MVM 3.3 MM MICROENDOSCOPE

K973304 · KARL STORZ Endoscopy-America, Inc. · HET · Dec 2, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K973304
• Device Name: MVM 3.3 MM MICROENDOSCOPE
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Dec 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This instrument is indicated for use during gynecologic laparoscopic murgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures. Specific Indications for Use: - unexplained pelvic pain (acute, chronic) . - infertility work-up ● - tubal sterilization . - unexplained primary or secondary amenorthea . - diagnosis and/or treatment of ectopic pregnancy ● - evaluation, diagnosis and/or treatment of small pelvic turnors, including ● myomata - evaluation of congenital anomalies of the pelvic organs . - retrieval of foreign bodies ● - determination of the presence and extent of pelvic endometriosis . - determination of the presence and extent of pelvic inflammatory disease ● - laparoscopic assisted vaginal hysterectomy ◆ - evaluation of ovarian endocrinopathy ● - visualization, diagnosis and/or treatment of perforate abdominal organs .

Device Story

Karl Storz MVM 3.3 mm Microendoscope; rigid, panoramic telescope utilizing rod lens technology. Device comprises endoscope module and video module; connects to camera control unit for visualization. Used by surgeons/physicians in clinical/OR settings for gynecologic laparoscopy. Provides visual feedback to clinician to assist in diagnosis and treatment of pelvic conditions. Benefits include minimally invasive visualization of pelvic cavity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid, panoramic telescope; rod lens technology; surgical grade stainless steel construction. Connects to external camera control unit. Non-powered optical device.

Indications for Use

Indicated for gynecologic laparoscopic surgical procedures in patients requiring diagnostic or therapeutic intervention for conditions including pelvic pain, infertility, tubal sterilization, amenorrhea, ectopic pregnancy, pelvic tumors/myomata, congenital anomalies, foreign body retrieval, endometriosis, pelvic inflammatory disease, ovarian endocrinopathy, or perforated abdominal organs.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is written in large, bold letters at the top of the logo. Below the word "STORZ" is the text "Karl Storz Endoscopy". The logo is white against a black background.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVE

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] | | DEC - 2 1997 |
|------------------------|---------------------------------------------------------------------------------------------------------------|--|--------------|
| Contact: | Kevin Kennan<br>Regulatory Affairs Specialist | | |
| Device Identification: | Common Name:<br>Video Endoscope | | |
| | Trade Name: (optional)<br>Karl Storz MVM 3.3 mm Microendoscope | | |

Indication: The KSEA MVM 3.3 mm Microendoscope is designed to be used by qualified surgeons and physicians for gynecologic laparoscopic surgical procedures.

Device Description: The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope are composed of surgical grade stainless steel, 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 3.3 mm Microendoscope 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 3.3 mm Microendoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.

Signed:

ed:

Kevin Kennan
Regulatory Affairs Specialist

000063

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1997

Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Re: K973304 MVM 3.3 mm Microendoscope Dated: September 2, 1997 Received: September 3, 1997 Regulatory Class: II 21 CFR 8884.1720/Product Code: 85 HET

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 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 requirement, 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 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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/dsmamain.html".

Sincerely vours.

W. Liao Yu

Lillian Yin, Ph.D. 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): K973304

## Device Name: MVM 3.3 mm Microendoscope

Indications for Use: This instrument is indicated for use during gynecologic laparoscopic murgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Specific Indications for Use

- unexplained pelvic pain (acute, chronic) .
- infertility work-up ●
- tubal sterilization .
- unexplained primary or secondary amenorthea .
- diagnosis and/or treatment of ectopic pregnancy ●
- evaluation, diagnosis and/or treatment of small pelvic turnors, including ● myomata
- evaluation of congenital anomalies of the pelvic organs .
- retrieval of foreign bodies ●
- determination of the presence and extent of pelvic endometriosis .
- determination of the presence and extent of pelvic inflammatory disease ●
- laparoscopic assisted vaginal hysterectomy ◆
- evaluation of ovarian endocrinopathy ●
- visualization, diagnosis and/or treatment of perforate abdominal organs .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Polor R. Anthing

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

| 510(k) Number | K973304 |
|---------------|---------|
|---------------|---------|

| Prescription Use: | <div style="display:inline-block; vertical-align:middle;">✓</div> | OR Over-The-Counter Use: | |
|----------------------|-------------------------------------------------------------------|--------------------------|--|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | |