THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE

K113872 · Vidacare Corporation · KNW · Mar 8, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K113872
• Device Name: THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
• Applicant: Vidacare Corporation
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Mar 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.

Device Story

System consists of reusable power driver and disposable sterile needle set. Under fluoroscopic guidance, clinician uses powered driver to insert 11-gauge stainless steel needle through bone cortex into vertebral body or lesion. Needle set includes outer cannula and inner stylet for penetration; stylet removed after cortex breach. Standard Luer lock on cannula allows syringe attachment for aspiration. Driver facilitates biopsy specimen collection. Device used in clinical settings by physicians. Output is bone biopsy specimen or access path for cement delivery. Benefits include controlled, powered bone access for biopsy and vertebroplasty procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

System comprises reusable power driver and disposable 11-gauge (3.05mm x 197mm) 304 stainless steel needle set. Features beveled cutting tip, stylet, and Luer lock connector. Powered by rechargeable battery. Operates via mechanical rotation for bone penetration. No software or complex algorithms described.

Indications for Use

Indicated for patients requiring vertebroplasty for vertebral body fracture fixation or bone biopsy of the vertebral body and bone lesions.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• The OnControl™ Bone Access System by Vidacare® (K112468)
• Clearview Plus Bone and Vertebral Body Biopsy Needles (K022169)
• The Bonopty® Coaxial Bone Biopsy System with Eccentric Drill (K962425)

Submission Summary (Full Text)

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K 113872, Addendum 2, Additional Indications for K112468

5. 510(k) Summary

:

vidacare

MAR - 8 2012 Page 1 of 3

4350 Lockhill Selma Road Shavano Park, TX 78249+2095 210-375-8500

### SUMMARY

Submitter's name: Address:

Phone: Fax number: Vidacare Corporation 4350 Lockhill Selma Road Shavano Park, TX 78249 210-375-8500 210-375-8537

K113872

Name of contact person: Grace Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine CA 92606 Telephone: [phone] Fax: [phone]

Date the summary was revised: February 24, 2012

The OnControl™ Bone Access and Bone Biopsy System Name of the device: bv Vidacare® Trade or proprietary name: The OnControl™ Bone Access and Bone Biopsy System by Vidacare® Common or usual name: Cement Dispenser Conduit for Vertebroplasty and Bone Biopsy Needle Classification panel: Orthopedic Spine Devices Branch

| Product Code | Classification Regulation | Classification Name |
|--------------|---------------------------|------------------------------------|
| OAR | 888.4200 | Injector, vertebroplasty |
| MOQ | 878.4820 | Battery, replacement, rechargeable |
| KNW | 876.1075 | Instrument, biopsy |

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

| | 510(k)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|---|------------------|--------------------------------------------------------------|------------------|
| 1 | K112468 | The OnControl™ Bone Access System by Vidacare® | Vidacare Corp. |
| 2 | K022169 | Clearview Plus Bone and Vertebral Body Biopsy Needles | Parallax Medical |
| 3 | K962425 | The Bonopty® Coaxial Bone Biopsy System with Eccentric Drill | AprioMed |

5 Page

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### Description of the device:

The OnControl Bone Access and Bone Biopsy 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 OnControl Bone Access System Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the OnControl Bone Access System (cleared via K112468, The OnControl Bone Access System by Vidacare®) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K112468, The OnControl Bone Access System by Vidacare®.

Under fluoroscopic imaging quidance, activation of the driver assists the clinician to insert the needle set through the cortex of the bone, into the vertebral body or area of lesion. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.

The driver is then separated from the needle assembly for specimen removal.

### Indications:

The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.

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

The predicates and The OnControl™ Bone Access and Bone Biopsy System were compared in the following areas and found to have similar characteristics with one or more of the predicates and to be equivalent.

Anatomical sites

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Biocompatibility Dimensional specifications Driver design features Energy type Environmental specifications Ergonomics of the patient-user interface Firmware Indication for Use

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a bird or a stylized human figure. The logo is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

- 8 2012

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

Re: K113872

Trade/Device Name: The OnControl™ Bone Access and Bone Biopsy System by Vidacare®

Regulation Number: 21 CFR 876.1075

Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: December 30, 2011

Received: December 30, 2011

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. 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 that FDA has made a determination that your device complies with other requirements of the Act

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### Page 2 - Ms. Grace Holland

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jon

Mark N. Melkerson
Director

Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and

Com
Dir

Radiological Health

Enclosure

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## 4. Indications for Use Statement

Device Name: The OnControl™ Bone Access and Bone Biopsy System by Vidacare®

Device 510(k) number: K113872

Indications for Use:

The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

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 Siem-Off)
(Division of Surgical, Division Siern-Off), Orthopedical
Division of Surgical Devices
Bread Restorative Devices
Breat Restorative Devices (1) 3 (Division Sien-Off)
Sturision of Sturgica Division of Surgical, Or
Division of Surgical, Division of Surgices
and Restorative Devices 510(k) Number -