(23 days)
Not Found
No
The device description focuses on mechanical components for surgical access and pneumoperitoneum maintenance. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is described as a "laparoscopic multi-instrument port" that facilitates surgical procedures by providing access and maintaining pneumoperitoneum. It does not directly treat or diagnose a disease or condition.
No
The device is described as an access port for laparoscopic surgery, designed to allow instruments to pass through and maintain pneumoperitoneum. Its function is to facilitate surgical procedures, not to diagnose conditions.
No
The device description clearly outlines physical components (introducer, retractor, valve) and its function as a physical port during surgery, 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 is for providing access during minimally invasive abdominal laparoscopic surgery. This is a surgical device used in vivo (within the body) during a procedure.
- Device Description: The description details a physical device used to retract an incision and maintain pneumoperitoneum during surgery. 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.), performing tests on specimens, or providing diagnostic results.
IVD devices are specifically designed to be used in vitro to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
The following is an extraction of the key information from the FDA summary provided:
Intended Use / Indications for Use
The ASC TriPort+ 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, GCJ
Device Description
The ASC TriPort+ Laparoscopic Access Device is, like the parent TriPort and QuadPort devices cleared by the FDA under K101794, a laparoscopic 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+ Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort+ Laparoscopic Access Device performs the same function as the TriPort and QuadPort parent devices.
Like the parent ASC TriPort Laparoscopic Access Device, the proposed ASC TriPort+Laparoscopic Access Device is comprised of the following three components: - . An introducer component, which delivers the Distal Ring of the ASC TriPort+ through a premade incision, into the abdominal cavity.
- . A retractor 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 ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort+ Laparoscopic Access Device is identical in function to the ASC TriPort & QuadPort Laparoscopic Access Devices, which have been cleared for marketing under K101794.
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)
Biocompatibility and performance verification testing of the TriPort+ demonstrates that the modifications that are the subject of this notification do not raise new issues of safety or effectiveness. Validation testing of the TriPort+ in a porcine model enrolled clinicians with various levels of experience and expertise and demonstrated that the device functioned as intended, that the performance did not raise new issues of safety and effectiveness and that formal user training was not required.
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
510(k) Summary 8.
8.1 SUBMITTER/510(K) Holder
Advanced Surgical Concepts Unit 4, Sunnybank Centre Upper Dargle Road Bray, Co. Wicklow Ireland Contact Person: Brian O'Connell Telephone: +353 (0)1 2864777
8.2 Consultant
Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 USA Contact Person: Jonathan Kahan Telephone: +1 202 637 5794
Establishment Registration Number: 8.3
9616720
Date Prepared: 8.4
January 3, 2011
8.5 DEVICE NAME & CLASSIFICATION
Proprietary Name: ASC TriPort+ Laparoscopic Access Devices Common/Usual Name: Laparoscopic Accessory Endoscopic Accessory and Surgical Retractor (21 CFR 876.1500) Classification Name: Classification Number: Class II
8.6 Predicate Device
TriPort & QuadPort Laparoscopic Access Devices (K101794)
Advanced Surgical Concepts (ASC), 510(k) TriPort+ Laparoscopic Access Device
Confidential Page 17 of 62 JAN 2 6 2011
1
K116004p.2.ofy
8.7 DEVICE DESCRIPTION
The ASC TriPort+ Laparoscopic Access Device is, like the parent TriPort and QuadPort devices cleared by the FDA under K101794, a laparoscopic 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+ Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort+ Laparoscopic Access Device performs the same function as the TriPort and QuadPort parent devices.
Like the parent ASC TriPort Laparoscopic Access Device, the proposed ASC TriPort+Laparoscopic Access Device is comprised of the following three components:
- . An introducer component, which delivers the Distal Ring of the ASC TriPort+ through a premade incision, into the abdominal cavity.
- . A retractor 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 ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort+ Laparoscopic Access Device is identical in function to the ASC TriPort & QuadPort Laparoscopic Access Devices, which have been cleared for marketing under K101794.
Advanced Surgical Concepts (ASC), 510(k) TriPort+ Laparoscopic Access Device
Confidential Page 18 of 62
2
- 3 of 4
The modifications made to the TriPort & QuadPort to produce the TriPort+ were made to improve the performance, ergonomics and cost of the system and are summarized as follows:
- · A change in the configuration of valve sizes.
- The gel valves have been replaced with more standard valve mechanisms.
- A redesign and material change to the Boot to accommodate the new valves and to improve ease-of-use.
- The removal of the Retaining Clips.
- · The addition of a foam guiding ring.
- · · The addition of printed gradations on the sleeve.
- · A material change to the Removal Ring.
- A redesign of the Introducer.
- A redesign and material change to the Insufflation ports.
- Packaging redesign.
The changes made to the parent TriPort & QuadPort Laparoscopic Access Devices to produce the TriPort+ are minor and do not represent changes to its intended use, operating principles or mechanism of action for the device.
8.8 INTENDED USE
The ASC TriPort+ Laparoscopic Access Device is intended for use as multiple instrument and/or camera port during minimally-invasive abdominal laparoscopic surgery.
Advanced Surgical Concepts (ASC), 510(k) TriPort+ Laparoscopic Access Device
Confidential Page 19 of 62
3
K110004 p. 40+Y
8.9 Technological Characteristics And Substantial Equivalence
The TriPort+ Laparoscopic Access Device provides an access path for multiple laparoscopic instruments through a small incision in the abdominal wall. Its function is identical to that of the parent TriPort & QuadPort Laparoscopic Access Devices (K101794).
The TriPort+ and the parent TriPort & QuadPort Laparoscopic Access Devices are laparoscopic instrument ports. Identically to the TriPort, the TriPort+ retracts an abdominal incision (12 -25mm) to allow laparoscopic instruments to pass through into the abdomen, and maintain pneumoperitoneum in the abdomen during the surgical procedure, whether or not laparoscopic instruments are passing through the port.
Both the TriPort+ and the predicate QuadPort allow the option for the simultaneous introduction of up to four laparoscopic instruments through a single incision.
Like the predicate devices, the TriPort+ is a sterile, single-use (disposable) device. The use of the TriPort+ and the predicates are identical in that they facilitate the passage of laparoscopic instrumentation while maintaining pneumoperitoneum.
The insertion method for the TriPort+ is identical to that of the parent TriPort device, where the Distal Ring is inserted, using the supplied Introducer, through a pre-made incision.
8.10 Performance Testing
Biocompatibility and performance verification testing of the TriPort+ demonstrates that the modifications that are the subject of this notification do not raise new issues of safety or effectiveness. Validation testing of the TriPort+ in a porcine model enrolled clinicians with various levels of experience and expertise and demonstrated that the device functioned as intended, that the performance did not raise new issues of safety and effectiveness and that formal user training was not required.
8.11 Conclusions
Based on design verification testing of TriPort+, along with design validation testing in a porcine model and on a simulator, the TriPort+ fulfills prospectively defined design and performance requirements, and is therefore substantially equivalent to the TriPort & QuadPort Laparoscopic Access Devices (K101794).
Advanced Surgical Concepts (ASC), 510(k) TriPort+ Laparoscopic Access Device
Confidential Page 20 of 62
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
Advanced Surgical Concepts % Hogan Lovells US LLP Mr. Jonathan Kahan Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004
JAN 2 6 201
Re: K110004
Trade/Device Name: ASC TriPort+ Laparoscopic Access Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OTJ, GCJ Dated: January 03, 2010 Received: January 03, 2010
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 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. Iisting 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.
5
Page 2 – Mr. Jonathan Kahan
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 (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.tcra.go.tz/miccard/CCS/Resource%20Store/Industry%20Guidance.html
Sincerely yours.
erely yours,
N. Melle
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Image /page/6/Picture/1 description: The image contains a close-up of handwritten text. The text appears to be the letter 'f' with another character to the left of it. The writing is in black ink on a white background.
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: ASC TriPort+ Laparoscopic Access Device
Indications For Use:
The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Prescription Use:_X
Over-The-Counter Use:
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
X.Y.P.O.L.M. for man
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110004
Advanced Surgical Concepts (ASC), 510(k) TriPort+ Laparoscopic Access Device
Confidential Page 10 of 62