(36 days)
Not Found
Not Found
No
The summary describes a simple mechanical device (abdominal access port with a stopcock) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an abdominal access port and stopcock for maintaining pneumoperitoneal pressure during laparoscopic procedures, which are surgical tools rather than devices intended to treat a disease or condition.
No
Explanation: The intended use of the device is to serve as an abdominal access port and for maintaining pneumoperitoneal pressure during laparoscopic procedures, which are interventional/surgical functions, not diagnostic.
No
The intended use describes a physical device (abdominal access port, stopcock) used during a laparoscopic procedure, which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a surgical procedure (laparoscopic abdominal access and insufflation). IVDs are used to examine specimens outside the body to provide information about a person's health.
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Other Information: The lack of mentions of image processing, AI/ML, input imaging modality, training/test sets, performance studies, or key metrics (like sensitivity/specificity) further supports that this is not an IVD. These are common elements in submissions for devices that analyze data or samples.
This device appears to be a surgical instrument used for direct access and manipulation within the body, not for testing biological samples.
N/A
Intended Use / Indications for Use
Intended Use: For use as an abdominal access port during a laparoscopic procedure and the 1-way stopcock for attaching insufflation tubing to maintain pneumoperitoneal pressure.
Product codes
GBW, HIF
Device Description
Peritoneal Catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or body. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 1999
Mr. Ronald D. Kenseth V. P. of Operations Taut, Inc. 2571 Kaneville Court Geneva, Illinois 60134
Re: K992904 Trade Name: Peritoneal Catheter Regulatory Class: II Product Code: GBW, HIF Dated: August 25, 1999 Received: August 30, 1999
Dear Mr. Kenseth:
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 requirement, 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.
1
Page 2 – Mr. Ronald D. Kenseth
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,
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
2
Peritoneal Catheter 510k Pre-Market Notification
INDICATIONS FOR USE STATEMENT
510(k) Number: (if known)
Device Name: Peritoneal Catheter
Indications for Use:
Intended Use: For use as an abdominal access port during a laparoscopic procedure and the 1-way stopcock for attaching insufflation tubing to maintain pneumoperitoneal pressure.
(PLEASE DO NOT WRITE BELOW THIS LINE THIS LINE -- CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
n-Off
General Restorative Devic 510(k) Number
V Prescription Use (Per 21 CFR & 801.109)
Over-The-Counter Use