AVAFLEX VERTEBRAL AUGMENTATION NEEDLE

K072133 · Cardinal Health, Inc. · NDN · Nov 20, 2007 · Orthopedic

Device Facts

• Record ID: K072133
• Device Name: AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
• Applicant: Cardinal Health, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Nov 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AVAflex Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with Radiopaque Bone Cement manufactured by Cardina Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma. The AVAflex Vertebral Augmentation Needle is used during a kyphoplasty to scrape and score bone in the spine to create a void within a fractured vertebral body and fill the void with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

Device Story

AVAflex Vertebral Augmentation Needle; manual surgical instrument used in vertebroplasty and kyphoplasty. Device scrapes/scores cancellous bone to create void within fractured vertebral body; facilitates injection of Radiopaque Bone Cement. Used in clinical/surgical settings by physicians. Output is physical void creation and delivery of bone cement; aids stabilization of fractured vertebrae; provides pain relief for patients with compression fractures.

Clinical Evidence

Bench testing only. Materials evaluated per ISO 10993-1 biological safety standards. Performance testing demonstrated functional equivalence to predicate curettes.

Technological Characteristics

Manual surgical needle/curette; stainless steel or similar medical-grade materials. Designed for bone scraping/scoring and cement delivery. Evaluated per ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for patients with painful pathological vertebral body compression fractures resulting from osteoporosis, or benign/malignant lesions (e.g., metastatic cancers, myeloma) requiring vertebroplasty or kyphoplasty procedures.

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

• Cardinal Health Chroma-Line Cervical and Lumbar Spine Curettes
• Kyphon, Inc., Kyphx Latitude Curette
• Medtronic Sofamor Danek, Arcuate Vertebral Augmentation System (K063248)

Submission Summary (Full Text)

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

K072133

## CardinalHealth

Cardinal Health 1430 Waukegan Road
McGaw Park, Illinois 60085-6787 847.578.6610 FAX: [phone]

NOV 2 0 2007

## SMDA REQUIREMENTS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS AVAflex Vertebral Augmentation Needle

| Sponsor: | Cardinal Health<br>1430 Waukegan Road MPKB<br>McGaw Park, IL 60085 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs:<br>Contact | Sharon Nichols |
| Telephone: | [phone] |
| Date Summary Prepared: | November 2007 |
| Common Name: | AVAflex Vertebral Augmentation Needle |
| Regulation Description: | Primary - Cement, Bone Vertebroplasty<br>Secondary - Tamp, Cement Dispenser |
| Device Class and<br>Requlation Number: | Class II per 21CFR §888.3027, Procode NDN<br>Class I per §888.4540, Procode HXG and §888.4200,<br>Procode OAR |
| Predicate Devices: | Cardinal Health Chroma-Line Cervical and Lumbar Spine<br>Curettes, Class I exempt<br>Kyphon, Inc., Kyphx Latitude Curette, Class I exempt<br>Medtronic Sofamor Danek, Arcuate Vertebral<br>Augmentation System, K063248 |

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

| Description: | The AVAflex Vertebral Augmentation Needle is a device<br>used to disrupt cancellous bone by scraping and scoring<br>the bone as and creating a void within a vertebral body.<br>After the bone is disrupted, Radiopaque Bone Cement is<br>injected through the AVAflex Vertebral Augmentation<br>Needle to fill the previously created void. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The AVAflex Vertebral Augmentation Needle is used<br>during a vertebroplasty to fill a fractured vertebral body<br>with Radiopaque Bone Cement manufactured by Cardina<br>Health. The painful pathological vertebral body<br>compression fractures may result from osteoporosis,<br>benign or malignant lesions such as metastatic cancers<br>and myeloma.<br>. |
| | The AVAflex Vertebral Augmentation Needle is used<br>during a kyphoplasty to scrape and score bone in the<br>spine to create a void within a fractured vertebral body<br>and fill the void with Radiopaque Bone Cement<br>manufactured by Cardinal Health. The painful<br>pathological vertebral body compression fractures may<br>result from osteoporosis, benign or malignant lesions<br>such as metastatic cancers and myeloma. |
| Summary of Technological<br>Characteristics: | The proposed device and the predicate device are<br>composed of the same or similar design, materials and<br>the manufacturing characteristics. |
| Summary of testing: | All materials used in the fabrication of the Vertebral<br>Augmentation Needle were evaluated through biological<br>qualification safety tests as outlined in ISO 10993 Part-1<br>"Biological Evaluation of Medical Devices". These<br>materials also were tested in accordance with industry<br>recognized test methods and were found to be<br>acceptable for the intended use. |
| Non-Clinical Testing: | Performance testing demonstrated that the proposed<br>device is substantially equivalent to the currently<br>marketed curettes with regard to functional<br>characteristics. |

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

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2007

CardinalHealth % Ms. Sharon Nichols Regulatory Affairs 1430 Waukegan Road McGwa Park, IL 60085-6787

Re: K072133

Trade/Device Name: AVAflex Vertebral Augmentation Needle Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, HXG, OAR Dated: October 25, 2007 Received: October 26, 2007

Dear Ms. Nichols:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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

Page 2 - Ms. Sharon Nichols

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The company name, "CardinalHealth", is written in a simple, sans-serif font.

Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: [phone]

## Indication for Use

510(k) Number (if known): K072133

Device Name: AVAflex Vertebral Augmentation Needle

Indications For Use:

The AVAflex Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

The AVAflex Vertebral Augmentation Needle is used during a kyphoplasty to scrape and score bone in the spine to create a void within a fractured vertebral body and fill the void with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

Prescription Use X or (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchner

Division of General, Restorative, and Neurological Devices

**510(k) Number** K072133