VERTEBRAL ACCESS SYSTEM BY VIDACARE

K081713 · Vidacare Corporation · MOQ · Nov 21, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081713
• Device Name: VERTEBRAL ACCESS SYSTEM BY VIDACARE
• Applicant: Vidacare Corporation
• Product Code: MOQ · General, Plastic Surgery
• Decision Date: Nov 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.

Device Story

Vertebral Access System facilitates access to vertebral body for vertebroplasty procedures. System comprises reusable power driver and disposable sterile needle set (11 gauge, 152 mm 304 stainless steel cannula with beveled cutting tip and stylet). Powered driver provides mechanical force to advance needle into bone. Used by clinicians in clinical settings to create conduit for subsequent cement delivery. System does not contain cement; requires separate standard cement delivery system. Benefits include powered assistance for needle placement, reducing manual effort during vertebral access.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Reusable power driver; disposable 11 gauge, 152 mm 304 stainless steel cannula with beveled cutting tip and stylet. Sterile, single-use needle set. Mechanical actuation via powered driver. No software or electronic sensing.

Indications for Use

Indicated for patients requiring fixation of vertebral body fractures via vertebroplasty. Used in conjunction with a standard cement delivery system.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• EZ-IO® Bone Marrow Biopsy System (K072045)
• Parallax EZFlow Cement Delivery System (K051820)

Submission Summary (Full Text)

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# 5. 510(k) Summary

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#### SUMMARY

Submitter's name: Address:

Vidacare Corporation 722 Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537

NOV 21 2008

Phone: Fax number:

Name of contact person:

Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone]

Date the summary was prepared: November 4, 2008

| Name of the device:<br>Trade or proprietary name:<br>Common or usual name: | Vertebral Access System by Vidacare®<br>Vertebroplasty System<br>Cement Dispenser Conduit for<br>Vertebroplasty |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name: | Injector, vertebroplasty (does not contain<br>cement) |
| Classification | Class I<br>21 CFR sec. 888.4200 Injector,<br>vertebroplasty (does not contain cement).<br>And<br>21CFR sec. 878.4820 Surgical instrument<br>motors and accessories/attachments. |
| Product Code | OAR and MOQ |

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The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

| | 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---------------|-------------------------------------------|---------------------|
| 1 | K072045 | EZ-IO® Bone Marrow Biopsy<br>System | Vidacare Corp. |
| 2 | K051820 | Parallax EZFlow Cement Delivery<br>System | Parallax<br>Medical |

Description of the device:

The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.

#### Indications:

The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.

Summary of the technological characteristics of our device compared to the predicate device:

The predicates and the Vidacare Vertebral Access System were compared in the following areas and found to have similar technological characteristics and to be equivalent.

- Indications for Use Target Population Driver Design Features Needle Design Technique Sterility Biocompatibilitv Anatomical Sites Where Used

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vidacare Corporation % Regulatory Specialists, Inc. Ms. Grace Holland Regulatory Specialist 3722 Avenue Sausalito Irvine, California 92606

## NOV 21 2008

Re: K081713

Tradc/Device Name: Vertebral Access System by Vidacare® Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: MOQ, OAR Dated: November 7, 2008 Received: November 10, 2008

Dear Ms. Holland:

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

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Page 2 - Ms. Grace Holland

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.

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 Compliary, 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 Postmanect 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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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### 4. Indications for Use Statement

### Indications for Use

510(k) Number (if known): K081713

Device Name: Vertebral Access System by Vidacare®

Indications for Use:

The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain 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 OF NEEDED) ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerm

(Division Sign-Of Division of Gene and Neurolog

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