NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021);
Device Facts
| Record ID | K232042 |
|---|---|
| Device Name | NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021); |
| Applicant | Mediconcepts Technology (Shenzhen) Company Limited |
| Product Code | GCJ · Gastroenterology, Urology |
| Decision Date | Oct 20, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
The NexPort Trocar System is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or other minimally invasive procedures to establish a path of entry for minimally invasive instruments.
Device Story
NexPort Trocar System is a sterile, single-use manual surgical instrument used in general, thoracic, and gynecologic minimally invasive procedures. The device consists of an obturator and a cannula. The surgeon inserts the obturator into the cannula, makes an incision on the patient's abdominal wall, and inserts the system to penetrate the cavity. Once positioned, the obturator is removed, allowing the surgeon to insert endoscopic instruments of corresponding diameters (5mm or 10mm) through the cannula. The device facilitates access to the abdominal cavity for surgical instruments. It is intended for use by surgeons in clinical settings. The system benefits patients by providing a stable, controlled access point for minimally invasive surgery, potentially reducing trauma compared to open procedures.
Clinical Evidence
No clinical data. Bench testing included biocompatibility (ISO 10993 series), sterilization validation (ISO 11137), packaging integrity (ASTM F1140, F88, F1929), and mechanical safety. An in vivo study was conducted on a porcine model to evaluate penetration force, fixation force, and tip integrity, confirming conformance to safety standards.
Technological Characteristics
Sterile, single-use manual trocar system. Available in 5mm and 10mm diameters with various lengths (65mm-105mm). Components include obturator, cannula, seals, valves, and stopcocks. Materials evaluated per ISO 10993-1. Sterilization via irradiation (SAL <= 10^-6). Complies with ANSI AAMI ISO 11137, 11607, and ASTM standards for packaging and seal strength.
Indications for Use
Indicated for use in general, thoracic, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for endoscopic instruments in patients requiring such procedures.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Disposable Laparoscope Trocar (K201641)
- Disposable Endoscopic Trocar (K180208)
Related Devices
- K202931 — Disposable Trocar · Wuxi Shukang Medical Appliance Co., Ltd. · Nov 17, 2020
- K060629 — GELPORT BLUNT TIP TROCAR SYSTEM · Applied Medical Resources Corp. · Apr 7, 2006
- K955412 — A.S.D. SAFETY TROCAR · American Surgical Devices · May 14, 1996
- K971738 — ENDOPATH RESPOSABLE TROCAR SYSTEM · Ethicon Endo-Surgery, Inc. · Aug 7, 1997
- K060096 — MODULAR TROCAR SYSTEM · Applied Medical Resources Corp. · Jan 24, 2006
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
October 20, 2023
MediConcepts Technology (Shenzhen) Company Limited Benjamin Chan Managing Director Building No. 37, Tongfu Industrial Estate, Dapeng New District Shenzhen City, Guangdong Province, China Shenzhen, Guangdong 518120 China
Re: K232042
Trade/Device Name: NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); NexPort™ Trocar System (TS221022); NexPort™ Trocar System (TS241020); NexPort™ Trocar System (TS241021); NexPort™ Trocar System (TS241022); NexPort™ Trocar System (TS331001); NexPort™ Trocar System (TS331002); NexPort™ Trocar System (TS331003); NexPort™ Trocar System (TS331004); NexPort™ Trocar System (TS332001); NexPort™ Trocar System (TS332002); NexPort™ Trocar System (TS332003); NexPort™ Trocar System (TS332004); NexPort™ Trocar System (TS332005); NexPort™ Trocar System (TS332006) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 17, 2023 Received: July 10, 2023
Dear Benjamin Chan:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.20
14:20:41 -04'00'
Mark Trumbore, Ph.D. Assistant Director 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
| Submission Number (if known) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K232042 |
| Device Name<br>NexPort™ Trocar System (TS211001);<br>NexPort™ Trocar System (TS211002);<br>NexPort™ Trocar System (TS211003);<br>NexPort™ Trocar System (TS211010);<br>NexPort™ Trocar System (TS211011);<br>NexPort™ Trocar System (TS211012);<br>NexPort™ Trocar System (TS221001);<br>NexPort™ Trocar System (TS221002);<br>NexPort™ Trocar System (TS221003);<br>NexPort™ Trocar System (TS221010);<br>NexPort™ Trocar System (TS221011);<br>NexPort™ Trocar System (TS221012);<br>NexPort™ Trocar System (TS221020);<br>NexPort™ Trocar System (TS221021);<br>NexPort™ Trocar System (TS221022);<br>NexPort™ Trocar System (TS241020);<br>NexPort™ Trocar System (TS241021);<br>NexPort™ Trocar System (TS241022);<br>NexPort™ Trocar System (TS331001);<br>NexPort™ Trocar System (TS331002);<br>NexPort™ Trocar System (TS331003);<br>NexPort™ Trocar System (TS331004);<br>NexPort™ Trocar System (TS332001);<br>NexPort™ Trocar System (TS332002);<br>NexPort™ Trocar System (TS332003);<br>NexPort™ Trocar System (TS332004);<br>NexPort™ Trocar System (TS332005);<br>NexPort™ Trocar System (TS332006)<br>Indications for Use (Describe) |
This device is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or minimally invasive procedures to establish a path of entry for minimally invasive instruments.
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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510(k) Summary
NexPort™ Trocar System
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### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| 1. Date: | July 8, 2023 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | MediConcepts Technology (Shenzhen) Company Limited<br>Building No. 37, Tongfu Industrial Estate, Dapeng New<br>District, Shenzhen City, Guangdong Province, 518120, P.R.<br>China |
| Contact person: | Nick Xu<br>Regulatory Affairs<br>MediConcepts Technology (Shenzhen) Company Limited<br>Building No. 37, Tongfu Industrial Estate, Dapeng New<br>District, Shenzhen City, Guangdong Province, 518120, P.R.<br>China<br>Telephone: +86 13338102750<br>Email: nick.xu@mediconcepts.com.hk |
- 3. Device Name: NexPort™ Trocar System
| Product Code | Classification | Regulation Section | Panel |
|--------------|----------------|----------------------------------------------------------------|----------------------------|
| GCJ | Class II | 21 CFR Part 876.1500<br>Laparoscope, General & Plastic Surgery | Endoscope &<br>accessories |
## 4. Predicate Devices:
| Predicate Device 510 (k)<br>number | Predicate Device name |
|------------------------------------|-------------------------------|
| K201641 | Disposable Laparoscope Trocar |
| K180208 | Disposable Endoscopic Trocar |
#### 5. Device Description:
The NexPort™ Trocar System is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed devices are available to accommodate 5mm and 10mm surgical instruments.
The 5mm NexPort™ Trocar System is consisted of:
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Image /page/6/Picture/2 description: This image shows an exploded view of a device with several labeled parts. Part a) is a long, thin tube with a wider section in the middle and a pointed end. Parts b), c), d), and e) are components that appear to fit together, forming a larger part of the device, while part f) is a separate, cylindrical piece with a handle. Finally, parts g) and h) are small, cylindrical pieces that seem to attach to the ends of part a).
- Obturator Shaft a)
- Cannula Cap b)
- Seal c)
- Duckbill Valve d)
- e) Cannula Body
- f) Luerlock Cap
- g) Obturator Tip Protector
- Cannula Tip Protector h)
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Image /page/7/Figure/2 description: This image shows an exploded view of a device with several components labeled with letters. On the left, component 'a' is a long, thin tool with a rounded top. In the center, components 'b' through 'i' are arranged in a vertical stack, suggesting how they fit together, while on the right, components 'j' through 'n' are similarly arranged, showing another set of parts and their assembly.
The 10mm NexPort™ Trocar System is consisted of:
- a) Obturator Shaft
- Cannula Cap b)
- Seal c)
- Cannula Intermediate Plate d)
- Duckbill Valve e)
- f) Cannula Housing
- Stopcock g)
- Face Seal h)
- i) Cannula Sleeve
- Reducer j)
- Adaptor Cap k)
- I) Adaptor Top Body
- m) Adaptor Seal
- n) Adaptor Bottom Body
| Table 5.1 the differences between these models | |
|------------------------------------------------|--|
|------------------------------------------------|--|
| Diameter | 5mm | 10mm |
|----------|----------------------|-------|
| Length | 65mm<br>70mm<br>95mm | 105mm |
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| Cannula Type | Microgroove Cannula<br>Ribbed Cannula | Microgroove Cannula |
|--------------|---------------------------------------|--------------------------------------------------------------|
| Pack | Single Pack<br>Dual Pack | Single Pack |
| Obturator | MicroFlat Obturator | MicroFlat Obturator<br>Blunt Obturator<br>Dilating Obturator |
| Transparency | Transparency<br>Non-transparency | Transparency<br>Non-transparency |
| Adaptor | N/A | Standard Adaptor<br>Slimline Adaptor |
- 6. Intended Use/Indications for Use:
The NexPort Trocar System is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or other minimally invasive procedures to establish a path of entry for minimally invasive instruments.
- 7. Technology:
The NexPort Trocar System employs the same fundamental scientific technology as its predicate devices.
- 8. Determination of Substantial Equivalence:
Comparison to Predicate Devices:
Below table is the summary comparison of features of the NexPort™ Trocar System and the predicate devices.
| Feature | Proposed Device:<br>NexPort™ Trocar System | Predicate Device:<br>Disposable Laparoscope<br>Trocar (K201641) | Predicate Device:<br>Disposable Endoscopic<br>Trocar (K180208) | Discussion of<br>Differences |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GCJ | GCJ | GCJ | Identical |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Feature | Proposed Device:<br>NexPort™ Trocar System | Predicate Device:<br>Disposable Laparoscope<br>Trocar (K201641) | Predicate Device:<br>Disposable Endoscopic<br>Trocar (K180208) | Discussion of<br>Differences |
| Intended/<br>Indications<br>for use | NexPort™ Trocar System is a<br>sterile, single-use device<br>and indicated for use in<br>general, thoracic,<br>gynecologic, or minimally<br>invasive procedures to<br>establish a path of entry for<br>minimally invasive<br>instruments. | The Disposable Laparoscope<br>Trocar has applications in<br>abdominal, thoracic, and<br>gynecologic minimally<br>invasive surgical procedures to<br>establish a path of entry for<br>endoscopic instruments. The<br>trocar may be used with or<br>without visualization for<br>primary and secondary<br>insertions. | The Disposable<br>Endoscopic Trocar has<br>applications in abdominal,<br>thoracic, and gynecologic<br>minimally invasive<br>surgical procedures to<br>establish a path of entry for<br>endoscopic instruments.<br>The trocar may be used<br>with or without<br>visualization for primary<br>and secondary insertions. | Identical |
| Application<br>Sites | Abdominal<br>Thoracic<br>Gynecologic | Abdominal<br>Thoracic<br>Gynecologic | Abdominal<br>Thoracic<br>Gynecologic | Identical |
| Principles of<br>Operation | 1. Installation<br>Surgeon inserts the obturator<br>in the cannula.<br><br>2. Insertion<br>Surgeon makes an incision<br>on the patients' abdominal wall<br>and inserts the installed<br>laparoscopic trocar system via<br>the incision.<br><br>3. Operation<br>Surgeon removes the<br>obturator from the cannula.<br>Surgeon can insert the<br>corresponding diameter<br>instrument in the cannula<br>based on his/ her needs. | Unkonwn | During the operation, the<br>trocar sleeve and the<br>obturator are used together.<br>The surgeon uses the<br>obturator to expand the<br>incision of the abdomen<br>and penetrates the trocar<br>sleeve through the<br>abdominal surface of the<br>human body into the<br>abdominal cavity, thereby<br>delivering gas to the<br>abdominal cavity and<br>establishing a path of entry<br>for endoscopic<br>instruments. | Identical |
| Signle use | Yes | Yes | Yes | Identical |
| Operation<br>Mode | Manually | Manually | Manually | Identical |
| Diameter | 5mm, 10mm | 5mm, 10mm, 12mm, 15mm | 5mm, 10mm, 12mm | The diameters<br>of proposed<br>device are<br>contained in the<br>predicated<br>device<br>(K201641). |
| Length | 65mm, 70mm, 95mm,<br>105mm | 96mm, 98mm, 99mm,<br>111mm | 100mm | Different, the<br>devices are all<br>offered in a<br>variety of<br>lengths to<br>accommodate<br>various clinical<br>use. |
| Feature | Proposed Device:<br>NexPort™ Trocar System | Predicate Device:<br>Disposable Laparoscope<br>Trocar (K201641) | Predicate Device:<br>Disposable Endoscopic<br>Trocar (K180208) | Discussion of<br>Differences |
| Biocompatibil<br>ity | Cytotoxicity<br>Sensitization<br>Intracutaneous reactivity<br>Acute systemic toxicity<br>Material-mediated<br>pyrogenicity | Cytotoxicity<br>Sensitization<br>Intracutaneous reactivity<br>Acute systemic toxicity<br>Material-mediated<br>pyrogenicity | Cytotoxicity<br>Sensitization<br>Intracutaneous reactivity<br>Acute systemic toxicity<br>Material-mediated<br>pyrogenicity | Identical |
| SAL | $<=10^{-6}$ | $<=10^{-6}$ | $<=10^{-6}$ | Identical |
| Method of<br>Sterilization | Irradiation | Ethylene Oxide sterilization | Irradiation | The proposed<br>device adopts the<br>same method of<br>sterilization as its<br>predicated device<br>Disposable<br>Endoscopic<br>Trocar (K180208) |
Table 5.2 Features comparison between proposed device and predicate devices
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Image /page/9/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a stylized, three-leaf clover design in blue and green. Below the clover is the text "MediConcepts" in a bold, blue sans-serif font, with the word "Group" appearing in a smaller font size directly underneath.
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From the comparison summary table, the NexPort™ Trocar System is substantially equivalent to the predicated devices with regard to intended use, technological characteristics, safety and effectiveness.
- The devices are all intended for used in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
- The devices are all offered in a variety of lengths and Diameter to ● accommodate various anatomical locations and differences in patient anatomy.
- The proposed device and its predicated device Disposable Endoscopic Trocar (K180208) have the same Principles of Operation.
- . The devices are all offered with single use, the Sterilization Assurance Level (SAL) are all <= 10-6, and proposed device adopts the same method of sterilization as its predicated device Disposable Endoscopic Trocar (K180208).
- 9. Summary of Non-Clinical Tests:
NexPort Trocar System has been evaluated for biocompatibility, accelerated aging test and real-time aging test as well as shelf life, sterilization, and mechanical safety, meantime in vivo study was conducted on porcine model to evaluate the penetration force, fixation force and tip integrity have been found to conform to applicable medical device safety standards. The NexPort Trocar System complies with below voluntary standards:
ANSI AAMI ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
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Image /page/11/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a stylized, three-lobed shape in blue and green, resembling a stylized flower or clover. Below the shape, the text "MediConcepts" is written in a bold, sans-serif font, with the word "Group" appearing underneath in a smaller font size.
ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
ANSI AAMI ISO 10993-5: 2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI AAMI ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation.
ANSI AAMI ISO 11137-1: 2006/(R)2015 Sterilization of health care products -Radiation - Part 1: Requirements for development.
ANSI AAMI ISO 11137-2:2013 Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose.
ANSI AAMI ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ANSI AAMI ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ASTM F1140/F1140M-13: 2020(E1) Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
ASTM F88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ASTM F1980-16 Sterile hypodermic needles for single use - Requirements and test methods.
The following quality assurance measures are applied to the development of the system:
- . Risk Analysis
- Performance testing (Verification) ●
- Safety testing (Verification) ●
The NexPort Trocar System is provided with sterilization and is biocompatible.
#### 10. Conclusion
MediConcepts Group considers the NexPort Trocar System to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
