(168 days)
No
The summary describes a mechanical device (balloon catheter) and its physical properties and performance, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as being used for the "reduction and fixation of fractures" and "creation of a void in cancellous bone in the spine" using a balloon catheter, which clearly indicates a direct medical intervention to treat a condition.
No
Explanation: The device description clearly states its intended use is for "reduction and fixation of fractures and or creation of a void in cancellous bone in the spine" using a balloon catheter, which are all therapeutic and surgical interventions, not diagnostic procedures.
No
The device description clearly details a physical balloon catheter and its mechanical properties, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a balloon catheter used within the body (in the spine) for mechanical purposes (reducing fractures, creating a void). It does not perform any tests on samples taken from the body.
- Intended Use: The intended use is for a surgical procedure (kyphoplasty) involving the physical manipulation of bone and the delivery of bone cement. This is a therapeutic intervention, not a diagnostic test.
Therefore, the Winch Kyphoplasty Balloon Catheter is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
Product codes
NDN, HRX
Device Description
Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon catheters are designed for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty in association with cleared spinal polymethylmethacrylate (PMMA) bone cements.
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. Winch Kyphoplasty (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyphoplasty procedure.
The low preinflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas. The stiff distal end of the balloon catheter provides rigidity for smooth insertion while flexible proximal catheter allows for easy maneuverability.
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
The testing included functional testing such as:
- dimensional characterization,
- inflation/deflation time,
- insertion/withdrawal force,
- fatigue testing,
- burst characteristics,
- ability of the device to be used for creation of a void in cancellous bone
and mechanical testing according to ISO 10555-1:2013, Intravascular catheters--Sterile and single-use catheters--Part 1: General requirements.
Key Metrics
Not Found
Predicate Device(s)
K130430, K123942, K113154, K113477, K103807, K093419, K110998
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, black line drawing style. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2016
G21 s.r.l. % Barry Sands President and Founder RQMIS Incorporated 29 Water Street, Suite 305 Newburyport, Massachusetts 01950
Re: K152557
Trade/Device Name: 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: January 19, 2016 Received: January 27, 2016
Dear Mr. Sands:
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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statement below.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known) K152557
Device Name
Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
Indications for Use (Describe)
The 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 percutancous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) SUMMARY
G21 S.R.L.
Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
1. General Information
| Submitter: | G21 srl
via S. Pertini, 8
41039 San Possidonio (MO)- ITALY
Phone: +39 0535 30312
Fax: +39 0535 417332 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------|
| Official contact: | Barry E. Sands
Phone: 978-358-7307
Fax: 978-358-7384 |
| Summary Preparation Date: | January 18, 2015 |
| Device | |
| Device Name: | Winch Kyphoplasty (15 and 20 mm) 11 Gauge
Balloon catheters |
| Common name: | Inflatable Bone Tamp |
| Classification name: | 888.3027 - PMMA bone cement
888.1100 - Arthroscope |
| Classification number: | Class II |
| Product Code: | NDN
HRX |
4
3. Predicate Devices
The subject devices Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon catheters are substantially equivalent to the following legally marketed predicate devices:
| Applicant | Device name | 510(k) Number | Product
code |
|-----------------|----------------------------------|---------------------------------------------------------|-----------------|
| STRYKER | STRYKER IVAS BALLOON
CATHETER | K130430, K123942, K113154,
K113477, K103807, K093419 | NDN,
HRX |
| ALGEA THERAPIES | AFFIRM 15P | K110998 | NDN,
HRX |
Additionally, reference devices, as listed below, were selected only to provide scientific or technological information to support the subject devices.
| Applicant | Device name | 510(k)
Number | Product code |
|------------|--------------------------|---------------------------------|--------------|
| CAREFUSION | AVAMAX VERTEBRAL BALLOON | K131820,
K103064,
K093463 | NDN,
HRX |
4. Device Description
Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon catheters are designed for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty in association with cleared spinal polymethylmethacrylate (PMMA) bone cements.
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. Winch Kyphoplasty (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyphoplasty procedure.
The low preinflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas. The stiff distal end of the balloon catheter provides rigidity for smooth insertion while flexible proximal catheter allows for easy maneuverability.
5. Indications for use
The 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.
5
Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters has the same general intended use and the same indications, as the previously cleared predicates and reference devices.
6. Summary of the technological characteristics of the subject devices compared to the predicate and reference devices
The Winch Kyphoplasty Balloon Catheters have similar technological characteristics as the predicate devices, including materials, functional characteristics, catheter and balloon sizes, maximum inflation volumes, and maximum inflation pressures.
7. Biocompatibility
As recommended by the FDA's Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #687-1 #8294) (blue book memo), the subject devices have been evaluated through the following tests:
- Cytoxicity
- Sensitization
- . Irritation/Intracutaneous Reactivity
- Acute systemic toxicity
- . Pyrogenicity
and are biocompatible.
8. Performance data
Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters met specifications and performance characteristics and are substantially equivalent to the predicate devices.
The testing included functional testing such as:
- . dimensional characterization,
- . inflation/deflation time,
- insertion/withdrawal force,
- . fatigue testing,
- . burst characteristics,
- . ability of the device to be used for creation of a void in cancellous bone
and mechanical testing according to ISO 10555-1:2013 , Intravascular catheters--Sterile and single-use catheters--Part 1: General requirements.
9. Conclusion and SE Determination
The information submitted in this premarket notification supports that Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are substantially equivalent in indications for use, technological and functional characteristics, basic design and principles of operation to the previously cleared predicate devices.