CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM

K992126 · Circon Corp. · GCX · Aug 3, 1999 · General Hospital

Device Facts

• Record ID: K992126
• Device Name: CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
• Applicant: Circon Corp.
• Product Code: GCX · General Hospital
• Decision Date: Aug 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2

Intended Use

Circon Corporation's Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.

Device Story

System consists of battery-powered Tsunami pump, irrigation tubing, Surgiflex WAVE handpiece, and suction tubing connected to external vacuum source. Pump provides controlled delivery of sterile irrigation fluid to surgical site; suction removes blood, tissue debris, and smoke. Used in OR by surgeons during laparoscopic or open procedures. Disposable, single-patient-use components supplied sterile. Enhances surgical visualization and facilitates site clearance.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, intended use, and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Battery-powered irrigation pump; mechanical suction-irrigation system. Components supplied sterile for single-use. No active electrical energy delivered to patient. Materials deemed safe for intended use.

Indications for Use

Indicated for patients undergoing laparoscopic or open surgical procedures requiring irrigation and suction for visualization, resection of filmy adhesions, or peritoneal lavage.

Regulatory Classification

Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• Cabot Medical Corporation's Surgiflex Suction-Irrigation Probes (K93266)
• Davol's Hydro-Surg Laparoscopic Irrigator (K961492)
• Stryker's Laparoscopic Suction Irrigator (K934094, K954726)

Submission Summary (Full Text)

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AUG -3 1999

510(k) Summary

#K992/2

- Submitter: Circon Corporation 1) 6500 Hollister Avenue Santa Barbara, CA 93117
- Dr. Ronald J. Ehmsen Contact: [phone] (tel.) or [phone] (fax)

# June 18, 1999 Date Prepared:

- Name of Device: Battery-Powered Irrigation Pump for Suction-Irrigation System 2)
# Proprietary/Trade Name:

Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System

Common/Usual Names: Irrigation Pump; Suction-Irrigation Probe

Classification: Class II (21 CFR §876.1500 and §884.1720).

Classification Names: Endoscope and accessories; Gynecologic laparoscope and accessories.

#### 3) Names of Predicate or Legally Marketed Devices:

Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is substantially equivalent to Cabot Medical Corporation's Surgiflex Suction-Irrigation Probes that were cleared by FDA for marketing on 06/08/94 under 510(k) #K93266;
Davol's Hydro-Surg Laparoscopic Irrigator that was cleared by FDA for marketing on 05/15/96 under 510(k) #K961492; and Stryker's Laparoscopic Suction Irrigator that was cleared by FDA for marketing on 02/18/94 under 510(k) #K934094. (A modification of Stryker's Laparoscopic Suction Irrigator was subsequently cleared for marketing on 11/29/95 under 510(k) #K954726.) These predicate devices are legally marketed for the same intended use (i.e., suctionirrigation during laparoscopic and open surgical procedures).

#### 4) Description of Device:

The Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is comprised of a Tsunami™ Battery-Powered Pump that may be attached to a source of irrigation tubing connected to a Surgiflex WAVE suction-irrigation handpiece, and a length of suction tubing connected between the handpiece and a vacuum source (usually a suction canister that is connected to a wall suction outlet). Irrigation solution is introduced to the surgical site and fluids, debris and smoke are evacuated from the site via a disposable suction-irrigation probe. All components of the system are supplied sterile, disposable in a sealed plastic tray for single patient use.

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510(k) Summary #K992 / 26 Circon Corporation Battery-Powered Irrigation Pump for Suction-Irrigation System June 18, 1999 Page 2

## Intended Use of Device: ર)

Circon Corporation's Tsunami™ Battery-Powered Irrigation Pump is intended to
be used in conjunction with Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.

## Comparison of Technological Characteristics: ()

Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is substantially equivalent' to Cabot's Surgiflex® Suction-Irrigation Probes, Davol's Hydro-Surgi Laparoscopic Irrigator and Stryker's Laparoscopic Suction Irrigator. All of these devices employ substantially equivalent design considerations and operating principles, and their materials of construction are safe for the intended uses. All of these devices are supplied sterile for single-use only, and none actively delivers any form of electrical energy to the patient. Any differences between the various devices do not raise new questions regarding safety or effectiveness.

^'The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with three swooping lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 1999

Dr. Ronald J. Ehmsen Vice President, Regulatory Affairs Circon Corporation 6500 Hollister Avenue Santa Barbara, California 93117

K992126 Re:

Trade Name: Circon Surgiflex® WAVE Tsunami™ Suction-Irrigation System Regulatory Class: II Product Code: GCX Dated: June 18, 1999 Received: June 23, 1999

Dear Dr. Ehmsen:

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, 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 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Dr. Ronald J. Ehmsen

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.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K992126

Device Name: Battery-Powered Irrigation Pump for Circon's Suction-Irrigation System

Indications for Use:

Circon Corporation's Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | | |
| Division of General Restorative Devices | | |
| 510(k) Number | K992126 | |

| Prescription Use (Per 21 CFR 801.109) | X |
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OR

| Over-The-Counter Use (Optional Format 1-2-96) | |
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