MICRO-FRANCE TROCARS AND ACCESSORIES

K993653 · Xomed, Inc. · HET · Jun 9, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993653
• Device Name: MICRO-FRANCE TROCARS AND ACCESSORIES
• Applicant: Xomed, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jun 9, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The trocars and accessories are intended to establish and maintain surgical access to the abdominal or thoracic cavity for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation.

Device Story

Micro-France trocars are manually operated surgical instruments used to establish and maintain access to abdominal or thoracic cavities. Device consists of stainless steel mandrel for initial access and sleeve for maintaining port; may include automatic valve and stopcock for insufflation. Accessories include threaded/smooth sleeves, reduction sleeves, and parietal elevators. Used by surgeons in clinical/OR settings to facilitate laparoscopic procedures. Provides physical conduit for instruments; does not involve electronic processing or automated decision-making.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel construction; manually operated; mechanical valve and stopcock components; dimensions/form factor typical of laparoscopic trocars.

Indications for Use

Indicated for patients requiring surgical or laparoscopic access to the abdominal or thoracic cavity. No specific age or gender restrictions stated.

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.

Predicate Devices

• Richard Wolf (K960299)
• Pilling Weck (K964450)
• Ethicon Endo-Surgery (K965045)

Submission Summary (Full Text)

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# JUN - 9 200

K993653
Page 1 of 2

# 510(k) Summary

#### 1.0 Date Prepared

October 28, 1999

# 2.0 Submitter (Contact)

Martin D. Sargent Xomed Surgical Products Jacksonville, FL [phone]

#### 3.0 Device Name

| Proprietary Name: | Micro-France trocars and accessories |
|-------------------------|--------------------------------------|
| Common Name(s): | Trocars and accessories |
| Classification Name(s): | Laparoscopic accessories |

#### 5.0 Device Classification

Gynecologic laparoscope accessories: Procode HET Class II 21 CFR 884.1720

### 6.0 Device Description

Micro-France trocars are manually operated surgical instruments. They consist of a stainless steel mandrel used to establish surgical access to the abdominal or thoracic cavity, and a sleeve the maintain access for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation. Trocar accessories include threaded and smooth sleeves, reduction sleeves, and parietal elevators.

#### 7.0 Intended Use

The trocars and accessories are used to establish and maintain surgical access to the abdominal or thoracic cavity, access for surgical and laparoscopic instruments, and may provide a port with stopcock for insufflation.

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K993653
Page 2 of 2

# 8.0 Substantial Equivalence

The trocars and accessories are substantially equivalent to devices marketed by Richard Wolf (K960299), Pilling Weck (K964450), and Ethicon Endo-Surgery (K965045).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2000

Mr. Martin D. Sargent Sr. Regulatory Affairs Specialist Medtronic Xomed Surgical Products 6743 Southpoint Dr., N. Jacksonville, FL 32216-0980

Re: K993653 Micro-France Trocars and Accessories Dated: March 31, 2000 Received: April 6, 2000 Regulatory Class: II 21 CFR §884.1720/Procode: 85 HET

Dear Mr. Sargent:

We have reviewed your Section 510(k) notification of intent to market the device and we 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). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Aproval), 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 requlation (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 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" (21CFR 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/dsmaldsmamain.html".

Sincerely yours.

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure(s)

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510(k) Number (if known): 1993653 Device Name: __ Trocars and Accessories Indications for Use:

> The trocars and accessories are intended to establish and maintain surgical access to the abdominal or thoracic cavity for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

Or

Over-the-Counter Use __

(Optional Format 1-2-96)

Ginid li. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

Radiological

510(k) Number K993653