(131 days)
The Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide 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.
I am sorry but this document does not contain the information you are requesting. This document is a 510(k) summary for a medical device called "Drill Free MMF Screw". It focuses on establishing substantial equivalence to previously marketed predicate devices, rather than detailing a specific study with acceptance criteria and performance metrics in the way you described.
Specifically, the document primarily discusses:
- Intended Use: Maxillomandibular fixation for stabilization of fractures.
- Technological Characteristics: Similarities and differences to predicate devices (mainly material composition).
- Substantial Equivalence: Arguing that the new device is equivalent to existing ones based on intended use, manufacturing, quality systems, and material.
It does not include information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, ground truth establishment, or expert involvement for a study proving device performance against acceptance criteria.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot extract the information requested from the provided text.
{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
{4}------------------------------------------------
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
Page 1 of
510(k) Number: K083432
§ 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.