(90 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI/ML terms or functionalities.
No
The device is a surgical access tool (trocar) used to create and maintain a port of entry for other surgical instruments, not to treat or cure a disease itself.
No
The device is used to create and maintain a port of entry for endoscopic procedures; it does not diagnose medical conditions.
No
The device description clearly outlines physical components (cannula assembly, obturator, anchoring assembly) and the performance studies focus on physical properties (leak rate, anchoring strength, biocompatibility), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for creating and maintaining a port of entry during endoscopic procedures. This is a surgical tool used in vivo (within the body) to facilitate access for other instruments.
- Device Description: The description details a physical device used for abdominal access during laparoscopic procedures. It describes components like a cannula, obturator, and anchoring assembly, all of which are physical tools for surgical intervention.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. The provided information does not mention any analysis of biological samples or diagnostic purposes.
- Performance Studies: The performance studies focus on the physical properties and safety of the device itself (leak rate, anchoring strength, biocompatibility), not on the accuracy or reliability of diagnostic results obtained from analyzing biological samples.
Therefore, the BLUNTPORT™ Blunt Trocar with Threaded Anchor is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Design verification studies were conducted to demonstrate that 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
- anchoring strength
- anchor position adjustment
- Biocompatibility
- cvtoxicity
- sensitization
- intracutaneous Irritation
- acute Systemic Toxicity
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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
1
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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
60 Middletown Avenue
North Haven, CT 06473
(203) 492-5284 (T) |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------|
| CONTACT PERSON: | Mary Mellows
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
device |
| LEGALLY MARKETED
DEVICES TO WHICH
EQUIVALENCY IS
CLAIMED: | Versaport™ V2 Bladeless Optical Trocar (K130435) |
CONFIDENTIAL
Special 510(k) Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm
4
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
with Threaded Anchor
5mm-12mm
(Proposed Device) | Predicate Versaport™ V2
Bladeless Optical Trocar
(K130435) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological/
Design Characteristics | Cannula Assembly
Sleeve:
Smooth | Cannula Assembly
Sleeve:
Smooth or Ribbed |
| | Housing:
Internal seal | Housing:
Same as proposed device |
| | Obturator Component:
Blunt-tipped dark
blue acrylonitrile butadiene
styrene (ABS) with solid
proximal and distal ends | Obturator Component:
Bladeless 304 Stainless Steel
and dark blue ABS with
transparent window at distal
end and scope retention
member at proximal opening. |
| | Anchoring Device:
White ABS housing with
dark blue nylon screw | Anchoring Assembly:
None |
CONFIDENTIAL
Special 510(k) Bluntport™ Blunt Trocar with Threaded Anchor 5mm-12mm
5
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
- In Vitro ●
- 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.