(131 days)
Not Found
No
The summary describes a mechanical screw for bone fixation and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used to provide stabilization of fractures of the maxilla and mandible, which is a therapeutic function.
No
The device is described as providing stabilization for fractures, not for diagnosing them.
No
The device description clearly indicates a physical screw intended for surgical implantation, which is a hardware 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 "maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both." This describes a surgical procedure performed directly on the patient's body to stabilize bones.
- Device Description: The device is a "Drill Free MMF Screw" used for "temporary occlusal and fracture stabilization." This further reinforces its use as a surgical implant/device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The provided description does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Drill Free MMF Screw is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
The Drill Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla, 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): 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.
KLS-Martin Drill Free MMF Screw (K042573), IMF Screws (K010527)
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
§ 872.4880 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
Kod3432 MAR 3 1 2009
510(K) SUMMARY
Submitter:
Contact Person:
Date of Summary:
Device Name:
Trade Name:
Common Name:
Classification Name and Number:
Requiatory Class:
Predicate Devices:
Intended Use:
Device Description:
..............................................................................................................................................................................
KLS-Martin, L.P. 11239 St. Johns Industrial Parkway South Jacksonville, FL 32246 Phone: 904-641-7746 Fax: 904-641-7378
Tom Faucett Senior RA/QA Specialist
17 November 2008
Drill Free MMF Screw
Drill Free MMF Screw
Screw, Fixation, Intraosseous
Intraosseous fixation screw or wire (CFR 872.4880)
Class II
KLS Martin Drill Free MMF Screw (K042573)
IMF Screws (K010527)
The Drill Free MMF Screw is intended for use maxillomandibular fixation provide to in stabilization of fractures of the maxilla, mandible, or both.
The Drill Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture.
1
Technological Characteristics:
Similarities to Predicate
The Drill Free MMF Screw is identical in intended use as the KLS-Martin Drill Free MMF Screw (K042573) and the IMF Screws (K010527)
Differences to Predicate
The Drill Free MMF Screw is manufactured from stainless steel and the KLS-Martin Drill Free MMF Screw (K042573) is manufactured from titanium alloy.
Substantial Equivalence:
The KLS-Martin Drill Free® MMF Screw is substantially equivalent in intended use, manufacturing and quality systems as the KLS-Martin Drill Free MMF Screw (K042573) and substantially equivalent in intended use and material as the IMF Screws (K010527)
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Faucett Senior Regulatory Affairs/ Quality Assurance Specialist KLS Martin L.P. 11239 Saint Johns Industrial Parkway South Jacksonville, Florida 32246
MAR 3 1 2009
Re: K083432
Trade/Device Name: Drill Free MMF Screw Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: February 24, 2009 Received: March 11, 2009
Dear Mr. Faucett:
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.
3
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.
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Sutte Y. Michaud MD
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1083432 510(k) Number (if known):
Drill Free MMF Screw Device Name:
Indications For Use: The Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Susan Penn
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
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510(k) Number: K083432