(120 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical components and their function in creating a surgical entry path. There is no mention of any computational or data-driven features that would suggest the use of AI or ML.
No
The device, a trocar, is used to create a path for instruments and maintain surgical space, which are surgical access functions, not direct therapeutic interventions.
No
The device is described as a "trocar" used to "establish a path of entry for minimally invasive instruments" and to maintain pneumoperitoneum during surgical procedures. Its function is to facilitate surgical access and instrument manipulation, not to diagnose medical conditions or identify diseases.
No
The device description clearly outlines physical components like obturators, sleeves, blades, shields, seals, and stopcocks, indicating it is a hardware medical device.
Based on the provided information, 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 minimally invasive instruments" and for "insufflation of the operative space." This describes a surgical tool used during a procedure to access the body cavity.
- Device Description: The description details a physical instrument with components like an obturator, sleeve, seals, and a stopcock. These are all mechanical parts designed for surgical access and maintaining a surgical environment.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any interaction with bodily specimens for diagnostic purposes.
- Performance Studies: The performance studies described focus on the mechanical function of the device during insertion and use in a surgical setting, not on the analysis of biological samples.
Therefore, the ENDOPATH® Dilating Tip Trocar is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the New Device is to establish a path of entry for minimally invasive instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.
The ENDOPATH® Dilating Tip Trocar has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.
Product codes
GCJ
Device Description
The ENDOPATH® Dilating Tip Trocar consists of two main sub-assemblies: an obturator sub-assembly and a sleeve sub-assembly.
The obturator consists of a sharp flat blade tip or pyramidal tip and a spring loaded shield. The shield is designed to cover the flat blade or pyramidal tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered.
The sleeve subassembly has an inner gasket seal or flapper door seal and an outer gasket seal to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the cannula during a surgical procedure. Some instruments are provided with a stopcock for insufflating the operative space and a flapper door lever to allow quick desufflation. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue.
The ENDOPATH® Dilating Tip Trocar shall be provided in a variety of sizes from 3mm to 12mm in diameter and 65mm to 150mm in length.
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)
Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in mating the obturator with the sleeve, insertion into the operative cavity, removal of the obturator from the sleeve, security of the sleeve in tissue, and maintenance of pneumoperitoneum of the operative space.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 21
K97/475
510(k) Summary of Safety and Effectiveness Appendix A
| Statement | Information supporting claims of substantial equivalence, as defined under the Federal
Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized
below. For the convenience of the Reviewer, this summary is formatted in accordance
with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR
§807) and can be used to provide a substantial equivalence summary to anyone
requesting it from the Agency. |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | The ENDOPATH® Dilating Tip Trocar consists of two main sub-assemblies:
an obturator sub-assembly and a sleeve sub-assembly. |
| | The obturator consists of a sharp flat blade tip or pyramidal tip and a spring
loaded shield. The shield is designed to cover the flat blade or pyramidal tip to
protect internal structures from puncture or laceration once the abdominal or
thoracic cavity has been entered. |
| | The sleeve subassembly has an inner gasket seal or flapper door seal and an
outer gasket seal to maintain pneumoperitoneum when instrumentation is
inserted and withdrawn through the cannula during a surgical procedure.
Some instruments are provided with a stopcock for insufflating the operative
space and a flapper door lever to allow quick desufflation. Integral threads
along the outside diameter of the cannula portion of the sleeve provide a
retention mechanism to stabilize the sleeve in tissue. |
| | The ENDOPATH® Dilating Tip Trocar shall be provided in a variety of sizes
from 3mm to 12mm in diameter and 65mm to 150mm in length. |
| Intended use | The intended use of the New Device is to establish a path of entry for
minimally invasive instruments. Instruments provided with a stopcock are
intended for insufflation of the operative space when the trocar is in place. |
| Indications
statement | The ENDOPATH® Dilating Tip Trocar has application in general, thoracic,
gynecologic, or other minimally invasive surgical procedures to establish a
path of entry for minimally invasive instruments. |
Continued on next page
l
|
1
| Appendix A
| Continued | 510(k) Summary of Safety and Effectiveness, |
|---|---|
| Technological | |
| characteristics | The technological characteristics of the New Device are the same as the |
| Predicate Device. | |
| Performance | |
| data | Pre-clinical laboratory evaluations were performed to ensure that the device |
| can be used as designed. The studies demonstrated acceptable performance to | |
| the Predicate Device in mating the obturator with the sleeve, insertion into the | |
| operative cavity, removal of the obturator from the sleeve, security of the | |
| sleeve in tissue, and maintenance of pneumoperitoneum of the operative space. | |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the |
| information provided herein, we conclude that the New Device is substantially | |
| equivalent to the Predicate Device under the Federal Food, Drug and | |
| Cosmetic Act. | |
| Contact | Ivan S. Placko |
| Project Manager | |
| Regulatory Affairs Department | |
| Ethicon Endo-Surgery, Inc. | |
| 4545 Creek Road | |
| Cincinnati, Ohio 45242 | |
| Date | April 21, 1997 |
:
1
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "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
Mr. Ed Billips, RAC Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
AUG 21 1997
Re: K971475 Trade Name: ENDOPATH® Dilating Tip Trocar Regulatory Class: II Product Code: GCJ Dated: July 30, 1997 Received: July 31, 1997
Dear Mr. Billips:
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 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.
3
Page 2 - Mr. Ed Billips, RAC
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,
Sincerely yours,
coope
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
4
Appendix B Indications for Use Statement
Following is the Indications for Use Statement: Statement
510(k) Number: K 971475
Device Name: ENDOPATH® Dilating Tip Trocar
Indications for Use:
The ENDOPATH® Dilating Tip Trocar has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.
Aciolo
on Sign-Off) IDivis Division of General Restorative Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
49