SMITH & NEPHEW DYONICS MICROLAPAROSCOPE

K982149 · Smith & Nephew, Inc. · HET · Sep 10, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K982149
• Device Name: SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
• Applicant: Smith & Nephew, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Sep 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures. For use in gynecological laparoscopy the following specific indications apply: - Unexplained pelvic pain (acute, chronic) ● - Infertility work-up ● - Tubal sterilization ● - Diagnosis and/or treatment of ectopic pregnancy ● - Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma . (less than 16 weeks gestational size) - Evaluation of congenital anomalies of the pelvic organs - . Retrieval of foreign bodies - . Determination of the presence and extent of pelvic endometriosis - Determination of the presence and extent of pelvic inflammatory disease . (if not in acute stage) - Access to abdomen for surgical procedures such as LAVH . - Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) . organs

Device Story

Dyonics 2.7mm Microlaparoscope is a rigid endoscope used in general and gynecological surgery; transfers light to surgical site via glass fiber optics; allows visualization of body cavities and organs via rigid rodlens optical design; operated by physicians in clinical/surgical settings; provides direct visualization to assist in diagnosis and surgical manipulation; benefits patients by enabling minimally invasive access to abdominal and pelvic cavities.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Rigid rodlens optical design; glass fiber optic illumination; 2.7mm diameter form factor; non-powered, manual surgical instrument.

Indications for Use

Indicated for patients undergoing general or gynecological laparoscopy for diagnostic or operative procedures, including evaluation of pelvic pain, infertility, tubal sterilization, ectopic pregnancy, pelvic tumors, congenital anomalies, foreign body retrieval, endometriosis, pelvic inflammatory disease, and perforated organs.

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 Medical 2.0mm mini laparoscope

Submission Summary (Full Text)

{0}------------------------------------------------

K982149

SEP 1 0 1998

## 510(k) Summary Smith & Nephew, Inc., Endoscopy Division Dyonics 2.7mm Microlaparoscope

#### Substantial Equivalence:

The Smith & Nephew Dyonics 2.7mm Microlaparoscope is substantially equivalent in design, materials, function, and intended use to the Richard Wolf Medical 2.0mm mini laparoscope.

## Predicate Device:

The predicate device for this submission is the Richard Wolf Medical 2.0mm mini laparoscope.

## Summary of Device Function:

The Smith & Nephew Dyonics 2.7mm Microlaparoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a rigid rodlens optical design.

#### Intended Use of Device:

The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures.

For use in gynecological laparoscopy the following specific indications apply:

- Unexplained pelvic pain (acute, chronic) ●
- Infertility work-up ●
- Tubal sterilization ●
- Diagnosis and/or treatment of ectopic pregnancy ●
- Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma . (less than 16 weeks gestational size)
- Evaluation of congenital anomalies of the pelvic organs
- . Retrieval of foreign bodies
- . Determination of the presence and extent of pelvic endometriosis
- Determination of the presence and extent of pelvic inflammatory disease . (if not in acute stage)
- Access to abdomen for surgical procedures such as LAVH .
- Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) . organs

{1}------------------------------------------------

# Comparison of Technological Characteristics of Predicate Device:

The basic technologies, design and function of the Smith & Nephew Dyonics 2.7mm Microlaparoscope is substantially equivalent in materials, design and function to the Richard Wolf Medical 2.0mm mini laparoscope.

Welsh J. Coman

Deborah J. Connors Sr. Regulatory Affairs Specialist

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features the department's seal, which includes an emblem of three stylized human profiles facing right, arranged in a stacked formation. The words "DEPARTMENT OF HEALTH & HU..." are arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

10 1998

Ms. Deborah J. Connors Senior Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, MA 01810

Re: K982149 Dyonics 2.7mm Microlaparoscope Dated: August 27, 1998 Received: August 28, 1998

21 CFR 884.1720/Procode: 85 HET

Regulatory Class: II

Dear Ms. Connors:

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 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 (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 equivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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%) 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/cdrb/dsmamain.html", -

Sincerely vours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K982149 510(k) Number :

Device Name : Smith & Nephew, Inc., Endoscopy Division Dyonics Microlaparoscope

Indications for Use :

The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures.

For use in gynecological laparoscopy the following specific indications apply:

- Unexplained pelvic pain (acute, chronic) .
- Infertility work-up ●
- . Tubal sterilization
- Diagnosis and/or treatment of ectopic pregnancy .
- . Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma (less than 16 weeks gestational size)

# (PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel C. Szyrm

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

510(k) Number K982149

ption Use OR Over-the-Counter

Prescription Use V (Per 21 CFR 801.109) Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

{4}------------------------------------------------

For use in gynecological laparoscopy the following specific indications apply: (cont'd)

- Evaluation of congenital anomalies of the pelvic organs .
- . Retrieval of foreign bodies
- Determination of the presence and extent of pelvic endometriosis .
- Determination of the presence and extent of pelvic inflammatory disease (if . not in acute stage)
- Access to abdomen for surgical procedures such as LAVH .
- Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) . organs