(56 days)
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.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or quantitative performance metrics are mentioned in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
No information is provided regarding a "test set" or a study designed to evaluate the performance of the Erich Arch Bar. The submission relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as no test set or ground truth establishment process is described for this specific device.
4. Adjudication Method for the Test Set
Not applicable, as no test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned. This 510(k) submission does not present data on human reader improvement with or without AI assistance, as it pertains to a physical medical device (arch bar) and not an AI/software device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable, as this is a physical medical device and not an algorithm or software.
7. The Type of Ground Truth Used
Not applicable, as the submission does not involve the establishment of ground truth for performance evaluation; it focuses on substantial equivalence to existing devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device is not an AI/machine learning model.
Summary of the K061271 Submission and Lack of Performance Data:
The provided 510(k) summary for the KLS-Martin Erich Arch Bar describes a submission focused on demonstrating substantial equivalence to predicate devices. This type of regulatory submission primarily relies on showing that the new device has "identical in application and indications for use" and similar "material composition and application" to devices already legally marketed.
Therefore, the document does not include:
- Specific acceptance criteria for performance.
- Results from a formal study (test set, training set).
- Details about expert ground truth, adjudication, or MRMC studies.
The FDA's letter (pages 2-4) confirms that they reviewed the submission and determined substantial equivalence, allowing the device to be marketed based on this comparison, rather than requiring new clinical performance data demonstrating its efficacy or safety against pre-defined performance criteria.
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510(K) SUMMARY
JUN 3 0 2006
| Submitter: | KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378 |
|---|---|
| Contact Person: | Jennifer DamatoDirector 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.
... .
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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).
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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.
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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
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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
Page 1 of 1
§ 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.