(16 days)
The Blunt Tip Trocar Port has applications for surgery in the legs for establishment of a port of entry for endoscopic instruments.
Not Found
I am sorry but this document is a letter from the FDA regarding the clearance of a medical device (Blunt Tip Trocar Port) and does not contain the detailed study information required to answer your request. The document confirms that the device can be marketed but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
- Details on the type of ground truth used or the sample size and ground truth establishment for a training set.
The letter is a regulatory approval, not a scientific study report.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1331
Lori E. Adels, Ph.D. Vice President, Regulatory Affairs Origin Medsystems, Inc. A Subsidiary of Guident Corp. 1525 O'Brien Drive Menlo Park, California 94025
K992353 Re: Trade Name: Blunt Tip Trocar Port Regulatory Class: II Product Code: GCJ Dated: July 13, 1999 Received: July 14, 1999
Dear Dr. Adels:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 910(x) notification of the indications for above and we have determined this es marketed in interstate commerce prior to use stated in the enclosure) to devices manetical Device Amendments, or to devices that May 28, 1976, the enactified 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 Cosment Act (7Nc). Tournaly, therefers, Includers, Include requirements for provisions of the Act. The general condinations 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 (Fremarket Approval), It may be subject to sam rain the Code of Federal Regulations, Title 21, regulations arrecting your device can or round to mination assumes compliance with the I arts 600 to 675. A 54.55.41.24.2017. In the Quality System Station in the Quality System Current Cloxi Manufacturing Practices: General regulation (21 CFR Part 820) and that, Regulation (QS) inspections, the Food and Drug Administration (FDA) will verify all ough portually (QD) inspections) with the GMP regulation may result in regulatory sucir assumptions. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission docs I cuctar Register. Frease noter initit have under sections 531 through 542 of the Act for not antect ary obtigation you might Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2 - Lori E. Adels, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k)
and the country of the FD to dian of substantial equivalence of your device to This letter will allow you to begin marketing of substantial equivalence of your device to a
premarket notification. The FDA finding of substantial equivalence of your devic premarket notification. The FDA finding of substantial equivals. So 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 the subseries in the same and advailable sentact the Office of If you desire specific advice for your devices), please contact the Office of
and additionally 809.10 for in vitro diagnostic devices on the promotion and and additionally 809.10 for in Vitto didn't on 1000) for questions on the promotion and Compliance at (301) 594-4391. Adultionally, Ior quotice of Compliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliance at (301) of the Also, please note the regulation entitled, "Misbranding by reference to premarket. Also, please note the regulation entitled, "Misoration on your responsibilities under the notification" (21 CFK 807.97). Onlie genchi internets Assistance at its toll-free
Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free
10 Act may be obtained from (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fu 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}------------------------------------------------
. .
ﺴﺐ
| 510(k) Number (if known): | Unknown |
|---|---|
| Device Name: | Blunt Tip Trocar Port |
Indications For Use:
.
l
i . .
The Blunt Tip Trocar Port has applications for surgery in the legs for establishment
of a port of entry for endoscopic instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use | X | OR | Over-The-Counter Use |
(Division Sign-Off)
Division of General Restorative Dr.
| 510(k) Number | K992353 | (Optional Format 1-2-96) |
|---|---|---|
| --------------- | --------- | -------------------------- |
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.