LAPARO-TENSER

K970712 · L & T S.N.C. DI E. Lucini & C. · HET · Jul 21, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K970712
• Device Name: LAPARO-TENSER
• Applicant: L & T S.N.C. DI E. Lucini & C.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jul 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laparo-Tenser is intended for use as a laparoscopic retractor in gasless laparoscopic procedures. the Laparo-Tenser creates a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.

Device Story

Laparo-Tenser is a mechanical laparoscopic retractor used in gasless laparoscopic surgery. Device creates a gasless cavity within the peritoneal space to allow direct visualization of organs for diagnostic or surgical procedures. Operated by surgeons in an OR setting. Provides physical retraction to maintain the surgical field without the need for insufflation gas. Benefits include avoidance of gas-related complications during laparoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical laparoscopic retractor; non-powered; designed for physical tissue retraction to create a gasless surgical cavity.

Indications for Use

Indicated for use as a laparoscopic retractor in gasless laparoscopic procedures to create a cavity for direct visualization of peritoneal organs during diagnostic and surgical procedures.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUL 21 1998
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

L & T S.N.C. DI E. LUCINI & C.
c/o Mr. Terry O'Brien
Project Marketing
112 Caviston Way
Cary, NC 27560

Re: K970712
Laparo-Tenser Laparoscopic Abdominal Retractor
Dated: May 6, 1998
Received: May 8, 1998
Regulatory Class: II
21 CFR 884.1720/Procode: 85 HET

Dear Mr. O'Brien:

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 requirements, 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.

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/dsma/dsmamain.html".

Sincerely yours,


Enclosure

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Page 2 of 2

510(k) Number (if known): K970712

ice Name: Laparo-Tenser

Indications For Use:

The Laparo-Tenser is intended for use as a laparoscopic retractor in gasless laparoscopic procedures. the Laparo-Tenser creates a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.


(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 Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970712

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)