Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology

K160740 · Surgical Instrument Service and Savings, Inc. · NLM · May 6, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160740
• Device Name: Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
• Applicant: Surgical Instrument Service and Savings, Inc.
• Product Code: NLM · Gastroenterology, Urology
• Decision Date: May 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar with OPTIVIEW Technology has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Medline ReNewal Reprocessed ENDOPATH XCEL Universal Trocar Stability Sleeve with OPTIVIEW Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

Device Story

Reprocessed single-use endoscopic trocar; creates access port for 5-mm instruments in abdominal, thoracic, gynecologic surgery. Device consists of sleeve and obturator; sleeve features integrated two-seal system to minimize gas leakage during instrument exchange and stopcock valve for insufflation. OPTIVIEW technology reduces endoscope lens smudging caused by bodily fluids/debris during insertion. Used in OR by surgeons; device facilitates minimally invasive access; maintains pneumoperitoneum; improves visualization by preventing lens contamination.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: simulated use, artificial soiling, seal leakage, seal drag, surface roughness, endoscope smudge, visualization, cleaning validation (protein/carbohydrate), biocompatibility (cytotoxicity, irritation, sensitization, pyrogenicity, acute systemic toxicity), and sterilization/packaging validation.

Technological Characteristics

Reprocessed single-use endoscopic trocar; sleeve and obturator assembly. Features integrated two-seal system and stopcock valve for gas insufflation. Includes OPTIVIEW technology for lens smudge reduction. Sterilized via ethylene oxide. Non-electronic, mechanical device.

Indications for Use

Indicated for abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish an entry path for endoscopic instruments. Used for primary and secondary insertions with or without visualization.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• ENDOPATH XCEL Trocar with OPTIVIEW Technology (K122511)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2016

Surgical Instrument Service and Savings Inc. Ms. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K160740

Trade/Device Name: Medline Renewal Reprocessed Endopath Xcel Trocar with Optiview Technology Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NLM Dated: March 14, 2016 Received: March 17, 2016

Dear Ms. Panteleon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson - A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Reprocessed Single-Use Device Models Included in Clearance:

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| Device Model | Device Name | Original<br>Manufacturer |
|--------------|-------------------------------------------------------------|--------------------------|
| 2B5ST | ENDOPATH XCEL® Bladeless Trocar with<br>OPTIVIEW Technology | Ethicon |
| 2B5LT | ENDOPATH XCEL® Bladeless Trocar with<br>OPTIVIEW Technology | Ethicon |
| 2B5XT | ENDOPATH XCEL® Bladeless Trocar with<br>OPTIVIEW Technology | Ethicon |
| 2CB5ST | ENDOPATH XCEL® Universal Sleeve with<br>OPTIVIEW Technology | Ethicon |
| 2CB5LT | ENDOPATH XCEL® Universal Sleeve with<br>OPTIVIEW Technology | Ethicon |

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Image /page/3/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are below the Renewal logo.

### 4.0 Indications for Use

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br>Indications for Use | | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | TBD | K160740 |
| Device Name | Medline ReNewal Reprocessed ENDOPATH YCEL Trocars with OPTIVIEW Technology | |
| Submitter/<br>Owner | Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 | |
| Contact Name | Brandi Panteleon<br>Director, Quality Assurance and Regulatory Affairs<br>P: 541-516-4180<br>F: 541-923-3375<br>E: [e-mail] | |
| Prepared by | Stephanie Boyle Mays<br>Technical Writer<br>P: 541-516-4205<br>F: 541-923-3375<br>E: [e-mail] | |
| Date Prepared | March 11, 2016 | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed ENDOPATH XCEL<br>Trocar with OPTIVIEW Technology<br>Common Name: Surgical Trocar<br>Model No.: 2B5ST, 2B5LT and 2B5XT ENDOPATH XCEL Bladeless Trocar<br>with OPTIVIEW Technology and 2CB5ST and 2CB5LT ENDOPATH XCEL<br>Universal Sleeve with OPTIVIEW Technology | |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed<br>Product code: NLM<br>Class: Class II, non-exempt<br>Regulation: Part 876.1500 of Title 21 of the Code of Federal Regulations | |
| Predicate<br>Device | K122511 ENDOPATH XCEL Trocar with OPTIVIEW Technology | |
| Device<br>Description | The Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with<br>OPTIVIEW Technology devices are sterile, single-patient use endoscopic<br>devices used to create an access port to the inside of the body cavity to<br>perform endoscopic surgery. The trocars accommodate instruments that<br>are 5-mm in diameter. The trocars contain two seals, an outer integrated<br>removable self-adjusting seal and an integrated seal. Together, these two<br>seals minimize gas leakage when instruments are inserted or withdrawn<br>through the trocar. A stopcock valve is compatible with standard luer lock<br>fittings and provides attachment for gas insufflation. The trocars contain<br>OPTIVIEW Technology that reduces the incidence of trocar-induced<br>endoscope lens smudging during endoscope insertion. Endoscope<br>smudging occurs when bodily fluids and debris smear across the<br>endoscope lens during a laparoscopic procedure. Trocar-induced smudging<br>occurs when these bodily fluids and debris are deposited within the trocar's<br>seal system when an endoscope or instrument has been exchanged<br>through the trocar. | |
| Indication for Use | The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar<br>with OPTIVIEW Technology has applications in abdominal, thoracic and<br>gynecologic minimally invasive surgical procedures to establish a path of<br>entry for endoscopic instruments. The trocar may be used with or without<br>visualization for primary and secondary insertions.<br>The Medline ReNewal Reprocessed ENDOPATH XCEL Universal Trocar<br>Stability Sleeve with OPTIVIEW Technology has applications in thoracic,<br>gynecologic laparoscopy and other abdominal procedures to establish a<br>path of entry for endoscopic instruments. | |
| Technological<br>Characteristics | The technological characteristics and the fundamental scientific technology<br>of the subject device are identical to the predicate device. The proposed<br>device is a reprocessed version of the predicate device. | |
| Performance<br>Testing | The functional characteristics of the proposed device have been evaluated<br>and were found to be substantially equivalent to the predicate device based<br>on the following tests:<br>Simulated use and artificial soiling; Functional performance studies: seal leakage; seal drag; surface roughness; endoscope smudge; and Visualization. Cleaning: protein and carbohydrates; visual inspection; and cleaning performance qualification. Biocompatibility: cytotoxicity (direct and indirect); irritation (whole device); sensitization (whole device) pyrogenicity (direct and indirect); and acute systemic toxicity (direct and indirect). Sterilization and packaging validations: bioburden enumeration testing; and ethylene oxide and ethylene chlorohydrin residuals testing. Product stability. | |
| Conclusion | In accordance with 21 CFR Part 807, and based on a comparison of<br>Indications for Use, technological characteristics and performance data,<br>Medline ReNewal concludes that the proposed Medline ReNewal<br>Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is<br>substantially equivalent to the predicate device. | |

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology

Indications for Use (Describe)

The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar with OPTWIEW Technology has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Medline ReNewal Reprocessed ENDOPATH XCEL Universal Trocar Stability Sleeve with OPTIVIEW Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| | <span> <span style="text-decoration:underline">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, and below it is the phrase "Full Circle Reprocessing" in smaller letters.

## 5.0 510(k) Summary

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Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a blue star-like symbol to the left. To the right of "MEDLINE" is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in smaller blue font below it.

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Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, and below it is the phrase "Full Circle Reprocessing".

| | Predicate Device | Proposed Device | |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Device<br>Characteristic | Ethicon ENDOPATH<br>XCEL Trocar with<br>OPTIVIEW Technology | Medline ReNewal<br>Reprocessed ENDOPATH<br>XCEL Trocar with<br>OPTIVIEW Technology | Comparison<br>Analysis |
| 510(k) Number | K122511 | TBD | NAa |
| Indications for<br>Use | The ENDOPATH XCEL<br>Bladeless Trocar with<br>OPTIVIEW Technology has<br>applications in abdominal,<br>thoracic and gynecologic<br>minimally invasive surgical<br>procedures to establish a<br>path of entry for<br>endoscopic instruments.<br>The trocar may be used<br>with or without visualization<br>for primary and secondary<br>insertions.<br>The ENDOPATH XCEL<br>Universal Trocar Stability<br>Sleeve with OPTIVIEW<br>Technology has<br>applications in thoracic,<br>gynecologic laparoscopy<br>and other abdominal<br>procedures to establish a<br>path of entry for<br>endoscopic instruments. | The Medline ReNewal<br>Reprocessed ENDOPATH<br>XCEL Bladeless Trocar with<br>OPTIVIEW Technology has<br>applications in abdominal,<br>thoracic and gynecologic<br>minimally invasive surgical<br>procedures to establish a<br>path of entry for endoscopic<br>instruments. The trocar may<br>be used with or without<br>visualization for primary and<br>secondary insertions.<br>The Medline ReNewal<br>Reprocessed ENDOPATH<br>XCEL Universal Trocar<br>Stability Sleeve with<br>OPTIVIEW Technology has<br>applications in thoracic,<br>gynecologic laparoscopy<br>and other abdominal<br>procedures to establish a<br>path of entry for endoscopic<br>instruments. | Same |
| Design<br>Configuration<br>and Models | ENDOPATH XCEL with<br>OPTIVIEW Technology<br>Bladeless Trocar models:<br>• 2B5ST Trocar, 5- x<br>75-mm stability sleeve;<br>• 2B5LT Trocar, 5- x<br>100-mm, stability sleeve;<br>• 2B5XT Trocar, 5- x<br>150-mm, stability sleeve. | Medline ReNewal<br>Reprocessed ENDOPATH<br>XCEL with OPTIVIEW<br>Technology<br>Bladeless Trocar models:<br>• 2B5ST Trocar, 5- x<br>75-mm stability sleeve;<br>• 2B5LT Trocar, 5- x<br>100-mm, stability sleeve;<br>• 2B5XT Trocar, 5- x<br>150-mm, stability sleeve. | |
| | Predicate Device | Proposed Device | |
| Device<br>Characteristic | Ethicon ENDOPATH XCEL<br>Trocar with OPTIVIEW<br>Technology | Medline ReNewal<br>Reprocessed ENDOPATH<br>XCEL Trocar with<br>OPTIVIEW Technology | Comparison<br>Analysis |
| Design<br>Configuration<br>and Model<br>(concluded) | Universal Trocar Stability<br>Sleeve models:<br>• 2CB5ST 5- x 75-mm<br>Sleeve (cannula);<br>• 2CB5LT 5- x 100-mm<br>Sleeve (cannula) | Universal Trocar Stability<br>Sleeve models:<br>• 2CB5ST 5- x 75-mm<br>Sleeve (cannula);<br>• 2CB5LT 5- x 100-mm<br>Sleeve (cannula) | Same |
| Technological<br>Attributes | ENDOPATH XCEL Trocars<br>with OPTIVIEW Technology<br>consist of two components:<br>a sleeve and an obturator.<br>The sleeve and obturator are<br>used to create the access<br>port. The obturator is a<br>subsystem used to assist in<br>the process of installing the<br>sleeve port through the body<br>tissue. After installation, the<br>obturator is not required for<br>trocar performance. The<br>bladeless trocar obturators<br>accommodate an<br>appropriately sized 0°<br>endoscope and provide<br>visibility of individual tissue<br>layers during insertion.<br>The sleeve has an<br>integrated two-seal system<br>for maintaining<br>pneumoperitoneum. The<br>trocar sleeves contain two<br>seals, an outer integrated<br>removable self-adjusting<br>seal that accommodates<br>instruments 5-mm in<br>diameter and an internal<br>seal. Together these two | The Medline ReNewal<br>Reprocessed ENDOPATH<br>XCEL Trocars with<br>OPTIVIEW Technology<br>consist of two components:<br>a sleeve and an obturator.<br>The sleeve and obturator are<br>used to create the access<br>port. The obturator is a<br>subsystem used to assist in<br>the process of installing the<br>sleeve port through the body<br>tissue. After installation, the<br>obturator is not required for<br>trocar performance. The<br>bladeless trocar obturators<br>accommodate an<br>appropriately sized 0°<br>endoscope and provide<br>visibility of individual tissue<br>layers during insertion.<br>The sleeve has an<br>integrated two-seal system<br>for maintaining<br>pneumoperitoneum. The<br>trocar sleeves contain two<br>seals, an outer integrated<br>removable self-adjusting<br>seal that accommodates<br>instruments 5-mm in<br>diameter and an internal<br>seal. Together these two | Same |
| Device<br>Characteristic | Predicate Device | Proposed Device | Comparison<br>Analysis |
| | Ethicon ENDOPATH XCEL<br>Trocar with OPTIVIEW<br>Technology | Medline ReNewal<br>Reprocessed ENDOPATH<br>XCEL Trocar with<br>OPTIVIEW Technology | |
| Technological<br>Characteristics<br>(concluded) | seals minimize gas leakage<br>5-mm in when instruments<br>are inserted through or<br>completely withdrawn from<br>the trocar. The sleeve has a<br>welded stopcock assembly,<br>which is compatible with<br>standard Luer lock fittings,<br>and provides attachment for<br>gas insufflation and<br>desufflation of the<br>pneumoperitoneum. The<br>sleeve cannula contains<br>integrated stability threads<br>for abdominal wall retention. | seals minimize gas leakage<br>5-mm in when instruments<br>are inserted through or<br>completely withdrawn from<br>the trocar. The sleeve has a<br>welded stopcock assembly,<br>which is compatible with<br>standard Luer lock fittings,<br>and provides attachment for<br>gas insufflation and<br>desufflation of the<br>pneumoperitoneum. The<br>sleeve cannula contains<br>integrated stability threads<br>for abdominal wall retention. | |

#### Predicate and Medline ReNewal Reprocessed ENDOPATH XCEL Trocar Table 1: with OPTIVIEW Technology comparison chart.

continued

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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are in smaller letters below the Renewal logo.

### Predicate and Medline ReNewal Reprocessed ENDOPATH XCEL Trocar Table 1: with OPTIVIEW Technology comparison chart (continued).

(continued)

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Image /page/8/Picture/0 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal Full Circle Reprocessing logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the Full Circle Reprocessing logo is in smaller blue letters below the Renewal logo.

### Predicate and Medline ReNewal Reprocessed ENDOPATH XCEL Trocar Table 1: with OPTIVIEW Technology comparison chart (concluded).