(90 days)
Not Found
No
The summary describes a mechanical device for jaw immobilization with a safety release mechanism. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is used for temporary jaw immobilization, which is a therapeutic intervention.
No
The device is used for temporary jaw immobilization (treatment), not for identifying or investigating a disease, injury, or other condition (diagnosis).
No
The device description explicitly states it is a "Kit" made of "four components" which are "installed" and provide "temporary jaw immobilization." This indicates a physical 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 is "in intermaxillary and maxillo-mandibular fixation," which is a physical procedure performed on a patient.
- Device Description: The device is described as components installed by a surgeon or dentist to provide "temporary jaw immobilization." This is a mechanical function within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The description of the Casey Surgical Safety Release ™ Arch Bar Kit does not involve any such testing of specimens.
Therefore, the Casey Surgical Safety Release ™ Arch Bar Kit is a medical device used for a surgical/mechanical purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Casey Surgical Safety Release ™ Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.
Product codes
DYX
Device Description
The Casey Surgical Safety Release ™ Arch Bar Kit is made of four components which are installed by an oral surgeon or dentist along with ligature wires. The installed device provides temporary jaw immobilization. The device incorporates a safety release mechanism.
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
oral surgeon or dentist
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
§ 872.4600 Intraoral ligature and wire lock.
(a)
Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.(b)
Classification. Class II.
0
VII. 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
Submitter Information:
Casey Surgical, LLC 17722 Loop Road Holt, MO 64048
Contact Person: Kevin Casey
Phone: 816-739-9959
Date Prepared: April 14, 2003
Device Information:
Proprietary Name: Safety Release TM Arch Bar Kit
Common Name: Intermaxillary Fixation System
Classification Name: Intraoral ligature and wire lock
Predicate Devices: Synthes Quick Lock ™ K991004 Unisplint K820944
Device Description: The Casey Surgical Safety Release ™ Arch Bar Kit is made of four components which are installed by an oral surgeon or dentist along with ligature wires. The installed device provides temporary jaw immobilization. The device incorporates a safety release mechanism.
Intended Use: Casey Surgical Safety Release TM Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.
Comparison of Technical Characteristics to Predicate Device: Similar to predicate devices K991004 Synthes Quick Lock™ IMF system and K8200944 Dental Arch Bar in materials of construction and indications for use. The Casey Surgical Safety Release ™ Arch Bar Kit has the additional safety release feature.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 2003
Casey Surgical. LLC C/O Mr. James Stanley Associate Director of Compliance & Medical Devices Regulatory Clinical Consultants, Incorporated 200 NE Mulberry, Suite 200 Lee's Summit, Missouri 64086
Re: K031207
Trade/Device Name: Casey Surgical Safety Release™ Arch Bar Kit Regulation Number: 21 CFR 872.4600 Regulation Name: Intraoral Ligature and Wire Lock Regulatory Class: II Product Code: DYX Dated: April 14, 2003 Received: April 23, 2003
Dear Mr. Stanley:
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 vour 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.
2
Page 2 - Mr. Stanley
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 Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Suser Runre
Susan Runner, DDS, MA Interim 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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Page 3 of 40
I. Indications for Use
510(k) Number (if known): K031207
Device Name: Casey Surgical Safety Release TM Arch Bar Kit
Indications for Use: Casey Surgical Safety Release ™ Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulkey for MSR
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K 031207