(87 days)
The ENDOPATH® Resposable Trocar System has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes.
The ENDOPATH® Resposable Trocar System consists of three main components: a Single Use obturator, a Single Use trocar sleeve housing and a reusable trocar sleeve. 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 reduce the likelihood of injury to internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The trocar sleeve housing has an inner and outer seal to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the cannula during a surgical procedure. Some trocar sleeve housings are provided with a stopcock for insufflating the operative space. Integral threads along the outside diameter of the cannula portion of the trocar sleeve provide a retention mechanism to stabilize the trocar sleeve in tissue. The reusable trocar sleeve, supplied smooth or threaded, is manufactured so that it may be cleaned, sterilized, and reused. The ENDOPATH® Resposable Trocar System shall be provided in a variety of sizes from 5mm to 12mm in diameter and 50mm to 150mm in length. In addition to the size variety they are supplied with or without stopcock for insufflation.
Here's a breakdown of the acceptance criteria and study information for the ENDOPATH® Resposable Trocar System, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text describes pre-clinical laboratory evaluations to demonstrate acceptable performance. However, it does not explicitly state specific quantitative acceptance criteria or detailed performance metrics. Instead, it indicates the device "demonstrated acceptable performance" in comparison to predicate devices across several functional aspects.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mating Obturator with Sleeve | Acceptable performance demonstrated. |
| Insertion into Operative Cavity | Acceptable performance demonstrated. |
| Shield Action to Cover Blade | Acceptable performance demonstrated. |
| Removal of Obturator from Sleeve | Acceptable performance demonstrated. |
| Security of Sleeve in Tissue | Acceptable performance demonstrated. |
| Maintenance of Pneumoperitoneum of Operative Space | Acceptable performance demonstrated. |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "Pre-clinical laboratory evaluations."
- Data Provenance: Not specified. It's likely these were in-house laboratory tests, not human or animal studies, given the nature of the device and the lack of ethical review board mentions. The country of origin for the data is implied to be the US since the submitting company (Ethicon Endo-Surgery, Inc.) is based in Cincinnati, Ohio, and the submission is to the FDA. The studies were retrospective in the sense that they were conducted for this 510(k) submission, but not "retrospective" in terms of analyzing pre-existing patient data.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The pre-clinical laboratory evaluations described likely involved engineering and technical testing against established performance benchmarks or predicate devices, rather than expert interpretation of a 'ground truth' as would be seen in diagnostic imaging.
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Adjudication Method for the Test Set:
- Not applicable. As described, this was a technical performance study, not one requiring expert adjudication of results.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document describes pre-clinical laboratory evaluations, not studies involving human readers or clinical cases.
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If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a surgical instrument, not an algorithm or AI system. Its performance evaluation is based on its physical and functional characteristics.
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The Type of Ground Truth Used:
- The "ground truth" for these pre-clinical evaluations would have been based on engineering specifications, established performance standards for similar predicate devices, and internal quality control benchmarks for mechanical and functional attributes.
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The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set mentioned or implied.
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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® Resposable Trocar System consists of three main components: a Single Use obturator, a Single Use trocar sleeve housing and a reusable trocar sleeve. |
| 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 reduce the likelihood of injury to internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. | |
| The trocar sleeve housing has an inner and outer seal to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the cannula during a surgical procedure. Some trocar sleeve housings are provided with a stopcock for insufflating the operative space. Integral threads along the outside diameter of the cannula portion of the trocar sleeve provide a retention mechanism to stabilize the trocar sleeve in tissue. | |
| The reusable trocar sleeve, supplied smooth or threaded, is manufactured so that it may be cleaned, sterilized, and reused. | |
| The ENDOPATH® Resposable Trocar System shall be provided in a variety of sizes from 5mm to 12mm in diameter and 50mm to 150mm in length. In addition to the size variety they are supplied with or without stopcock for insufflation. | |
| Intended use | The intended use of the New Device is to establish a path of entry for minimally invasive instruments and establishment of pneumoperitoneum. |
| Indications statement | The ENDOPATH® Resposable Trocar System has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes. |
| Continued on next page |
Continued on next page
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Appendix A 510(k) Summary of Safety and Effectiveness,
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Continued
| Technologicalcharacteristics | The technological characteristics of the New Device are the same as the PredicateDevices. |
|---|---|
| Performancedata | Pre-clinical laboratory evaluations were performed to ensure that the device can beused as designed. The studies demonstrated acceptable performance to the PredicateDevices in mating the obturator with the sleeve, insertion into the operative cavity,shield action to cover blade, 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 Devices under the Federal Food, Drug and Cosmetic Act. |
| Contact | Ivan S. PlackoProject ManagerRegulatory Affairs DepartmentEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
| Date | May 9, 1997 |
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Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles facing to the right. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ivan S. Placko Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
AUG ---7 1997_
Re: K971738
Trade Name: ENDOPATH® Resposable Trocar System Regulatory Class: II Product Code: GCJ Dated: May 9, 1997 Received: May 12, 1997
Dear Mr. Placko:
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
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Page 2 - Mr. Ivan S. Placko
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. ... ......... ... .-
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,
icolleto
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_97173 8 Device Name: ENDOPATH® Trocar
Indications for Use:
The ENDOPATH® Reusable Trocar System has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
colly
(Divis
Division of Devices
| 510(k) Number | K971738 |
|---|---|
| --------------- | --------- |
Ethicon Endo-Surgery, Inc.
§ 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.