This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus, including:

Abnormal uterine bleeding
Evaluation of abnormal hysterosalpingogram
Evaluation of abnormal ultrasound image
Infertility and pregnancy wastage
Pelvic pain

Device Description

This subject device is videoscope used for diagnosis within the uterus. New type of CCD is lead to be more easier observation and diagnosis. In HYF-V, a light guide connector and a video connector are separated each other. The light guide connector is to connect with a light source and the video connector is with a video system center.

AI/ML Overview

This 510(k) summary (K022445) is for a Hysteroscope, a rigid or flexible endoscope used for diagnostic and therapeutic procedures within the uterus. The document provided does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way described in your request.

The information in the provided document is mostly administrative and focuses on establishing substantial equivalence to previously cleared devices, rather than presenting a performance study with detailed acceptance criteria.

Here's a breakdown based on the information provided, and where information is missing:

Reported Device Performance and Acceptance Criteria

(1) A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. This type of information is usually associated with AI/CADe (Computer-Aided Detection) devices or novel technologies where quantifiable performance is a key aspect of demonstrating safety and effectiveness.

For the VISERA Hysterovideoscope, the FDA cleared it based on substantial equivalence to existing predicate devices (BF-240 and HYF-P Flexible hysterofiberscope). This means the manufacturer argued that the new device has "no significant change for its safety and efficacy" compared to the predicate device, and therefore detailed performance acceptance criteria in the format you described were not required or presented.

The summary states: "Compare to the predicate device, this subject device "HYF-V" does not incorporate any significant change for its safety and efficacy to the predicate device. Observation within uterus has been spread, therefore clinical date is not necessary for its evaluation of safety and efficacy."

This explicitly states that clinical data (which would include performance studies against acceptance criteria) was deemed not necessary because the device's technological characteristics and intended use are considered similar to already cleared devices.

Study Design Information (Not Applicable/Missing for this submission)

The following points refer to details typically found in the clinical testing of devices, especially AI/CADe. Since this 510(k) was based on substantial equivalence without clinical data, these details are not present in the provided document.

(2) Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. No test set was used for a performance study.

(3) Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided.

(4) Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided.

(5) 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 / Not Provided. This is not an AI/CADe device.

(6) If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided. This is not an AI/CADe device.

(7) The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable / Not Provided.

(8) The sample size for the training set

Not Applicable / Not Provided. This is not a machine learning device.

(9) How the ground truth for the training set was established

Not Applicable / Not Provided.

Summary of K022445 Content Regarding Performance/Testing:

The provided 510(k) summary for the VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V focuses on:

Device Description: A videoscope for diagnosis within the uterus, featuring a new CCD for easier observation. It has separate light guide and video connectors.
Intended Use: Endoscopic diagnosis within the uterus for conditions like abnormal uterine bleeding, evaluation of abnormal hysterosalpingogram/ultrasound, infertility, and pelvic pain.
Technological Characteristics: States it "does not have special technological characteristics compared to the existence videoscope such as GI tract bronchial application."
Safety Standards: Complies with IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.
Materials: No new patient-contacting materials; all are cleared by previous 510(k)s and confirmed with ISO 10993-1.
Substantial Equivalence: Claims substantial equivalence to Olympus BF-240 and Olympus HYF-P Flexible hysterofiberscope. The core argument for clearance is that it does not present significant changes in safety or efficacy compared to these predicate devices, making clinical data "not necessary."

This type of 510(k) demonstrates safety and effectiveness largely through comparison to predicate devices, rather than through extensive new clinical performance studies with specific acceptance criteria.

Summary

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Ko22445

SMDA 510(k) SUMMARY

This summary of 510(k safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR Section 807.92.

A. Submitter's Name, Address, Phone and Fax Number

1. Applicant:	Olympus Optical Co., Ltd.2-3-1 Shinjuku Monolis Nishi-shinjukuShinjuku-ku, Tokyo, Japan, 163-0914
---------------	-----------------------------------------------------------------------------------------------------------

1. Registration No. 8010047
1. Initial Importer Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157
2429304 4. Registration No.
1. Contact Person Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 Tel (631)-844-5688 Fax(631)-844-5416

B. Device Name, Common Name

1. Trade/Proprietary Name and Common Name

Trade Name: VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V Common Name: Hysteroscope

2. Class, Classification Number and Classification Name

Classification Number	Classification Name	Class
21 CFR 884.1690	Hysteroscope and accessories	II
21 CFR 876.1500	Endoscopes and accessories	II

Identification of Legally Marketed Devices Which we Claim Substantial Equivalence 3.

The following listed devices are seem to be as predicate devices in consideration of its characteristic and the following table shows regulatory history.

Model	Device Description &510(k)#/ Date of Cleared	Manufacturer	Class
BF-240	#K963033	Olympus Optical Co.,	II
OlympusHYF-P Flexiblehysterofiberscope	#K891451	Olympus Optical Co.,	II

D. Summary Description of the Device

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1. Summary

This subject device is videoscope used for diagnosis within the uterus.

New type of CCD is lead to be more easier observation and diagnosis. In HYF-V, a light guide connector and a video connector are separated each other. The light guide connector is to connect with a light source and the video connector is with a video system center.

2. Design

"HYF-V" has been designed, manufactured and tested in compliance with voluntary safety standards.

lt meets the requirement of IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.

3. Materials

There are no new patient contacting materials. All of patient contacting materials are cleared by previous 510(k). And all materials have been confirmed with ISO 10993-1.

4. Intended Use of the device

Abnormal uterine bleeding -
Evaluation of abnormal hysterosalpingogram -
-Evaluation of abnormal ultrasound image
Infertility and pregnancy wastage -
Pelvic pain

5. Technological Characteristics

This endoscope does not have special technological characteristics compared to the existence videoscope such as GI tract bronchial apprication.

6. Reason for not requiring

Compare to the predicate device, this subject device "HYF-V" does not incorporate any significant change for its safety and efficacy to the predicate device.

Observation within uterus has been spread, therefore clinical date is not necessary for its evaluation of safety and efficacy.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2003

Olympus Optical Co., Ltd. % Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-3157 Re: K022445

Trade/Device Name: Visera Hysterovideoscope Olympus HYF Type V Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Dated: November 12, 2002 Received: November 13, 2002

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OLYMPUS

Indications for Use Statement

510(k) Number(if known): 长0.22445 Device Name: VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V

Indications for Use :

Abnormal uterine bleeding •
Evaluation of abnormal hysterosalpingogram 1
Evaluation of abnormal ultrasound image 1
Infertility and pregnancy wastage -
Pelvic pain

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Nancy Brogdon (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number __ K022445

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.