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.

AI/ML Overview

The provided document describes the acceptance criteria and study for the ASC QuadPort+ Laparoscopic Access Device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Defined Design & Performance Requirements)	Reported Device Performance
Device is easy to insert.	The device was easy to insert.
Instruments are easy to insert and withdraw.	Instruments are easy to insert and withdraw.
Device maintained pneumoperitoneum.	Device maintained pneumoperitoneum.
Surgeons are able to manipulate instruments for a laparoscopic procedure.	Surgeons were able to manipulate instruments for a laparoscopic procedure.
Surgeons are able to conduct a typical laparoscopic procedure.	Surgeons were able to conduct a typical laparoscopic procedure.
The device stayed in position during surgery.	The device stayed in position during surgery.
Does not raise new issues of safety or effectiveness.	Validation testing in a porcine model demonstrated that the performance did not raise any new issues of safety and effectiveness.
IFU adequately allows for device use without further training.	Validation testing in a porcine model demonstrated that the IFU adequately allowed for the use of the device without any further training.
Meets defined design and performance requirements.	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.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of subjects. The study involved a "porcine model," implying animal subjects.
Data Provenance: The study was conducted on a "porcine model," which suggests an experimental, prospective study in a controlled animal setting. The country of origin is not specified but is likely the location of Advanced Surgical Concepts (Ireland) or a contracted research facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated as a specific number. The document mentions "clinicians who were experienced with single port devices."
Qualifications of Experts: They were "experienced with single port devices." Specific qualifications like "radiologist with 10 years of experience" are not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The criteria are reported as direct observations (e.g., "The device was easy to insert"), implying a consensus or direct observation by the participating clinicians rather than a secondary adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a laparoscopic access device, not an AI-powered diagnostic tool. The performance study evaluated its functional aspects in a surgical setting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical surgical instrument, not an algorithm. The performance was evaluated with clinicians using the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Type of Ground Truth: The ground truth was established through expert observation and assessment during a simulated surgical procedure in a porcine model. The clinicians directly observed and evaluated the device's functional performance against predefined criteria.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not provided. This device is a physical medical instrument, not a machine learning algorithm that requires a training set. The "design inputs" and "design verification testing" serve a similar purpose to initial development and validation, but not in the context of a "training set" for AI.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable/not provided for the reasons stated above. The "ground truth" for the device's design and manufacturing (analogous to training for an algorithm) would be established through engineering specifications, material testing, and internal design verification processes against known quality and safety standards, but not in the sense of labeled data for AI.

Summary

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-8. 510(k) Summary

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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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

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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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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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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

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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

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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

Regulation Number and Section

§ 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.