OSSTAPLE, CRANIOFACIAL

K023488 · Biomedical Enterprises, Inc. · JEY · Oct 31, 2002 · Dental

Device Facts

• Record ID: K023488
• Device Name: OSSTAPLE, CRANIOFACIAL
• Applicant: Biomedical Enterprises, Inc.
• Product Code: JEY · Dental
• Decision Date: Oct 31, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the OSStaple™ are fixation of unloaded craniofacial bone fractures and cranioplasty. The OSStaple™ is contraindicated for craniofacial patients with a skull thickness less than the selected prong length.

Device Story

BioWarm™ is a heating unit modification for the OSStaple™ bone staple system; used to heat shape-memory Nitinol staples to achieve bone fixation. Device consists of a console with user-adjustable current and time controls; electrode handle with activation button. Operator (physician) sets parameters based on staple size; applies electrode to staple. System provides visual/audible feedback for current delivery and contact status; features automatic current cessation. Used in clinical settings for craniofacial procedures. Benefits include controlled, reliable staple activation for bone stabilization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrically powered heating unit for shape-memory Nitinol staples. Features user-adjustable current and time controls, electrode handle with contact/flow indicators, and automatic current cessation circuitry. Standalone console unit.

Indications for Use

Indicated for fixation of unloaded craniofacial bone fractures and cranioplasty. Contraindicated for patients with skull thickness less than the selected staple prong length.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Warmsystem (K993714)
• Warmsystem (001219)
• Warmsystem (001353)
• Warmsystem (001354)

Submission Summary (Full Text)

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OCT 31 2002

#### BioWarm™ Product:

BioMedical Enterprises, Inc. (BME) intends to introduce a device modification to the original approved Warmsystem to heat shape memory Nitinol staples (the "OSStaple™") to achieve compression.

- Submittor Information ટા.
BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: [phone] Contact: Dr. W. Casey Fox (President)

Date Prepared: September 25, 2002

- Classification name: Staple, Fixation, Bone b. Common/Usual Name: Bone staple Proprietary Name: OSStaple™, BioWarm™
- Intended Use: C.

Indications for the OSStaple" are fixation of unloaded craniofacial bone fractures and The OSStaple™ is contraindicated for craniofacial patients with a skull cranioplasty. thickness less than the selected prong length.

- Device Description d.
The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm™ gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm" electrode and will cease if the button is released prior to the automatic cessation by the circuitry

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#### Substantial Equivalence: e.

The Warmsystem heating unit was approved via 510(k)s K993714, 001219, 001353 and 001354 and no fundamental technology changes are represented with the BioWarm" modification.

(Signature)

W. Casey Fox, Ph.D. P.E.
President
BioMedical Enterprises, Inc.

10/14/02
(Date)

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#### GEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 31 2002

Dr. W. Casey Fox President BioMedical Enterprises, Incorporated 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245

Re: K023488

Trade/Device Name: Memograph® Staple System (OSStaple™) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: 76 JEY and 87 HRS Dated: October 15, 2002 Received: October 17, 2002

Dear Dr. Fox:

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.

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Page 2 - Dr. Fox

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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023488

### APPENDIX III (Indication For Use)

Device Name: Memograph® Staple System (OSStaple

Indications for the OSStaple™ are fixation of unloaded craniofacial bone fractures and cranioplasty. The OSStaple™ is contraindicated for craniofacial patients with a skull thickness less than the selected prong length.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use レ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Curry

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K031188

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