(104 days)
Not Found
No
The summary describes a mechanical device (inflatable bone tamp) and its intended use for vertebral augmentation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is used for the reduction of fractures and/or creation of a void in cancellous bone in the spine due to conditions like osteoporosis or metastatic cancer, 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. It is a bone tamp with an inflatable component, used for treatment (vertebral augmentation), not for diagnosing conditions.
No
The device description explicitly states it is a "balloon catheter" which is a physical hardware component used in a medical procedure. The summary does not mention any software component as the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure performed on the patient's spine to treat fractures. This is a therapeutic intervention, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device is a bone tamp with an inflatable balloon, designed to be inserted into the vertebral body. This is a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment decisions. The Stryker® iVAS system is a surgical device used to treat a condition directly within the body.
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 with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma.
Product codes (comma separated list FDA assigned to the subject device)
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. Testing was completed in the previous 510k submissions (K113477, K103807 and K093419) and is reflective of the substantial equivalence to the predicate devices. Bench testing was performed for the removal of the contraindication "Fractures in which more than 68% of vertebral height is lost."
Clinical Testing:
No clinical testing was deemed necessary for this submission.
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.
K113477, K103807, K093419, K110998, K041454
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.
Not Found
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
§ 888.3027 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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stryker®
Instruments
APR 0 3 2013
510(k) Summary
1. Contact Details
4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 269 324 5412
Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 (p) 269-323-7700 (f) 269-389-5412
Christina McKee Christina.McKee@Stryker.com
December 7, 2012
2. Device Name
Trade Name: Stryker® iVAS Balloon Catheter
Common Name: Inflatable Bone Tamp
Classification Name: Arthroscope Cement, Bone, Vertebroplasty
Regulation Number: 8888.1100 §888.3027
3. Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K113477 | HRX | Stryker® iVAS Balloon | |
| Catheter | Stryker Instruments | ||
| K103807 | HRX | Stryker® iVAS Balloon | |
| Catheter | Stryker Instruments | ||
| K093419 | HRX | Stryker® iVAS Balloon | |
| Catheter | Stryker Instruments |
1
| K110998 | HRX
NDN. | AFFIRM™ VCF System | Algea Therapies |
|---------|-------------|----------------------------------|-----------------|
| K041454 | HRX | Xpander Inflatable Bone
Tamps | Kyphon Inc. |
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 body.
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 with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma.
| Stryker® iVAS
Balloon Catheter | Stryker® iVAS
Balloon Catheter
(Predicates)
Indications for Use | AFFIRM™ VCF
System | Xpander
Inflatable
Bone Tamps | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 with
Cortoss ® and cleared
spinal | 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
Polymethylmethacrylat
e (PMMA) bone
cements and Cortoss®
Bone Augmentation
Material indicated for | The AFFIRM™ VCF
System is intended to
be used for the
reduction and fixation
of fractures and/or
creation of a void in.
cancellous bone in the
spine, hand, tibia,
radius, and calcaneus.
This includes
percutaneous vertebral
augmentation. Vertebral
Compression fractures
may result from
osteoporosis, benign
lesions and/or
malignant lesions such
as metastatic cancer and
myeloma. The system | KyphX®
Inflatable Bone
Tamps are
intended to be
used as
conventional
bone tamps for
the reduction of
fractures and/or
creation of a
void in
cancellous bone
in the spine
(including use
during balloon
kyphoplasty with
KyphX® HV-
RTM Bone
Cement), hand, | All products are
indicated for the
reduction of
fractures and/or
creation of a void in
cancellous bone.
Kyphon Xpander is
indicated for
kyphoplasty while
Stryker® iVAS's
indications call out
percutaneous
vertebral
augmentation.
Percutaneous
vertebral
augmentation is a
generic term and
includes |
6. Substantial Equivalence Comparison
2
| augmentation
procedures, such as
kyphoplasty.
Vertebral Compression
fractures may result
from osteoporosis,
benign lesions and/or
malignant lesions such
as metastatic cancer
and myeloma. | use during percutaneous
vertebral augmentation
procedures, such as
kyphoplasty. | is to be used with
cleared spinal
Polymethylmethacrylat
e (PMMA) bone
cements indicated for
use during percutaneous
vertebral augmentation,
such as kyphoplasty. | tibia, radius and
calcaneus. | Kyphoplasty which
is a type of
percutaneous
vertebral
augmentation.
The Stryker® iVAS
Inflatable Vertebral
Augmentation
System and the
AFFIRM™ VCF
System indications
for use include a
statement that
Vertebral
Compression
fractures may result
from osteoporosis,
benign lesions
and/or malignant
lesions such as
metastatic cancer
and myeloma. |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
7. Non-clinical Testing
The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. Testing was completed in the previous 510k submissions (K113477, K103807 and K093419) and is reflective of the substantial equivalence to the predicate devices. Bench testing was performed for the removal of the contraindication "Fractures in which more than 68% of vertebral height is lost."
8. Clinical Testing
No clinical testing was deemed necessary for this submission.
9. Conclusions
The Stryker® iVAS balloon catheter is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the Stryker® iVAS Balloon Catheter, the AFFIRM™ VCF System 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® iVAS balloon catheter is 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 U.S. Department of Health & Human Services. 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 symbol featuring three curved shapes that resemble a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 3, 2013
Stryker Corporation % Ms. Christina McKee Regulatory Affairs Associate Analyst 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K123942
Trade 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: February 27, 2013 Received: February 28, 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 (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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark Nigelkerson -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 with Cortoss ® and cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty. Vertebral Compression fractures may result from osteoporosis, benigh lesions and/or malignant lesions such as metastatic cancer and myeloma.
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)
Laurençe D. (Goyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123942