NTERO RF SLEEVE

K992572 · Ntero Surgical, Inc. · GEI · Sep 24, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992572
• Device Name: NTERO RF SLEEVE
• Applicant: Ntero Surgical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coaqulate tissue.

Device Story

NTERO RF Sleeve is a laparoscopic surgical accessory. It functions as a port of entry maintainer and an electrosurgical tool for tissue coagulation. Used in laparoscopic surgery by physicians. Device provides a physical conduit for instruments while delivering radiofrequency energy to coagulate tissue. Benefits include simultaneous access and hemostasis during minimally invasive procedures.

Clinical Evidence

In vitro and in vivo testing performed. No clinical trial data provided. Biocompatibility of materials confirmed.

Technological Characteristics

Electrosurgical device for laparoscopic use. Provides port maintenance and RF tissue coagulation. Materials confirmed biocompatible. Class II device.

Indications for Use

Indicated for use during laparoscopic surgery to maintain a port of entry and to coagulate tissue in patients undergoing such procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• USSC Versaport Sleeve (K954108)
• Surgical Laser SLT Hemosleeve Bipolar Sheath (K984018)
• Dorsal Orthopedic Coaqulating Cannula (K953696)

Submission Summary (Full Text)

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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 30, 1999

510(k) number: K992572

# Applicant Information:

NTERO Surgical, Inc. 1137D San Antonio Rd Palo Alto, CA 94303

| Contact Person: | D. Bommi Bommannan |
|-----------------|-------------------------|
| Phone Number: | [phone] ext. 101 |
| Fax Number: | [phone] |

# Device Information:

Classification: Class II Trade Name: NTERO RF Sleeve Classification Name: Electrosurqical Device and accessories (21 CFR 870,4400)

## Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the USSC Versaport Sleeve (K954108), the Surgical Laser SLT Hemosleeve Bipolar Sheath (K984018) and the Dorsal Orthopedic Coaqulating Cannula (K953696).

#### Intended Use:

The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coaqulate tissue.

# Test Results:

#### Performance

Results of in vitro and in vivo testing demonstrate that the NTERO RF Sleeve is safe and effective for its intended function.

#### Biocompatibility

The materials used in the NTERO Probe have been shown to be biocompatible.

#### Summary:

Based on the intended use, product, performance and biocompatability 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Mr. D. Bommi Bommannan President NTERO Surgical, Inc. 1137D San Antonio Road Palo Alto, California 94303

Re: K992572 Trade Name: NTERO RF Sleeve Regulatory Class: II Product Code: GEI Dated: July 30, 1999 Received: August 2, 1999

Dear Mr. Bommannan:

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 Ouality 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 – Mr. D. Bommi Bommannan

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,

to welle

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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# Indications for Use

510(k) Number (if known):

K992572 ---------

Device Name:

NTERO RF Sleeve . . . . . . . . . . . .

Indications for Use:

The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coagulate tissue.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K992572 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">✓</div> | OR | Over-the Counter Use |
|------------------------------------------|-----------------------------------------|----|----------------------|
|------------------------------------------|-----------------------------------------|----|----------------------|

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