(254 days)
The BowTi Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
The BowTi Anterior Buttress Staple System consists of a staple and a screw. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two prongs, which engage the vertebral body and prevent rotation, and a screw slot for final fixation. The staples have a 5-degree bend, and are available in two sizes, 20mm and 24mm. The self-tapping cancellous screws have a 6.25mm major diameter and are available in lengths of 20mm, 25mm, and 30mm. Both components of BowTi Anterior Buttress Staple System are the manufactured from titanium alloy and have a smooth anodized finish.
The provided text describes a medical device, the BowTi Anterior Buttress Staple System, and its 510(k) submission to the FDA. However, the document does not contain information related to acceptance criteria, specific device performance metrics, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
The "Performance Data" section merely states: "Biomechanical testing, including static and fatigue cantilever beam loading, were conducted." This is a general statement and does not provide detailed results or acceptance criteria.
Therefore, I cannot fulfill the request for information on acceptance criteria and the study proving the device meets them because the necessary data is not present in the provided document.
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| IX. 510(k) Summary | |||
|---|---|---|---|
| SUBMITTER: | DePuy AcroMed™, Inc.325 Paramount DriveRaynham, MA 02767-0350 USA | K 02103 | |
| CONTACT PERSON: | Karen F. JurczakPhone: (508) 828-3704Fax: (508) 828-3797 | page 1 | |
| DATE PREPARED: | November 01, 2002 | DEC 11 2002 | |
| PROPRIETARY NAME: | BowTi Anterior Buttress Staple System | ||
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Intervertebral Body | ||
| PREDICATE DEVICE: | MacroPore OS Spinal System (K010911) | ||
| INTENDED USE: | The BowTi Anterior Buttress Staple System, in conjunctionwith traditional rigid fixation, is intended for use in spinalfusion procedures as a means to maintain the relativeposition of weak bony tissue such as allografts orautografts. This device is not intended for load bearingapplications. | ||
| MATERIALS: | ASTM F-136 Material (Ti-6Al-4V) | ||
| PERFORMANCE DATA: | Biomechanical testing, including static and fatiguecantilever beam loading, were conducted. | ||
| DEVICE DESCRIPTION: | The BowTi Anterior Buttress Staple System consists of a |
- The BowTi Anterior Buttress Staple System consists of a DEVICE DESCRIPTION: staple and a screw. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two prongs, which engage the vertebral body and prevent rotation, and a screw slot for final fixation. The staples have a 5-degree bend, and are available in two sizes, 20mm and 24mm. The self-tapping cancellous screws have a 6.25mm major diameter and are available in lengths of 20mm, 25mm, and 30mm. Both components of BowTi Anterior Buttress Staple System are the manufactured from titanium alloy and have a smooth anodized finish.
K OD 1039
page (o
DEC 11 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -
DEC 11 2002
Ms. Karen F. Jurczak Depuy Acromed'" 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K021039
Trade/Device Name: BowTi Anterior Buttress Staple System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 1, 2002 Received: November 4, 2002
Dear Ms. Jurczak;
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 - Ms. Karen F. Jurczak
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark n Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
HFZ-401 DMC cc: HFZ-404 510(k) Staff HFZ-410 DGRND D.O. f/t:MMattera:elh:12/09/02
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BowTi Anterior Buttress Staple System
page to fil
IV. Indications for Use
K021039 510(k) Number (if known):
BowTi Anterior Buttress Staple System Device Name:
Indications For Use:
The BowTi Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)
to Mark N. Melleus
(Division Sign-Off) Dision of General, Restorative Jeurological Devices
Number K02/039
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.