(217 days)
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Not Found
No
The device description and intended use clearly describe a simple, disposable plastic trap for collecting bone particles, with no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is described as a "trap for collecting bone particles" for later use in transplantation, and its intended use is in "oral surgical procedures." It does not actively treat a condition or restore a function, but rather collects material for subsequent therapeutic procedures.
No
The device is described as a "sterile, disposable plastic trap for collecting bone particles" for later use in "bone or tissue transplantation." Its intended use is for collection, not for diagnosing any medical condition or disease.
No
The device description explicitly states it is a "sterile, disposable plastic trap," indicating it is a physical hardware device, not software.
Based on the provided information, the boneTRAP device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The boneTRAP is designed to collect bone particles and tissue fragments from a patient for later use in transplantation back into the patient. This is a surgical procedure involving the collection and handling of human tissue, not a diagnostic test performed in vitro (outside the body) to analyze a sample for diagnostic purposes.
- Device Description: It's described as a sterile, disposable plastic trap for collecting bone particles. This aligns with a surgical tool for tissue collection, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing the collected material, performing tests on it, or using it to diagnose a condition. The purpose is collection for transplantation.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The boneTRAP's function falls outside this definition.
N/A
Intended Use / Indications for Use
The boneTRAP is designed for use in various oral surgical procedures (implant surgery, periodontal surgery, etc.) where the oral surgeon desires to collect a patient's own bone particles and other tissue fragments for later use in bone or tissue transplantation.
Product codes
EIA
Device Description
boneTRAP is a sterile, disposable plastic trap for collecting bone particles.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
oral surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles merging into a single form, resembling a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG / 1 1998
Bladhs Plast AB C/O Mr. William E. Murphy U.S. Requlatory Affairs Consultant 59 Swiftwater Road 18349 Pocono Manor, Pennsylvania
- K980049 Re : Trade Name: BoneTRAP Regulatory Class: I Product Code: EIA Dated: May 13, 1998 Received: May 14, 1998
Dear Mr. Murphy:
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 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). 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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A -substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Murphy
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) 594-4692. 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 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/dsma/dsmamain.html".
Sincerely yours,
Clus L/s
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure_____________________________________________________________________________________________________________________________________________________________________
2
Page 1 of 1
"0(k) Number (if known): K980049
Device Name:
boneTRAP is a sterile, disposable plastic trap for collecting bone particles.
Indications for Use:
The boneTRAP is designed for use in various oral surgical procedures (implant surgery, periodontal surgery, etc.) where the oral surgeon desires to collect a patient's own bone particles and other tissue fragments for later use in bone or tissue transplantation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruanr
(Division Sign-Off) Division of Dantal, Infection Control, and General Cinstitut De Alans
510(k) Number K200041
Prescription Use: (Per 21 CFR 801.109)
OR
Over-The-Counter-Use:_________________________________________________________________________________________________________________________________________________________
Rev. 8/8/98