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 Description

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.

AI/ML Overview

This 510(k) summary (K992126) for the Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System does not contain specific acceptance criteria or the details of a study proving the device meets acceptance criteria in the way typically expected for performance claims of AI/ML-enabled devices.

This document is for a traditional medical device (a battery-powered irrigation pump) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing numerical performance metrics against predefined acceptance criteria for a new clinical function or AI algorithm.

Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluations, which is not applicable here.

Here's an explanation based on the provided text, highlighting why certain information is absent and what is available:

1. A table of acceptance criteria and the reported device performance

Not Applicable/Not Provided: This document does not present acceptance criteria in a quantitative, measurable format (e.g., sensitivity, specificity, accuracy thresholds) for a specific clinical outcome or an algorithm's performance. The "performance" assessment here is focused on demonstrating that the device functions similarly to legally marketed predicate devices for its intended use, without raising new questions of safety or effectiveness. The comparison is primarily around design, operating principles, materials, sterility, and method of delivery/evacuation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Provided: There is no "test set" in the context of an AI/ML device evaluation. This device is a hardware component. Any testing conducted would likely involve engineering verification and validation (e.g., flow rate, pressure, battery life, material compatibility, sterility) rather than a clinical study with a patient data test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Provided: Since there's no test set requiring ground truth labeling (e.g., image annotation, diagnosis), there's no mention of experts for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Provided: No test set, no ground truth adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable/Not Provided: This is not an AI-assisted device, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Provided: This is a hardware device; there is no standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable/Not Provided: No ground truth in the AI/ML sense is mentioned. Any "ground truth" equivalent for this device would be established through engineering specifications, standards, and possibly bench testing against known values (e.g., measuring actual fluid flow against specified flow rates).

8. The sample size for the training set

Not Applicable/Not Provided: There is no AI/ML model, hence no training set.

9. How the ground truth for the training set was established

Not Applicable/Not Provided: No training set, no ground truth for it.

Summary of what is described in the document relevant to device acceptance (though not in the requested AI/ML format):

The primary "acceptance criteria" and "study" for this device are framed around substantial equivalence to predicate devices already on the market.

Intended Use: The device is intended 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." This intended use is compared directly to predicate devices.
Technological Characteristics Comparison: The document states that "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."
- Basis for Substantial Equivalence: "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."
- Conclusion: "Any differences between the various devices do not raise new questions regarding safety or effectiveness."

In essence, the "study" is a comparison with predicate devices, showing that the new device shares fundamental technological characteristics and intended use with already cleared devices, and any differences do not negatively impact safety or effectiveness. This comparison is the method for demonstrating that the device meets the (implied) regulatory acceptance criteria for market clearance via the 510(k) pathway.

Summary

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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: (805) 961-3290 (tel.) or (805) 968-7385 (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:

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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

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

Prescription Use (Per 21 CFR 801.109)	X
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Over-The-Counter Use (Optional Format 1-2-96)
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Regulation Number and Section

§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a)
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).(b)
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.