IOTEC TROCAR AND FLEXIBLE CANNULA

K970888 · Iotec Industries · GCJ · Jan 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K970888
• Device Name: IOTEC TROCAR AND FLEXIBLE CANNULA
• Applicant: Iotec Industries
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The product is intended to create a point of entry for curved endoscopic instruments into the abdominal and chest cavities during a endoscopic procedure.

Device Story

Iotec Trocar and Flexible Cannula facilitates endoscopic access to abdominal and chest cavities. Device consists of a trocar tip (stainless steel or plastic) and a flexible plastic cannula tube. Designed to accommodate both straight and curved endoscopic instruments. Used by surgeons in clinical settings during endoscopic procedures to create entry points. Provides a conduit for instruments; enables maneuverability of curved tools within the cavity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Plastic and stainless steel. Components: Trocar tip and flexible plastic cannula tube. Design: Flexible cannula to accommodate curved instruments. No performance standards cited.

Indications for Use

Indicated for patients undergoing endoscopic procedures requiring access to the abdominal or chest cavities for the insertion of straight or curved endoscopic instruments.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Access Surgical Intl. Inc. (K940587)
• Ethicon, Inc. (K931111)

Submission Summary (Full Text)

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K970988
JAN - 9 1998

# F: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## 510(k) SUMMARY

1) Submitter:
Iotec Industries™
7538 Pebble Drive
Fort Worth, TX 76118
Phone No.: [phone]

Contact Person:
Roger Cooper
Executive Vice President
Regulatory Affairs

Date Prepared:
Monday, 3 March 1997

2) Name of Device:
Iotec Trocar and Flexible Cannula

Common Name:
Trocar and Flexible Cannula

3) Predicate Device:
Access Surgical Intl. Inc. K940587
Ethicon, Inc. K931111

4) Description of Device:
The Iotec Trocar and Flexible Cannula is composed of Plastic, Stainless Steel (or plastic rod) for attachment of the trocar tip; and a flexible plastic cannula tube.

5) Intended Use:
The intended use of this device is to create a point of entry for endoscopic instruments into the abdominal and chest cavities during a endoscopic procedure. The Cannula is flexible to accommodate curved instruments.

6) Technological characteristics of this device are comparable to the predicate device in that predicate device is also used to create a point of entry for endoscopic instruments into the abdominal cavity during a endoscopic procedure.

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# SECTION G:

## MANUFACTURER'S STATEMENT OF SUBSTANTIAL EQUIVALENCE

(To be provided with 510(k) notification for tier 2 devices)

STATEMENT OF INDICATIONS FOR USE: The product is intended to create a point of entry for curved endoscopic instruments into the abdominal and chest cavities during a endoscopic procedure.

CLAIMS: Creates a point of entry for straight and curved endoscopic instruments into the abdominal and chest cavities.

This notification contains all of the information required by 21 CFR 807.87.

A completed copy of the "DRAERD Premarket Notification 510(k) Reviewer's Screening Checklist" is attached.

The subject device conforms to the following voluntary and mandatory standards:

There are no existing performance standards available.

The subject device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent. If the subject device is a kit, all of the contents of the kit are either pre-Amendment devices or have been cleared for marketing through previous 510(k)s. The kit contains no drug or biologic products.

The above statements are accurate representations of this 510(k) premarket notification and of the device this firm intends to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted (21 CFR 807.87(J)).

MANUFACTURER: Iotec Ind.

OFFICIAL CORRESPONDENT:
Roger Cooper
(signature)
(printed name)

TITLE: Executive Vice President - Regulatory Affairs

DATE: 3 March 1997

Page 13 of 81

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

Mr. James Lutkenhaus
Quality Assurance Regulatory
Iotec Industries™
P.O. Box 821834
North Richland Hills, Texas 76182

JAN - 9 1998

Re: K970888
Trade Name: Iotec Trocar and Flexible Cannula
Regulatory Class: II
Product Code: GCJ
Dated: November 25, 1997
Received: December 2, 1997

Dear Mr. Lutkenhaus:

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

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Page 2 - Mr. Lutkenhaus

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/dsmamain.html".

Sincerely yours,


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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Page 1 of 1

510(k) Number (if known): K970888

Device Name: Iotec Trocar and Flexible Cannula

Indications For Use:
The product is intended to create a point of entry for curved endoscopic instruments into the abdominal and chest cavities during a endoscopic procedure.

(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)