(118 days)
No
The summary describes a mechanical system for vertebral augmentation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, which is a therapeutic intervention.
No.
The device is used for fracture reduction and void creation in bone, not for diagnosis.
No
The device description explicitly lists hardware components such as a Vertebral Access Kit, Biopsy Kit, vertebral augmentation balloons (including balloon-catheter, stiffening wire, and syringe), and an Inflation System. It also describes mechanical and biomechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical reduction of fractures and creation of voids in bone within the spine. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of instruments, balloons, and an inflation system used for a surgical intervention.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- Focus on Mechanical Action: The device's function is to physically manipulate bone tissue.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Synflate Vertebral Balloon 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 indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Product codes
NDN, HRX
Device Description
The Synflate Vertebral Balloon System is a comprehensive array of instrumentation (Vertebral Access Kit as well as a Biopsy Kit), vertebral augmentation balloons (inclusive of balloon-catheter, stiffening wire, and syringe with luer lock), and Inflation System (previously cleared via K110604). All instruments and implants are provided sterile and packaged separately. The Synflate balloon catheter includes a stiffening wire and syringe with luer lock. The balloon is inflated within the vertebral body via the Inflation System. The Synflate balloon catheter 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 indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
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
Mechanical and biomechanical testing was performed in order to provide data to support a substantial equivalence determination. These tests were performed to characterize the properties and functionality of the Synflate System, as well as to allow comparison with established acceptance criteria. Mechanical and biomechanical testing was performed to assess balloon pressure and volume limitations, burst characteristics, and ability of the device to be used for the reduction of fractures and/or creation of a void in cancellous bone. The conclusions drawn from testing demonstrate that the Synflate System is as safe and effective as the predicate devices identified. Clinical data was not needed to demonstrate the safety and effectiveness of this system.
Key Metrics
Not Found
Predicate Device(s)
Synthes Vertebral Body Balloon (VBB) System (K110604), Kyphon KyphX Xpander Inflatable Bone Tamp (K041454)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
® SYNTHES®
Spine
Spine
MAY 2 0 2013
| 6 | 510(k) Summary | MAY 2 |
|---|---|---|
| Name of Firm: | Depuy Synthes Spine | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| 510(k) Contact: | Stacey Bonnell | |
| Senior, Regulatory Affairs Specialist - Depuy Synthes Spine | ||
| Telephone: 610-719-5895 Facsimile: 610-719-5102 | ||
| Email: bonnell.stacey@synthes.com | ||
| Date Prepared: | January 18, 2013 | |
| Trade Name: | Synthes Synflate Vertebral Balloon System | |
| Classification: | Orthopaedic and Rehabilitation Devices Panel | |
| Class II | ||
| 21 CFR 888.1100 - Arthroscope, Orthopedic | ||
| Class II; Product Code HRX | ||
| 21 CFR 888.3027 - Cement, Bone, Vertebroplasty | ||
| Class II; Product Code NDN | ||
| Predicate Devices: | Synthes Vertebral Body Balloon (VBB) System (K110604) | |
| Kyphon KyphX Xpander Inflatable Bone Tamp (K041454) | ||
| Device Description: | The Synflate Vertebral Balloon System is a comprehensive array of | |
| instrumentation (Vertebral Access Kit as well as a Biopsy Kit), vertebral | ||
| augmentation balloons (inclusive of balloon-catheter, stiffening wire, | ||
| and syringe with luer lock), and Inflation System (previously cleared via | ||
| K110604). All instruments and implants are provided sterile and | ||
| packaged separately. | ||
| The Synflate balloon catheter includes a stiffening wire and syringe with | ||
| luer lock. The balloon is inflated within the vertebral body via the | ||
| Inflation System. | ||
| The Synflate balloon catheter 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 indicated for use during percutaneous vertebral augmentation | ||
| procedures, such as kyphoplasty. | ||
| Intended Use / | ||
| Indications for Use: | The Synflate Vertebral Balloon 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 indicated for use during percutaneous vertebral | ||
| augmentation procedures, such as kyphoplasty |
Synthes Synflate Vertebral Balloon System Traditional 510(k)
1
| Comparison of the
technological
characteristics of the
device to the
predicate device: | The design features, material, and indications for use of the Synflate
System are substantially equivalent to the predicate devices identified.
Additionally, the safety and effectiveness of this system is adequately
supported by documentation within this premarket notification. |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data
(Non-clinical and/or
Clinical) | Mechanical and biomechanical testing was performed in order to
provide data to support a substantial equivalence determination. These
tests were performed to characterize the properties and functionality of
the Synflate System, as well as to allow comparison with established
acceptance criteria. Mechanical and biomechanical testing was
performed to assess balloon pressure and volume limitations, burst
characteristics, and ability of the device to be used for the reduction of
fractures and/or creation of a void in cancellous bone. The conclusions
drawn from testing demonstrate that the Synflate System is as safe and
effective as the predicate devices identified.
Clinical data was not needed to demonstrate the safety and effectiveness
of this system. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, topped by three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2013
Depuy Synthes Spine % Ms. Stacev Bonnell Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K130146
Trade/Device Name: Synthes Synflate Vertebral Balloon System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: March 26, 2013 Received: March 27, 2013
Dear Ms. Bonnell:
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
3
Page 2 - Ms. Stacey Bonnell
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,
Image /page/3/Picture/7 description: The image shows the name "Erin I. Keith" in a stylized font. The letters "I" and "." are designed with concentric lines, creating a unique visual effect. The name is presented in a clear, bold typeface, making it easily readable.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
@ SYNTHES Spine
5 Indications for Use Statement
510(k) Number:
Device Name: Synthes Synflate Vertebral Balloon System
Indications for Use:
The Synflate Vertebral Balloon 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 clearad spiral polymethylmethacrylate (PMMA) bone cements indicated for use during percutated us vertebral augmentation procedures, such as kyphoplasty.
Prescription Use × (21 CFR 801 Subpart D)
AND / OR
Over-the-Counter Use (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)
Laurence D. Coyne - A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130146
Synthes Synflate Vertebral Balloon System Traditional 510(k)