(56 days)
Not Found
No
The device description and intended use describe a purely mechanical device for jaw immobilization, with no mention of software, image processing, or AI/ML terms.
No
A therapeutic device intends to treat or cure a disease or condition. The Erich Arch Bar is used for temporary jaw immobilization, which is a supportive measure rather than a direct treatment or cure for a disease.
No
The device description states its purpose is for temporary jaw immobilization, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is made of stainless steel and is a physical arch bar, not software.
Based on the provided information, the Erich Arch Bar is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "intermaxillary and maxillo-mandibular fixation," which is a mechanical process performed directly on the patient's teeth and jaws.
- Device Description: The device is a physical bar made of stainless steel that is "affixed temporarily to the teeth... with ligature wire." This describes a physical implant or fixation device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on biological markers
- Being used in a laboratory setting
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Erich Arch Bar is a physical device used for mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.
Product codes
DYX
Device Description
The Erich Arch Bar is made of fully annealed electro polished stainless steel which is affixed temporarily to the teeth by an oral surgeon or dentist with ligature wire. The installed device provides temporary jaw immobilization.
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)
K031207, K022821, K991004, K820944
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
510(K) SUMMARY
JUN 3 0 2006
| Submitter: | KLS-Martin, L.P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director RA/QA |
| Date of Summary: | 24 March 2006 |
Device Name:
Trade Name:
Common Name:
Classification Name and Number:
Regulatory Class:
Predicate Devices:
Intended Use:
Device Description: Erich Arch Bar
Erich Arch Bar
Arch bar
Lock, Wire, and Ligature, Intraoral (CFR 872.4600)
ll
Safety Release Arch Bar Kit (K031207)
Wire Aragon Wiring System Cartridge (K022821)
Synthes Quick Lock IMF System (K991004)
Dental Arch Bar (K820944)
The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.
The Erich Arch Bar is made of fully annealed electro polished stainless steel which is affixed temporarily to the teeth by an oral surgeon or dentist with ligature wire. The installed device provides temporary jaw immobilization.
... .
1
Technological Characteristics:
Similarities to Predicate
The Erich Arch Bar is identical in application and indications for use as the Safety Release Arch Bar Kit (K031207), Synthes Quick Lock IMF System (K991004) and the Dental Arch Bar (K820944).
Differences to Predicate
The Erich Arch Bar is manufactured from 304 stainless steel and the Synthes Quick Lock IMF System (K991004) is manufactured from 316L stainless steel.
Substantial Equivalence:
The Erich Arch Bar is substantially equivalent in indications for use, material composition and application to the Safety Release Arch Bar Kit (K031207), Aragon Wiring System Wire Cartridge (K022821), Synthes Quick Lock IMF System (K991004) and the Dental Arch Bar (K820944).
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
JUN 3 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Damato Director, Regulatory Affairs & Quality Assurance KLS-Martin, L.P. 11239-1 Saint John's Industrial Parkway South Jacksonville, Florida 32246
Re: K061271
Trade/Device Name: Erich Arch Bar Regulation Number: 872.4600 Regulation Name: Intraoral Ligature and Wire Lock Regulatory Class: II Product Code: DYX Dated: April 21, 2006 Received: May 5, 2006
Dear Ms. Damato:
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 vour 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 vour device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely vours.
Susan Knorr
Ex, Chiu Lin. Ph.D. 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
510(k) Number (if known):
Device Name: Erich Arch Bar
Indications For Use:
The Erich Arch Bar is indicated for use in intermaxillary and maxillomandibular fixation.
Prescription Use V (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)
Suver Runare
of Anesthesiology, General Hospital Control, Dental Devices
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