FDA cleared spinal Polymethylmethacrylate (PMMA) bone cements. Additionally, the AVAmax indication for use is being modified to include its use with Cortoss® Bone Augmentation Material, which was cleared in K080108.
The subject devices were both recently cleared in K150523 (AVAmax) and K151125 (AVAflex). Since those clearances there have been no changes to the device design that effect its performance. There have been no changes to the materials, manufacturing or processing of the subject devices their previous clearances in K150523 (AVAmax) and K151125 (AVAflex).
Sterilization and Shelf Life:
The AVAmax and AVAflex Vertebral Balloon Systems kits are provided sterile, for single use only, and are labeled with a shelf life of 2 years.
There have been no changes to the sterilization, packaging, or shelf life of the AVAmax and A VAflex Vertebral Balloon Systems since their previous clearances in K150523 and K151125. Therefore, no additional information is required to establish substantial equivalence.
Biocompatibility:
There have been no changes to the patient contacting materials, manufacturing or processing since the devices were previously cleared in K150523 and K151125. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.
Performance Data:
As there were no changes to the device that effect its performance specifications, no new performance testing is required to establish substantial equivalence.
Substantial Equivalence Conclusion:
Based on the comparison of both the technological characteristics and the indications for use, the minor modifications made to the indication statements of the subject device do not alter the intended use and do not raise new questions of safety or effectiveness. Therefore, the subject devices can be found substantially equivalent to the predicate devices.