The ENDOPATH® Dilating Tip Trocar has application in thoracic, gynecologic and general surgical procedures to establish a path of entry for endoscopic instruments.

Device Description

The ENDOPATH® Dilating Tip Trocar in sizes ranging from 5mm to 12mm in diameter is a sterile, single patient use instrument consisting of a sharp flat bladed tip and a spring-loaded shield. The shield is designed to cover the flat bladed tip to protect internal organs once the abdominal or thoracic cavity has been entered. The trocar sleeve contains an outer gasket and internal flapper valve with a seal to minimize gas leakage when instruments are inserted or removed in that trocar. There is a stopcock valve for gas insufflation and a desufflation lever for gas evacuation.

AI/ML Overview

Here's an analysis of the provided text regarding the ENDOPATH® Dilating Tip Trocar, focusing on acceptance criteria and supporting studies:

Based on the provided "510(k) Summary of Safety and Effectiveness" and the FDA's clearance letter, the details regarding acceptance criteria and the study are extremely limited. It appears this device underwent a premarket notification (510(k)) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies with predefined acceptance criteria.

Here's what can be extracted and what information is not present in the document based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of specific metrics or thresholds. The document states the device must "perform as intended."	"All testing demonstrated satisfactory performance."

Observation: The document does not provide a quantifiable or measurable acceptance criterion (e.g., "puncture force must be less than X N," "seal integrity must maintain X psi for Y minutes," or "tip deployment success rate must be > Z%"). Instead, it uses a general statement of satisfactory performance.

Study Details

2. Sample sized used for the test set and the data provenance:

Test set sample size: Not specified.
Data provenance: Not specified, but "Bench testing" is mentioned, implying laboratory or in-vitro testing. No country of origin is mentioned for the data, nor is it specified as retrospective or prospective (which would typically apply to clinical data, not bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not applicable. For bench testing, ground truth is typically established by engineering specifications, calibration standards, or direct measurement by qualified technical personnel, not clinical experts.
Qualifications of experts: Not applicable as per the above.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, not for bench testing where objective measurements are typically taken.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC study: No. This is a surgical device, not an imaging AI device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone study: Not applicable. This refers to AI algorithm performance. The device is a physical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Type of ground truth: Implied to be based on engineering specifications and objective measurements during "Bench testing." The document does not specify particular metrics but suggests the device was tested against its intended functional performance.

8. The sample size for the training set:

Training set sample size: Not applicable. There is no mention of machine learning or an algorithm that would require a training set. This is a physical medical device.

9. How the ground truth for the training set was established:

Ground truth establishment for training set: Not applicable, as there is no training set for this type of device.

Summary of Study Findings

The document states: "Performance Data: Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance."

This indicates that internal bench tests were conducted, and the results were deemed acceptable by the manufacturer (Ethicon Endo-Surgery, Inc.) for the purpose of demonstrating substantial equivalence for 510(k) clearance. However, the specific details, methodologies, results, and acceptance criteria of these bench tests are not disclosed in the provided 510(k) summary. The FDA's clearance letter confirms their review of this information and determination of substantial equivalence.

Summary

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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.

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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.

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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,

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

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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

Regulation Number and Section

§ 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.