(17 days)
Not Found
No
The description focuses on the mechanical and optical features of a surgical access port and does not mention any AI or ML capabilities.
No
The device is described as an access port that provides a pathway for surgical devices, not a device that treats or diagnoses a condition itself.
No
The device is described as an access port used during surgical procedures to provide a pathway for surgical instruments, not to diagnose a condition. Its function is to facilitate surgery, not to determine the nature or presence of a disease.
No
The device description clearly describes a physical, hardware-based laparoscopic access port with components like an obturator, cannula, and dilating tip. It is not software-only.
Based on the provided information, the Weck® Vista™ Optical Bladeless Laparoscopic Access Port is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a pathway for surgical devices during minimally invasive surgical procedures performed on the patient (in vivo). IVD devices are used to examine specimens from the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly outlines a device used for accessing body cavities during surgery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
The device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Weck® Vista™ Optical Bladeless Laparoscopic Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
Product codes
GCJ
Device Description
Weck® Vista™ Optical Bladeless Laparoscopic Access Port is used to establish a port of entry into the abdominal cavity, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The port is positioned into the peritoneum during minimally invasive surgical procedures, in order to provide a pathway for the insertion and removal of various sized surgical devices. The obturator of the Optical Bladeless Laparoscopic Access Port provides a channel for the insertion of a camera. At the proximal end of the obturator is a clear dilating tip for initial port entry to have visibility of the fasical layers. Additional stability ridges have been added to the outer cannula wall to enhance port fixation during surgery. Weck® Vista™ Optical Bladeless Laparoscopic Access Port is intended to be used by trained physicians.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, abdominal, and gynecologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
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
The bench testing has been performed to verify that the performance of the proposed Weck® Vista™ Optical Bladeless Laparoscopic Access Port is substantially equivalent to the predicate devices, and that the Weck® Vista™ Optical Bladeless Laparoscopic Access Port will perform as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Page 1 of
MAY 2 5 2012
Veck® Vista™ Optical Bladeless Laparoscopic Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness
K121380
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Weck® Vista™ Optical Bladeless Laparoscopic Access Port
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8049 Fax: 919-433-4996
B. Contact Person
Natalie Smith Regulatory Affairs Specialist
C. Date Prepared
May 7, 2012
D. Device Name
Trade Name: Weck® Vista™ Optical Bladeless Laparoscopic Access Port
Common Name: Surgical Trocar
Classification Name: Endoscope and Accessories (21 CFR 876.1500, Product Code GCJ)
E. Device Description
Weck® Vista™ Optical Bladeless Laparoscopic Access Port is used to establish a port of entry into the abdominal cavity, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The port is positioned into the peritoneum during minimally invasive surgical procedures, in order to provide a pathway for the insertion and removal of various sized surgical devices. The obturator of the Optical Bladeless Laparoscopic Access Port provides a channel for the insertion of a camera. At the proximal end of the obturator is a clear dilating tip for initial port entry to have visibility of the fasical layers. Additional stability ridges have been added to the outer cannula wall to enhance port fixation during surgery. Weck® Vista™ Optical Bladeless Laparoscopic Access Port is intended to be used by trained physicians.
Teleflex Medical, Inc.
1
Page 2 of 2
Weck® Vista™ Optical Bladeless Laparoscopic Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness
F. Indications for Use
The Optical Bladeless Laparoscopic Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
G. Contraindications
Where minimally invasive techniques are contraindicated, other methods and instrumentation should be employed.
H. Substantial Equivalence
The proposed Optical Bladeless Laparoscopic Access Port is substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| ADAPtTM Laparoscopic Port | |||
| and Accessory | Teleflex Medical, Inc. / | ||
| Taut, Inc. | K010007 | 02/22/01 | |
| ADAPtTM Universal | |||
| Laparoscopic Port | Teleflex Medical, Inc. | K082156 | 09/10/2008 |
I. Comparison To Predicate Devices
This proposed change is to enhance the previously approved features from K010007; ADAPt™ Laparoscopic Port and Accessory and K082156; ADAPt™ Universal Laparoscopic Port, to produce an Optical Port with a stability feature.
The new design adds stability ridges along the length of the cannula to enhance port fixation during surgery. The obturator was modified to accommodate the use with a camera. The shaft will be composed of stainless steel with the cyrolite asymmetrical tissue separating tip as the predicate devices. The obturator cap will also be modified for the insertion of the camera. The floating top seal will be modified to form a funnel (conical entry feature) that will assist and guide surgical instruments into the port.
J. Materials
All patient contacting materials are in compliance with ISO10993-1.
2
Weck® Vista™ Optical Bladeless Laparoscopic Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness
K. Technological Characteristics
A comparison of the technological characteristics of the proposed Weck® Vista™ Optical Bladeless Laparoscopic Access Port and the predicate has been performed. The results of this comparison demonstrate that the Weck® Vista™ Optical Bladeless Laparoscopic Access Port is equivalent to the marketed predicate devices in performance characteristics.
L. Performance Data
The bench testing has been performed to verify that the performance of the proposed Weck® Vista™ Optical Bladeless Laparoscopic Access Port is substantially equivalent to the predicate devices, and that the Weck® Vista™ Optical Bladeless Laparoscopic Access Port will perform as intended.
L. Conclusion
Based upon the comparative test results, the proposed Weck® Vista™ Optical Bladeless Laparoscopic Access Port is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K010007 and K082156. The modifications made to the Weck® Vista™ Optical Bladeless Laparoscopic Access Port do not introduce any new issues of safety and effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 5 2012
Teleflex Medical, Inc % Ms. Natalie Smith Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K121380
Trade/Device Name: Weck® Vista™ Optical Bladeless LaParoscopic Access Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: May 07, 2012 Received: May 08, 2012
Dear Ms. Natalie Smith
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.
4
Page 2 - Ms. Natalie Smith
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Page 1 of 1
21380
510(k) Number:
Device Name:
Weck® Vista™ Optical Bladeless Laparoscopic Access Port
Indications for Use:
The Weck® Vista™ Optical Bladeless Laparoscopic Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil P. O'Shea Luxmore
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K21380