K Number
K970888
Device Name
IOTEC TROCAR AND FLEXIBLE CANNULA
Manufacturer
Date Cleared
1998-01-09

(304 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
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.
More Information

Not Found

No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.

No
The device is described as creating a point of entry for instruments, which is an access function, not a therapeutic intervention to treat a disease or condition.

No
The device is described as creating a point of entry for endoscopic instruments, which is a surgical tool, not a diagnostic one. There is no mention of it being used to identify or analyze medical conditions.

No

The device description explicitly states it is composed of physical components like plastic and stainless steel, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to create a point of entry for surgical instruments into the body during an endoscopic procedure. This is a surgical device used in vivo (within the living body).
  • Device Description: The description details physical components used for surgical access.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status.

IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device's function is purely mechanical and surgical.

N/A

Intended Use / Indications for 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.

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

Product codes

GCJ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal and chest cavities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K940587, K931111

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.

0

K970888

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.: (817) 589-3799 | |
|----|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | 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.
Ethicon, Inc. | K940587
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. | |

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

1

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.

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

Image /page/1/Picture/10 description: The image shows a black and white drawing of a leaf. The leaf is dark and solid black, with a pointed tip and a rounded base. To the left of the leaf, there are two curved lines, which may represent the stem or veins of the leaf. The background is plain white.

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 intents 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

DATE: 3 March 1997

Image /page/1/Picture/15 description: The image is a black and white silhouette of an animal. The animal appears to be a tapir, with a distinctive short, prehensile trunk. The tapir is facing left, and its body is mostly obscured by shadow.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it. Above the caduceus, the text "HUMAN SERVICES • USA" is arranged in a semi-circle. Below the caduceus, the text "DEPARTMENT OF HEALTH &" is arranged in a semi-circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN - 9 1998

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:

Re:

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

3

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

4

510(k) Number (if known): ___K970888

Device Name:

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)

(Division Sign-Off)
Division of General Restorative Devices K970888
510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)