(102 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a surgical trocar system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a trocar system used to establish a path of entry for surgical instruments during minimally invasive procedures. It is an access tool, not a device designed to treat a condition or disease.
No
Explanation: The device is described as a surgical tool used to establish a path for instruments, not to diagnose a condition or disease.
No
The device description clearly lists multiple physical components (Obturator Shaft, Cannula Cap, Seal, etc.) and the performance studies focus on physical properties and in vivo testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a path of entry for minimally invasive instruments" during surgical procedures. This is a surgical tool used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details components of a surgical trocar system designed to create an opening for instruments. These are physical tools for surgical access.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect markers, or provide any diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility, aging, sterilization, mechanical safety, and in vivo performance (penetration force, fixation force, tip integrity). These are typical evaluations for surgical devices, not IVDs which would focus on analytical performance (sensitivity, specificity, accuracy, etc.).
In summary, the NexPort™ Trocar System is a surgical access device, not a diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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:
- 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)
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal, Thoracic, Gynecologic
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)
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.
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.
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
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
1
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
2
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
3
Indications for Use
| Submission Number (if known) |
|---|
| 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); |
| 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) |
| 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)
4
Image /page/4/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, sans-serif font, with the word "Group" appearing in a smaller font size underneath.
510(k) Summary
NexPort™ Trocar System
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Image /page/5/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features three interlocking shapes in blue and green, resembling a stylized clover or trefoil. Below the symbol, the text "MediConcepts Group" is written in a sans-serif font, with "MediConcepts" in a larger, bolder font and "Group" in a smaller font size.
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 |
| Building No. 37, Tongfu Industrial Estate, Dapeng New | |
| District, Shenzhen City, Guangdong Province, 518120, P.R. | |
| China | |
| Contact person: | Nick Xu |
| Regulatory Affairs | |
| MediConcepts Technology (Shenzhen) Company Limited | |
| Building No. 37, Tongfu Industrial Estate, Dapeng New | |
| District, Shenzhen City, Guangdong Province, 518120, P.R. | |
| China | |
| Telephone: +86 13338102750 | |
| Email: nick.xu@mediconcepts.com.hk |
-
- Device Name: NexPort™ Trocar System
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| GCJ | Class II | 21 CFR Part 876.1500 | |
| Laparoscope, General & Plastic Surgery | Endoscope & | ||
| accessories |
4. Predicate Devices:
| Predicate Device 510 (k)
| 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:
6
Image /page/6/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features three overlapping shapes in the colors blue and green. The shapes are arranged in a circular pattern. Below the shapes, the text "MediConcepts Group" is written in a sans-serif font, with "MediConcepts" in a slightly larger and bolder font than "Group".
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)
7
Image /page/7/Picture/0 description: The image shows the logo for MediConcepts Group. The logo features a three-leaf clover design in blue and green. Below the clover is the text "MediConcepts Group" in a sans-serif font, with "MediConcepts" in a larger, bolder font than "Group."
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 | |
| 70mm | ||
| 95mm | 105mm |
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Image /page/8/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, sans-serif font, with the word "Group" appearing in a smaller font size underneath.
| Cannula Type | Microgroove Cannula
Ribbed Cannula | Microgroove Cannula |
|--------------|---------------------------------------|--------------------------------------------------------------|
| Pack | Single Pack
Dual Pack | Single Pack |
| Obturator | MicroFlat Obturator | MicroFlat Obturator
Blunt Obturator
Dilating Obturator |
| Transparency | Transparency
Non-transparency | Transparency
Non-transparency |
| Adaptor | N/A | Standard Adaptor
Slimline Adaptor |
-
- 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.
- Intended Use/Indications for Use:
-
- Technology:
The NexPort Trocar System employs the same fundamental scientific technology as its predicate devices.
- Technology:
-
- Determination of Substantial Equivalence:
Comparison to Predicate Devices:
- Determination of Substantial Equivalence:
Below table is the summary comparison of features of the NexPort™ Trocar System and the predicate devices.
| Feature | Proposed Device:
NexPort™ Trocar System | Predicate Device:
Disposable Laparoscope
Trocar (K201641) | Predicate Device:
Disposable Endoscopic
Trocar (K180208) | Discussion of
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:
NexPort™ Trocar System | Predicate Device:
Disposable Laparoscope
Trocar (K201641) | Predicate Device:
Disposable Endoscopic
Trocar (K180208) | Discussion of
Differences |
| Intended/
Indications
for use | NexPort™ Trocar System 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. | The Disposable Laparoscope
Trocar has applications in
abdominal, thoracic, and
gynecologic minimally
invasive surgical procedures to
establish a path of entry for
endoscopic instruments. The
trocar may be used with or
without visualization for
primary and secondary
insertions. | The Disposable
Endoscopic Trocar has
applications in abdominal,
thoracic, and gynecologic
minimally invasive
surgical procedures to
establish a path of entry for
endoscopic instruments.
The trocar may be used
with or without
visualization for primary
and secondary insertions. | Identical |
| Application
Sites | Abdominal
Thoracic
Gynecologic | Abdominal
Thoracic
Gynecologic | Abdominal
Thoracic
Gynecologic | Identical |
| Principles of
Operation | 1. Installation
Surgeon inserts the obturator
in the cannula.
-
Insertion
Surgeon makes an incision
on the patients' abdominal wall
and inserts the installed
laparoscopic trocar system via
the incision. -
Operation
Surgeon removes the
obturator from the cannula.
Surgeon can insert the
corresponding diameter
instrument in the cannula
based on his/ her needs. | Unkonwn | During the operation, the
trocar sleeve and the
obturator are used together.
The surgeon uses the
obturator to expand the
incision of the abdomen
and penetrates the trocar
sleeve through the
abdominal surface of the
human body into the
abdominal cavity, thereby
delivering gas to the
abdominal cavity and
establishing a path of entry
for endoscopic
instruments. | Identical |
| Signle use | Yes | Yes | Yes | Identical |
| Operation
Mode | Manually | Manually | Manually | Identical |
| Diameter | 5mm, 10mm | 5mm, 10mm, 12mm, 15mm | 5mm, 10mm, 12mm | The diameters
of proposed
device are
contained in the
predicated
device
(K201641). |
| Length | 65mm, 70mm, 95mm,
105mm | 96mm, 98mm, 99mm,
111mm | 100mm | Different, the
devices are all
offered in a
variety of
lengths to
accommodate
various clinical
use. |
| Feature | Proposed Device:
NexPort™ Trocar System | Predicate Device:
Disposable Laparoscope
Trocar (K201641) | Predicate Device:
Disposable Endoscopic
Trocar (K180208) | Discussion of
Differences |
| Biocompatibil
ity | Cytotoxicity
Sensitization
Intracutaneous reactivity
Acute systemic toxicity
Material-mediated
pyrogenicity | Cytotoxicity
Sensitization
Intracutaneous reactivity
Acute systemic toxicity
Material-mediated
pyrogenicity | Cytotoxicity
Sensitization
Intracutaneous reactivity
Acute systemic toxicity
Material-mediated
pyrogenicity | Identical |
| SAL | $