(244 days)
No
The device description focuses on mechanical components and functions for laparoscopic access and pneumoperitoneum maintenance. There is no mention of software, data processing, or any features indicative of AI/ML.
No
The device is described as an access port for instruments during laparoscopic surgery, not as a device that directly treats a condition or restores function.
No
The device is described as a "laparoscopic multi-instrument port" that facilitates instrument passage and maintains pneumoperitoneum during surgery. Its function is to assist in surgical procedures, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components (introducer, retractor, valve) and mentions material changes (colorant), indicating it is a hardware device, not software-only.
Based on the provided information, the ASC TriPort 15 Laparoscopic Access Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery." This describes a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The description details a device that physically interacts with the body (retracting an incision, maintaining pneumoperitoneum) to facilitate surgical access. It does not describe a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnostic, monitoring, or screening purposes. The ASC TriPort 15 does not fit this description.
N/A
Intended Use / Indications for Use
The ASC TriPort 15 Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
OTJ
Device Description
The ASC TriPort 15 Laparoscopic Access Device is a faparoscopic multi-instrument port which performs the following two functions:
- Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery.
- Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical . procedure, whether or not one or more laparoscopic instruments are passing through the device.
The ASC TriPort 15 Laparoscopic Access Device is comprised of the following three components:
- An introducer component, which delivers the Distal Ring through a pre-made incision, . into the abdominal cavity.
- A refractor component, which retracts an abdominal incision to allow the passage of . laparoscopic instruments.
- A valve component which maintains the pneumoperitoneum established for the surgical . procedure.
The minor design changes to the cleared TriPort+ (K110004) device to create the TriPort 15 are as follows:
-
- Changing the valve configuration from a four valve (3 x 5mm & 1 x 10mm) to a three valve (2 x 5mm & 1 x 15mm) configuration.
-
- The introduction of a new colorant for the 15mm Valve Cap. Note that this portion of the device does not contact the patient.
The changes made to the parent TriPort+ Laparoscopic Access Devices to produce the TriPort 15 are minor and do not represent changes to its intended use, or the operating principles or mechanism of action of the device.
The ASC TriPort 15 Laparoscopic Access Device is sterile and disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization and shelf life testing, biocompatibility testing, design validation testing, and animal testing of the TriPort 15 was conducted to verify that the changes to the technological characteristics do not affect safety or effectiveness. In all instances, the TriPort 15 functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K11140.7
Page 1 of (2)
JAN 1 8 2012
510(k) SUMMARY Advanced Surgical Concepts' (ASC) TriPort 15 Laparoscopic Access Device
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 USA Contact Person: Jonathan Kahan +1 202 637 5794 Telephone: January 17, 2012 Date Prepared:
ﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ 2 - 1
Name of Device and Name/Address of Sponsor
TriPort 15 Laparoscopic Access Device
Advanced Surgical Concepts Unit 4, Sunnybank Centre Upper Dargle Road Bray, Co. Wicklow Ireland Contact Person: Ed Hyland +353 (0)1 2864777 Telephone:
Common or Usual Name
Laparoscopic single port access device (Product Code OTJ)
Classification Name
21 C.F.R. §876.1500, Endoscope and accessories Class II
Predicate Device
ASC TriPort+ Laparoscopic Access Device (K110004)
Intended Use / Indications for Use
The ASC TriPort 15 Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Technological Characteristics
The ASC TriPort 15 Laparoscopic Access Device is a faparoscopic multi-instrument port which performs the following two functions:
1
KIII 407
Page 2 of 2
- Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery.
- Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical . procedure, whether or not one or more laparoscopic instruments are passing through the device.
The ASC TriPort 15 Laparoscopic Access Device is comprised of the following three components:
- An introducer component, which delivers the Distal Ring through a pre-made incision, . into the abdominal cavity.
- A refractor component, which retracts an abdominal incision to allow the passage of . laparoscopic instruments.
- A valve component which maintains the pneumoperitoneum established for the surgical . procedure.
The minor design changes to the cleared TriPort+ (K110004) device to create the TriPort 15 are as follows:
-
- Changing the valve configuration from a four valve (3 x 5mm & 1 x 10mm) to a three valve (2 x 5mm & 1 x 15mm) configuration.
-
- The introduction of a new colorant for the 15mm Valve Cap. Note that this portion of the device does not contact the patient.
The changes made to the parent TriPort+ Laparoscopic Access Devices to produce the TriPort 15 are minor and do not represent changes to its intended use, or the operating principles or mechanism of action of the device.
The ASC TriPort 15 Laparoscopic Access Device is sterile and disposable.
Performance Data
Sterilization and shelf life testing, biocompatibility testing, design validation testing, and animal testing of the TriPort 15 was conducted to verify that the changes to the technological characteristics do not affect safety or effectiveness. In all instances, the TriPort 15 functioned as intended.
Substantial Equivalence
The ASC TriPort 15 Laparoscopic Access Device is as safe and effective as the predicate device. The TriPort 15 device has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the TriPort 15 model and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the TriPort 15 is as safe and effective as the predicate device. Thus, the ASC TriPort 15 Laparoscopic Access Device is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and its body forming a flowing, abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 8 2012
Advanced Surgical Concepts % Hogan Lovells US LLP Mr. Jonathan S. Kahan 355 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K111407
Trade/Device Name: TriPort 15 Laparoscopic Access Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OTJ Dated: January 17, 2012 Received: January 17, 2012
Dear Mr. Kahan:
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 each and to review is substantially equivalent (for the indical commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclasion with the provisions of the Medical Device Amendments, or to
and Cosmetic Act (Act) that do not require approvise of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act that do not require approval of the Federal Food, Drug,
You may, therefore, market the device, subject to the a premarket approval application You may, therefore, market the device, subject to the general controls provisions of PMA).
general controls provisions of the Act include result 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
3
Page 2 – Mr. Jonathan S. Kahan
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 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
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Sṭatement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TriPort 15 Laparoscopic Access Device
Indications for Use:
The ASC TriPort 15 Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page | of |
Neil R. Poole for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111407