ABBOTT SPINE, INC. SPINNAKER SYSTEM

K052638 · Abbott Spine, Inc. · KNW · Nov 7, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052638
• Device Name: ABBOTT SPINE, INC. SPINNAKER SYSTEM
• Applicant: Abbott Spine, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

Device Story

Spinnaker System is a manual surgical instrument kit for vertebral body biopsy and cement delivery. Components include aspiration/injection taps, handles, targeting needle, bone awl, ports, dilators, Luer cap, and k-wire. Used in clinical settings by surgeons to perform bone biopsy via aspiration and to deliver bone cement for vertebral body augmentation. Device provides access to the surgical site and facilitates cement injection. Benefits include combined biopsy and augmentation capability in a single system. No automated processing or software involved.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated that the Spinnaker System meets functional requirements for vertebral body bone biopsy and cement dispensing for vertebral body augmentation.

Technological Characteristics

Manual surgical instrument kit. Components: aspiration/injection taps, handles, targeting needle, bone awl, ports, dilators, Luer cap, k-wire. Non-powered, mechanical device. No software or electronic components.

Indications for Use

Indicated for patients requiring vertebral body bone biopsy for diagnostic purposes or vertebral body augmentation via vertebroplasty. Used by surgeons to remove bone tissue samples and dispense spinal-cleared cement into the vertebral body.

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

• Stryker Capture Vertebral Body and Bone Biopsy Kit
• Parallax Medical Core-Assure Bone and Vertebral Body Biopsy Kit

Submission Summary (Full Text)

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K 052638

### Abbott Spine, Inc. Spinnaker System

### 510(k) Summary of Safety and Effectiveness

| SUBMITTED BY | Abbott Spine, Inc.<br>5301 Riata Park Court, Bldg. F<br>Austin, TX 78727 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | 1649384 |
| CONTACT PERSON | Lisa Peterson<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED | September 19, 2005 |
| CLASSIFICATION NAME | KNW 876.1075- Gastroenterology-Urology Biopsy<br>Instrument: Class II<br>KIH 888.4200- Cement Dispenser: Class I |
| COMMON NAME | Vertebral Body Biopsy Needle<br>Cement Dispenser |
| PROPRIETARY NAME | Abbott Spine Inc. Spinnaker System |
| SUBSTANTIAL<br>EQUIVALENCE | The Abbott Spine Spinnaker System was determined to<br>be substantially equivalent to the Stryker Capture<br>Vertebral Body and Bone Biopsy Kit and the Parallax<br>Medical Core-Assure Bone and Vertebral Body Biopsy<br>Kit. |

### DEVICE DESCRIPTION:

The Abbott Spine, Inc. Spinnaker System is intended for use as a vertebral body biopsy and cement dispenser device. The system is comprised of aspiration/injection taps, handles, a targeting needle, a bone awl, ports and dilators, a Luer cap, and k-wire. The system provides the surgeon with a convenient method of performing vertebral body bone biopsy, as well as dispensing cement cleared for use in the spine into a vertebral body using a single system.

Abbott Spine, Inc.

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## INDICATIONS:

The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.

When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

# MECHANICAL TEST DATA

Mechanical testing demonstrated that the Spinnaker System exhibits the functional requirements to support its use for performing vertebral body bone biopsy and dispensing cement into a vertebral body for vertebral body augmentation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2005

Lisa Peterson Abbott Spine, Inc. Regulatory Affairs Manager 5301 Riata Park Court, Building F Austin, Texas 78727

Re: K052638

Trade/Device Name: Spinnaker System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW, KIH Dated: September 19, 2005 Received: September 27, 2005

Dear Ms. Peterson:

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.

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### Page 2 -Lisa Peterson

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 Office of Compliance at [phone] . 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/industry/support/index.html.

Sincerely yours,

Signature

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

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known):

KOS2638

Abbott Spine, Inc. Spinnaker System Device Name:

Indications for Use:

The Abbott Spine Spinnaker System is intended for use as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.

When used as a cement dispenser, the Spinnaker System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

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

Over-The-Counter Use (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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K05 2638