KIVA VCF TREATMENT SYSTEM

K132817 · Benvenue Medical, Inc. · NDN · Jan 24, 2014 · Orthopedic

Device Facts

• Record ID: K132817
• Device Name: KIVA VCF TREATMENT SYSTEM
• Applicant: Benvenue Medical, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Jan 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kiva® VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

Device Story

Kiva VCF Treatment System is a sterile, single-use implantable device for percutaneous reduction and treatment of spinal fractures. System includes nitinol Kiva Coil, PEEK Optima implant with barium sulfate, deployment cannula, and manual orthopedic access instruments. Procedure involves guiding nitinol coil into vertebral body via deployment cannula; PEEK implant is guided over coil to achieve height distraction of vertebral body. Once positioned, PMMA bone cement is injected into implant to stabilize fracture and minimize posterior extravasation. Used in clinical settings by physicians. Benefits include vertebral height restoration and fracture stabilization.

Clinical Evidence

Clinical evidence provided via the KAST trial, a prospective, multi-center, randomized, controlled study (n=300) comparing Kiva system to balloon kyphoplasty for osteoporotic VCF. Primary endpoint: composite of pain reduction and functional improvement without device-related serious adverse events. Secondary endpoints: vertebral height restoration, cement volume, quality of life, ambulatory status, subject satisfaction, cement extravasation, migration, and subsequent fracture. Results supported safety and effectiveness.

Technological Characteristics

Implant: PEEK Optima with barium sulfate. Deployment system: Nitinol coil, deployment cannula. Access instruments: Class I manual orthopedic needles, stylets, cannulas. Sterilization: Terminal irradiation (ANSI/AAMI/ISO 11137). Biocompatibility: ANSI/AAMI/ISO 10993 compliant. Energy source: Manual mechanical operation.

Indications for Use

Indicated for reduction and treatment of spinal fractures in thoracic and/or lumbar spine (T6-L5).

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

• StaXxTM FX System (K063606)
• Benvenue VCF Osteo Coil System (K070293)
• KyphX® HV-RTM Bone Cement (K041584)
• KyphX® Inflatable Bone Tamp (K010246)

Submission Summary (Full Text)

{0}------------------------------------------------

K 132817 Page 1 of 5 .

JAN 2 4 2014

# 510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92

#### 510(k) Owner:

Barbara S. Lindsay Vice President, Clinical, Regulatory and Quality Affairs BENVENUE MEDICAL, INC 3052 Bunker Hill Lane, Suite 120 Santa Clara, CA 95054 Phone: [phone] Fax: [phone]

#### 510(k) Contact:

Cindy Domecus, R.A.C. (US & EU) Principal Domecus Consulting Services LLC Consultant to Benvenue Medical, Inc. Phone: [phone] Fax: [phone] [e-mail]

Date Prepared: January 23, 2014

Kiva® VCF Treatment System Device Trade Name:

Common Name:

Polymethylmethacrylate (PMMA) Bone Cement

Classification Name:

Polymethylmethacrylate (PMMA) Bone Cement (21 CFR

888.3027)

Device Product Code:

NDN, LOD

### Page 1 of 5

{1}------------------------------------------------

Predicate Device(s): The Kiva® VCF Treatment System is substantially equivalent to the following devices:

| Device | Manufacturer | 510(k) |
|--------------------------------|--------------------------|---------|
| StaXxTM FX System | SpineWave, Inc | K063606 |
| Benvenue VCF Osteo Coil System | Benvenue Medical, Inc | K070293 |
| KyphX® HV-RTM Bone Cement | Kyphon, Inc. (Medtronic) | K041584 |
| KyphX® Inflatable Bone Tamp | Kyphon, Inc. (Medtronic) | K010246 |

#### Device Description:

The Kiva® VCF Treatment System is provided as a sterile, single use, implantable device which may be used in percutaneous procedures for the reduction and treatment of spinal fractures. The device consists of an implant, a deployment system for the implant, and a set of accessory access instruments. The deployment system component is a single-use, nonimplantable device that is used to properly position and deliver the implant. It consists of a nitino! Kiva Coil, which is guided through a deployment cannula into the bone via a hand operated mechanism. The Kiva Implant, made from PEEK Optima with barium sulfate for radiopacity, is guided over the nitinol Kiva Coil. As the Kiva Implant is pushed over the Kiva Coil, it reduces the fracture via height distraction of the vertebral body. Once the Implant is placed into the vertebral body. PMMA bone cement is deployed into the Kiva Implant. The Kiva Implant contains the PMMA bone cement and helps minimize posterior extravasation. A collection of manual surgical orthopedic instrumentation (Class I needles, stylets, cannulas) is used to gain access to the vertebral body at the start of the procedure, then again later for bone cement deployment.

#### Statement of Intended Use:

The Kiva® VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

{2}------------------------------------------------

#### Sterilization:

The Kiva® VCF Treatment System is terminally sterilized via irradiation according to the requirements of ANSI/AAMI/ISO 11137 to ensure a sterility assurance level (SAL) of 10°

#### Biocompatibility:

The materials comprising the Kiva® VCF Treatment System (implant, deployment system, and access instrumentation) have been evaluated and tested for biocompatibility according to applicable requirements of ANSI/AAMI/ISO 10993. Results demonstrated that the Kiva® VCF Treatment System is biocompatible.

#### Non-Clinical/Mechanical Testing:

The safety and performance of the Kiva® VCF Treatment System have been substantiated through extensive non-clinical mechanical testing. Results of the testing confirm that the Kiva® VCF Treatment System can reliably perform as intended.

#### Clinical Performance Discussion:

A clinical trial was conducted under an approved IDE. The study is titled Kiva® System as a Vertebral Augmentation Treatment -- A Safety and Effectiveness Trial (KAST trial). This was a prospective, multi-center, randomized, controlled study designed to evaluate the safety and effectiveness of the Kiva® VCF Treatment System in comparison to balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures (VCF). The primary endpoint was a composite of reduction in paintenance or improvement in function in the absence of device related serious adverse events. Secondary endpoints include vertebral height restoration, cement volume, quality of life, ambulatory status, subject satisfaction, cement extravasation, device or cement migration, and subsequent fracture. A total of 300 subjects were enrolled at 21 sites in the US, Canada, and Europe. The results demonstrate the safety and effectiveness of the Kiva® VCF Treatment System and support substantial equivalence to predicate devices.

{3}------------------------------------------------

### Substantial Equivalence:

The rationale for substantial equivalence of the Kiva® VCF Treatment System to cited predicates is summarized in the following bullet points:

- A substantial part of this device (Kiva Coil and Deployment System) is the cleared . Benvenue VCF Osteo Coil System.
- The implantable PEEK Optima Kiva Implant part of the device is substantially . equivalent to the stackable PEEK wafers of the Spine Wave StaXxTM FX device.
- The Kiva® VCF Treatment System reduces compression fracture via height . distraction as do the predicate devices.
- The Kiva® VCF Treatment System functions in concert with PMMA bone cement to . achieve fracture reduction and treatment as do the predicate devices. The following table describes and shows similarities of the indications for use among the predicate devices and the Kiva® VCF Treatment System.

{4}------------------------------------------------

| Device | Indications for Use |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| StaXx™ FX System | The StaXx™ FX System is indicated for use in the reduction<br>of spinal fractures. It is intended to be used in combination<br>with Stryker Spineplex Radiopaque Bone Cement. |
| Benvenue VCF Osteo Coil<br>System | The Benvenue VCF Osteo Coil System is indicated for the<br>treatment of pathological compression fractures of the<br>vertebral body that may result from osteoporosis, benign<br>lesions, and/or malignant lesions, by creating channels in the<br>existing spinal bone structure for the flow of PMMA bone<br>cement. |
| KyphX® HV-R™ Bone<br>Cement | KyphX® HV-R™ Bone cement is indicated for the treatment<br>of pathological fractures of the vertebral body due to<br>osteoporosis, cancer, or benign lesions using a balloon<br>kyphoplasty procedure. Cancer includes multiple myeloma<br>and metastatic lesions, including those arising from breast or<br>lung cancer or lymphoma. Benign lesions include hemagioma<br>and giant cell tumor. |
| KyphX® Inflatable Bone<br>Tamp | KyphX® Inflatable Bone Tamps are intended to be used as<br>conventional bone tamps for the reduction of fractures and/or<br>creation of a void in cancellous bone in the spine (including<br>use during balloon Kyphoplasty with KyphX® HV-R™ Bone<br>Cement), hand, tibia, radius and calcaneus. |
| Kiva® VCF Treatment<br>System | The Kiva® VCF Treatment System is indicated for use in the<br>reduction and treatment of spinal fractures in the thoracic<br>and/or lumbar spine from T6-L5. It is intended to be used in<br>combination with the Benvenue Vertebral Augmentation<br>Cement Kit. |

- The extensive non-clinical and clinical testing performed on this device provides . support that the Kiva® VCF Treatment System performs as intended and presents no different questions of safety or effectiveness.
The Kiva® VCF Treatment System device technological characteristics compared to predicate devices, indications for use compared with predicate devices, non-clinical test results, and clinical data demonstrate that the Kiva® VCF Treatment System is safe, effective, performs as intended, and is substantially equivalent to the currently marketed predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird-like figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

January 24, 2014

Benvenue Medical, Incorporated % Ms. Cindy Domecus, Regulatory Affairs Consultant Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K132817

Trade/Device Name: Kiva® VCF Treatment System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, LOD Dated: January 6, 2014 Received: January 7, 2014

Dear Ms. Domecus:

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

{6}------------------------------------------------

#### Page 2 - Ms. Cindy Domecus

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance 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

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

#### BENVENUE MEDICAL, INC KIVA® VCF TREATMENT SYSTEM - TRADITIONAL 510(k) PREMARKET NOTIFICATION

### 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K132817

Device Name: Kiva® VCF Treatment System

Indications for Use:

The Kiva® VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132817