REPROCESSED DIAMOND BURS

K041978 · Alliance Medical Corp. · NLN · Nov 23, 2004 · Neurology

Device Facts

• Record ID: K041978
• Device Name: REPROCESSED DIAMOND BURS
• Applicant: Alliance Medical Corp.
• Product Code: NLN · Neurology
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Diamond burs are intended for use to cut and drill bone and bony structures during orthopedic procedures.

Device Story

Reprocessed diamond burs are surgical accessories used to cut and drill bone during orthopedic procedures. The device is a reprocessed version of original diamond burs, involving cleaning, decontamination, and functional testing to ensure performance equivalent to the original device. It is used by surgeons in clinical settings. The device functions as a mechanical cutting tool; it does not involve electronic or software components. The reprocessed bur provides a cost-effective alternative to single-use devices while maintaining the same mechanical design, materials, and sizes as the predicate.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, and functional testing to demonstrate that the reprocessed burs perform as originally intended.

Technological Characteristics

Mechanical surgical accessory; diamond-coated bur. Design, materials, and sizes are identical to the predicate device. No electronic components, software, or energy sources. Sterilization is performed as part of the reprocessing cycle.

Indications for Use

Indicated for patients requiring surgery involving bone and bony structures during orthopedic procedures.

Regulatory Classification

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Predicate Devices

• Dendia Werk Burs and Cutting Discs (K901967)

Submission Summary (Full Text)

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## SECTION B: 510(k) SUMMARY

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Contact: | Eric Varty<br>Research and Development Manager<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | |
| Date of preparation: | July 15, 2004 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Diamond Burs<br>Common or Usual Name: Diamond Burs<br>Classification Name: Dental Diamond Coated Bur, Dental<br>Diamond Instrument, ENT diamond Coated bur | |
| Predicate device: | | |
| K#<br>K901967 | Device Description<br>Dendia Werk Burs and Cutting<br>Discs | Product Code<br>DZP |
| Device description: | Diamond Burs are specially designed surgical accessories<br>designed to help the surgeon cut and drill bone and bony<br>structures during orthopedic procedures. | |
| Intended use: | Diamond burs are intended for use to cut and drill bone and<br>bony structures during orthopedic procedures. | |
| Indications<br>statement: | Reprocessed diamond burs are indicated for use in patients<br>requiring surgery involving bone and bony structures during<br>orthopedic procedures. | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Diamond Burs are identical to the predicate devices. The<br>mechanism of action of Reprocessed Diamond Burs is identical<br>to the predicate devices in that the same standard mechanical<br>design, materials and sizes are utilized. There are no changes<br>to the claims, intended use, clinical applications, patient<br>population, performance specifications, or method of operation.<br>Alliance Medical Corporation's reprocessing of Diamond Burs<br>includes removal of adherent visible soil and decontamination.<br>Each individual Diamond Bur is tested for appropriate function of<br>its components prior to packaging and labeling operations. | |
| | Alliance Medical Corporation<br>Reprocessed Diamond Burs<br>Traditional 510(k) | 10 |

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Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Diamond Burs.

- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .

Performance testing demonstrates that Reprocessed Diamond Burs perform as originally intended.

Conclusion: Alliance Medical Corporation concludes that the modified device (the Reprocessed Diamond Bur) is safe, effective and substantially equivalent to the predicate devices as described herein.

> Alliance Medical Corporation Reprocessed Diamond Burs Traditional 510(k)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2004

Mr. Eric Varty Research and Development Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

Re: K041978

Trade/Device Name: Alliance Medical Corporation Reprocessed Diamond Burs Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: NLN Dated: November 10, 2004 Received: November 12, 2004

Dear Mr. Varty:

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 - Mr. Eric Varty

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/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark N. Mikkelsen

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

Enclosure

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## Indications for Use Statement 2.

510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed Diamond Burs

Indications for Use: Reprocessed Diamond Burs are indicated for use in patients requiring surgery involving bone and bony structures.

Mark N. Miller

ion- Off Division of General, Restorative, and Neurological Devices

K041978 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

or

Over-the-Counter Use ________

Alliance Medical Corporation Reprocessed Diamond Burs Traditional 510(k)