The MH-246R Balloon Sheath for female reproductive tract is designed to be used with the Olympus Ultrasonic Probe UM-2R/UM3R for intraluminal ultrasonic imaging of the female reproductive tract.

Device Description

The MH-246R Balloon Sheath for female reproductive tract consists of two sections - insertion section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe locking ring, sheath locking ring, and irrigation port.

The insertion section is connected to the connector body through a sheath locking ring, while the ultrasonic probe is inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual.

AI/ML Overview

This document primarily focuses on the Olympus MH-246R Balloon Sheath for female reproductive tract use, specifically its 510(k) summary and FDA clearance. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a device with no AI/software component. Therefore, most of the requested information regarding AI performance and studies is not applicable.

However, I can extract the relevant information that is present:

Device Name: Olympus MH-246R Balloon Sheath (for female reproductive tract)

Intended Use: Designed to be used with the Olympus Ultrasonic Probe UM-2R/UM3R for intraluminal ultrasonic imaging of the female reproductive tract.

General Safety Statement: When compared to the predicate devices, Olympus MH-246R Balloon Sheath does not incorporate any significant change in method of operation, material, or design that could affect the safety or effectiveness.

Since there is no AI component, the following questions are not applicable to the provided text.

A table of acceptance criteria and the reported device performance: Not applicable (no AI/software component).
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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KQ82725

510(k) SUMMARY

OLYMPUS MH-246R BALLOON SHEATH

Device Name:	Olympus MH-246R Balloon Sheath (for female reproductive tract)
Common/Usual Name:	Balloon Sheath
Classification Number & Name:	Class II, 21CFR892.1570, Diagnostic Ultrasonic TransducerClass II, 21CFR884.1690, Hysteroscope and accessories
Predicate Devices:	Olympus	MH-246R (for GI use)	K961048
Submitted By:(Contact Person)	Laura Storms-TylerOlympus America Inc.Regulatory AffairsTwo Corporate Center DriveMelville, New York 11747-3157(516) 844-5688

May 25, 1998 Summary Preparation Date:

Statement of Intended Use

The MH-246R Balloon Sheath for female reproductive tract is designed to be used with the Olympus Ultrasonic Probe UM-2R/UM3R for intraluminal ultrasonic imaging of the female reproductive tract.

Device Description

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General Safety

When compared to the predicate devices, Olympus MH-246R Balloon Sheath does not incorporate any significant change in method of operation, material, or design that could affect the safety or effectiveness.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 1998

Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Dr. Melville, NY 11747-3157

Re: K982725

Olympus MH-246R Balloon Sheath, for Female Reproductive Tract Use Dated: August 4, 1998 Received: August 5, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Ms. Storms-Tyler:

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, 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 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 Regulations, 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 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 regulation may result in regulatory 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 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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

William Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K982725
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Device Name:

్ట్ర పార్టీ

Olympus MH-246R Balloon Sheath (for female reproductive tract)

Indications for Use:

Olympus MH-246R Balloon Sheath have been designed to be used with the Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of the female reproductive tract.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982225
(Optional Format 1-2-96)
DRs

Regulation Number and Section

§ 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.