(14 days)
No
The device description focuses on a mechanical modification (addition of a compression spring) to improve controlled and repeatable insertion force. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is used to fix and stabilize craniofacial bones after fractures or during reconstructive procedures, which is a therapeutic function.
No
The device is described as a "Resorbable Tack System" and "Automated Tack Driver" used for fixation and stabilization of craniofacial bones during surgical procedures, not for identifying a disease or condition.
No
The device description explicitly details a physical device ("Automated Tack Driver") with mechanical components ("compression spring") designed for inserting physical objects ("Resorbable Tacks") into bone. This is clearly a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for the fixation and stabilization of bones during surgical procedures on the craniofacial skeleton. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device description details a mechanical system (tacks and a tack driver) used to physically secure bone fragments. This is consistent with a surgical implant and instrument, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) from the human body to provide diagnostic information.
IVD devices are used to perform tests on specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Synthes Resorbable Tack System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton.
Synthes Resorbable Tack System is not intended for use in the mandible or other full load-bearing situations, for areas with active infection or for patient conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
Product codes
JEY, GXN
Device Description
Synthes Automated Tack Driver is designed for use with Synthes Resorbable Tacks. Resorbable Tacks provide fixation and aid in the alignment and stabilization of craniofacial bones when used in conjunction with Resorbable Fixation System plates and meshes. To facilitate tack insertion into a predrilled hole in bone, the Self-Retaining Tack Driver previously cleared has been modified for more controlled and repeatable insertion force. A compression spring has been added to the design, which upon release allows automatic tack insertion into a pre-drilled hole in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, naso-ethmoidal and infraorbital areas, frontal sinus wall, midface, mandible
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
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.(b)
Classification. Class II.
0
MAY 1 6 2002
3. 510(k) Summary:
| Submitter | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Bonnie Smith
(610) 647-9700 |
| Name of the Device | Synthes Automated Tack Driver
(An accessory to Synthes Resorbable Tack System) |
| Predicate Device | Synthes Resorbable Tack System, Self-Retaining Tack Driver -
K000560 |
| Device Description | Synthes Automated Tack Driver is designed for use with Synthes
Resorbable Tacks. Resorbable Tacks provide fixation and aid in the
alignment and stabilization of craniofacial bones when used in
conjunction with Resorbable Fixation System plates and meshes. To
facilitate tack insertion into a predrilled hole in bone, the Self-
Retaining Tack Driver previously cleared has been modified for
more controlled and repeatable insertion force. A compression
spring has been added to the design, which upon release allows
automatic tack insertion into a pre-drilled hole in bone. |
| Intended Use | Synthes Resorbable Tack System is intended for fractures of the
craniofacial skeleton including, but not limited to, comminuted
fractures of the naso-ethmoidal and infraorbital areas, comminuted
fractures of the frontal sinus wall, and midfacial fractures; and
reconstructive procedures of the midface or craniofacial skeleton.
Synthes Resorbable Tack System is not intended for use in the
mandible or other full load-bearing situations, for areas with active
infection or for patient conditions including blood supply.
limitations, insufficient quantity or quality of bone, or latent infections. |
00005
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P. O. Box 1766 Paoli, Pennsylvania 19301
Re: K021382
Trade/Device Name: Synthes (USA) Automated Tack Driver Regulation Number: 872.4760 and 882.5330 Regulation Name: Bone Plate and Preformed Nonalterable Cranioplasty Plate Regulatory Class: II Product Code: JEY and GXN Dated: April 30, 2002 Received: May 2, 2002
Dear Ms. Smith:
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
2
Page 2 - Ms. Smith
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.
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) 594-4613. 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,
Patricia Cicerata Kfor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2. Indications for Use
Special 510(k) Device Modification
INTENDED USE STATEMENT
510(k) Number (if known):
Device Name:
Indications
Synthes Automated Tack Driver (An accessory to Synthes Resorbable Tack System)
Synthes Resorbable Tack System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton.
Synthes Resorbable Tack System is not intended for use in the mandible or other full load-bearing situations, for areas with active infection or for patient conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
00004
Subject (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices XIXI3K
510(k) Number ________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
CONFIDENTIAL Synthes (USA) Special 510(k): Automated Tack Driver for Synthes Resorbable Tack System