KIVA VCF TREATMENT SYSTEM

• K Number: K132817
• Device Name: KIVA VCF TREATMENT SYSTEM
• Manufacturer: BENVENUE MEDICAL, INC.
• Date Cleared: 2014-01-24 ( 137 days)
• Product Code: NDN LOD
• Regulation Number: 888.3027

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 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.

Predicate Devices

K063606, K070293, K041584, K010246

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and summary of performance studies focus on mechanical components and surgical procedures, with no mention of AI or ML.

Therapeutic

Yes
The device is used for the "reduction and treatment of spinal fractures," which directly addresses and treats a medical condition.

Diagnostic

No

The device is indicated for the reduction and treatment of spinal fractures, which is a therapeutic purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile, single-use, implantable device consisting of an implant, a deployment system, and accessory access instruments, all of which are hardware components.

IVD (In Vitro Diagnostic)

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 and treatment of spinal fractures in the thoracic and/or lumbar spine." This is a surgical procedure performed directly on the patient's body.
• Device Description: The device is described as an "implantable device" used in "percutaneous procedures." It involves physically manipulating and augmenting bone within the patient.
• IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.

The Kiva® VCF Treatment System is a surgical device used for treating vertebral compression fractures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

NDN, LOD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic and/or lumbar spine from T6-L5

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

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). A total of 300 subjects were enrolled at 21 sites in the US, Canada, and Europe.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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.

Predicate Device(s)

K063606, K070293, K041584, K010246

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.”

Summary

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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

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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.

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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.

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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.

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

• 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.

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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

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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