(24 days)
Not Found
No
The device description and performance studies focus on mechanical function and safety, with no mention of AI/ML terms or capabilities.
No.
The trochlear is used to establish a path of entry for endoscopic instruments, which is a surgical tool, not a therapeutic one. It facilitates surgical procedures rather than treating a disease or condition itself.
No
Explanation: The device description states its purpose is to establish a path of entry for endoscopic instruments, and there is no mention of it being used to diagnose a condition or disease.
No
The device description clearly details physical components like a sharp flat bladed tip, spring-loaded shield, trocar sleeve, outer gasket, internal flapper valve, seal, stopcock valve, and desufflation lever, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a path of entry for endoscopic instruments" during surgical procedures. This is a surgical tool used directly on the patient's body.
- Device Description: The description details a physical instrument with a sharp tip, shield, sleeve, valves, etc., designed for creating an opening in the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis of biological samples.
The device described is a surgical instrument used for accessing body cavities during minimally invasive procedures.
N/A
Intended Use / Indications for Use
The ENDOPATH® Dilating Tip Trocar has application in thoracic, gynecologic Illtended Ose. The LNDO PATIF Disaming of o establish a path of entry for endoscopic instruments..
Product codes
GCJ
Device Description
The ENDOPATH® Dilating Tip Trocar in sizes ranging from 5mm to Device Description: The ENDOT ATTI - Dhamber of consisting of a sharp Ilat bladed tip
12mm in diameter is a sterile, single patient use instrument consisting and interest I zmm in diameter is a sterne, smell patient is designed to cover the flat bladed tip to protect internal and a spring-foaded sincid. The sticle is destgared to theracic cavity has been entered.
The trocar sleeve contains an outer gasket and internal flapper valve with a seal to minimize gas The focal sleeve contains an outer gazes and the trocar corresponds to the trocar corresponds to the for a leakage when mistrument are morted of wased in that trocar. There is a stopcock valve for gas insufflation and a desufflation lever for gas evacuation.
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
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
Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance.
Key Metrics
Not Found
Predicate Device(s)
ENDOPATH® Dilating Tip Trocar, ENDOPATH® Non-Bladed Obturator and Sleeve
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
ENDOPATH® Dilating Tip Trocar 510(k) Summary of Safety and Effectiveness
Company
MAR 4 2002
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact Elizabeth Miller Regulatory Affairs Specialist
Date Prepared: February 21, 2002
Name of Device Trade Name: ENDOPATH® Dilating Tip Trocar Trade Name: Laparoscope, General & Plastic Surgery
Predicate Device: ENDOPATH® Dilating Tip Trocar ENDOPATH® Non-Bladed Obturator and Sleeve
Device Description: The ENDOPATH® Dilating Tip Trocar in sizes ranging from 5mm to Device Description: The ENDOT ATTI - Dhamber of consisting of a sharp Ilat bladed tip
12mm in diameter is a sterile, single patient use instrument consisting and interest I zmm in diameter is a sterne, smell patient is designed to cover the flat bladed tip to protect internal and a spring-foaded sincid. The sticle is destgared to theracic cavity has been entered.
The trocar sleeve contains an outer gasket and internal flapper valve with a seal to minimize gas The focal sleeve contains an outer gazes and the trocar corresponds to the trocar corresponds to the for a leakage when mistrument are morted of wased in that trocar. There is a stopcock valve for gas insufflation and a desufflation lever for gas evacuation.
Intended Use: The ENDOPATH® Dilating Tip Trocar has application in thoracic, gynecologic Illtended Ose. The LNDO PATIF Disaming of o establish a path of entry for endoscopic instruments..
Technological Characteristics: The technological characteristics of the new device are the I echnological Characteristics. The technology. The sleeve/housing. The material is the characteristic that differs from the predicate device to the new.
Performance Data: Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles three overlapping human profiles with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2002 MAR
Ethicon Endo-Surgery, Inc. Elizabeth Miller Regulatory Affairs Specialist 4545 Creek Road Cincinnati, Ohio 45242
Re: K020428
Trade Name: Endopath® Dilating Rip Trocar Regulation Number: 876.1500 Regulation Name: Laparoscope, General and Plastic Surgery Regulatory Class: II Product Code: GCJ Dated: February 7, 2002 Received: February 8, 2002
Dear Ms. Miller:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Elizabeth Miller
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oogin mailsoning your and equivalence of your device to a legally premaired 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 If you desire speonne ad 100 for you in vitro diagnostic devices), please contact the Office of additionally 21 CFR Fart 007.10 for mirraally, for questions on the promotion and advertising of Compliance at (301) 594-4637. Thursday) . Inchience at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). I churion citinou, - Misoranaing of responsibilities under the Act may be obtained from the Other general monmation on your respontional 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,
Sincerely yours,
Martin N Milken
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
3
510(k) Number (if known): K020428
Device Name: ENDOPATH® Dilating Tip Trocar
Indications for Use:
The ENDOPATH® Dilating Tip Trocar has application in thoracic, gynecologic The ENDOI ATTI "Dhamg Tip Trocedures to establish a path of entry for endoscopic instruments.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Mark N Melleuson
Sign-Off) ivision of General, Restorative and Neurological Devices
510(k) Number K020128