(62 days)
Not Found
No
The device description and intended use focus on mechanical components and their function in creating a path for instruments. There is no mention of any computational or data-driven features that would suggest the use of AI or ML.
No
The device is described as an instrument to establish a path of entry for other endoscopic instruments during minimally invasive procedures, not to treat a condition or disease.
No
This device, a trocar, is used to establish an entry path for surgical instruments during minimally invasive procedures. Its function is to facilitate access, not to diagnose medical conditions or analyze patient data.
No
The device description clearly details physical components like sleeves, obturators, seals, and a stopcock valve, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "establish a path of entry for endoscopic instruments" in surgical procedures (abdominal, thoracic, and gynecologic). This is a surgical access device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical components of the trocar (sleeve, obturator, seals, stopcock) and how they function to create and maintain a surgical port. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting or measuring specific analytes (e.g., biomarkers, pathogens).
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The ENDOPATH® III Trocars are surgical instruments used to facilitate minimally invasive procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ENDOPATH® III Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The ENDOPATH® III Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® III Blunt Tip Trocar has applications in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
Product codes
GCJ
Device Description
The ENDOPATH® III Trocars are sterile single patient use instruments consisting of a radiolucent sleeve and obturator in sizes ranging from 5-12 mm in diameter. There are three different obturators Bladeless, Blunt Tip and Dilating Tip. The Bladeless obturator contains a clear, tapered optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. The Bladeless obturator accommodates an appropriately sized zero endoscope. The Blunt Tip obturator has a blunt plastic tip, which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The Dilating Tip obturator has a sharp flat-bladed tip and a spring-loaded shield. The shield on the Dilating Tip obturator is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered.
The trocar sleeve contains two seals, an outer integrated removable self-adjusting seal to accommodate instruments ranging from 5mm to 12mm in diameter where indicated and an internal seal. Together, these seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5mm trocar sleeve does not contain an integrated removable seal and accommodates only 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in closed position when it is parallel to the sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, and gynecologic
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)
Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ENDOPATH® Dilating Tip Trocar, ENDOPATH® Non-Bladed Obturator and Sleeve, ENDOPATH® Bladeless Trocar, ENDOPATH® Blunt Tip Trocar, ENDOPATH® OneSeal Reducer Cap, ENDOPATH® TRISTAR™ Low Profile Trocars with Threaded 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
OCT 3 0 2003
Ethicon Endo-Surgery, Inc. 510(k) Premarket Notification for ENDOPATH® III Trocar System
ENDOPATH® III Trocar System 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Elizabeth Miller Regulatory Affairs Associate I
Date Prepared:
August 28, 2003
Name of Device
Trade Name: ENDOPATH® III Bladeless Trocars ENDOPATH® III Blunt Tip Trocars ENDOPATH® III Dilating Tip Trocars Classification Name: Laparoscope, General & Plastic Surgery
Predicate Device: ENDOPATH® Dilating Tip Trocar
ENDOPATH® Non-Bladed Obturator and Sleeve ENDOPATH® Bladeless Trocar ENDOPATH® Blunt Tip Trocar ENDOPATH® OneSeal Reducer Cap ENDOPATH® TRISTAR™ Low Profile Trocars with Threaded Sleeve
Device Description: The ENDOPATH® III Trocars are sterile single patient use instruments consisting of a radiolucent sleeve and obturator in sizes ranging from 5-12 mm in diameter. There are three different obturators Bladeless, Blunt Tip and Dilating Tip. The Bladeless obturator contains a clear, tapered optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. The Bladeless obturator accommodates an appropriately sized zero endoscope. The Blunt Tip obturator has a blunt plastic tip, which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The Dilating Tip obturator has a sharp flat-bladed tip and a spring-loaded shield. The shield on the Dilating Tip obturator is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered.
The trocar sleeve contains two seals, an outer integrated removable self-adjusting seal to accommodate instruments ranging from 5mm to 12mm in diameter where indicated and an internal seal. Together, these seals minimize gas leakage when instruments are
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032676 2/2
Ethicon Endo-Surgery, Inc. 510(k) Premarket Notification for ENDOPATH® III Trocar System
inserted or withdrawn through the trocar. The 5mm trocar sleeve does not contain an integrated removable seal and accommodates only 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in closed position when it is parallel to the sleeve.
Intended Use: The ENDOPATH® III Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The ENDOPATH® III Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® III Blunt Tip Trocar has applications in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
Technological Characteristics: The technological characteristics of the new device are different in that the new trocar has two seals a universal removable seal and an internal duckbill seal made of polyisoprene. A latch has been added for the removal and locking of the universal seal. The design of the obturator cannula and trocar sleeve housing has been changed to incorporate a low profile design for ergonomic consideration.
Performance Data: Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2003
Ms. Elizabeth Miller Regulatory Affairs Associate I Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K032676
Trade/Device Name: ENDOPATH® III Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: GCJ Dated: August 28, 2003 Received: August 29, 2003
Dear Ms. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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.
3
Page 2 - Ms. Elizabeth Miller
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Miriam C. Provost
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
4
Page __ of ___________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ENDOPATH® III Trocar System
Indications for Use:
The ENDOPATH® III Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The ENDOPATH® III Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® III Blunt Tip Trocar has applications in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_Ko 32676
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)