DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2

K011876 · Circon Video · HIG · Jan 8, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K011876
• Device Name: DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
• Applicant: Circon Video
• Product Code: HIG · Obstetrics/Gynecology
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

Device Story

DOLPHIN® II Fluid Management System is a hysteroscopic insufflator used in clinical settings by physicians. It provides low viscosity liquid for uterine distension during hysteroscopic procedures. The device monitors intrauterine pressure, total fluid usage, and fluid deficit. By managing fluid balance and pressure, it assists the clinician in maintaining a clear view of the uterine cavity while monitoring for potential fluid overload or complications. The system provides real-time feedback to the operator, allowing for adjustments during the procedure to ensure patient safety and procedural efficacy.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Hysteroscopic insufflator for fluid management. System provides liquid distension, pressure monitoring, and fluid deficit calculation. Class II device under 21 CFR 884.1700.

Indications for Use

Indicated for patients undergoing hysteroscopy requiring low viscosity liquid uterine distension, intrauterine pressure monitoring, and fluid deficit tracking.

Regulatory Classification

Identification

A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 JAN

Mr. John A. Delucia Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs CIRCON CORPORATION 492 Old Connecticut Path FRAMINGHAM MA 01701-4584

Re: K011876

Trade/Device Name: DOLPHIN® II Fluid Management System Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopic insufflator Regulatory Class: II Product Code: 85 HIG Dated: October 11, 2001 Received: October 12, 2001

Dear Mr. Delucia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 was barned in the Mer. 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, atores, orovisions 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing comply with and the Fee broquiers Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nredicate 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## CIRCON CORPORATION CONFIDENTIAL

## CIRCON CORPORATION

DOLPHIN® II Fluid Management System FDA Premarket Notification 510(k)

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 011876

Device Name: DOLPHIN® II Fluid Management System

The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

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Concurrence of CRDH, Office of Device Evaluation (ODE)

Dinard G. Symon

Prescription Use