(49 days)
Use to connect brackets and help to close gaps between teeth. They are normally used for a period of 4 to 6 weeks, then replaced with new chain.
Glenroe Glow-In-Dark Elastomeric Ligature Chain
This is a 510(k) clearance letter from 1998 for a Glenroe Glow-In-Dark Elastomeric Ligature Chain. This document does not contain the type of detailed information about acceptance criteria, study design, and performance metrics that you are requesting. These types of regulatory submissions for medical devices have evolved significantly over time.
In 1998, for a Class I device seeking 510(k) clearance, the regulatory pathway focused primarily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring formal clinical trials or complex performance studies with detailed statistical analysis as is common for higher-risk devices or software as a medical device (SaMD) today.
Therefore, an exhaustive answer to your questions, based solely on the provided text, is not possible. The document states:
- Device Name: Glenroe Glow-In-Dark Elastomeric Ligature Chain
- Indications For Use: Use to connect brackets and help to close gaps between teeth. They are normally used for a period of 4 to 6 weeks, then replaced with new chain.
- Regulatory Class: I
- Product Code: ECI
The letter confirms the FDA "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This "substantial equivalence" is the primary "acceptance criterion" for this type of clearance in that era.
I cannot create the table or provide the detailed study information you requested because this document does not contain that level of detail. It simply states the device was found substantially equivalent to a predicate.
Modern SaMD submissions would typically include a much more extensive clinical or performance study report with specific acceptance criteria (e.g., sensitivity, specificity, accuracy, F1-score, AUC), sample sizes, ground truth establishment, expert qualifications, and potentially comparative effectiveness studies. This 1998 document for a Class I physical device does not.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 24 1998
Mr. John Bozman President Gainesville Orthodontics 1912 44th Avenue, East Bradenton, Florida 34203
K980053 Re : Trade Name: Glenroe Chain Requlatory Class: I .... Product Code: ECI Dated: December 31, 1997 Received: January 6, 1998
Dear Mr. Bozman:
We have reviewed your Section 510(k)-notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, fabeling; and provise prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. प्र substantially equivalent determination assumes compliance with -the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: " this response to your premarket notification submission does
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Page 2 - Mr. Bozman
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Patrice Cusenier Hoc
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
of
510(k) Number (if known): K980053
Device Name: Glenroe Glow-In-Dark Elastomeric Ligature Chain
Indications For Use:
Use to connect brackets and help to close
gaps between teeth.
They are normally used for a period of 4 to 6
weeks, then replaced with new chain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rre
(Division Sign Off)
Division of Dental, Infection Control,
F
mospital Devices
!
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__
(Optional Format 1-2-96)
§ 872.5410 Orthodontic appliance and accessories.
(a)
Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.