ZVPLASTY

K141419 · Zavation, LLC · NDN · Sep 12, 2014 · Orthopedic

Device Facts

• Record ID: K141419
• Device Name: ZVPLASTY
• Applicant: Zavation, LLC
• Product Code: NDN · Orthopedic
• Decision Date: Sep 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

ZVplasty system comprises manual surgical instruments for percutaneous access to vertebral bodies and delivery of PMMA bone cement. Used in vertebroplasty/kyphoplasty procedures to treat vertebral compression fractures. Instruments include diamond tip/bevel tip introducers, drills, biopsy needles, and cement cannulas. Introducer cannulas feature detachable handles for improved visualization. System used by physicians in clinical settings; requires integration with separately cleared balloon catheters, inflation/vacuum syringes, stopcocks, and PMMA bone cement. Device facilitates site preparation and cement delivery to stabilize fractures, potentially reducing pain and restoring vertebral height.

Clinical Evidence

No clinical data submitted. Substantial equivalence established via bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Materials: Stainless steel (ASTM A276, ASTM F899). Components: Diamond/bevel tip introducers, drill, biopsy needle, cement cannula. Features: Detachable handles on introducer cannulas. Connectivity: Luer lock connections (ISO 594/1, ISO 594-2). Sterilization: Ethylene Oxide (ISO 11135-1, ISO 10993-7). Packaging: ISO 11607-1, ASTM F1929-12.

Indications for Use

Indicated for patients with vertebral compression fractures in the lumbar or thoracic regions caused by primary or secondary osteoporosis, cancer, or trauma, requiring 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

• CareFusion, AVAmax Vertebral Balloon (K131820)
• Stryker, iVas 2-10 Balloon Catheter (K093419)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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# 510K Summary

| Date: | Aug 20, 2014 |
|---------------------------------|---------------------------------------------------------------------------------------------------------|
| Submitter: | Zavation LLC<br>400 Liberty Park Drive<br>Flowood, MS 39232<br>Phone: [phone]<br>Fax: [phone] |
| 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<br>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.

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#### 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.

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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.