Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and sealing properties, with no mention of AI/ML or data processing.

Therapeutic

No

Explanation: This device is used to create and maintain access to the abdominal or thoracic cavity during laparoscopic or thoracoscopic procedures. While it facilitates surgical procedures, it does not directly treat or cure a disease or condition itself.

Diagnostic

No

The YelloPort Elite port access system is described as a device used to provide access to the abdominal or thoracic cavity during laparoscopic or thoracoscopic procedures, enabling the introduction of endoscopes and instruments. Its intended use is for access and maintenance of pneumoperitoneum, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (trocar, cannula, universal seal, Hasson adaptor) and performance studies focus on mechanical and physical properties, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide access to the abdominal and thoracic cavities during laparoscopic and thoracoscopic procedures. This is a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description details a system of physical components (trocar, cannula, seal, adaptor) used for creating and maintaining access during surgery. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Indicators: There is no mention of analyzing blood, tissue, or other bodily fluids, nor any reference to diagnostic information being generated by the device.
Performance Studies: The performance studies focus on the physical and mechanical properties of the device (sealing, insertion force, compatibility, etc.) and its ability to function as a surgical access tool. They do not involve the analysis of biological samples or diagnostic accuracy.

Therefore, the YelloPort Elite Port Access System is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.

The YelloPort Elite port access system is also indicated for use in thoracoscopic procedures to give access to the thoracic cavity.

Product codes (comma separated list FDA assigned to the subject device)

GCJ

Device Description

The YelloPort Elite Port Access System comprises a trocar, available with a range of tip styles, cannula. Universal Seal and Hasson (fascia) adaptor. The trocar, cannula and Hasson (fascia) adaptor elements of the device are fully reusable and can be sterilised in pressurised steam. The Universal seal is single use only.

In order to obtain access to the surgical site during laparoscopic surgery, the YelloPort Elite Trocar is introduced into the YelloPort Elite Cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the YelloPort Elite Universal 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. Generically, trocars and cannulas are available in a range of lengths and diameters.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Abdominal cavity, thoracic cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital

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)

Non-Clinical Tests (Performance/Physical Data):
The YelloPort Elite Port Access System was evaluated for its safety and effectiveness based on the following testing:

Sealing Performance
Instrument Insertion Force (Universal Seal)
Seal Contamination Testing
Instrument Compatibility Testing (Universal Seal)
Port Insertion Force Testing
Insufflation Testing
Seal Inversion Testing
Trocar Knob Pull Testing
Stopcock Torque Lever Test
Universal Seal Attachment and Removal Test
Cannula Mechanical Testing
Pressure Retention of Universal Seal (With Use of Locking Shielded Trocar)
Trocar Peritoneum Insertion Simulation Test (Locking Shielded)
Torque Force Test (Locking Shielded)
Tensile Test (Locking Shielded)
Biocompatibility Testing in accordance with ISO 10993-1
Shelf life and lifecycle studies
Transit studies
Cleaning and sterilisation validation
Clinical (Design) validations which include a simulated surgical evaluation by a consultant surgeon
Usability assessments.

Clinical Studies:
No clinical studies were conducted as part of submission to prove substantial equivalence. Non-Clinical Bench testing was sufficient to prove equivalence to the predicate device.

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.

K070712, K032676

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

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.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.

April 29, 2019

Surgical Innovations Limited Ms. Shazia Chaudhry Quality Assurance and Regulatory Manager Clayton Wood House 6 Clayton Wood Bank Leeds, West Yorkshire, LS16 6QZ, United Kingdom

Re: K190592

Trade/Device Name: YelloPort Elite Port Access System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 28, 2019 Received: March 7, 2019

Dear Ms. Chaudhry:

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. 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.

1

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 801and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K190592

Device Name YelloPort Elite Port Access System

Indications for Use (Describe)

The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.

The YelloPort Elite port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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3

For YelloPort Elite Port Access System 510(k) Summary - 510(k)190592

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's Name:

Surgical Innovations Ltd.

Submitter's Address:

Clayton Wood House 6 Clayton Wood Bank Leeds LS16 6QZ United Kingdom

Telephone: +44(0)113 230 7597

Establishment Registration Number:

9680952

Contact Person:

Miss Shazia Chaudhry (BSc. M.Phil. MBA)

Clayton Wood House 6 Clayton Wood Bank Leeds LS16 6QZ United Kingdom

Telephone: +44(0)113 230 7597

E-Mail: shazia.chaudhry@surginno.co.uk

Date Prepared:

24 April 2019

4

For YelloPort Elite Port Access System 510(k) Summary - 510(k)190592

The information below summarises the Device Classification Information regarding the YelloPort Elite Port Access System:

Primary Product Code:

| Regulation
Number | Device | Device Class | Product
Code | Classification
Panel |
|----------------------|-------------------------------------------|--------------|-----------------|------------------------------|
| 876.1500 | Laparoscope, General &
Plastic Surgery | Class 2 | GCJ | General &
Plastic Surgery |

Device Trade Name:

YelloPort Elite Port Access System

Device Common Name:

YelloPort Elite Port Access System

Intended/ Indications Use:

The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.

The YelloPort Elite port access system is also indicated for use in thoracoscopic procedures to give access to the thoracic cavity.

Summary of Substantial Equivalence:

The predicate devices which are used to claim equivalence of the YelloPort Elite Port Access System are detailed in the summary table below.

5

For YelloPort Elite Port Access System 510(k) Summary – 510(k)190592

Summary of Comparison between Proposed Device and Predicate Device

General Information
Property	Proposed Device	Primary Predicate	Secondary Predicate	Secondary Predicate
	YelloPort Elite Port
Access System	YelloPort Plus Port
Access System	YelloPort Port
Access System	ENDOPATH XCEL
Bladeless Trocar
Universal Seal
Common
Name	Laparoscope,
General & Plastic
Surgery	Laparoscope,
General & Plastic
Surgery	Laparoscope,
General & Plastic
Surgery	Laparoscope, General
& Plastic Surgery
Device
Manufacturer	Surgical Innovations	Surgical Innovations	Surgical Innovations	Ethicon Endo-Surgery,
LLC
Device
Classification	II	II	II	II
Primary
Product Code	GCJ	GCJ	GCJ	GCJ
510(k)
Number	N/A	K070712	K070712	K032676
Environment	Hospital	Hospital	Hospital	Hospital
Intended Use/
Indication for
Use	The YelloPort Elite
Port Access System is
indicated for use in
laparoscopic
procedures to give
access to the
abdominal cavity while
maintaining
pneumoperitoneum.

The YelloPort Elite
Port access system is
also indicated for use
in thoracoscopic
procedures to give
access to the thoracic
cavity. | The YelloPort Plus
Port Access System is
indicated for use in
laparoscopic
procedures to give
access to the
abdominal cavity
whilst maintaining
pneumoperitoneum.

The YelloPort Plus
Port Access System is
also indicated for use
in laparoscopic
procedures to give
access to the thoracic
cavity. | The YelloPort Port
Access System is
indicated for use in
laparoscopic
procedures to give
access to the
abdominal cavity
whilst maintaining the
pneumoperitoneum.

6

For YelloPort Elite Port Access System 510(k) Summary - 510(k)190592

Any technical differences have been justified, both scientifically and using performance testing. These do not affect the safety or effectiveness of the proposed device.

Device Description:

The YelloPort Elite Port Access System comprises a trocar, available with a range of tip styles, cannula. Universal Seal and Hasson (fascia) adaptor. The trocar, cannula and Hasson (fascia) adaptor elements of the device are fully reusable and can be sterilised in pressurised steam. The Universal seal is single use only.

In order to obtain access to the surgical site during laparoscopic surgery, the YelloPort Elite Trocar is introduced into the YelloPort Elite Cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the YelloPort Elite Universal 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. Generically, trocars and cannulas are available in a range of lengths and diameters.

7

For YelloPort Elite Port Access System 510(k) Summary - 510(k)190592

Technological Characteristics:

A comparative review of the YelloPort Elite Port Access System with the predicate devices found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent to the predicate devices.

Non-Clinical Tests (Performance/Physical Data):

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

Sealing Performance
Instrument Insertion Force (Universal Seal)
Seal Contamination Testing
Instrument Compatibility Testing (Universal Seal)
Port Insertion Force Testing
. Insufflation Testing
Seal Inversion Testing
. Trocar Knob Pull Testing
Stopcock Torque Lever Test
Universal Seal Attachment and Removal Test
Cannula Mechanical Testing
Pressure Retention of Universal Seal (With Use of Locking Shielded Trocar) .
Trocar Peritoneum Insertion Simulation Test (Locking Shielded)
Torque Force Test (Locking Shielded)
Tensile Test (Locking Shielded)
. Biocompatibility Testing in accordance with ISO 10993-1
. Shelf life and lifecycle studies
. Transit studies
. Cleaning and sterilisation validation
Clinical (Design) validations which include a simulated surgical evaluation by a consultant surgeon
. Usability assessments.

Clinical Studies

No clinical studies were conducted as part of submission to prove substantial equivalence. Non-Clinical Bench testing was sufficient to prove equivalence to the predicate device.

Safety and Effectiveness/Conclusion:

Based on the information presented in these 510(k) premarket notifications the YelloPort Elite Port Access System is considered substantially equivalent. The YelloPort Elite Port Access System is as safe and effective as the currently marketed predicate devices.

Based on testing and comparison with the predicate device. the YelloPort Elite Port Access System shows no adverse indications or results. It is our determination that the YelloPort Elite Port Access System is safe, effective and performs within its design specifications and is substantially equivalent to the predicate devices.