ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 by ETHICON ENDO-SURGERY, LLC

The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories and Fixed-Length Access Retractors are indicated for use in procedures where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The device has application in colorectal, urological, gynecologic, and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.

The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories, when used in conjunction with the ENDOPATH DEXTRUS Fixed-Length Access Retractor, is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during minimally invasive surgery.

The Fixed-Length Access Retractor, when used independently, is also intended to provide wound retraction and protection against wound contamination during minimally invasive and open surgery.

Device Description

The device is a sterile, single patient use abdominal access system comprised of two separately packaged components:

Seal Cap Assembly with Accessories
Fixed-Length Access Retractor

The ENDOPATH DEXTRUS Seal Cap Assembly consists of stationary and rotating rings interconnected by means of an elastomeric material that functions as an irris valve seal with an adjustable aperture. The seal cap assembly is designed to connect with the fixed-length access retractor. The assembled device can maintain peritoneal gas pressure while allowing for insertion of the surgeon's hand or surgical instruments into the abdominal cavity.

The Fixed-Length Access Retractor is available in three sizes to accommodate a wide range of abdominal wall thicknesses. The retractor consists of a top rigid ring and a bottom flexible ring interconnected by means of an elastomeric material. The top rigid ring provides for circumferential wound retraction and is also the connection ring to the seal cap assembly. The bottom flexible ring is inserted into the abdomen for device fixation.

Accessories provided with the ENDOPATH DEXTRUS Seal Cap Assembly include a marking pen, ruler, and forearm wrap. The ruler and marking pen help measure and represent incision length, depending on surgeon glove size. The forearm wrap can be wrapped over the surgeon's glove and gown from the wrist to the upper forearm to facilitate the transition of the surgeon's gown through the iris valve during an extended reach within the abdominal cavity.

AI/ML Overview

The provided 510(k) summary for the Endopath® Dextrus™ Seal Cap Assembly with Accessories and Fixed-Length Access Retractors does not contain the specific details required to complete many sections of your request.

This document is a premarket notification for a medical device and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance metrics for an AI/algorithm-based device.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended.

Explanation: The 510(k) summary states that "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended." However, it does not provide specific acceptance criteria (e.g., maximum leak rate, force required for insertion, etc.) or quantitative performance results from these tests. These details are typically found in a more comprehensive testing report, not the summary.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: The document refers to "preclinical laboratory evaluations," which implies animal models or simulated environments, and "bench testing." It does not mention human patient data, nor country of origin for any data.

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

Not applicable. The device is a surgical access system, not an AI/diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device would be its physical performance characteristics (e.g., sealing ability, retractor strength) measured via engineering tests.

4. Adjudication method for the test set

Not applicable. This device does not involve subjective interpretations requiring adjudication.

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

Not applicable. This is not an AI/diagnostic device.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used

For mechanical devices, "ground truth" refers to verified performance against engineering specifications or established physical principles. In this case, it would be the objective measurements from bench testing and preclinical laboratory evaluations confirming the device functions as intended (e.g., maintaining pneumoperitoneum, providing wound retraction). No specific "type of ground truth" (like pathology or outcomes data) is mentioned, as it's not relevant for this device.

8. The sample size for the training set

Not applicable. This device does not use an AI model that requires a training set.

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

Not applicable. This device does not use an AI model that requires a training set.

Summary of what is present:

Device Description: Provides a detailed overview of the Endopath® Dextrus™ Seal Cap Assembly with Accessories and Fixed-Length Access Retractors.
Indications for Use: Clearly states the intended surgical procedures where the device is applicable.
Technological Characteristics Comparison to Predicate Device: Highlights similarities and key differences (e.g., two-piece design, sterilization method, materials, accessories).
Performance Data (General Statement): Confirms that bench testing and preclinical laboratory evaluations were performed to show the device performs as intended, but lacks specific details.

To get the details requested in your prompt, one would typically need access to the full 510(k) submission, which would include detailed test reports, protocols, and results. The public 510(k) summary is designed to provide a high-level overview for review and substantial equivalence determination.

Summary

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K070198

510(k) Summary

Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, Puerto Rico 00969
Contact Wendy L. Turner, RAC
Director, Regulatory Affairs
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, OH 45242
Telephone: (513) 337-8807
Fax: (513) 337-2807
Email: wturner@eesus.jnj.com

Page 1 of 2

UN 1 3 2007

Date Prepared January 19 , 2007

Trade Name: Endopath® Dextrus™ Seal Cap Assembly with Accessories Device Name and Endopath® Dextrus™ Fixed-Length Access Retractors

Common or Usual Names: Extended Laparoscopy Device; Access Retractors

Classification Names:

Laparoscope, General & Plastic Surgery [21 CFR 876.1500 (GCJ)] Drape, Surgical, General & Plastic Surgery [21 CFR 878.4370 (KKX)]

Predicate Devices LAP DISC Hand Access Device (Hakko Medical Division of Hakko Shoji, Co. Ltd.), cleared under K030824 on June 4, 2003, K020307 on April 26, 2002, and K010870 on June 18, 2001

Alexis™ Wound Retractors (Applied Medical Resources Corp.), cleared under K020435 on April 15, 2002

Device Description The device is a sterile, single patient use abdominal access system comprised of two separately packaged components:

Seal Cap Assembly with Accessories
Fixed-Length Access Retractor

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<070198

Page 2 of (2)

circumferential wound retraction and is also the connection ring to the seal cap assembly. The bottom flexible ring is inserted into the abdomen for device fixation.

Indications for Use The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories and Fixed-Length Access Retractors are indicated for use in procedures where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The device has application in colorectal, urological, gynecologic, and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.

The Fixed-Length Access Retractor, when used independently, is also intended to provide wound retraction and protection against wound contamination during minimally invasive and open surgery.

Technological Characteristics The ENDOPATH DEXTRUS Seal Cap Assembly and Fixed-Length Access Retractors are similar in design to the predicate device, the LAP DISC Hand Access Device. While the predicate device is a single piece design, the new device enables detachment of the seal cap assembly from the retractor. The sterilization method and materials differ from the predicate device. The new device includes the following accessories: marking pen, ruler, and forearm wrap.

Performance Data. Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended.

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon Endo-Surgery, Inc. % Ms. Wendy L. Turner, RAC Director, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242-2839

JUN 1 8 2007

Re: K070198

Trade/Device Name: Endopath® Dextrus™ Seal Cap Assembly with Accessories and Fixed-Length Access Retractors

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 31, 2007 Received: June 1, 2007

Dear Ms. Turner:

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

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Page 2 - Ms. Wendy L. Turner, RAC

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.

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, permitte 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain other general information on your responsibilities under the Act from the Division of Sonall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson
Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K070198 510(k) Number (if known):

Device Name: Endopath® Dextrus™ Seal Cap Assembly with Accessories and Fixed-Length Access Retractors

Indications for Use:

The Fixed-Length Access Retractor, when used independently, is also intended to provide wound retraction and protection against wound contamination during minimally invasive and open surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ice Evaluation (SDE)

(Division Sign-Off) Division of General, Restorative, and Neurological DeviceBage 1 of 1

510(k) Number

(Posted November 13, 2003)

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.