(14 days)
Not Found
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device description and intended use indicate it is an access system for surgical procedures, not a device that directly treats a disease or condition.
No
Explanation: The device, YelloPort port access system, is described as a surgical instrument (trocar and cannula) used to create access to the abdominal or thoracic cavity during laparoscopic procedures. Its function is to facilitate access and maintain pneumoperitoneum, not to diagnose medical conditions by identifying or analyzing symptoms, signs, or data.
No
The device description clearly outlines physical components such as trocars, cannulas, bases, caps, valves, and seals, made from materials like surgical steel and medical grade polymers. It also details sterilization methods for these physical components. There is no mention of software as a component of this device.
Based on the provided information, the YelloPort port access system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in laparoscopic procedures to provide access to the abdominal and thoracic cavities. 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 surgical instrument (trocar and cannula) used for creating and maintaining access 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 blood, urine, tissue, or other bodily fluids.
- Detecting or measuring specific substances (analytes).
- Providing diagnostic information.
- Using reagents or calibrators.
The YelloPort system is a surgical tool used for access during minimally invasive procedures.
N/A
Intended Use / Indications for Use
The YelloPort port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
In laparoscopic surgery the trocar is introduced into the cannula to accomplish cannula penetration of the abdominal wall. The cannula has a valve system at its proximal end and the trocar is removed from the cannula after the puncture of the abdominal wall. The cannula acts as a channel for the introduction of the endoscopes and instruments. Generically, trocars and cannulae are available in a range of sizes from 3mm to 13mm in diameter.
The device comprises a trocar, available with a range of tips styles, and a base. The base forms the cannula and has a removable 'cap' which retains the valve and/or lip seal. The trocar and cannula elements of the device are fully reusable and can be sterilised in pressurised steam. Valves and seals are essential accessories used in conjunction with the cannula and are available in a range of formats depending on the specific market requirements.
YelloPort is ergonomically designed to be strong and durable yet lightweight and easy to handle. Medical grade polymers ensure the main elements are fully reusable and can be autoclaved in pressurised steam. Cannulae are available with a choice of internal diameters and a range of working lengths.
Trocars are made from the finest surgical steels, hand finished to give reliable and lasting performance. The patented shielded trocar is also fully reusable and can be taken apart for ease of cleaning and maintenance. The precision ground and polished cutting tubes can be replaced economically if they become blunt or damaged.
The combination of reusable cannulae and trocars together with single-use valves / seals makes YelloPort a highly cost effective solution.
The device is manufactured from materials that comply with the requirements of ISO 10993 in terms of biocompatibility.
The YelloPort valves and seals are sterilised using a validated method of gamma irradiation, thereby providing a sterility assurance level of 106.
The YelloPort cannulae bodies and trocars are provided non-sterile. Sterilisation instructions are provided in the instructions for use. The Surgical Innovations steam sterilisation and cleaning validation methods are based on the AAMI TIR No 12-1994, Designing, Testing and Labelling Reusable Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufactures and proves a sterility assurance level of 106. Sterilisation validation of the steam sterilisations is based on three sterilisation cycles at one half the exposure time. The use of Bacillus sterothermophilus spore strips or inoculum is the utilised indicator.
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
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)
Trocar Reliability and Insertion Performance: Bench tests were undertaken to determine the insertion performance and reliability of the YelloPort trocars. No known standards are available but a methodical approach has been undertaken based on extensive experience and advice from industry experts and clinicians. Many tests have been undertaken and a full list of all tests conducted has been attached. Nonetheless, tests worthy of particular note are detailed in TN100097, TN100144, TN100199 and TN100200.
Sealing Performance: Test work has been undertaken to ensure that cannulae maintain pneumoperitoneum both when instruments are inserted in the cannula and when no instruments are inserted. This includes testing both seal and valve performance at ranges from 0mmHg to a maximum of 24mmHg. A full list of all tests conducted has been attached. Nonetheless, tests worthy of particular note are detailed in TN100131, TN100155, and TN100156.
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
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMISSION TYPE: | Special |
| SUBMITTED BY: | Surgical Innovations Group plc |
| Clayton Park | |
| Clayton Wood Rise | |
| LEEDS | |
| LS16 6RF |
|
| Tel: | + 44 (0) 113 2307 597 |
| Fax: | + 44 (0) 113 2307 598 |
| CONTACT PERSON: | Stuart Moran
Joint Managing Director |
| DATE OF PREPARATION: | 12th January 2007 |
| NAME OF DEVICE: | YelloPort Port Access System |
| CLASSIFICATION NAME: | General and Plastic Surgery
(Regulation Number 21CFR 876.1500) |
| TRADE NAME: | YelloPort |
| PREDICATE DEVICES: | Surgical Innovations' PortLand Trocars which are
cleared to market under premarket notification K962193. |
INDICATIONS FOR USE:
The YelloPort port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.
SUMMARY STATEMENT:
In laparoscopic surgery the trocar is introduced into the cannula to accomplish cannula penetration of the abdominal wall. The cannula has a valve system at its proximal end and the trocar is removed from the cannula after the puncture of the abdominal wall. The cannula acts as a channel for the introduction of the endoscopes and instruments. Generically, trocars and cannulae are available in a range of sizes from 3mm to 13mm in diameter.
The device comprises a trocar, available with a range of tips styles, and a base. The base forms the cannula and has a removable 'cap' which retains the valve and/or lip seal. The trocar and cannula elements of the device are fully reusable and can be sterilised in pressurised steam. Valves and seals are essential accessories used in conjunction with the cannula and are available in a range of formats depending on the specific market requirements.
The YelloPort port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum. The YelloPort port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.
YelloPort is ergonomically designed to be strong and durable yet lightweight and easy to handle. Medical grade polymers ensure the main elements are fully reusable and can be autoclaved in pressurised steam. Cannulae are available with a choice of internal diameters and a range of working lengths.
510(k) Summary for YelloPort Port Access System - Surgical Innovations Group
1
Trocars are made from the finest surgical steels, hand finished to give reliable and lasting performance. The patented shielded trocar is also fully reusable and can be taken apart for ease of cleaning and maintenance. The precision ground and polished cutting tubes can be replaced economically if they become blunt or damaged.
The combination of reusable cannulae and trocars together with single-use valves / seals makes YelloPort a highly cost effective solution.
The device is manufactured from materials that comply with the requirements of ISO 10993 in terms of biocompatibility.
The YelloPort valves and seals are sterilised using a validated method of gamma irradiation, thereby providing a sterility assurance level of 106.
The YelloPort cannulae bodies and trocars are provided non-sterile. Sterilisation instructions are provided in the instructions for use. The Surgical Innovations steam sterilisation and cleaning validation methods are based on the AAMI TIR No 12-1994, Designing, Testing and Labelling Reusable Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufactures and proves a sterility assurance level of 106. Sterilisation validation of the steam sterilisations is based on three sterilisation cycles at one half the exposure time. The use of Bacillus sterothermophilus spore strips or inoculum is the utilised indicator.
The YelloPort Port Access System is substantially equivalent to Surgical Innovations' own PortLand Trocars, which are cleared to market under premarket notification K962193 in terms of intended use, design and use methodology, and are manufactured from similar materials.
Surgical Innovations is the manufacturer of the device and has followed design control regulations per 21 CFR § 820.30. The design controls have been in place since 1998 and have been audited by FDA on several occasions. The design of the YelloPort Port Access System was undertaken entirely within the Surgical Innovations Design Control System.
A design Risk Assessment was conducted in accordance with Surgical Innovations internal Stand Operating Procedures, ISO 9001/ISO 13485, ISO 14971 and 21 CFR § 820.30, validation and verification activities addressed in the profile. Based on the risk analysis, validation and verification activities were formally controlled and addressed by Surgical Innovations, the activities included the methods, tests used and acceptance criteria applied.
REVIEW OF PERFORMANCE DATA
Trocar Reliability and Insertion Performance
It is essential that laparoscopic trocars are sharp, are capable of ease of insertion into the abdominal wall, and are reliable if they contain moving parts. Furthermore, Surgical Innovations has undertaken a range of bench tests to determine the insertion performance and reliability of the YelloPort trocars. No known standards are available but a methodical approach has been undertaken based on extensive experience and advice from industry experts and clinicians. Many tests have been undertaken and a full list of all tests conducted has been attached. Nonetheless, tests worthy of particular note are detailed in TN100097, TN100144, TN100199 and TN100200.
510(k) Summary for YelloPort Port Access System - Surgical Innovations Group
2
Sealing Performance
It is essential that cannulae maintain pneumoperitoneum both when instruments are inserted in the cannula and when no instruments are inserted. Therefore, it is important to test both seal and valve performance at ranges from 0mmHg to a maximum of 24mmHg.
A substantial amount of test work has been undertaken and a full list of all tests conducted has been attached. Nonetheless, tests worthy of particular note are detailed in TN100131, TN100155, and TN100156.
Conclusion
It can be concluded from the above bench testing that the product performs well and is fit for purpose.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2007
Surgical Innovations Group, plc % Intertek Testing Services NA, Inc. Mr. Neil E. Devine, Jr. 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K070712
Trade/Device Name: YelloPort Port Access System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 13, 2007 Received: March 14, 2007
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Mr. Neil E. Devine, Jr.
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
YelloPort Port Access System
The YelloPort port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.
V
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
l676^
Prescription Use (Part 21CFR801 Subpart D) AND/OR
Over-The-Counter Use (Part 21CFR801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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