Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
Applicant
Covidien
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Dec 9, 2014
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The BLUNTPORT™ Blunt Trocar with Threaded Anchor 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
Sterile, single-use surgical trocar for abdominal access during laparoscopic procedures. Device comprises cannula assembly, blunt-tipped obturator, and threaded anchoring assembly. Cannula accommodates 5mm-12mm diameter instruments while maintaining pneumoperitoneum. Anchoring assembly secures cannula to tissue at access site. Used in OR by surgeons for gynecologic, general, thoracic, and urologic procedures. Provides stable port of entry for endoscopic instrumentation; facilitates surgical access; maintains insufflation.
Clinical Evidence
Bench testing only. In vitro testing included pneumoperitoneum leak rate, anchoring strength, and anchor position adjustment. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous irritation, and acute systemic toxicity.
Technological Characteristics
Cannula assembly with smooth sleeve; blunt-tipped obturator made of ABS; threaded anchoring assembly made of ABS housing and nylon screw. Materials tested per ISO 10993-1. Dimensions accommodate 5mm-12mm instruments. Single-use, sterile device.
Indications for Use
Indicated for patients undergoing gynecologic, general, thoracic, or urologic endoscopic procedures requiring abdominal access and maintenance of pneumoperitoneum.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2014
Covidien % Ms. Mary Mellows Senior Regulatory Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K142547
Trade/Device Name: Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 7, 2014 Received: November 10, 2014
Dear Ms. Mellows:
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 (reporting of medical
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K142547
Device Name
Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm
#### Indications for Use (Describe)
The BLUNTPORT™ Blunt Trocar with Threaded Anchor is intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white plus sign in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The plus sign is made up of several smaller squares of varying shades of blue and white.
## 510(k) Summary
This 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92.
| SUBMITTER: | Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473<br>(203) 492-5284 (T) |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------|
| CONTACT PERSON: | Mary Mellows<br>Senior Specialist, Regulatory Affairs |
| DATE PREPARED: | November 7, 2014 |
| TRADE/PROPRIETRY NAME: | Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm |
| COMMON/USUAL NAME: | Surgical Trocar |
| CLASSIFICATION NAME: | Endoscope and Accessories |
| FDA PANEL NUMBER: | 78 |
| PRODUCT CODE: | GCJ |
| CLASS CODE: | Pursuant to 21 CFR 876.1500, surgical trocar is a Class II<br>device |
| LEGALLY MARKETED<br>DEVICES TO WHICH<br>EQUIVALENCY IS<br>CLAIMED: | Versaport™ V2 Bladeless Optical Trocar (K130435) |
CONFIDENTIAL
Special 510(k) Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm
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Image /page/4/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white square in the center and a light blue vertical line running through the center of the white square. To the right of the square is the word "COVIDIEN" in a dark blue sans-serif font.
REFERENCED DEVICES NOTED IN THIS SUBMISSION:
Auto Suture™ Modified Grip (K942885) Endo GIA Radial Reload (K132493) SILS Hand Instruments (K091869)
REASON FOR 510(K) SUBMISSION:
Obtain market clearance for Covidien's Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm.
DEVICE DESCRIPTION: The Bluntport™ with Threaded Anchor 5mm-12mm is a sterile. single use device used for abdominal access during laparoscopic procedures. The device consists of a cannula assembly, blunttipped obturator component and an anchoring assembly. The cannula assembly accommodates various size laparoscopic devices ranging from 5mm to 12mm in diameter while still maintaining pneumoperitoneum. The anchoring device provides stability of the cannula at the access site.
INTENDED USE: Intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
TECHNICAL
CHARACTERISTICS:
Bluntport™ with Threaded Anchor 5mm-12mm The is substantially equivalent and has not introduced any new features relative to the predicate or referenced devices. An anchoring assembly (K942885) has been incorporated to secure the cannula assembly against tissue.
| | Bluntport™ Blunt Trocar<br>with Threaded Anchor<br>5mm-12mm<br>(Proposed Device) | Predicate Versaport™ V2<br>Bladeless Optical Trocar<br>(K130435) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological/<br>Design Characteristics | Cannula Assembly<br>Sleeve:<br>Smooth | Cannula Assembly<br>Sleeve:<br>Smooth or Ribbed |
| | Housing:<br>Internal seal | Housing:<br>Same as proposed device |
| | Obturator Component:<br>Blunt-tipped dark<br>blue acrylonitrile butadiene<br>styrene (ABS) with solid<br>proximal and distal ends | Obturator Component:<br>Bladeless 304 Stainless Steel<br>and dark blue ABS with<br>transparent window at distal<br>end and scope retention<br>member at proximal opening. |
| | Anchoring Device:<br>White ABS housing with<br>dark blue nylon screw | Anchoring Assembly:<br>None |
CONFIDENTIAL
Special 510(k) Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm
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Image /page/5/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white square inside, and a blue vertical line running through the center. To the right of the square is the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
- MATERIALS: All components of the blunt-tipped obturator component and cannula assembly are similar to the predicate device Versaport™ V2 Bladeless Optical Trocar (K130435). Components of the anchoring assembly are similar to the Auto Suture™ Modified Grip (K942885) and materials used in the anchoring assembly are also used in the Endo GIA Radial Reload (K132493) and the SILS Hand Instruments (K091869). All materials have been tested in accordance with ISO Standard 10993-1.
- Design verification studies were conducted to demonstrate that PERFORMANCE DATA: the Bluntport™ with Threaded Anchor 5mm-12mm is safe and effective and performs as intended. Testing to support the intended use of this device includes:
- In Vitro ●
- pneumoperitoneum leak rate o
- o anchoring strength
- anchor position adjustment O
- Biocompatibility ●
- cvtoxicity o
- sensitization O
- O intracutaneous Irritation
- acute Systemic Toxicity o
- CONCLUSION: The result of these tests demonstrate that the Bluntport™ with Threaded Anchor 5mm-12mm is substantially equivalent to the predicate device and does not introduce additional risk to the patient.
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