ASCENDX VCF REDUCTION SYSTEM

K100404 · Aoi Medical, Inc. · NDN · Dec 14, 2012 · Orthopedic

Device Facts

• Record ID: K100404
• Device Name: ASCENDX VCF REDUCTION SYSTEM
• Applicant: Aoi Medical, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Dec 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascendx™ VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.

Device Story

Ascendx VCF Repair System treats painful pathological vertebral body fractures due to osteoporosis; used in combination with Ascendx Cement. System components include Acu-Cut Cutting Instrument, RDX Repair Device, and inflation syringe. Device used by physicians in clinical settings to mechanically restore vertebral body structure; involves insertion and deployment of repair device within vertebral body followed by cement delivery. Provides pain and functional relief for patients. Bench testing confirms mechanical integrity, biocompatibility (ISO 10993), and performance specifications. Clinical evaluation of 60 subjects demonstrated procedural success and safety comparable to predicate devices.

Clinical Evidence

Clinical study of 60 subjects treated with Ascendx System and Cement. Outcomes: procedural success, pain, function, and adverse events (leakage, subsequent fractures). Follow-up at discharge, 1, 3, 6, and 12 months. Results compared to 113 subjects treated with cement alone, 29 subjects treated with predicate device, and 31 subjects treated with vertebroplasty. Study demonstrated pain and functional relief, supporting substantial equivalence.

Technological Characteristics

System includes Acu-Cut Cutting Instrument, RDX Repair Device, and inflation syringe. Materials meet ISO 10993 biocompatibility standards. Features include radiopaque marker bands. Mechanical operation involves balloon inflation and cement delivery. Sterilization and shelf life validated per industry standards.

Indications for Use

Indicated for treatment of painful pathological vertebral body fractures resulting from osteoporosis.

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

• Kyphon, Inc.'s Kyphx Inflatable Bone Tamps

Submission Summary (Full Text)

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#### 510(k) SUMMARY

# DEC 1 4 2012

K100404

AGE 1 OF 2

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## AOI Medical, Inc.'s AscendxTM VCF Repair System

#### Submitter

AOI Medical, Inc. 7079 University Blvd Winter Park FL 32792

Phone: [phone] Facsimile: 321 280 4801

Contact Person: Julian Mackenzie, President and CEO

Date Prepared: July 1, 2011

#### Name of Device

Ascendx™ VCF Repair System

#### Classification Name

Arthroscope

#### Predicate Devices

Kyphon, Inc.'s Kyphx Inflatable Bone Tamps

#### Intended Use / Indications for Use

The Ascendx™M VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.

#### Technological Characteristics

The Ascendx™ VCF Repair System consists of the Ascendx™ Acu-Cut Cutting Instrument, AscendxTM RDX Repair Device, and AscendxTM Inflation Syringe.

The Ascendx™ System is packaged with a previously cleared bone cement (Ascendx™ Cement, manufactured by TECRES S.p.A, K042415), as well as several class I tools, including manual orthopedic surgical instruments and cement mixing and dispensing tools.

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K100404
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#### Performance Data

Comprehensive bench and clinical testing of the Ascendx™ System was conducted. The testing demonstrated that the System conforms to its design specifications. The testing also demonstrated the Ascendx™ VCF Repair System's ability to mechanically withstand insertion and deployment within a vertebral body. In all instances, the Ascendx™ VCF Repair System functioned as intended.

Nonclincial tests performed included biocompatibility testing in accordance with ISO 10993, sterilization validation, shelf life testing, and the following performance testing: Compressive strength and stiffness testing; maximum balloon inflation pressure testing; balloon inflation pressure testing post-sterilization; maximum balloon inflation pressure testing; balloon force comparison testing; balloon insertion and withdrawal force testing; balloon removal force postcement inscrtion testing; balloon assembly bond strength testing; balloon fatigue testing; balloon physical characteristics testing; tentacle pressure testing; flexural stiffness testing; radiopacity testing of marker bands; bond and pressure strength testing; cutting torque testing; weld strength testing; post-repair bone cement porosity testing; bone cement curing properties testing; and bone cement mixing testing. All bench testing confirmed that the product met the necessary specifications for its intended use.

In addition to the bench testing listed above, biocompatibility of the device has been confirmed in accordance with ISO 10993, and the company has conducted sterilization and shelf life validation in accordance with recognized industry standards.

Clinical testing included cvaluation of 60 subjects treated with the Ascendx™M System and the Ascendx™ Cement. Outcomes evaluated included acute procedural success, pain, function, and adverse events including leakage and subsequent fractures. Follow-up was performed at discharge and 1, 3, 6, and 12 months post-treatment. Results were compared to an investigation using the same cement without the Ascendx™ in 113 subjects, as well as an investigation for 29 subjects undergoing treatment with the predicate device, and 31 subjects undergoing vertebroplasty. The results of this investigation demonstrated that the device could be used as intended to achieve pain and functional relief, and that the safety and effectiveness supported substantial cquivalence to the predicate.

#### Substantial Equivalence

The Ascendx™ VCF Repair System is substantially equivalent to the predicate device. The Ascendx™ VCF Repair System has the same intended uses and indications as the predicate Kyphon Kyphx Inflatable Bone Tamp. Its technological characteristics and principles of operation are also similar to the predicate. The minor technological differences between the Ascendx™ VCF Repair System and its predicate device, e.g., with respect to dimensions, mechanism of coment delivery, etc., raise no new issues of safety or effectiveness, as confirmed by nonclinical and clinical testing.

1779

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#### Public Health Service

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

#### . Letter dated: December 14, 2012

AOI Medical, Incorporated % Mr. Julian Mackenzie President and CEO 7079 University Boulevard Winter Park, Florida 32792

Re: K100404

Trade/Device Name: Ascendx™ VCF Repair System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: October 9, 2012 Received: October 10, 2012

Dear Mr. Mackenzie:

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 r no general connous proctice, 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 r head be admised a determination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I eather of 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 CI ic rail 607); laboring (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Julian Mackenzie

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

# Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic 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):_K100404_

Device Name: Ascendx™ VCF Repair System

Indications for Use: .

The Ascendx™ VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with Ascendx™ Cement.

Prescription Use ਮ (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 OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Dision of Orthopedic Device :0(k) Number K100404 Page __ of

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