PRE-VIEW CHOLANGIOGRAPHY CLAMP

K973621 · Nashville Surgical Instruments · GBZ · Dec 17, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973621
• Device Name: PRE-VIEW CHOLANGIOGRAPHY CLAMP
• Applicant: Nashville Surgical Instruments
• Product Code: GBZ · General, Plastic Surgery
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1

Intended Use

The Pre-View Cholangiography Clamp is intended to provide a method of laparoscopic cholangiography.

Device Story

The PRE-VIEW Cholangiography Clamp is a 5mm manual surgical instrument featuring a side channel for catheter introduction. Used by surgeons during minimally invasive or open surgical procedures, the device allows for the grasping of the gallbladder and the introduction of contrast medium to facilitate cholangiography. By enabling the visualization of stones, blockages, or other abnormalities, the device assists the clinician in diagnostic assessment during surgery. It is a hand-held, manually activated tool.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical design and technological characteristics to the predicate device.

Technological Characteristics

Manually activated surgical instrument; 5mm clamp with side channel for catheter introduction; hand-held form factor.

Indications for Use

Indicated for use in minimally invasive or open surgical procedures to grasp and introduce contrast medium into the gallbladder for evaluation of stones, blockage, and/or other abnormalities.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

• ENDOPATH Cholangiography Clamp (K942450)

Submission Summary (Full Text)

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NASHVILLE SURGICAL INSTRUMENTS PREMARKET NOTIFICATION

DEC 17 1997

## XIII. Kit Certification Statement

The Reusable Clamp or the Single-Use catheter will not be sold as part of any kits.

## Summary Of Safety And Effectiveness xIV.

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's "510(k) 'SE' Decision Making Process Documentation" and can be used to provide a substntial equivalence summary to anyone requesting it from the Agency.

NEW DEVICE NAME: PRE-VIEW* Cholangiography Clamp

## PREDICATE DEVICE NAME: ENDOPATH* Cholangiography Clamp K 942450

## 510 (k) "SE" DECISION-MAKING PROCESS

INDICATIONS STATEMENT: YES. The New Device and the ENDOPATH* Cholangiography Clamp Predicate Device have identical indications The two devices, in fact, are the same instrument. for use.

The New Device and the ENDOPATH* Cholangiography INDICATED USE: YES. Clamp are designed to grasp and introduce contrast medium into the gallbladder for evaluation of stones, blockage and/or other abnormalities. Both of these devices are intended for use in either minimally invasive or open surgical procedures.

TECHNOLOGICAL CHARACTERISTICS: YES. The technological characteristics of the New Device are the same as the Predicate Device. Both of these devices are manually activated surgical instruments.

DEVICE CHARACTERISTICS: The PRE-VIEW* Cholangiography Clamp just like the ENDOPATH* Cholangiography Clamp consists of a 5mm clamp with a side channel for the introduction of a catheter. It is a hand held manual instrument designed for grasping and introducing contrast medium for cholangiography.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1997

S.S. Kumar, M.D. President Nashville Surgical Instruments 322 Northcrest Drive Springfield, Tennessee 37172

Re: K973621

> Trade Name: PRE-VIEW* Cholangiography Clamp Regulatory Class: II Product Code: KOG Dated: September 19, 1997 Received: September 23, 1997

Dear Dr. Kumar:

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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - S.S. Kumar, M.D.

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 vour 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.

f. coell

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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Springfield Surgery PC 2.00P

September 1997

如果有用意的心理的

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510(k) Number (if known):_K973621

Device Name:__Pre-View Cholangiography Clamp

Indications For Use:

The Pre-View Cholangiography Clamp is intended to provide a method of laparoscopic cholangiography.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | <div align="right">(Division Sign-Off)</div> <div>Division of General Restorative Devices</div> <div>510(k) Number: K973621</div> | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |

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