(85 days)
K 942450
Not Found
No
The description focuses on a manual surgical instrument for grasping and introducing contrast medium, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device is used to introduce contrast medium for diagnostic imaging (cholangiography), not to treat a disease or condition.
Yes
The device is used for laparoscopic cholangiography, which is a diagnostic imaging procedure to visualize the bile ducts. Introducing contrast medium for this purpose makes it a diagnostic tool.
No
The device description explicitly states it is a "5mm clamp" and a "hand held manual instrument," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a method of laparoscopic cholangiography." This is a surgical procedure involving imaging, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a "hand held manual instrument designed for grasping and introducing contrast medium for cholangiography." This describes a surgical tool used during a procedure, not a device for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical instrument used for imaging during a procedure.
N/A
Intended Use / Indications for 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.
Product codes
KOG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gallbladder
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 942450
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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.
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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 (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.
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.
(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)
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