VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V

K022445 · Olympus Optical Co., Ltd. · HIH · Jan 24, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K022445
• Device Name: VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
• Applicant: Olympus Optical Co., Ltd.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Indications for Use

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 Story

The Visera Hysterovideoscope Olympus HYF Type V is a flexible videoscope used for endoscopic diagnosis within the uterus. It captures visual data via an integrated CCD sensor and transmits the signal to an external Olympus video system center, light source, and display monitor. The device features a separated light guide connector and video connector for connection to ancillary equipment. It is intended for use by clinicians in a clinical setting to visualize the uterine cavity. The output is a real-time video feed displayed on a monitor, which assists the physician in diagnosing conditions such as abnormal bleeding, infertility, or pelvic pain. The device benefits patients by providing direct visualization for diagnostic evaluation.

Clinical Evidence

No clinical data provided; bench testing only. The device was evaluated for safety and efficacy through compliance with voluntary safety standards including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18.

Technological Characteristics

Flexible videoscope featuring a CCD sensor. Materials are previously cleared and compliant with ISO 10993-1. Meets IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18 standards. Connects to external video system center and light source via separated connectors.

Indications for Use

Indicated for endoscopic diagnosis within the uterus in patients presenting with abnormal uterine bleeding, abnormal hysterosalpingogram, abnormal ultrasound images, infertility, pregnancy wastage, or pelvic pain.

Regulatory Classification

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.

Predicate Devices

• BF-240 (K963033)
• Olympus HYF-P Flexible hysterofiberscope (K891451)

Submission Summary (Full Text)

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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.<br>2-3-1 Shinjuku Monolis Nishi-shinjuku<br>Shinjuku-ku, Tokyo, Japan, 163-0914 |
|---------------|-----------------------------------------------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------------------------------------------|

- 2. Registration No. 8010047
- 3. Initial Importer Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157
- 2429304 4. Registration No.
- 5. Contact Person Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 Tel [phone] Fax[phone]

### 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 &<br>510(k)#/ Date of Cleared | Manufacturer | Class |
|------------------------------------------------|--------------------------------------------------|----------------------|-------|
| BF-240 | #K963033 | Olympus Optical Co., | II |
| Olympus<br>HYF-P Flexible<br>hysterofiberscope | #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

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

#### 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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, "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 [phone] or [phone] 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 :

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 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