BAHO AUTOCLAVABLE LAPAROSCOPE

K982276 · Microptix Int'L, LLC · HET · Feb 18, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K982276
• Device Name: BAHO AUTOCLAVABLE LAPAROSCOPE
• Applicant: Microptix Int'L, LLC
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Feb 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

Like the Predicate device, Storz 26033, the Baho Autoclavable Laparoscope is inicated for use in the visual examination of body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Story

Baho Autoclavable Laparoscope is a rigid endoscope used for visual examination of body cavities, hollow organs, and canals. Device functions as a visualization tool; requires connection to external light source and camera system (not included) to transmit images to a monitor for physician viewing. Used in clinical settings (OR/clinic) by physicians to facilitate diagnostic and therapeutic procedures. Benefits include minimally invasive access to internal anatomy for visualization and surgical intervention.

Clinical Evidence

Bench testing only.

Technological Characteristics

Rigid endoscope; autoclavable design; optical lens system for visualization; compatible with standard endoscopic accessories; intended for use with external light sources and imaging systems.

Indications for Use

Indicated for visual examination of body cavities, hollow organs, and canals, and for use with accessories to perform diagnostic and therapeutic procedures in patients requiring laparoscopic intervention.

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

• Storz 26033

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 1 8 1999

Mr. George N. Hallack MicroOptix International., LLC 310 Main Street Suite LL-D East Haven, CT 06512

Re: K982276

BAHO Autoclavable Laparoscope Dated: November 14, 1998 Received: November 20, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET

Dear Mr. Hallack:

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 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 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 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 regult 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,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## MICROOPTIX INTERNATIONAL, LLC

The Endoscope Repair People ----

Page one of one

## INDICATIONS FOR USE

1. Submitter: Microptix International, LLC. 310 Main Street East Haven, CT 06512

- 2. 510(k) Number: K982276
- 3. Device Name: Baho Autoclavable Laparoscope
- 4. Indication for use: Like the Predicate device, Storz 26033, the Baho Autoclavable Laparoscope is inicated for use in the visual examination of body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures.

(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

(Division Sign-Off)

Over-the-counter (Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K982276/5001