(19 days)
Not Found
No
The summary describes a mechanical device (screws) for bone fixation and contains no mention of AI, ML, image processing, or data analysis that would suggest AI/ML technology.
No.
The device is described as screws indicated for internal fixation of fractures and osteotomies of the craniofacial skeleton, which is a structural and support function, not a therapeutic one.
No
Explanation: The device is described as screws for internal fixation of fractures and osteotomies, which are surgical tools, not diagnostic tools. Its indicated use is for treatment (fixation, reconstruction), not for identifying or characterizing a disease or condition.
No
The device description and intended use clearly describe physical screws used for internal fixation of bone fractures and osteotomies, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the internal fixation of fractures and osteotomies of the craniofacial skeleton. This is a surgical procedure performed directly on the patient's body.
- Anatomical Site: The anatomical site is the craniofacial skeleton, which is part of the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention.
N/A
Intended Use / Indications for Use
The Kinamed NeuroPro™, Quick Tap™ Self Drilling Screws are indicated for use in conjunction with bone plates and mesh implants of the parent NeuroPro System in internal fixation of fractures and osteotomies of the craniofacial skeleton including fixation of cranial bone flap osteotomies as well as for reconstruction of bony defects and deficits of the craniofacial skeleton.
The Kinamed NeuroPro™, Quick Tap™ Self Drilling Screws are not indicated for use in the spine.
Product codes
DZL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 SEP
Mr. Robert Bruce Vice President, Sales & Marketing Kinamed, Incorporated 2192-C Anchor Court Newbury Park, California 91320
Re : K982927 Trade Name: Quick Tap Self Drilling Screw Regulatory Class: II Product Code: DZL Dated: August 19, 1998 Received: August 20, 1998
Dear Mr. Bruce:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Bruce
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97) . Other general *** information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Dutman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 1-3
Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws
Modification To 510(k) No. K964362
Statement Of Indications For Use
KGXADD 510(k) Number (if known):
Device Name: Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws
Indications For Use:
The Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws are indicated for use in conjunction with bone plates and mesh implants of the parent NeuroPro System in internal fixation of fractures and osteotomies of the craniofacial skeleton including fixation of cranial bone flap osteotomies as well as for reconstruction of bony defects and deficits of the craniofacial skeleton.
The Kinamed NeuroPro™ , Quick Tap™ Self Drilling Screws are not indicated for use in the spine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_100 x) 100
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_