(128 days)
No
The device description and performance studies focus on mechanical functions (retraction, pneumoperitoneum maintenance) and do not mention any computational or analytical capabilities that would suggest AI/ML.
No.
The device is a laparoscopic access port, which is a surgical tool used to facilitate minimally invasive surgery by providing a portal for instruments and maintaining pneumoperitoneum. It is not designed to treat a disease or medical condition.
No
The device is a surgical access port designed to facilitate minimally invasive abdominal laparoscopic surgery by allowing multiple instruments to pass through a single incision and maintaining pneumoperitoneum. It does not perform any diagnostic functions.
No
The device description explicitly details physical components (introducer, retroctor, valve) and their mechanical functions in laparoscopic 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 "use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery." This describes a surgical tool used during a procedure, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a physical device used to retract an incision and maintain pneumoperitoneum during surgery. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is clearly a surgical access port used to facilitate laparoscopic procedures.
N/A
Intended Use / Indications for Use
The QuadPort+ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Product codes
OTJ
Device Description
The ASC QuadPort+ Laparoscopic Access Devices are, like the parent TriPort+ device cleared by the FDA under K110004, laparoscopic multi-instrument ports which perform 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 QuadPort+ laparoscopic multi-instrument port is sterile and disposable. The QuadPort+ laparoscopic multi-instrument ports perform the same function as the TriPort+ parent device.
Like the parent ASC TriPort+ Laparoscopic Access Device, the QuadPort+ laparoscopic multi-instrument port is comprised of the following three components:
- An introducer component, which delivers the Distal Ring of the device through a pre-made . incision, into the abdominal cavity.
- A retroctor 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 QuadPort+ laparoscopic multi-instrument port is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The QuadPort+ laparoscopic multi-instrument port functions in the same way as the ASC parent TriPort+ device cleared by the FDA under K110004.
QuadPort+ Modifications
The modifications to the TriPort + (K110004) to produce the QuadPort+ are as follows:
- A change in the configuration of the valve sizes .
- The addition of an extra port to allow greater flexibility regarding instrument placement .
- Range of Valve sizes is larger (QuadPort+ can accommodate 12 and 15mm instruments) .
- Device is larger, to allow use through larger incision (25-60mm) .
- Valve housing section (boot) is overmolded to ensure it remains in position .
- . Packaging redesign.
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
Description of the test set: validation testing in a porcine model and on a simulator. Clinicians experienced with single port devices were enrolled to demonstrate the device functioned as intended when used in a variety of laparoscopic procedures, that the performance did not raise any new issues of safety and effectiveness, and that the IFU adequately allowed for the use of the device without any further training.
Summary of Performance Studies
Study Type: Design Verification testing and Design Validation testing.
The device functioned as expected and showed the following:
- The device was easy to insert, a.
- Instruments are easy to insert and withdraw, b.
- Device maintained pneumoperitoneum C.
- Surgeons were able to manipulate instruments for a laparoscopic procedure d.
- Surgeons were able to conduct a typical laparoscopic procedure e.
- f. The device stayed in position during surgery.
Result: The device met the defined design and performance requirements outlined in the Design Inputs.
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.
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Page 1 of 5
SEP
6 2012
-8. 510(k) Summary
r
8.1 Submitter/510(K) Holder
Advanced Surgical Concepts Unit 4, Sunnybank Centre Upper Dargle Road Bray, Co. Wicklow Ireland Contact Person: Ed Hyland +353 (0)1 2864777 Telephone:
8.2 Consultant
Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 USA Jonathan Kahan Contact Person: +1 202 637 5794 Telephone:
8.3 Establishment Registration Number: 9616720
8.4 Date Prepared:
April 30, 2012
8.5 DEVICE NAME & Classification
Proprietary Name: ASC QuadPort+ Laparoscopic Access Devices Common/Usual Name: Laparoscopic Single Port Access Device Endoscope and Accessories (21 CFR §876.1500) Classification Name: Classification Number: Class II OTJ Product Code:
8.6 Predicate Device
ASC TriPort+ Laparoscopic Access Device (K110004)
Advanced Surgical Concepts (ASC), Special 510(k) QuadPort+ Laparoscopic Access Device
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Page 2 of (5)
8.7 DEVICE DESCRIPTION
The ASC QuadPort+ Laparoscopic Access Devices are, like the parent TriPort+ device cleared by the FDA under K110004, laparoscopic multi-instrument ports which perform 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 QuadPort+ laparoscopic multi-instrument port is sterile and disposable. The QuadPort+ laparoscopic multi-instrument ports perform the same function as the TriPort+ parent device.
Like the parent ASC TriPort+ Laparoscopic Access Device, the QuadPort+ laparoscopic multiinstrument port is comprised of the following three components:
- An introducer component, which delivers the Distal Ring of the device through a pre-made . incision, into the abdominal cavity.
- A retroctor 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 QuadPort+ laparoscopic multi-instrument port is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The QuadPort+ laparoscopic multi-instrument port functions in the same way as the ASC parent TriPort+ device cleared by the FDA under K110004.
Advanced Surgical Concepts (ASC), Special 510(k) QuadPort+ Laparoscopic Access Device
2
QuadPort+ Modifications
The modifications to the TriPort + (K110004) to produce the QuadPort+ are as follows:
- A change in the configuration of the valve sizes .
- The addition of an extra port to allow greater flexibility regarding instrument placement .
309
- Range of Valve sizes is larger (QuadPort+ can accommodate 12 and 15mm instruments) .
- Device is larger, to allow use through larger incision (25-60mm) .
- Valve housing section (boot) is overmolded to ensure it remains in position .
- . Packaging redesign.
The changes made to the parent Triport + Laparoscopic Access Device to produce the QuadPort+ are minor and do not represent change to its intended use, fundamental scientific technology, operating principles or mechanism of actuation of the device.
8.8 Intended Use
The QuadPort+ laparoscopic multi-instrument port is intended for use as multiple instrument and/or camera port during minimally-invasive abdominal laparoscopic surgery.
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Page 4 of 5
8.9 TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The QuadPort+ Laparoscopic Access Device provides an access path for multiple laparoscopic instruments through a small incision in the abdominal wall. Its function is the same as that of the parent TriPort + Laparoscopic Access Device (K110004).
The QuadPort+ and the parent TriPort+ Laparoscopic Access devices are Laparoscopic instrument ports. As with the TriPort +, the QuadPort+ retracts an abdominal incision to allow laparoscopic instruments to pass through into the abdomen, and maintains pneumoperitoneum in the abdomen during the surgical procedure, whether or not laparoscopic instruments are passing through the port.
Both the Quadport+ and the predicate TriPort + allow the option for the simultaneous introduction of up to four laparoscopic instruments through a single incision.
Like the predicate device, the QuadPort+ device is a sterile, single use (disposable) device.
The insertion method for the QuadPort+ is the same as that for the TriPort +. This introducer is identical in actuation to that already supplied with the approved TriPort+(K110004). The distal ring is inserted, using this introducer, into the abdominal cavity through a pre-made incision.
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Page 5 of S
8.10 Performance Testing
Design Verification testing of the QuadPort+ demonstrates that the modifications that are the subject of this notification do not raise new issues of safety or effectiveness. Validation activities included repeating all those tests carried out on the parent device as well as any others highlighted as part of Risk Analysis. Validation testing of the QuadPort+ in a porcine model enrolled clinicians who were experienced with single port devices to demonstrate the device functioned as intended when used in a variety of laparoscopic procedures, that the performance did not raise any new issues of safety and effectiveness, and that the IFU adequately allowed for the use of the device without any further training.
The device functioned as expected and showed the following:
- The device was easy to insert, a.
- Instruments are easy to insert and withdraw, b.
- Device maintained pneumoperitoneum C.
- Surgeons were able to manipulate instruments for a laparoscopic procedure ದ.
- Surgeons were able to conduct a typical laparoscopic procedure e.
- f. The device stayed in position during surgery.
8.11 Conclusions
Following Design Verification testing of the QuadPort+ along with Design Validation testing in a porcine model and on a simulator, the device has met the defined design and performance requirements outlined in the Design Inputs.
Advanced Surgical Concepts (ASC), Special 510(k) QuadPort+ Laparoscopic Access Device
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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 Partner Columbia Square 355 Thirteenth Street, NW Washington, District of Columbia 20004
SEP 6 2012
Re: K121309
Trade/Device Name: ASC Quad + Laparoscopic Access Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OTJ Dated: August 10, 2012 Received: August 10, 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 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
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Page 2 - Mr. Jonathan Kahan
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement 4.
510(k) Number (if known):
1&,30
Device Name: ASC QuadPort+ Laparoscopic Access Device
Indications For Use:
The QuadPort+ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Prescription Use: X
AND/OR
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Dahlen for mxm
Tivision Sigr Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121309
Advanced Surgical Concepts (ASC), Special 510(k) QuadPort+ Laparoscopic Access Device
Confidential Page 10 of 59