BALLOON FOR ULTRASONIC ENDOSCOPES

K992178 · N.M. Beale Co., Inc. · ITX · May 12, 2000 · Radiology

Device Facts

• Record ID: K992178
• Device Name: BALLOON FOR ULTRASONIC ENDOSCOPES
• Applicant: N.M. Beale Co., Inc.
• Product Code: ITX · Radiology
• Decision Date: May 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

For Endoscopic Ultrasound Applications using the Balloon Method in the Upper or Lower Gastrointestinal Tract.

Device Story

The Endoscopic Ultrasound Balloon is a single-use accessory designed for use with endoscopic ultrasound (EUS) equipment. It is placed over the tip of an endoscope to facilitate acoustic coupling between the transducer and the gastrointestinal wall. The balloon is filled with water or saline to create a fluid-filled interface, which improves image quality by eliminating air gaps and allowing for clear visualization of the GI tract layers and surrounding structures. It is intended for use by trained physicians in clinical settings during diagnostic or therapeutic endoscopic procedures. The device aids in the accurate assessment of lesions, masses, or anatomical structures, potentially improving diagnostic precision and clinical decision-making for patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex-free material construction. Designed for use as an endoscopic ultrasound accessory. Functions as a fluid-filled coupling interface for ultrasound transducers. Form factor is a balloon attachment for endoscope tips.

Indications for Use

Indicated for use in endoscopic ultrasound procedures within the upper or lower gastrointestinal tract. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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