KSEA RIGID CULDOSCOPE AND ACCESSORIES

K993804 · KARL STORZ Endoscopy-America, Inc. · HEW · Feb 7, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993804
• Device Name: KSEA RIGID CULDOSCOPE AND ACCESSORIES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HEW · Obstetrics/Gynecology
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1640
• Device Class: Class 2

Intended Use

The KSEA Rigid Culdoscope and Accessories is intended for use by qualified surgeons for viewing the organs within the peritoneal cavity, via a posterior vaginal fornix entry, using CO2 gas insufflation. This Culdoscope is not intended for trausvaginal hydrolaparoscopy (transflotation). This Culdoscope has the following diagnostic indications: Unexplained pelvic pain (acute, chronic) Menstrual abnormalities Infertility and sterility Indefinite pelvic mass Ectopic pregnancy Pelvic endometriosis Polycystic ovaries Pelvic inflammatory disease Pain mapping Congenital anomalies of the pelvic organs

Device Story

Manual reusable surgical device; consists of forward-oblique 300 telescope, sheath, and sharp obturator. Used by surgeons in clinical settings for direct visualization of pelvic organs via posterior vaginal fornix entry. Requires CO2 gas insufflation for cavity access. Provides optical visualization to assist in diagnosing pelvic conditions; aids clinical decision-making by allowing direct inspection of anatomical structures. Benefits patient through minimally invasive diagnostic access to peritoneal cavity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual reusable surgical instrument. Components: forward-oblique 300 telescope, sheath, sharp obturator. Material: surgical grade stainless steel. Energy source: none (optical/mechanical).

Indications for Use

Indicated for qualified surgeons to visualize peritoneal cavity organs via posterior vaginal fornix entry using CO2 insufflation for diagnostic evaluation of pelvic pain, menstrual abnormalities, infertility, pelvic masses, ectopic pregnancy, endometriosis, polycystic ovaries, PID, and congenital anomalies. Contraindicated for transvaginal hydrolaparoscopy.

Regulatory Classification

Identification

A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. 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 preheaters, light source and cables, and component parts.

Submission Summary (Full Text)

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FEB 7 2000

K993804
Page 1 of 2

## 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 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>Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Culdoscope |
| | Trade Name: (optional)<br>KSEA Culdoscope |

Indication: The KSEA Rigid Culdoscope and Accessories is intended for use by qualified surgeons for viewing the organs within the peritoneal cavity, via a posterior vaginal fornix entry, using CO2 gas insufflation. This Culdoscope is not intended for trausvaginal hydrolaparoscopy (transflotation). This Culdoscope has the following diagnostic indications:

- Unexplained pelvic pain (acute, chronic) ●
- . Menstrual abnormalities
- Infertility and sterility
- . Indefinite pelvic mass
- Ectopic pregnancy
- . Pelvic endometriosis
- � Polycystic ovaries
- . Pelvic inflammatory disease
- . Pain mapping
- Congenital anomalies of the pelvic organs

Device Description: The KSEA Culdoscope and Accessories are manual reusable surgical devices. The KSEA Culdoscope and Accessories are composed of a Forward-Oblique 300 Telescopes, Culdoscope Sheath and a sharp obturator. The body contact portions of the KSEA Culdoscope and Accessories 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.

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Substantial Equivalence: The KSEA Culdoscope and Accessories is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Culdoscope 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:

Kevin Kennan Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

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

Re: K993804

KSEA Rigid Culdoscope and Accessories, Series G27 Dated: November 5, 1999 Received: November 9, 1999 Requiatory Class: II 21 CFR §884.1640/Procode: 85 HEW

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 proor 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 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 device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance 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

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or body. The logo is black and white.

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## 510(k) Number (if known): 993804

## Device Name: Rigid Culdoscope and Accessories

Indications for Use: The KSEA Rigid Culdoscope and Accessories is intended for use by qualified surgeons for viewing the organs within the peritoneal cavity, via a posterior vaginal fornix entry, using CO2 gas insufflation. This Culdoscope is not intended for transvaginal hydrolaparoscopy (transflotation). This Culdoscope has the following diagnostic indications:

●

- Unexplained pelvic pain (acute, chronic) .
- Menstrual abnormalities ●
- Infertility and sterility .
- Indefinite pelvic mass .
- Ectopic pregnancy .
- Pelvic endometriosis ●
- Polycystic ovaries ●
- Pelvic inflammatory disease .
- Pain mapping C
- Congenital anomalies of the pelvic organs

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ✓ OR Over-The-Counter Use: **__**
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K993804