MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE

K990411 · Karl Storz Endoscopy · HIH · May 11, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K990411
• Device Name: MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
• Applicant: Karl Storz Endoscopy
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: May 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA MVM 7.5 French Hysteroscope is indicated for examination of the cervix and uterus and, using additional accessories, to perform various diagnostic and therapeutic procedures including; Diagnostic Hysteroscopy - abnormal uterine bleeding - infertility and pregnancy wastage - evaluation of abnormal hysterosalpingegram - intrauterine foreign body - amenortiea - polvic pain - evaluation of abnormalities of the endometrium - monitoring IUD status Operative Hysteroscopy - directed biopsy - removal of submucous fibroids and large polps - submucous myomectomy - transection of intrauterine adhesions - transection of intrauterine septa - endometrial ablation

Device Story

Flexible, fiber-optic hysteroscope with integrated video module; connects to camera control unit for visualization of cervix and uterus. Used by physicians in clinical settings for diagnostic and operative procedures. Provides real-time imaging to assist in biopsy, myomectomy, and ablation. Biocompatible medical-grade polyurethane construction. Enables minimally invasive visualization and surgical intervention, reducing need for more invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Flexible fiber-optic endoscope with video module. Body contact materials: medical-grade polyurethane. Connectivity: connects to external camera control unit. Sterilization: not specified.

Indications for Use

Indicated for diagnostic and operative hysteroscopy in patients requiring examination of the cervix and uterus, including management of abnormal uterine bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, intrauterine foreign bodies, amenorrhea, pelvic pain, endometrial abnormalities, IUD monitoring, biopsy, fibroid/polyp removal, myomectomy, and treatment of adhesions, septa, or endometrial ablation.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K990411'. The characters are written in a bold, sans-serif style, and they are the primary focus of the image.

MAY 1 1 1999

# 510(Is) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Video Endoscope |
| | Trade Name: (optional)<br>Karl Storz Micro Video Module (MVM) 7.5 French Hysteroscope |

Indication: The KSEA MVM 7.5 French Hysteroscope is indicated for examination of the cervix and uterus and, using additional accessories, to perform various diagnostic and therapeutic procedures including;

#### Diagnostic Hysteroscopy

- abnormal uterine bleeding ◀
- infertility and pregnancy wastage ●
- evaluation of abnormal hysterosalpingegram .
- . intrauterine foreign body
- . amenortiea
- . polvic pain
- � evaluation of abnormalities of the endometrium
- . monitoring IUD status

### Operative Hysteroscopy

- directed biopsy
- removal of submucous fibroids and large polps
- . submucous myomectomy
- transection of intrauterine adhesions
- . transection of intrauterine septa
- endometrial ablation

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Device Description: The KSEA MVM 7.5 French Hysteroscope is comprised of a video module, and a endoscope module. The endoscope module is a flexible, fiber optic endoscope. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 7.5 French Hysteroscope are composed of medical grade polyurethane, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Substantial Equivalence: The KSEA MVM 7.5 French Hysteroscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA MVM 7.5 French Hysteroscope and the predicate devices raise no now issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.

Signed:
kevin kennan

Senior Regulatory Affairs Specialist

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Public Health Service

Image /page/2/Picture/17 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 1999

Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver City, CA 90230-7600

Re: K990411

Micro Video Module (MVM) 7.5 French Flexible Hysteroscope Dated: February 4, 1999 Received: February 10, 1999 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH

Dear Mr. Kennan:

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 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). 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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the 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, "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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): 990411

# Device Name: Micro Video Module MVM 7.5 French Flexible Hysteroscope

Indications for Use: This instrument is indicated for examination of the cervix and uterus and, using additional accessories, to perform various diagnostic and therapeutic procedures including;

# Diagnostic Hysteroscopy

- abnormal uterine bleeding .
- infertility and pregnancy wastage .
- evaluation of abnormal hysterosalpingogram .
- intrauterine foreign body .
- . amenorrhea
- . pelvic pain
- . evaluation of abnormalities of the endometrium
- . monitoring IUD status

### Operative Hysteroscopy

- directed biopsy ●
- . removal of submucous fibroids and large polps
- . submucous myomectomy
- transection of intrauterine adhesions ●
- transection of intrauterine septa .
- endometrial ablation ●

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