PARALLAX EZFLOW CEMENT DELIVERY SYSTEM

K051820 · Arthrocare Corp. · OAR · Sep 6, 2005 · Orthopedic

Device Facts

• Record ID: K051820
• Device Name: PARALLAX EZFLOW CEMENT DELIVERY SYSTEM
• Applicant: Arthrocare Corp.
• Product Code: OAR · Orthopedic
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACER Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Story

Manual, single-use disposable instrument system for delivery of Parallax Acrylic Resin (with TRACERS or TRACER Ta) during vertebroplasty or kyphoplasty. Used by surgeons in clinical settings to inject bone cement into vertebral bodies for fracture fixation. System contains no cement material; provides mechanical means for controlled resin delivery. Benefits include stabilization of pathological vertebral fractures.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence supported by functional testing and prospective clinical data.

Technological Characteristics

Manual, single-use disposable instruments. No electronic components, software, or energy sources. Materials are not specified by ASTM standard in the provided text.

Indications for Use

Indicated for patients with painful vertebral compression fractures resulting from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma) requiring fixation via vertebroplasty or kyphoplasty.

Regulatory Classification

Identification

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.

Predicate Devices

• Parallax® Cement Injector Kit (K980064)

Submission Summary (Full Text)

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### 510(k) Summary of Safety and Effectiveness ArthroCare Corporation Parallax® EZFlow™ Cement Delivery System

**General Information**

| Manufacturer: | ArthroCare, Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085 |
|------------------------------------|-----------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng<br>Director, Regulatory Affairs |
| Date Prepared: | July 1, 2005 |

**Device Description**

| Classification: | Cement Dispenser: Class I Exempt per 21 CFR 888.4200 |
|----------------------|------------------------------------------------------------------|
| Trade Name: | Parallax ^® EZFlow ^™ Cement Delivery System |
| Device Code: | OAR and KIH |
| Generic/Common Name: | Cement Dispenser |

**Predicate Devices**

Parallax® Cement Injector Kit

K980064

### Intended Use

Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACER Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

### Product Description

Parallax® EZFlow™ Cement Delivery System is a delivery system for the Parallax Acrylic Resin with TRACERS and Parallax Acrylic Resin with TRACERS Ta. It is designed to provide surgeons with a means to inject Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The EZFlow Cement Delivery System does not contain any bone cement material, as this system only consists of general instruments. All of the system components are manual, single-use disposable instruments.

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## Substantial Equivalence

In establishing substantial equivalence, ArthroCare evaluated the indications for use, functional testing, and prospective clinical data to demonstrate equivalence to the predicate devices. We believe the EZFlow Cement Delivery System is substantially equivalent to the currently marketed device in its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.

JAN 3 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ArthroCare Corporation % Ms. Valerie DeFiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085

Re: K051820

Trade/Device Name: Parallax EXFlow Cement Delivery System Regulation Number: 21 CFR 888.4200 Regulation Name: Cement Dispenser Regulatory Class: Class I Exempt Product Code: OAR Dated: September 6, 2005 Received: September 6, 2005

Dear Ms. Defiesta-Ng:

This letter corrects our exempt letter of September 6, 2005.

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.

We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 CFR Part 888.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type, that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 888.9 will be exempt from the premarket notification requirements of the Act.

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

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Page 2 - Ms. Valerie DeFiesta-Ng

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 I loase be deviloed that I Dr brains that your device complies with other requirements of the Act that I Drimas intatutes 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. production 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 premaince holicated 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 Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours,

Barbara Brown

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

Enclosure

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# Page 3 – Ms. Valerie DeFiesta-Ng

# Indications for Use

510(k) Number (if known): K051820

Device Name: Paralax® EXFlow™ Cement Delivery System

Indications For Use:

Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)