ARAGON SURGICAL LAPCAP

K070651 · Aragon Surgical, Inc. · HIF · May 30, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070651
• Device Name: ARAGON SURGICAL LAPCAP
• Applicant: Aragon Surgical, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: May 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdoming I wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

Device Story

Aragon Surgical LapCap is a single-use, bell-shaped polycarbonate dome device used during laparoscopic surgery. It features a pass-through port for a standard Veress needle and a vacuum port for connection to a standard hospital vacuum line. The device is placed in the peri-umbilical region of the abdominal wall. By applying vacuum, the device secures to the skin, allowing the surgeon to safely introduce the Veress needle to establish pneumoperitoneum. This facilitates the creation of the working space necessary for laparoscopic procedures. It is intended for use by surgeons in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, bell-shaped polycarbonate dome. Includes a pass-through port for Veress needle and a vacuum port for hospital vacuum line connection. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing gynecologic (pelvic) or general surgical (intraabdominal) laparoscopic procedures requiring the establishment of a pneumoperitoneum.

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

• Veresure Bell (K061387)
• Taut - Insufflation Needle (K003703)

Submission Summary (Full Text)

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#### 510(K) SUMMARY 5.

K070651

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: March 7, 2007

510(k) number: .........

## Applicant Information:

Aragon Surgical, Inc. 1810 Embarcadero Road, Suite B Palo Alto, CA 94304

## Device Information:

Aragon Surgical LapCap Trade Name: 21CFR 884.1730 Classification: Class II Product Code: HIF Laparoscopic Insufflator and Accessories Classification Name:

#### Physical Description:

The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.

#### Intended Use:

The Aragon Surgical LapCap is intended for use in the pen-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

#### Equivalent Device:

The subject device is substantially equivalent in intended usertechnological characteristics and/or method of operation to the Veresure Bell (KO61387) and the Taut - Insufflation Needle (K003703).

#### Summary:

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

Confidential

MAY 3 0 2007

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Image /page/1/Picture/0 description: The image shows a circular logo with an abstract image of an eagle. The logo also contains text around the circle, which reads "DEPARTMENT OF HEALTH & HUMAN...USA". The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services in the United States.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 3 0 2007

Mr. Alan Curtis Vice President Regulatory/Quality/Clinical Affairs Aragon Surgical. Inc. 1810 Embarcadero Road Suite B PALO ALTO CA 94303

Re: K070651

Trade/Device Name: Aragon Surgical LapCap Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: April 19, 2007 Received: April 24, 2007

Dear Mr. Curtis:

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.

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Protecting and Promoting Public Health

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Page 2 -

Enclosure

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 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), 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 hitto://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

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

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# Indications for Use

510(k) Number (if known): K070651

Device Name: Aragon Surgical LapCap

Indications For Use:

The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdoming I wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

Prescription Use र (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Lemo

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_