(120 days)
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 general, thoracic, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.
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.
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seal or flapper door seal and an outer gasket seal to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the cannula during a surgical procedure.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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ENDOPATH® Dilating Tip Trocar:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mating of obturator with sleeve | Acceptable performance |
| Insertion into operative cavity | Acceptable performance |
| Removal of obturator from sleeve | Acceptable performance |
| Security of sleeve in tissue | Acceptable performance |
| Maintenance of pneumoperitoneum of the operative space | Acceptable performance |
Note: The document explicitly states "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..." The acceptance criteria are not quantified with specific thresholds (e.g., "no more than X force required for insertion," "no leaks exceeding Y ml/min"). Instead, the performance is reported as "acceptable" in comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: The studies were "Pre-clinical laboratory evaluations." This suggests the tests were conducted in a laboratory setting, likely in the US (given the submission to the FDA in Cincinnati, Ohio). It is a prospective study as newly manufactured devices were tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. The "ground truth" for this type of device (a surgical trocar) would be based on engineering specifications and functional testing, not expert consensus on medical images or clinical outcomes in the same way an AI diagnostic tool would.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. As noted above, the testing is functional and engineering-based, not reliant on human interpretation or adjudication in the medical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation tools, not for a physical surgical device like a trocar.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical surgical instrument, not a software algorithm.
7. The Type of Ground Truth Used:
- The ground truth (or more appropriately, the standard) for evaluation was likely established through engineering specifications for the device's functional components and comparative performance against a predicate device. The studies "demonstrated acceptable performance to the Predicate Device." This implies the predicate device's established performance served as the benchmark.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI-based device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, there is no "training set."
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AUG 21
K97/475
510(k) Summary of Safety and Effectiveness Appendix A
| Statement | Information supporting claims of substantial equivalence, as defined under the FederalFood, Drug and Cosmetic Act, respecting safety and effectiveness is summarizedbelow. For the convenience of the Reviewer, this summary is formatted in accordancewith 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 anyonerequesting it from the Agency. |
|---|---|
| Devicedescription | 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 springloaded shield. The shield is designed to cover the flat blade or pyramidal tip toprotect internal structures from puncture or laceration once the abdominal orthoracic cavity has been entered. | |
| The sleeve subassembly has an inner gasket seal or flapper door seal and anouter gasket seal to maintain pneumoperitoneum when instrumentation isinserted and withdrawn through the cannula during a surgical procedure.Some instruments are provided with a stopcock for insufflating the operativespace and a flapper door lever to allow quick desufflation. Integral threadsalong the outside diameter of the cannula portion of the sleeve provide aretention mechanism to stabilize the sleeve in tissue. | |
| The ENDOPATH® Dilating Tip Trocar shall be provided in a variety of sizesfrom 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 forminimally invasive instruments. Instruments provided with a stopcock areintended for insufflation of the operative space when the trocar is in place. |
| Indicationsstatement | The ENDOPATH® Dilating Tip Trocar has application in general, thoracic,gynecologic, or other minimally invasive surgical procedures to establish apath of entry for minimally invasive instruments. |
Continued on next page
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| Appendix AContinued | 510(k) Summary of Safety and Effectiveness, |
|---|---|
| Technologicalcharacteristics | The technological characteristics of the New Device are the same as thePredicate Device. |
| Performancedata | Pre-clinical laboratory evaluations were performed to ensure that the devicecan be used as designed. The studies demonstrated acceptable performance tothe Predicate Device in mating the obturator with the sleeve, insertion into theoperative cavity, removal of the obturator from the sleeve, security of thesleeve 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 theinformation provided herein, we conclude that the New Device is substantiallyequivalent to the Predicate Device under the Federal Food, Drug andCosmetic Act. |
| Contact | Ivan S. PlackoProject ManagerRegulatory Affairs DepartmentEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
| Date | April 21, 1997 |
:
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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.
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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
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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
§ 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.