The Port Access System consists of reusable and single use components sold in various configurations. The ports accommodate laparoscopic instrument diameters from 5mm up to the diameter indicated on the chosen accompanying cannula. All single use parts are sterlised using gamma irradiation and supplied to the customer in a sterile condition.

In order to obtain access to the surgical site during laparoscopic surgery, the trocar is introduced into the cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the single use seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a device called the "Port Access System." It details the device's indications for use, comparison with a predicate device, and performance data. However, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI-powered system or a study involving human readers.

Here's why the prompt's requested information cannot be fully extracted from the provided text:

Type of Device: The "Port Access System" is a surgical instrument (laparoscopic port system), not an AI-powered diagnostic or decision-making tool. Therefore, many of the requested criteria (e.g., AI model performance metrics, ground truth establishment for AI, MRMC studies) are not applicable.
Nature of Performance Data: The performance data discussed are related to the physical characteristics and functionality of the surgical device (biocompatibility, sealing performance, insertion force, fatigue, shelf life, cleaning/sterilization), not to diagnostic accuracy or human interpretation tasks.
Absence of Specific Acceptance Criteria Table: While safety and effectiveness are general criteria, there isn't a table of specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, AUC) and reported device performance against those criteria in the context of an AI study.
No Clinical Studies: The document explicitly states, "No Clinical Studies were conducted as part of this submission. Non-Clinical Testing was sufficient to demonstrate substantial equivalence to the predicate device." This means there would be no data on human reader performance, expert ground truth, or adjudication methods in a clinical setting for this device regarding diagnostic or interpretive tasks.

Given the context of the provided document, the following points can be addressed, and others explicitly stated as not applicable or not found:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for the type of device described (surgical instrument, not AI/diagnostic). The document broadly states "safety and effectiveness" and "performs within its design specifications" were evaluated through non-clinical testing. Specific numerical acceptance criteria for functional performance tests (e.g., maximum insertion force, minimum seal integrity) are likely present in the underlying test reports but are not provided in this summary document.

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

Test Set Sample Size: Not specified for individual non-clinical tests. The tests were performed on components and the system itself (e.g., seals, cannulas, trocars). This is not a "dataset" in the sense of AI or clinical studies.
Data Provenance: The device is manufactured by Surgical Innovations Limited in the United Kingdom. Testing was conducted to US FDA guidance and international standards (ISO 10993-1).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of AI or diagnostic accuracy studies is not relevant for a physical surgical instrument's mechanical and material performance testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements in expert interpretations, which is not relevant for the non-clinical testing of a surgical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, 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. The device is a surgical instrument, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This concept is not applicable as the device is a physical surgical port system, not an algorithm.

7. The type of ground truth used

Not applicable in the sense of diagnostic/AI ground truth. For the non-clinical tests, the "ground truth" would be the measured physical properties and performance characteristics against pre-defined engineering specifications and regulatory standards. For example, "sealing performance" would be measured directly against a specified leakage rate.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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June 18, 2021

Surgical Innovations Limited Stephen Seed Compliance Director Clayton Wood House, 6 Clayton Wood Bank Leeds, West Yorkshire LS16 6OZ United Kingdom

Re: K210495

Trade/Device Name: Port Access System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 27, 2021 Received: June 1, 2021

Dear Stephen Seed:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long H. Chen. Ph.D. Assistant Director Non-Light Based Energy Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210495

Device Name Port Access System

Indications for Use (Describe)

The Port Access System is indicated for use in laparoscopic procedures to the abdominal and thoracic cavities while maintaining pneumoperitoneum.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 201.5 Subject to Rx)
☐ Over-The-Counter Use (21 CFR 201.5 Subject to OTC)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Surgical Innovations. The word "Surgical" is in a teal color, and the word "Innovations" is in a gray color. The logo is simple and modern.

Port Access System Section 5: 510(k) Summary

-Submitter

Surgical Innovations Limited Clayton Wood House 6 Clayton Wood Bank Leeds LS16 6QZ United Kingdom

Phone: +44 (0) 113 230 7597

Contact Person: Stephen Seed Date Prepared: 25 March 2021

II. Device

Name of Device: Port Access System Common Name: Laparoscopic Port System Classification Name: Endoscope and Accessories (21 CFR 876.1500) Requlatory Class: II Product Code: GCJ

lll. Predicate Device

YelloPort Elite Port Access System - K190592

The predicate has not been subject to any design-related recalls.

IV. Device Description

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Image /page/4/Picture/1 description: The image contains the logo for Surgical Innovations. The word "Surgical" is in a teal color, and the word "Innovations" is in a gray color. The logo is simple and modern.

V. Indications for Use

The Port Access System is indicated for use in laparoscopic procedures to give access to the abdominal and thoracic cavities while maintaining pneumoperitoneum.

VI. Comparison of Technological Characteristics with the Predicate Device

Property	Proposed Device	Primary Predicate

Common Name	Port Access SystemLaparoscope, General & PlasticSurgery	YelloPort Elite Port Access SystemLaparoscope, General & PlasticSurgery
Device Manufacturer	Surgical Innovations	Surgical Innovations
Device Classification	II	II
Primary Product Code	GCJ	GCJ
510(k) Number	N/A	K190592
Environment	Hospital	Hospital
Intended Use/ Indication for Use	The Port Access System is indicatedfor use in laparoscopic procedures togive access to the abdominal andthoracic cavities while maintainingpneumoperitoneum.	The YelloPort Elite Port AccessSystem is indicated for use inlaparoscopic procedures to giveaccess to the abdominal cavity whilemaintaining pneumoperitoneum.The YelloPort Elite Port accesssystem is also indicated for use inlaparoscopic procedures to giveaccess to the thoracic cavity.
Trocar Tip Geometries	Bladeless, Pencil point, LockingShielded, Quill	Blunt, Pencil point, Pyramidal,Shielded (locking)
Trocar / Cannula Diameter andLengths	Available in 5, 10 and 12 mmdiameters; and in 55, 70, 95, and 105and 150 mm working lengths.	Available in 10 and 12 mm diameter;and in 75, 105 and 150 mm workinglengths.
Comparison of Use:	Allows instruments from 5mm -12mmin diameter to be used.	Allows instruments from 5mm -12mmin diameter to be used.
Trocar Patient Contacting Material	Single Use: CopolyesterReusable: Stainless Steel	Stainless Steel
Trocar Supplied:	Single Use: SterileReusable: Non-Sterile	Non-sterile (Reusable)
Cannula Patient ContactingMaterials	Single Use: CopolyesterReusable: PEEK plastic	PEEK plastic
Cannula Supplied:	Single Use: SterileReusable: Non-Sterile	Non-sterile (Reusable)
Seal	Consists of:Non-Return Valve &Instrument Seal	Consists of:Non-Return Valve &Instrument Seal
Seal Supplied:	Sterile	Sterile

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Image /page/5/Picture/1 description: The image contains the logo for Surgical Innovations. The word "Surgical" is in teal, and the word "Innovations" is in gray. The logo is simple and modern.

VII. Performance Data

A comparative review of the Port Access System with the predicate devices was conducted and the following performance data are provided in support of determining substantial equivalence of Port Access System to the predicate devices.

Biocompatibility

Biological evaluation of the single use and reusable components of the Port Access System was conducted in accordance with International Standard ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process and the US FDA quidance document Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process' (2016 & 2020).

Non-Clinical Testing

The Port Access System was evaluated for its safety and effectiveness based on the following testing:

Sealing Performance ●
Instrument Insertion Force (Universal Seal)
Instrument Shaft Friction (Universal Seal)
. Instrument Compatibility (Universal Seal)
Seal Contamination
Insertion Force
. Insufflation
. Seal Core Inversion Testing
Tensile ●
. Torque
Endoscope Insertion/Retraction
. Fatigue
Shelf Life
Transit studies
. Cleaning & Sterilisation Validation
. Usability

Clinical Studies

No Clinical Studies were conducted as part of this submission. Non-Clinical Testing was sufficient to demonstrate substantial equivalence to the predicate device.

VIII. Conclusions

The information presented in the 510(k) premarket notifications demonstrates that the Port Access System is considered substantially equivalent to the predicate device. The Non-Clinical Bench Testing performed demonstrates that the Port Access System is safe, effective and performs within its design specifications and is substantially equivalent to the predicate devices. The Port Access System is as safe and effective as the currently marketed predicate devices.

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.