(319 days)
For Endoscopic Ultrasound Applications using the Balloon Method in the Upper or Lower Gastrointestinal Tract.
Endoscopic Ultrasound Balloon Device Name: Latex Free
The provided text describes a 510(k) clearance letter for the "Endoscopic Ultrasound Balloon" device. It outlines the FDA's determination of substantial equivalence to a predicate device for the stated indications for use.
Crucially, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a detailed study report within this document. While the manufacturer would have submitted testing data to the FDA to support their claim of substantial equivalence, those details are not present in the provided letter.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
MAY 1 2 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nathaniel M. Beale President N.M. Beale Co. 89 Olde Shirley Road Harvard, MA 01451
Re:
K992178 Endoscopic Ultrasound Balloon Dated: March 2, 2000 Received: March 10, 2000 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Beale:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the vice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices ree for to tabolance commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that manked in mitchate Onlinero 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 against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to If your device is classines (see above) and eller eller in the Code of Federal Regulations , Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice r ars oo oo ooo. A babalandin (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Uni Tegulation night of this response to your premarket notification submission does not affect any obligation you might the reactions 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of This letter will allow you to begilly 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 809.10 for in xito if you done openite dation for your can be office of Compliance at (301) 594-4591. 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, adventing of your device, picks concert of other of other general information on your responsibilities under the ender the ender the contribution only and and the find of the Misolanding by Torontoo to promance is mall Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Don Stetler, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510(k) Number (If known)_K992178
Endoscopic Ultrasound Balloon Device Name: Latex Free Indications For Use: For Endoscopic Ultrasound Applications using the Balloon Method in the Upper or Lower
Gastrointestinal Tract.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The Counter Use (Optional Format 1-2-9)
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices
20000000
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.