VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP

K100548 · Covidien Lp, Formerly Registered AS Tyco Healthcar · GCJ · Apr 26, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100548
• Device Name: VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP
• Applicant: Covidien Lp, Formerly Registered AS Tyco Healthcar
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 26, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Versaport™ Bladeless Low Profile trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

Device Story

Versaport™ Bladeless Low Profile Trocar is a surgical access device used in endoscopic procedures. It creates and maintains a port of entry for surgical instruments. The device features a low-profile housing, a radiolucent fixation sleeve, and a seal system that accommodates 2mm-3mm to 5mm instrumentation while preventing pneumoperitoneum loss during instrument exchange. It includes a luer lock with a cap for insufflation and desufflation. The 2mm-3mm version utilizes an obturator tip with two linear non-bladed fins and a rounded tip. Used by surgeons in clinical settings, the device facilitates minimally invasive access, potentially reducing patient trauma compared to traditional bladed trocars.

Clinical Evidence

In-vitro and in-vivo performance testing was conducted to verify substantial equivalence and validate device functionality. No clinical trial data was required or presented.

Technological Characteristics

Low-profile housing; radiolucent fixation sleeve; internal seal system for 2mm-3mm to 5mm instrumentation; luer lock with cap for insufflation/desufflation. Materials comply with ISO 10993-1. Non-bladed obturator tip with 2 linear fins (2mm-3mm size).

Indications for Use

Indicated for patients undergoing gynecologic, general, thoracic, or urologic endoscopic procedures requiring a port of entry for instrumentation.

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

• Versaport™ Bladeless Trocar

Submission Summary (Full Text)

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100548

## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Covidien LP (formerly registered as Tyco Healthcare, LP)<br>60 Middletown Avenue<br>North Haven, CT 06473 USA | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Angela Van Arsdale<br>Associate II, Regulatory Affairs | APR 2 3 2010 |
| DATE PREPARED: | February 19, 2010 | |
| TRADE/PROPRIETARY NAME: | Versaport™ Bladeless Low Profile Trocar | |
| COMMON/USUAL NAME: | Surgical Trocar | |
| CLASSIFICATION NAME: | Endoscope and Accessories | |
| PREDICATE DEVICE(S): | Versaport™ Bladeless Trocar | |
| DEVICE DESCRIPTION: | The Versaport™ Bladeless low profile housing design is<br>available in 2mm-3mm to 5mm in various lengths with<br>radiolucent fixation sleeve. The 2mm-3mm to 5mm<br>Versaport™ seal system accommodates 2mm-3mm to 5mm<br>instrumentation respectively. There is a luer lock with cap for<br>insufflation and rapid desufflation (in place of a stopcock). | |
| INTENDED USE: | The Versaport™ Bladeless Low Profile trocar is intended for<br>use in a variety of gynecologic, general, thoracic and urologic<br>endoscopic procedures to create and maintain a port of entry. | |
| TECHNICAL<br>CHARACTERISTICS: | The Versaport™ Bladeless trocar with Low Profile design and<br>radiolucent fixation sleeve is equivalent to the predicate<br>devices in terms of its intended use. The 5mm size(s) change<br>only includes the low profile housing and seal design. The<br>Versaport™ seal system in the low profile housing has been<br>modified to fit the low profile design, containing an internal seal<br>to prevent loss of pneumoperitoneum when instruments are<br>inserted or withdrawn accommodating 2mm-3mm to 5mm<br>instrumentation respectively. There is a luer lock with cap (in<br>place of a stopcock) for insufflation and rapid desufflation. The<br>Versaport™ Bladeless 2mm-3mm to 5mm sized low profile<br>trocars come in the same various lengths and radiolucent<br>fixation sleeves as the predicate. The 2mm-3mm size has an<br>obturator tip with 2 linear non-bladed fins and a non-bladed<br>rounded tip. | |
| MATERIALS: | All components of the Versaport™ Bladeless Low Profile<br>trocar are comprised of materials which are in accordance with<br>ISO Standard 10993-1. | |
| PERFORMANCE DATA: | In-vitro and in-vivo tests were performed to verify that the<br>performance of the Versaport™ Bladeless Low Profile trocar is<br>substantially equivalent to the predicate device(s), and to<br>validate that the Versaport™ Bladeless Low Profile trocar will<br>perform as intended. | |

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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.

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

APR 2 3 2010

Covidien LP % Ms. Angela Van Arsdale Associate II. Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K100548

Trade/Device Name: Versaport™ Bladeless Low Profile Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 05, 2010 Received: April 06, 2010

Dear Ms. Arsdale:

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'

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Page 2 - Ms. Angela Van Arsdale

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

sincerely yours,

Oarbarefneehn

Dent

Mark N. Me Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

## VERSAPORT™ Bladeless Trocar

Indications For Use:

The Versaport™ Bladeless Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

Prescription Use _ × (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 IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle for mixn

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K00548