ACU-CUT VERTEBRAL AUGMENTATION SYSTEM

K113452 · Ascendx Spine, Inc. · NDN · Feb 17, 2012 · Orthopedic

Device Facts

• Record ID: K113452
• Device Name: ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
• Applicant: Ascendx Spine, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Feb 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.

Device Story

Acu-Cut Vertebral Augmentation System creates cavities within vertebral bodies to facilitate bone cement delivery. System components include cutting instrument, cannulas, trocars (tri-point and bevel tips), hand drill, and cement delivery tubes with plungers. Used in conjunction with previously cleared bone cement. Physician-operated in clinical setting. Cutting instrument creates cavity in cancellous bone; cement delivery tubes inject bone cement to stabilize fracture. Procedure aims to alleviate pain associated with vertebral compression fractures. Mechanical design allows for insertion and deployment within vertebral body.

Clinical Evidence

Comprehensive bench and clinical testing conducted. Bench testing included cutting torque, tensile strength, flex cable weld strength, insertion/removal force, and handle strength. System also underwent sterilization, packaging, shipping, biocompatibility, and aging validation. Clinical testing performed via Ascendx VCF Repair System IDE study. Results demonstrated system conforms to design specifications and functions as intended.

Technological Characteristics

System includes cutting instrument, cannulas, trocars, hand drill, and cement delivery tubes. Mechanical principle of operation for cavity creation and cement delivery. Class I instruments. Biocompatible materials. Sterilization validation performed.

Indications for Use

Indicated for treatment of painful pathological vertebral body fractures in patients with osteoporosis, benign lesions, or malignant lesions (e.g., metastatic cancer, myeloma).

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

• Arcuate Vertebral Augmentation System (K070527)

Submission Summary (Full Text)

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K113452
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### 510(k) SUMMARY for K113452

Ascendx Spine, Inc.'s Acu-Cut Vertebral Augmentation System FEB 17 2012

### Submitter

Ascendx Spine, Inc. 7079 University Blvd Winter Park FL 32792

Phone: [phone] Facsimile: [phone] Contact Person: Teresa Cherry Date Prepared: July 16, 2012 (12/15ed)

### Name of Device

Acu-Cut Vertebral Augmentation System

### Classification Name

Vertebroplasty, Cement, Bone

### Predicate Devices

Medtronic USA, Inc.'s Arcuate Vertebral Augmentation System (K070527)

### Intended Use / Indications for Use

The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.

### Technological Characteristics

The Acu-Cut Vertebral Augmentation System consists of:

- the Acu-Cut Cutting Instrument .
- . 2 Cannulas
- 1 Tri-Point Tip Trocar .
- 1 Bevel Tip Trocar ●
- 1 Hand Drill ●

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- · 5 Cement Delivery Tubes with Plungers
- · A previously FDA cleared bone cement.

# Performance Data

Comprehensive bench and clinical testing of the Acu-Cut Vertebral Augmentation System was conducted. Testing included:

- Bench testing for the Acu-Cut Cutting Instrument .
- Cutting torque testing in osteoporotic vertebrae and sawbones o
- Tensile strength testing of Cutting Instrument band o
- Cutting Instrument flex cable weld strength testing o
- Bench testing for the Trocars, Cannulas, Hand Drills and Cement Delivery ● Devices
- o Insertion testing
- Trocar Handle Strength Testing 0
- Torque and Tensile Strength Testing O
- Cement Delivery Instrument Testing O
- o Removal Force Testing
- Sterilization Validation ●
- Packaging and Shipping Validations .
- Biocompatibility Testing ●
- Clinical Testing Ascendx VCF Repair System IDE study ●
- Accelerated and Real Time Aging Testing .

The testing demonstrated that the System conforms to its design specifications. The testing also demonstrated the Acu-Cut System's ability to mechanically withstand insertion and deployment within a vertebral body. In all instances, the Acu-Cut System functioned as intended.

## Substantial Equivalence

The Acu-Cut Vertebral Augmentation System is substantially equivalent to the predicate device. The Acu-Cut Vertebral Augmentation System has the same intended uses and indications as the predicate Arcuate Vertebral Augmentation System. Both systems include a cutting device that is used to create a cavity by cutting cancellous bone within the vertebral body. Both systems include Class I instruments for gaining access to the vertebral body and for delivering previously cleared bone cement. The technological characteristics and principles of operation of the Acu-Cut System are also similar to the predicate. The minor technological differences between the Acu-Cut Vertebral Augmentation System and its predicate device, e.g., with respect to dimensions, etc., raise no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that form the body, wings, and tail feathers.

Public Health Service

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

FEB 17 2012

Ascendx Spine, Incorporated % Hogan LovellsUS LLP Ms. Janice M. Hogan Regulatory Counsel 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K113452

Trade/Device Name: Acu-Cut Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, KIH Dated: November 21, 2011 Received: November 21, 2011

Dear Ms. Hogan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) and enough the Medical Device Amendments, or to connineres phot to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, increasing market the act include requirements for annual registration, listing of gencial controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease note: OD10 : 0010 : abeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (300 acree, insisting major regulations affecting your device can be may be subject to additions, 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 that IDA has made a accornmancir in administered by other Federal agencies. You must or any rederal statutes and regulations annualing, but not limited to: registration and listing (21 Comply with an the For 8 requirements (1); medical device reporting (reporting of medical CrK Fall 607), laocing (21 OFR 803); good manufacturing practice requirements as set

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# Page 2 - Ms. Janice M. Hogan

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 n you active spothio ad 1100 corpor JDA/Centers Offices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Somer 10. BOTTess and ing by reference to premarket notification" (21CFR Part note the 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 I ou may 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eind Keith

~ Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

510(k) Number (if known):

K113452

Device Name: Acu-Cut Vertebral Augmentation System

Indications for Use:

The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-(Division Sign-Sign-Sical, Orthopedic, and Restorative Devices

510(k) Number

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