VERESURE BELL

K061387 · Veresure, Inc. · HIF · Jul 21, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061387
• Device Name: VERESURE BELL
• Applicant: Veresure, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.

Device Story

The VereSure Bell is a single-use, bell-shaped polycarbonate housing designed for gynecologic laparoscopic surgery. It features a sealable port for the introduction of a standard Veress needle and a stopcock for connection to a standard hospital vacuum line. During surgery, the device is placed in the peri-umbilical region of the abdominal wall. By applying vacuum suction, the device stabilizes the abdominal wall, facilitating the safe insertion of the Veress needle to establish pneumoperitoneum. The device is operated by a surgeon or clinical staff in a surgical setting. It simplifies the needle insertion process, potentially reducing the risk of injury during the creation of the pneumoperitoneum.

Clinical Evidence

The submission includes results from animal and clinical testing to support safety and effectiveness. No specific quantitative metrics (e.g., p-values, sensitivity) are provided in the summary document.

Technological Characteristics

Single-use, bell-shaped polycarbonate housing; includes a sealable port for Veress needle introduction and a stopcock for vacuum line attachment. Operates via mechanical vacuum stabilization. No electronic or software components.

Indications for Use

Indicated for use in the peri-umbilical region of the abdominal wall to assist in the establishment of pneumoperitoneum during gynecologic laparoscopic procedures using a Veress needle.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• Taut insufflation Needle (K003703)
• EndoPath Ultra Veress Needle (K983925)
• Allis Tissue Forceps (K852726)

Submission Summary (Full Text)

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# JUL 2 1 2006

# 510(K) SUMMARY

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: July 15, 2006

510(k) number: _______________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________

## Applicant Information:

VereSure Inc. 900 Welch Road Palo Alto, CA 94304

## Contact Person

Robert Chin. Ph.D. Phone Number: [phone] [e-mail] E-mail: and the comments of the country

#### Device Information:

| Trade Name: | VereSure Bell |
|----------------------|------------------------------------------|
| Classification: | Class II |
| Classification Name: | Laparoscopic Insufflator and Accessories |

#### Physical Description:

The VereSure Bell is a single-use device used during gynecologic laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate housing containing a sealable port for introduction of standard Veress needles and a stopcock for attachment to a sterile standard hospital vacuum line.

#### Intended Use:

The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.

#### Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the Taut insufflation Needle (K003703), the EndoPath Ultra Veress Needle (K983925), and the Allis Tissue Forceps (K852726).

#### Test Results:

Results of animal and clinical testing demonstrate that the VereSure Bell is safe and effective for its intended use.

#### Summarv:

Based on the intended use, product, performance and clinical information provided in this notification the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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JUL 2 1 2006

VereSure, Inc. % Robert J. Chin, Ph.D. Regulatory Consultant 25 Hartford Avenue SAN CARLOS CA 94070

Re: K061387

Trade/Device Name: VereSure Bell Regulation Number: 21 CFR 884.1730 Regulation Name: Laproscopic insufflator Regulatory Class: II Product Code: HIF Dated: May 12, 2006 Received: May 18. 2006

## Dear Dr. Chin:

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 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) 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/9 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-2006" are printed in a smaller font size. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The entire logo is surrounded by a dotted circle.

noting Public Gr

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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 (21 CFR Part 807); labeling (21 CFR 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.

This letter will allow you to begin marketing your device as described in your Section \$10/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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon
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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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: VereSure Bell

Indications for Use:

The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Szymanski
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1061387

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