(81 days)
This device is used in surgery for the application of wires to the jaws of adults and children. The device can be used to directly wire bony segments together, or for the application of arch bars to the teeth for stabilization of bony fragments or wiring the teeth together (maxillomandibular fixation).
22, 24 and 26 gauge annealed 316LVM stainless steel wire in 5 ft. coils packaged in a thermoplastic cartridge that mounts on forceps
This request cannot be fulfilled. The provided text is a 510(k) summary for a medical device (Aragon Wiring System Wire Cartridge) which outlines its substantial equivalence to existing predicate devices. However, this type of document, particularly for devices like wires for mandibular fixation, typically does not contain acceptance criteria for device performance or the results of a study designed to prove the device meets such criteria.
Medical devices cleared through the 510(k) pathway demonstrate substantial equivalence, meaning they are as safe and effective as a legally marketed predicate device. This often relies on comparing technical characteristics, materials, and intended use to existing devices, rather than conducting new performance studies with specific acceptance criteria and detailed statistical analysis on human subjects that would be typical for a drug or a novel, high-risk medical device.
Therefore, I cannot extract the requested information because it is not present in the provided text. The document explicitly states: "The technical differences between this product and the predicate devices do not adversely affect safety or efficacy," which is the core conclusion for a 510(k) clearance, not a report of meeting specific performance metrics through a study.
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SECTION C - 510(K) SUMMARY
NOV 1 5 2002
Ideatrics, Inc. 7341 South Meadow Court Boulder, Colorado 80301 phone: 303-527-0515 FAX: 303-449-7805 contact: James W. Heller, President
Submitted: August 19, 2002
Trade Name: Aragon Wiring System Wire Cartridge (models I0007, I0008, I0009, I0010, I0011 and I0012)
Common Name: Stainless Steel Wire for Mandibular Fixation
- Classification: Class II, Dental classification panel, product code Intraosseous Fixation Wire, CFR section DZK , 872.4880. Intraosseous Fixation Screw or Wire
- Predicate Devices: Intraosseous Fixation Wire by Synthes, Biomet-Kirschner, Stryker Instruments, Dupuy International Ltd., Zimmer, Inc. and Mathys Medical Ltd.
Device description: 22, 24 and 26 gauge annealed 316LVM stainless steel wire in 5 ft. coils packaged in a thermoplastic cartridge that mounts on forceps
Intended Use: Stabilization of mandibular fractures
- Technical differences from Predicate devices: Wire is identical to predicate devices. It is packaged in a 5 ft. length in a single use cartridge that mounts on forceps. In predicate devices the wire is packaged in a 75-675 ft. length on a reusable spool that is kept on the surgical instrument tray.
Conclusion: The technical differences between this product and the predicate devices do not adversely affect safety or efficacy.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2002
Mr. James W. Heller President Ideatrics, Incorporated 7341 South Meadow Court Boulder, Colorado 80301
Re: K022821
Trade/Device Name: Aragon Wiring System Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZK Dated: August 19, 2002 Received: August 26, 2002
Dear Mr. Heller:
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.
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Page 2 - Mr. Heller
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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
Timothy A Ulatowski 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 One of One
510(k) Number (if known): K022821
Device Name:_ Aragon Wiring System
Indications For Use:
This device is used in surgery for the application of wires to the jaws of adults and children. The device can be used to directly wire bony segments together, or for the application of arch bars to the teeth for stabilization of bony fragments or wiring the teeth together (maxillomandibular fixation).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ..
§ 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.