Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 G-21 S.R.L. % Mr. Paul Speidel Senior Regulatory/Quality Consultant ROMIS. Inc. 110 Haverhill Road Suite 526 Amesbury, Massachusetts 01913 August 23, 2017 Re: K172214 Trade/Device Name: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: July 21, 2017 Received: July 24, 2017 Dear Mr. Speidel: 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 Image /page/0/Picture/11 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. {1}------------------------------------------------ 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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/ResourcesforYou/Industry/default.htm. 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 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 {2}------------------------------------------------ #### INDICATIONS FOR USE 510(k) Number (if known): K172214 #### Device Name: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters Indications for Use: The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty. Prescription Use ____X________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use ________ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ # 510(k) SUMMARY # G-21 S.R.L.'s Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | Submitter | G-21 S.R.L.<br>Maurizio Foroni<br>Via S. Pertini, 8<br>San Possidonio, Italy 41039<br>Phone: +39 0535 30312 | |--------------------------|-------------------------------------------------------------------------------------------------------------| | Contact Person: | Barry Sands<br>RQMIS, Inc.<br>110 Haverhill Road, Suite 526<br>Amesbury, MA 01913<br>Phone: 978-358-7307 | | Date Prepared: | July 21, 2017 | | Name of Device | Modified Winch Kyphoplasty<br>(15 and 20 mm) 11 Gauge<br>Balloon Catheters | | Name/Address of Sponsor: | G-21<br>Maurizio Foroni<br>Via S. Pertini, 8<br>San Possidonio, Italy 41039 | #### Common or Usual Name Kyphoplasty Balloon Catheter # Classification Name Cement, Bone, Vertebroplasty, Class II (21 CFR 888.3027) Arthroscope, Class II (21 CFR, Sec. 888.1100) {4}------------------------------------------------ # Product Codes HRX and NDN # Predicate Device K152557, Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters # Intended Use / Indications for Use # Indications for Use: The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty. # Technological Characteristics The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are primarily composed of polyurethane, polycarbonate, and polyether/polyamide materials. A Silicone lubricant is provided to facilitate insertion of the catheters. This premarket submission represents a change to the balloon material to a different type of polyurethane. # Device Description The inflation of the balloon serves to create a cavity in the vertebral body, compressing the cancellous bone and/or move cortical bone, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. Modified Winch Kypholplasy (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyhoplasty procedure. The low pre-inflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas. Image /page/4/Picture/12 description: The image shows a medical device, possibly a catheter or similar instrument, laid out horizontally. It features a connector at one end, a long, slender tube, and a tip at the opposite end, which is encircled and labeled 'A'. The device appears to be designed for insertion into the body, with the connector facilitating attachment to other medical equipment. Figure 1: Modified Winch Kyphoplasty 11 Gauge Balloon Catheter {5}------------------------------------------------ Image /page/5/Picture/0 description: This image is a figure that shows an isometric view of the modified winch kyphoplasty 11 gauge balloon catheter. The catheter is long and thin, with a balloon at the end. The catheter is used to treat vertebral compression fractures. The figure is labeled as Figure 2. The stiff distal end of the balloon catheter provides rigidity for smooth insertion while the flexible proximal catheter allows for easy maneuverability. The inflating component, laserbonded to the shaft, is a low-pressure elastomeric balloon of tubular shape (which is inflated by volume, not pressure). The inflation can expand the balloon several times its original size, it can be inflated to precise dimensions and retain well defined shapes and high pressures and when the pressure is released, it recovers close to its original size and shape, re-folding back to similar original profiles. # Performance Data Using design FMECA, G21 identified the necessary verification and validation testing to assure the new balloon met the catheters original performance specifications. All testing demonstrated that the modified catheters continues to meet all performance specifications. #### Substantial Equivalence G-21 used dFMECA to determine substantial equivalence. The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters and the K152557 predicate device have the same intended use/indications for use, equivalent technical characteristics, and identical principles of operation. G-21 submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is substantially equivalent in indications, design principles, and performance standards to the predicate device.