Who is the manufacturer of STRYKER IVAS BALLOON CATHETER?

Stryker Corporation filed the 510(k) submission for STRYKER IVAS BALLOON CATHETER (K123942).

What is the FDA product code for STRYKER IVAS BALLOON CATHETER?

NDN. It is classified under 21 CFR 888.3027 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for STRYKER IVAS BALLOON CATHETER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for STRYKER IVAS BALLOON CATHETER?

Stryker® iVAS Balloon Catheter (K113477); Stryker® iVAS Balloon Catheter (K103807); Stryker® iVAS Balloon Catheter (K093419).

Who can help prepare an FDA 510(k) submission like STRYKER IVAS BALLOON CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STRYKER IVAS BALLOON CATHETER

K123942 · Stryker Corporation · NDN · Apr 3, 2013 · Orthopedic

Device Facts

Record ID	K123942
Device Name	STRYKER IVAS BALLOON CATHETER
Applicant	Stryker Corporation
Product Code	NDN · Orthopedic
Decision Date	Apr 3, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3027
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Stryker iVAS is an inflatable bone tamp used in percutaneous vertebral augmentation. Device consists of a catheter with an inflatable balloon at the distal end. Operated by a physician in a clinical setting (e.g., OR). Balloon is inserted into the vertebral body and inflated to create a void or reduce fractures in cancellous bone. Once the void is created, the balloon is deflated and removed, allowing for the subsequent injection of cleared spinal PMMA bone cements or Cortoss bone augmentation material. The procedure aims to stabilize the vertebral body and alleviate pain associated with compression fractures. Device benefits include minimally invasive access to the vertebral body for fracture reduction.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Inflatable bone tamp; catheter with distal balloon. Mechanical inflation mechanism. Materials and design are identical to previously cleared Stryker iVAS predicates. No software or electronic components.

Indications for Use

Indicated for patients with vertebral compression fractures resulting from osteoporosis, benign lesions, or malignant lesions (e.g., metastatic cancer, myeloma) requiring fracture reduction or void creation in spinal cancellous bone during percutaneous vertebral augmentation.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

Stryker® iVAS Balloon Catheter (K113477)
Stryker® iVAS Balloon Catheter (K103807)
Stryker® iVAS Balloon Catheter (K093419)

Reference Devices

AFFIRM™ VCF System (K110998)
Xpander Inflatable Bone Tamps (K041454)

Related Devices

K103807 — IVAS 2-10MM (10 GUAGE) BALLON CATHETER · Stryker Corporation · Jun 28, 2011
K113154 — IVAS BALLOON CATHETER · Stryker Corporation · Jan 24, 2012
K093419 — IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS · Stryker Instruments, Instruments Div. · Mar 18, 2010
K113477 — IVAS 20MM (10 GAUGE) BALLOON CATHETER · Stryker Instruments, Instruments Div. · Jan 6, 2012
K130430 — IVAS 10MM AND 15MM BALLOON CATHETER · Stryker Corporation · May 23, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ K123942 1/3 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 www.stryker.com 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