(319 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is for a simple balloon device used in endoscopic ultrasound.
Yes
The device is used for Endoscopic Ultrasound Applications in the gastrointestinal tract, which implies a medical procedure aimed at diagnosis or treatment, thus fitting the description of a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" states "For Endoscopic Ultrasound Applications using the Balloon Method," which describes a tool used during endoscopic ultrasound, not a device that itself diagnoses. It facilitates a procedure, but the diagnosis is made by interpreting the ultrasound images.
No
The device description explicitly states "Endoscopic Ultrasound Balloon Device Name: Latex Free," indicating a physical hardware component (a balloon) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Endoscopic Ultrasound Applications using the Balloon Method in the Upper or Lower Gastrointestinal Tract." This describes a procedure performed within the body (in vivo) using a physical device (a balloon) in conjunction with endoscopic ultrasound.
- Device Description: The device is described as an "Endoscopic Ultrasound Balloon Device." This is a physical medical device used during a procedure.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to diagnose diseases or conditions. The provided information does not mention any analysis of specimens or any in vitro testing.
Therefore, this device is a medical device used for an in vivo procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For Endoscopic Ultrasound Applications using the Balloon Method in the Upper or Lower Gastrointestinal Tract.
Product codes
90 ITX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Upper or Lower Gastrointestinal Tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
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)
1
Page 1 of 1
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
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