KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES

K972488 · Karl Storz Endoscopy · HET · Jan 22, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K972488
• Device Name: KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES
• Applicant: Karl Storz Endoscopy
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

These instruments are indicated for use by qualified surgeons and physicians to provide pressurized fluid, with a heating option, for irrigation to the surgical site or hydro-dissection during laparoscopic surgical and diagnostic procedures.

Device Story

KSEA Hydromat 263110-20 is a low-pressure infusion pump system used in laparoscopic and pelviscopic surgical/diagnostic procedures. System components include a pump, metal pressure chambers, and tubing sets. Pressure chambers hold and pressurize bags of sterile irrigation fluid; an integrated heating option warms fluid to body temperature or slightly above. Operated by surgeons or physicians in clinical/OR settings. Device delivers fluid to operative sites to facilitate irrigation or hydro-dissection. System provides controlled fluid delivery to assist visualization and surgical access during minimally invasive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Low-pressure infusion pump system. Components: metal pressure chambers, tubing sets. Features: pressurized fluid delivery, optional fluid heating to body temperature. Intended for laparoscopic/pelviscopic use. Class II device (21 CFR 884.1720).

Indications for Use

Indicated for qualified surgeons and physicians to provide pressurized fluid irrigation or hydro-dissection during laparoscopic surgical and diagnostic procedures. Contraindicated for hysteroscopic procedures.

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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Karl Storz Endoscopy-America. Inc

600 Corporate Pointe Culver City, California 90230-7 Phone [phone]

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submutted 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 rest of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy-America, Inc.<br>600 Corporate Pointe<br>Culver City, California 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Marlena Allen Piercy, Ph.D.<br>Senior Clinical Affairs Specialist |
| Device Identification: | Common Name<br>Irrigation Pump System |
| | Trade Name (optional)<br>KSEA Hydromat 263110-20, Pressure Chambers and Accessories |

Indication: The KSEA Hydromat 263110-20 and Pressure Chambers are, indicated for use by qualified surgeons and physicians to provide low-pressure irrigation to the peritoneal cavity and operative sites during laparoscopic and pelviscopic surgical and diagnostic procedures.

Device Description: The KSEA Hydromat 263110-20 is a low-pressure infusion pump designed to deliver sterile irrigating fluid to the operative site. The KSEA Pressure Chambers are metal chambers designed to hold and pressurize bags of irrigation fluid for infusion into the peritoneal cavity; a pressure chamber is available which heats the irrigation fluid to body temperature or to slightly above body temperature. The Accessories (Tubing Sets) are designed to convey the sterile irrigation solution into the peritoneal cavity.

Substantial Equivalence: The KSEA Hydromat 263110-20 and Pressure Chambers are substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Hydromat 263110-20 and Pressure Chambers 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: Marlena Allen Piercy
Marlena Allen Piercy, Ph.D.

Senior Clinical Affairs Specialist

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is in black and white and appears to be a scanned or printed image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 22 1998

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

Re: K972488

KSEA Hydromat 263110-20 pressure chambers and accessories Dated: October 23, 1997 Received: October 24, 1997 Regulatory Class: II 21 CFR 884.1720/Procode: 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 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.

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/dsmamain.html".

Sincerely yours.

h7liau Yhi

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): K972488

Device Name: KSEA Hydromat 263110-20; Pressure Chambers and Accessories

Indications for Use: These instruments are indicated for use by qualified surgeons and physicians to provide pressurized fluid, with a heating option, for irrigation to the surgical site or hydro-dissection during laparoscopic surgical and diagnostic procedures.

Contraindications for Use: These instruments are contraindicated for hysteroscopic procedures.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Dokir R. Sothling
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K972488

Prescription Use: (Per 21 CFR 801.109)

OR Over-The-Counter Use:

(Optional Format 1-2-96)