Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars

K153258 · Surgical Instrument Service and Savings (Dba Medline Renewal · NLM · Apr 5, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153258
• Device Name: Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
• Applicant: Surgical Instrument Service and Savings (Dba Medline Renewal
• Product Code: NLM · Gastroenterology, Urology
• Decision Date: Apr 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

Device Story

Reprocessed single-use surgical trocar; enables port of entry for endoscopic procedures. Input: manual insertion by surgeon; accommodates 0° laparoscope for optical visualization of tissue layers. Operation: bladeless obturator creates entry; cannula maintains port; internal seals prevent pneumoperitoneum loss during instrument exchange. Used in OR by surgeons. Output: established surgical port. Benefits: provides access for minimally invasive surgery; reprocessed to reduce waste while maintaining original device functionality.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included simulated use, artificial soiling, seal leakage, seal drag, surface roughness, visualization, cleaning performance qualification, biocompatibility (cytotoxicity, irritation, sensitization, pyrogenicity, acute systemic toxicity), and sterilization/packaging validation.

Technological Characteristics

Reprocessed single-use surgical trocar. Components: transparent cannula, bladeless obturator with optical window, scope retention mechanism, internal seals, three-way stopcock. Diameters: 5-mm, 11-mm, 12-mm. Lengths: 70-mm, 100-mm, 150-mm. Sterilization: Ethylene oxide.

Indications for Use

Indicated for patients undergoing gynecologic, general, thoracic, or urologic endoscopic procedures requiring a port of entry. No specific age or gender contraindications provided.

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.

Predicate Devices

• Covidien Versaport V2 Bladeless Optical Trocar (K112349)

Reference Devices

• Covidien Versaport V2 Bladeless Optical Trocar (K130435)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. In the center is a stylized design of a human figure, represented by three overlapping profiles, with a wing-like shape extending from the head.

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

April 5, 2016

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

Re: K153258

Trade/Device Name: Medline Renewal Reprocessed Versaport V2 Bladeless Optical Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: March 7, 2016 Received: March 8, 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

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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

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| Manufacturer<br>Model No. | Description | Diameter x Length |
|---------------------------|------------------------------------------------------------|-------------------|
| ONB5STF | Optical bladeless Standard Trocar with<br>Fixation Cannula | 5- x 100-mm |
| ONB5SHF | Optical bladeless Short Trocar with Fixation<br>Cannula | 5- x 70-mm |
| ONB5LGF | Optical bladeless Standard Trocar with<br>Fixation Cannula | 5- x 150-mm |
| ONBFCA5LG | Long Fixation Cannula | 5- x 150-mm |
| ONBFCA5SH | Short Fixation Cannula | 5- x 70-mm |
| ONBFCA5ST | Standard Fixation Cannula | 5- x 100-mm |
| ONB11STF | Optical bladeless Standard Trocar with<br>Fixation Cannula | 11-x 100-mm |
| ONB11LGF | Optical bladeless Long Trocar with Fixation<br>Cannula | 11-x 150-mm |
| ONBFCA11ST | Standard Fixation Cannula | 11-x 100-mm |
| ONB12STF | Optical bladeless Standard Trocar with<br>Fixation Cannula | 12- x 100-mm |
| ONB12LGF | Optical bladeless Long Trocar with Fixation<br>Cannula | 12- x 150-mm |
| ONB12SHF | Optical bladeless Short Trocar with Fixation<br>Cannula | 12- x 70-mm |
| ONB12STS | Optical bladeless Standard Trocar with<br>Smooth Cannula | 12- x 100-mm |
| ONBFCA12ST | Standard Fixation Cannula | 12- x 100-mm |
| ONBFCA12LG | Long Fixation Cannula | 12- x 150-mm |

Reprocessed Single-Use Device Models Included in Clearance:

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## Indications for Use

510(k) Number (if known) K153258

Device Name

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar

#### Indications for Use (Describe)

The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/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 of it. To the right of "Medline" is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.

# 510(k) Summary K153258

| Submitter/<br>Owner | Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon<br>Director, QA/RA<br>P: 541-516-4180<br>F: 541-923-3375<br>E: [e-mail] |
| Prepared by | Stephanie Mays<br>Technical Writer<br>P: 541-516-4205<br>F: 541-923-3375<br>E: [e-mail] |
| Date Prepared | November 9, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Versaport V2<br>Bladeless Optical Trocar<br>Common Name: Surgical Trocar |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed<br>Product code: NLM<br>Class: Class II, non-exempt<br>Classification Number: 21 CFR § 876.1500 |
| Predicate Device | K112349 Covidien Versaport V2 Bladeless Optical Trocar (11-mm and 12-<br>mm trocars) |
| Reference<br>Device | K130435 Covidien Versaport V2 Bladeless Optical Trocar (5-mm trocars) |
| Device<br>Description | The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical<br>Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator,<br>allows optical entry for visualization of tissue layers during insertion. It is<br>available in standard (100 mm), short (70 mm) and long (150 mm) cannula<br>lengths. The obturator housing contains a scope retention mechanism and<br>the trocar housing contains internal seals to prevent loss of<br>pneumoperitoneum when instruments are inserted into a port or withdrawn<br>completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal<br>system accommodate instruments indicated as 5-mm up to 11-mm and<br>12-mm respectively. |
| Intended Use | The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical<br>Trocar is intended for use in a variety of gynecologic, general, thoracic and<br>urologic endoscopic procedures to create and maintain a port of entry. The<br>trocar may be used with or without visualization for primary and secondary<br>insertions. |
| Technological<br>Characteristics | The technological characteristics and the fundamental scientific<br>technology of the subject device are identical to the predicate device. The<br>proposed device is a reprocessed version of the predicate device. |

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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 symbol to the right of it. To the right of the Medline logo is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" are the words "Full Circle Reprocessing" in a smaller font.

The functional characteristics of the proposed device have been evaluated and were found to be substantially equivalent to the predicate device based on the following tests:

- Simulated use and artificial soiling;
- Functional performance studies:
- Seal leakage; O
- Seal drag; O
- Surface roughness; O
- Visualization. O
- Cleaning:

O

.

- Protein and carbohydrates; o
- Visual inspection;

Performance Testing

- O Cleaning performance qualification.
- Biocompatibility:
- Cytotoxicity (direct and in-direct patient contacting); O
- Irritation (direct and in-direct patient contacting); O
- Sensitization (direct and in-direct patient contacting); O
- Material-mediated pyrogenicity (direct and in-direct patient O contacting); and
- Acute systemic toxicity (direct and in-direct patient O contacting).
- . Sterilization and packaging validations:
- O Bioburden enumeration testing;
- O Ethylene oxide and ethylene chlorohydrin residuals testing
- . Product stability.

| | Manufacturer<br>Model No. | Description | Diameter x<br>Length |
|---------------|---------------------------|------------------------------------------------------------|----------------------|
| Device models | ONB5STF | Optical bladeless Standard Trocar<br>with Fixation Cannula | 5- x 100-mm |
| | ONB5SHF | Optical bladeless Short Trocar with<br>Fixation Cannula | 5- x 70-mm |
| | ONB5LGF | Optical bladeless Standard Trocar<br>with Fixation Cannula | 5- x 150-mm |
| | ONBFCA5LG | Long Fixation Cannula | 5- x 150-mm |
| | ONBFCA5SH | Short Fixation Cannula | 5- x 70-mm |
| | ONBFCA5ST | Standard Fixation Cannula | 5- x 100-mm |
| | ONB11STF | Optical bladeless Standard Trocar<br>with Fixation Cannula | 11- x 100-mm |
| | ONB11LGF | Optical bladeless Long Trocar with<br>Fixation Cannula | 11- x 150-mm |
| | ONBFCA11ST | Standard Fixation Cannula | 11- x 100-mm |
| | ONB12STF | Optical bladeless Standard Trocar<br>with Fixation Cannula | 12- x 100-mm |
| | ONB12LGF | Optical bladeless Long Trocar with<br>Fixation Cannula | 12- x 150-mm |
| | ONB12SHF | Optical bladeless Short Trocar with<br>Fixation Cannula | 12- x 70-mm |
| | ONB12STS | Optical bladeless Standard Trocar<br>with Smooth Cannula | 12- x 100-mm |
| | ONBFCA12ST | Standard Fixation Cannula | 12- x 100-mm |
| | ONBFCA12LG | Long Fixation Cannula | 12- x 150-mm |

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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 Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.

In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Conclusion Medline ReNewal concludes that the proposed Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is substantially equivalent to the predicate device.

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Image /page/7/Picture/0 description: The image contains the Medline Renewal logo. 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, with the words "Full Circle Reprocessing" in smaller letters below. The logo is simple and professional, and it is likely used to promote Medline Renewal's products or services.

### Predicate, Reference, and Medline ReNewal Reprocessed Covidien Versaport V2 Bladeless Optical Trocar device comparison chart.

| | Predicate Device | Reference Device | Proposed Device | Comparison<br>Analysis |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Device Characteristic | Covidien Versaport<br>Bladeless Optical Trocar | Covidien Versaport V2<br>Bladeless Optical Trocar | Medline ReNewal Versaport<br>Bladeless Optical Trocar | |
| 510(k) Number | K112349 | K130435 | K153258 | NA |
| Intended<br>Use/Indications for Use | The Versaport Bladeless<br>Optical Trocar is intended for<br>use in a variety of gynecologic,<br>general, thoracic and urologic<br>endoscopic procedures to<br>create and maintain a port of<br>entry. The trocar may be used<br>with or without visualization for<br>primary and secondary<br>insertions. | The Versaport V2 Bladeless<br>Optical Trocar is intended for<br>use in a variety of gynecologic,<br>general, thoracic and urologic<br>endoscopic procedures to<br>create and maintain a port of<br>entry. The trocar may be used<br>with or without visualization for<br>primary and secondary<br>insertions. | The Medline ReNewal<br>Reprocessed Versaport<br>Bladeless Optical Trocar is<br>intended for use in a variety of<br>gynecologic, general, thoracic<br>and urologic endoscopic<br>procedures to create and<br>maintain a port of entry. The<br>trocar may be used with or<br>without visualization for<br>primary and secondary<br>insertions. | Same |
| Design Configuration<br>and Model | 5-mm diameter in models:<br>ONB5STF (100 mm)<br>ONB5SHF (70 mm)<br>ONB5LGF (150 mm)<br>ONBFCA5LG (150 mm)<br>ONBFCA5SH (70 mm)<br>ONBFCA5ST (100 mm) | NA | 5-mm diameter in models:<br>ONB5STF (100 mm)<br>ONB5SHF (70 mm)<br>ONB5LGF (150 mm)<br>ONBFCA5LG (150 mm)<br>ONBFCA5SH (70 mm)<br>ONBFCA5ST (100 mm) | same |
| | NA | 11-mm diameter in models:<br>ONB11STF (100 mm)<br>ONB11LGF (150 mm)<br>ONBFCA11ST (100 mm) | 11-mm diameter in models:<br>ONB11STF (100 mm)<br>ONB11LGF (150 mm)<br>ONBFCA11ST (100 mm) | Same |

Continued

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Image /page/8/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 Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it.

Predicate, Reference, and Medline ReNewal Reprocessed Covidien Versaport Bladeless Optical Trocar device comparison chart (concluded).

| Device Characteristic | Predicate Device | Reference Device | Proposed Device | Comparison<br>Analysis |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Covidien Versaport V2<br>Bladeless Optical Trocar | Covidien Versaport V2<br>Bladeless Optical Trocar | Medline ReNewal Versaport<br>Bladeless Optical Trocar | |
| Design Configuration<br>and Model (concluded) | NA | 12-mm diameter in models:<br>ONB12STF (100 mm)<br>ONB12LGF (150 mm)<br>ONB12SHF (70 mm)<br>ONB12STS (100 mm)<br>ONBFCA12ST (100 mm)<br>ONBFCA12LG (150 mm) | 12-mm diameter in models:<br>ONB12STF (100 mm)<br>ONB12LGF (150 mm)<br>ONB12SHF (70 mm)<br>ONB12STS (100 mm)<br>ONBFCA12ST (100 mm)<br>ONBFCA12LG (150 mm) | Same |
| Technological<br>Characteristics | Transparent cannula,<br>bladeless obturator with<br>transparent optical window at<br>distal end, obturator housing<br>scope retention mechanism<br>and external interlocking<br>snaps.<br>Scope retention mechanism is<br>within the obturator housing for<br>secured insertion and retention<br>of appropriately sized 0°<br>laparoscope for visualization of<br>tissue layers during insertion<br>into body cavity.<br>Three-way stopcock for<br>insufflation and rapid<br>desufflation. External<br>interlocking snaps secure | Transparent cannula,<br>bladeless obturator with<br>transparent optical window at<br>distal end, obturator housing<br>scope retention mechanism<br>and external interlocking<br>snaps.<br>Scope retention mechanism is<br>within the obturator housing for<br>secured insertion and retention<br>of appropriately sized 0°<br>laparoscope for visualization of<br>tissue layers during insertion<br>into body cavity.<br>Three-way stopcock for<br>insufflation and rapid<br>desufflation. External<br>interlocking snaps secure | Transparent cannula,<br>bladeless obturator with<br>transparent optical window at<br>distal end, obturator housing<br>scope retention mechanism<br>and external interlocking<br>snaps.<br>Scope retention mechanism is<br>within the obturator housing for<br>secured insertion and retention<br>of appropriately sized 0°<br>laparoscope for visualization of<br>tissue layers during insertion<br>into body cavity.<br>Three-way stopcock for<br>insufflation and rapid<br>desufflation. External<br>interlocking snaps secure | Same |