(106 days)
Not Found
No
The device description and summary of performance studies indicate a system of manual instruments for a surgical procedure, with no mention of AI or ML capabilities.
Yes
The device is described as being used for the "reduction of fractures and/or creation of a void in cancellous bone in the spine" and for "treatment of vertebral compression fractures," which are therapeutic interventions.
No
The provided text describes a system and instruments used for the treatment of vertebral compression fractures by delivering bone cement. It is a therapeutic device used for reducing fractures and creating voids, not a device for diagnosing a medical condition.
No
The device description explicitly states the system consists of "a variety of manual instruments" used for accessing the vertebral body and delivering bone cement, indicating it is a hardware-based medical device.
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 reduction of fractures and/or creation of a void in cancellous bone in the spine, specifically for percutaneous vertebral augmentation procedures like kyphoplasty. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device consists of manual instruments used to access the vertebral body, prepare a site, and deliver bone cement. These are physical tools used in a surgical setting.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Zavation ZV plasty (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 (comma separated list FDA assigned to the subject device)
NDN, HRX, GAA
Device Description
The Zavation ZVplasty system is designed for use in vertebroplasty procedures for treatment of vertebral compression fractures in the lumbar or thoracic regions brought on by primary or secondary osteoporosis, cancer or trauma. The Zavation ZVplasty system consist of a variety of manual instruments which provide physicians with a means to access the vertebral body with a mechanical device in order to prepare a site for vertebroplasty. Once the site is prepared the Zavation ZVplasty system instruments are used to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine. The Zavation ZVplasty system instruments are to be used with the following previously FDA cleared items, balloon catheter, inflation syringe, vacuum syringe, stopcock, PMMA bone cement, cement mixing system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (lumbar or thoracic regions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / 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)
No clinical tests were submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence because the technological performance characteristics of the subject system are the same as the predicates device.
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.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2014
Zavation LLC Mr. John Walker Engineering Manager 400 Liberty Park Drive Flowood, Mississippi 39232
Re: K141419 Trade/Device Name: ZVplasty Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX, GAA Dated: June 30, 2014 Received: July 3, 2014
Dear Mr. Walker:
This letter corrects our substantially equivalent letter of September 12, 2014.
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
1
807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/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 yours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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See PRA Statement below.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
Indications for Use
510(k) Number (if known) K141419
Device Name ZVplasty
Indications for Use (Describe)
The Zavation ZV plasty (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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510K Summary
| Date: | Aug 20, 2014 |
|---|---|
| Submitter: | Zavation LLC |
| 400 Liberty Park Drive | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact person: | John Walker |
| Type of 510(k) submission: | Traditional |
| Trade name: | ZVplasty |
| Common Name: | Accessories for Inflatable Bone Tamp |
| Classification regulation/code: | 888.1100, HRX |
| 888.3027, NDN | |
| Subsequent Product Code | 878.4800, GAA |
| Classification name: | Arthroscope |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Basis for submission: | New device |
Device Description:
The Zavation ZVplasty system is designed for use in vertebroplasty procedures for treatment of vertebral compression fractures in the lumbar or thoracic regions brought on by primary or secondary osteoporosis, cancer or trauma. The Zavation ZVplasty system consist of a variety of manual instruments which provide physicians with a means to access the vertebral body with a mechanical device in order to prepare a site for vertebroplasty. Once the site is prepared the Zavation ZVplasty system instruments are used to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine. The Zavation ZVplasty system instruments are to be used with the following previously FDA cleared items, balloon catheter, inflation syringe, vacuum syringe, stopcock, PMMA bone cement, cement mixing system.
4
Intended Use:
The Zavation ZVplasty (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.
Predicate Device:
CareFusion, AVAmax Vertebral Balloon (K131820) Stryker, iVas 2-10 Balloon Catheter (K093419)
Technological Characteristics:
The Zavation ZVplasty system possesses the same technological characteristics as the predicate. These include: basic design (size), material (stainless steel), and intended use (as described above). Both the ZVplasty system and the predicate contain the following instruments: diamond tip and bevel tip introducers, drill, biopsy needle, and cement cannula. The Zavation ZVplasty system introducer cannulas have detachable handles whereas the predicates have a permanently mounted handle. The detachable handle provides the physician the choice of removing the handle for unobstructed viewing during the procedure or leaving the handle attached as would be if the handle were permanently attached. The added option for removing the handle of the introducer does not raise new issues of safety or efficacy.
Non-clinical Test:
No clinical tests were submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence because the technological performance characteristics of the subject system are the same as the predicates device.
Non-clinical Data:
The Stainless Steel, which is the only patient contacting material, and contacts the patient in a limited use is in conformance with ASTM A276 and ASTM F899. FDA Standards Recognition Number 8-343.
The luer lock connection that is molded as part of the plastic handles is in conformance with ISO 594/1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. FDA Standards Recognition Number 6-11. The luer lock connection that is molded as part of the plastic handle is in conformance with ISO 594-2 Second edition 1998-09-01, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. FDA Standards Recognition Number 6-129.
5
The following standards apply to the sterilization of the finished device.
ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. FDA Recognition Number 14-331.
ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. FDA Recognition Number 14-335.
ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. FDA Recognition Number 14-355 ASTM F1929-12 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration". FDA recognition number 14-378.
Conclusion:
Based on the similarities in materials, design, principles of function, intended use and indications, the Zavation ZVplasty system has been shown to be substantially equivalent to the predicate device. Both systems contain instruments for gaining access to the vertebral body and for delivering previously cleared cement. Non-clinical data demonstrates the ZVplasty system is as safe, effective, and performs as well as the predicate device. The added option for removing the handle of the introducer does not raise new issues of safety or efficacy.