KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES

K971518 · KARL STORZ Endoscopy-America, Inc. · HIH · Jul 24, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971518
• Device Name: KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The KSEA Semi-Rigid Hysteroscope and Accessories are designed to view the uterus, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken Motion Control Device attaches to an instrument channel to precisely guide the introduction of small instrument into the patient.

Device Story

KSEA Semi-Rigid Hysteroscope is a straight, graduated shaft endoscope with a remote eyepiece; used for uterine visualization. Alken Motion Control Device attaches to the instrument channel to guide accessory introduction and movement. Both are manually operated, reusable surgical instruments. Used by physicians in clinical settings for diagnostic and therapeutic gynecological procedures. Provides direct visualization of the uterine cavity to assist in biopsy, septa/adhesion transection, and foreign body removal. Benefits include precise instrument guidance and minimally invasive access to the uterus.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: stainless steel (chromium-plated Monel 400). Design: straight, graduated shaft endoscope with remote eyepiece. Operation: manual. Reusable. No software or electronic components.

Indications for Use

Indicated for diagnostic procedures including infertility, pregnancy wastage, abnormal uterine bleeding, intrauterine foreign body, pelvic pain, IUD monitoring, and evaluation of abnormal hysterosalpingogram or endometrial abnormalities. Also indicated for operative procedures including directed biopsy, transection of intrauterine septa, and transection of intrauterine adhesions. Absolute contraindication: acute PID. Relative contraindications: inability to distend uterus, cervical/vaginal infection, known pregnancy, uterine bleeding/menses, invasive cervical carcinoma, recent uterine perforation, medical contraindication, anesthesia intolerance, cervical stenosis.

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 shows the logo for Karl Storz Endoscopy. The logo is white text on a black background. The top line of the logo says "STORZ" in large, bold letters. The second line of the logo says "Karl Storz Endoscopy" in smaller letters.

# K97 1578

## JUL 2 4 1997

#### 510(k) 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 are accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Marlena Allen Piercy, Ph.D.<br>Senior Clinical Affairs Specialist |
| Device Identification: | Common Name<br>Semi-Rigid Hysteroscope and Accessories<br>Trade Name |

KSEA Semi-Rigid Hysteroscope KSEA Alken Motion Control Device

Indication: The KSEA Semi-Rigid Hysteroscope and Accessories are designed to view the uterus, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken Motion Control Device attaches to an instrument channel to precisely guide the introduction of small instrument into the patient.

Device Description: The KSEA Semi-Rigid Hysteroscope is a straight, graduated shaft endoscope with a remote eyepiece. The Alken Motion Control Device is an attachment to the instrument channel to control the introduction and movement of accessories. All devices are manually operated, reusable surgical devices. Body contact materials are stainless steel (chromium-plated Monel 400®).

Substantial Equivalence: The KSEA Semi-Rigid Hysteroscope and Accessories are substantially equivalent to the predicate devices since the basic features, design, and intended uses are the same or similar. The minor differences in dimensions between the KSEA Semi-Rigid Hysteroscope and Accessories and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function, or intended use of these devices,

Signed: Mhelina Allen Piercey
Mariana Allen Piercey, Ph.D.

Marlena Allen Piercy, Ph.D. Senior Clinical Affairs Specialist

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the eagle in a circular pattern. The eagle is a symbol of the United States, and the seal represents the department's mission to protect the health of all Americans.

Semi-Rigid Hysteroscope and Alken Motion

21 CFR §884.1690/Product code: 85 HIH

Control Device . ..........................

Dated: April 23, 1997

Regulatory class: II

Received: April 25, 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Marlena Allen Piercy, Ph.D. Senior Clinical Affairs Specialist Karl Storz Endoscopy-America, Inc. . 600 Corporate Pointe Culver City, California 90230-7600

JUL 2 4 1997

Dear Dr. Piercy:

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 intenstated 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, 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.

Re: K971518

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 (OS) 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 80) 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 yours.

h.7liau Yu
Lillian Yin, Ph.D.

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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Kan Storz Endoscopy-America, Inc.

600 Corporate Pointe Culver City, California 90230-7600 Phone [phone]

Toll Free 800 421 0837 Fax [phone]

### 510(k) Number (if known): Not yet assigned

### Device Name: Semi-Rigid Hysteroscope with Accessories

Indications for Use: The Karl Storz Semi-Rigid Hysteroscope and Accessories are indicated in the following conditions:

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

### Operative

directed biopsy transection of intrauterine septa transection of intrauterine adhesions

Absolute Contraindications for Use: acute PID

#### Relative Contraindications for Use:

inability to distend uterus cervical/vaginal infection known pregnancy uterine bleeding or menses invasive carcinoma of the cervix recent uterine perforation medical contraindication intolerance to anesthesia cervical stenosis

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------------------------------------------|
| Prescription Use: | <span style="text-decoration: overline;">✓</span> |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use: |
| | |
| | (Optional Format 1-2-96) |
| | <span style="text-decoration: overline;">Rolera satting</span> |
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | <span style="text-decoration: overline;">K971518</span> |
| | 000003 |