(27 days)
Not Found
Not Found
No
The summary describes a standard surgical trocar kit and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is a surgical tool (trocar) used during laparoscopic procedures, not a therapeutic device. It assists in surgery rather than providing a direct therapeutic effect.
No
The provided text states the device is "intended for use during laparoscopic/ endoscopic surgery," indicating it is a surgical tool used for intervention, not for diagnosing a condition.
No
The device is described as "Sterile Trocar Kits," which are physical instruments used in surgery. The summary does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during laparoscopic/endoscopic surgery under the guidance of a physician. This indicates a surgical tool used directly on or within the patient's body.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Being used in a laboratory setting
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Gibbons' Surgical Corporation Sterile Trocar Kits, as described, are surgical instruments used for accessing body cavities during minimally invasive procedures.
N/A
Intended Use / Indications for Use
The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.
Product codes
FBQ
Device Description
Gibbons' Sterile Trocar Kit
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle or bird with outstretched wings.
AUG - 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Crisson Director of Quality Assurance/ Regulatory Affairs Gibbons Surgical Corporation 1112 Jensen Drive, Suite 101 Virginia Beach, Virginia 23451
Re: K012198
Trade/Device Name: Gibbons' Sterile Trocar Kit Regulation Number: 876.5090 Regulatory Class: II Product Code: FBQ Dated: July 5, 2001 Received: July 13, 2001
Dear Ms. Crisson:
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 legally marketed predicate 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.
1
Page 2 - Ms. Lisa Crisson
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) 594-4659. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
for Mark N. Milhusan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K012198
Page_One_of One
510(k) Number (if known): Not Known Device Name: Gibbons' Sterile Trocar Kit FDA's Statement of the Indications For Use for device:
The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.
Prescription Use_ X OR (Per 21 CFR 801.109)
Over-The-Counter Use_
fo Mark N Millheuser
sion of General. " estorative and Neurological Devices KOI 2198
510(k) Number -