PRE-VIEW CHOLANGIOGRAPHY CLAMP

• K Number: K973621
• Device Name: PRE-VIEW CHOLANGIOGRAPHY CLAMP
• Manufacturer: NASHVILLE SURGICAL INSTRUMENTS
• Date Cleared: 1997-12-17 ( 85 days)
• Product Code: GBZ , KOG
• Regulation Number: 878.4200
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The New Device and the ENDOPATH* Cholangiography Clamp Predicate Device have identical indications for use. The two devices, in fact, are the same instrument. The New Device and the ENDOPATH* Cholangiography 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. The Pre-View Cholangiography Clamp is intended to provide a method of laparoscopic cholangiography.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the PRE-VIEW* Cholangiography Clamp. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data as would be required for a new device type.

Therefore, the information typically requested regarding acceptance criteria and detailed study design to prove performance is largely not applicable to this document. The core of this submission is to show that the new device is essentially the same as a previously cleared device.

However, I can extract the relevant information showing how "substantial equivalence" was established, which serves as the "study" in this context.

Here's a breakdown based on the provided text, acknowledging the limitations for a 510(k) submission:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are effectively that the new device (PRE-VIEW* Cholangiography Clamp) performs equivalently to the predicate device (ENDOPATH* Cholangiography Clamp K 942450) across key characteristics.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (PRE-VIEW* Cholangiography Clamp)
Identical Indications For Use	The New Device and the ENDOPATH* Cholangiography Clamp Predicate Device have identical indications for use. Both are designed to grasp and introduce contrast medium into the gallbladder for evaluation of stones, blockage, and/or other abnormalities, for use in minimally invasive or open surgical procedures.
Identical Indicated Use	The New Device and the ENDOPATH* Cholangiography 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.
Same Technological Characteristics	The technological characteristics of the New Device are the same as the Predicate Device. Both are manually activated surgical instruments.
Equivalent 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.

Study Information (Based on 510(k) Substantial Equivalence Process)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. No "test set" in the traditional sense of evaluating performance with patient data was described. The submission focuses on comparing the new device's design, indications, and technological characteristics to the predicate.
   • Data Provenance: The 'data' is a comparison of product specifications and intended use of the new device against the predicate device. This is internal information from the manufacturer (Nashville Surgical Instruments) and publicly available information about the predicate device (ENDOPATH* Cholangiography Clamp K 942450). It is retrospective in the sense that the predicate device was already marketed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. "Ground truth" in this context is the established characteristics and intended use of the predicate device. This is determined by the predicate device's existing 510(k) clearance and regulatory classification, not by experts establishing a new ground truth for a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. There was no "test set" requiring adjudication by multiple readers or judges for performance evaluation. The "adjudication" is the FDA's regulatory review of the substantial equivalence claim.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a manual surgical instrument, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth," in the context of this 510(k), is the established regulatory profile (indications for use, technological characteristics, device characteristics, safety, and effectiveness) of the predicate device, the ENDOPATH* Cholangiography Clamp (K 942450). This is based on its prior clearance by the FDA.

7. The sample size for the training set:

   • Not applicable. There is no training set for an algorithm as this is a physical medical device.

8. How the ground truth for the training set was established:

   • Not applicable for the reasons stated above.

Summary

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

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.

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

Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a larger document or heading. The words are printed in black against a white background.

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.

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

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

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

Springfield Surgery PC 2.00P

September 1997

如果有用意的心理的

Page_1 of 1

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.

(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 510(k) Number: K973621
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use ______

(Optional Format 1-2-96)

Image /page/3/Picture/11 description: The image shows a crescent shape. The crescent is mostly black, with a thin white outline on the left side. The black part of the crescent is larger than the white part, taking up most of the space in the image.

Regulation Number and Section

§ 878.4200 Introduction/drainage catheter and accessories.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.