(123 days)
Not Found
No
The 510(k) summary describes a mechanical surgical tool (diamond burs) and its reprocessing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on material properties, reprocessing validation, and basic function, not algorithmic performance.
No.
Diamond Burs are surgical accessories used to cut and drill bone during surgery, not to treat or cure a disease or condition. They are tools used in a therapeutic procedure, but are not therapeutic devices themselves.
No
The device, Diamond Burs, is described as a surgical accessory designed to cut and drill bone during surgery. Its function is to perform a physical action during a procedure, not to diagnose a condition or disease.
No
The device description and performance studies clearly indicate a physical, hardware-based medical device (diamond burs) used for cutting and drilling bone. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgery involving bone and bony structures" and "cut and drill bone and bony structures during orthopedic procedures." This describes a surgical tool used directly on the patient's body, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose or monitor a condition.
- Device Description: The description reinforces its use as a "surgical accessory" for cutting and drilling bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument.
N/A
Intended Use / Indications for Use
Diamond burs are intended for use to cut and drill bone and bony structures during orthopedic procedures. Reprocessed diamond burs are indicated for use in patients requiring surgery involving bone and bony structures during orthopedic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DZP, NLN
Device Description
Diamond Burs are specially designed surgical accessories designed to help the surgeon cut and drill bone and bony structures during orthopedic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and bony structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a date stamp. The date is November 23, 2004. The text is in all capital letters and is slightly blurry.
:
:
SECTION B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Contact: | Eric Varty
Research and Development Manager
(480) 763-5335 (o)
(480) 763-5320 (f)
evarty@alliance-medical.com | |
| Date of preparation: | July 15, 2004 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Diamond Burs
Common or Usual Name: Diamond Burs
Classification Name: Dental Diamond Coated Bur, Dental
Diamond Instrument, ENT diamond Coated bur | |
| Predicate device: | | |
| K#
K901967 | Device Description
Dendia Werk Burs and Cutting
Discs | Product Code
DZP |
| Device description: | Diamond Burs are specially designed surgical accessories
designed to help the surgeon cut and drill bone and bony
structures during orthopedic procedures. | |
| Intended use: | Diamond burs are intended for use to cut and drill bone and
bony structures during orthopedic procedures. | |
| Indications
statement: | Reprocessed diamond burs are indicated for use in patients
requiring surgery involving bone and bony structures during
orthopedic procedures. | |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed
Diamond Burs are identical to the predicate devices. The
mechanism of action of Reprocessed Diamond Burs is identical
to the predicate devices in that the same standard mechanical
design, materials and sizes are utilized. There are no changes
to the claims, intended use, clinical applications, patient
population, performance specifications, or method of operation.
Alliance Medical Corporation's reprocessing of Diamond Burs
includes removal of adherent visible soil and decontamination.
Each individual Diamond Bur is tested for appropriate function of
its components prior to packaging and labeling operations. | |
| | Alliance Medical Corporation
Reprocessed Diamond Burs
Traditional 510(k) | 10 |
1
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)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or feathers. The overall design is simple and recognizable, representing the department's role in health and human services.
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
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)