(230 days)
Not Found
Not Found
No
The device description and intended use describe a mechanical screwdriver for bone fixation, with no mention of AI or ML capabilities.
No
The device is described as a screwdriver for inserting bone fixation screws, which is a tool used during a therapeutic procedure but is not therapeutic in itself. It does not treat or cure a disease or condition.
No
Explanation: The device is described as a screwdriver for pre-drilling and insertion of bone fixation screws, which are surgical functions, not diagnostic ones. It does not mention any ability to identify or characterize medical conditions.
No
The device description explicitly lists physical components like a handle, shaft, screw holder, and attachments, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- The Synthes 90 ° Screwdriver is a surgical tool used directly on the patient during oral/maxillofacial surgery for drilling and inserting screws.
Its function is mechanical and procedural, not diagnostic based on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Synthes 90 ° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.
Product codes (comma separated list FDA assigned to the subject device)
DZI, DZJ
Device Description
The Synthes 90 ° Screwdriver consists of a screwdriver handle, shaft, screw holder, screw holder insert and a variety of attachments such as drill bits and screwdriver blades for manual and powered right angled pre-drilling and insertion of screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
Synthes Electric Pen Drive System
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A registered trademark symbol is located to the right of the word.
510(k) Summary
3.0
:
长082649
APR 3 0 2009
:
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 Contact: Andrea M. Tasker Phone: (610) 719-6920 Fax: (484) 356-9682 tasker.andrea@synthes.com |
|---|---|
| Device Name: | Synthes 90 ° Screwdriver |
| Classification: | Regulation Number: §872.4120 Device: drill, bone, powered Regulation Description: Bone cutting instrument and accessories Regulation Medical Specialty: Dental . |
| Predicate Device: | Synthes Electric Pen Drive System |
| Device Description: | The Synthes 90 ° Screwdriver consists of a screwdriver handle, shaft, screw holder, screw holder insert and a variety of attachments such as drill bits and screwdriver blades for manual and powered right angled pre-drilling and insertion of screws. |
| Intended Use: | The Synthes 90 ° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery. |
| Substantial Equivalence: | Documentation provided supports substantial equivalence to other legally marketed devices such as the Synthes Electric Pen Drive System. |
.
.
.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Andrea M. Tasker CMF Regulatory Affairs Manager Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
APR 3 0 2009
Re: K082649
Trade/Device Name: Synthes 90 ° Screwdriver Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, DZJ Dated: April 17, 2009 Received: April 29, 2009
Dear Ms. Tasker:
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 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
2
Page 2- Ms. Tasker
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Christer V.m.ton
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small registered trademark symbol is located to the right of the word.
1.0 Indications for Use
510(k) Number (if known):
Device Name:
Synthes 90 ° Screwdriver
Indications for Use:
The Synthes 90 ° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.
X Prescription Use (Per 21 CFR 801.109)
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)
Kein Muluy for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
.510(k) Number: K082649