(53 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the trocars, with no mention of AI or ML.
No
The device is used to create a working channel for abdominal surgery, but it does not treat a disease or condition itself. It is an accessory device.
No
Explanation: The device, Disposable Abdominal Trocars, is used to create a working channel for abdominal surgery by puncturing the abdominal wall. Its purpose is to facilitate surgical procedures, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly details physical components such as cannulas, obturators, valves, and tips, indicating it is a hardware medical device. There is no mention of software as a component or the primary function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Function: The description clearly states that the Disposable Abdominal Trocars are used to "puncture the abdominal wall of human body during laparoscopy and operation to establish the working channel for abdominal surgery." This is a surgical instrument used within the body (in vivo) to facilitate a surgical procedure.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze biological samples or provide diagnostic information. Its purpose is purely mechanical – creating an access point for other surgical instruments.
The information provided about biocompatibility, sterilization, and performance testing (insertion/removal force, air leakage) are all relevant to a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is used to puncture the abdominal wall of human body during laparoscopy and operation to establish the working channel for abdominal surgery.
Product codes
GCJ
Device Description
The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are available in total of eight (8) sizes.
The Disposable Abdominal Trocars (Bladed Trocars), knows as Auto-Locking Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladed Trocars) is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered.
The Disposable Abdominal Trocars (Bladeless Trocars) has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladeless Trocars) is available in one (1) size: 5mm.
The Disposable Abdominal Trocars (Optical Trocars), knows as Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip, which is designed for open Laparoscopy. The Disposable Abdominal Trocars (Optical Trocars) is available in four (4) sizes: 5mm, 10mm, 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock.
Based on the filter valve, the Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are divided into two (2) product series: CNTCI series without smoke evacuation function and CNTCII series with smoke evacuation. The cannula consists of sleeve, stopcock valve, valve lever, gas check valve and lip seal. The obturator consists of fixed base, obturator tube and obturator tip. There are various specifications available depending on the inner diameter and length of sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
A series of tests were performed to assess the safety and effectiveness of the Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars). Biocompatibility tests were conducted in accordance with ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-12:2021 and ISO 10993-23:2021. The biocompatibility tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity and Material-Mediated Pyrogenicity. Sterilization was performed per ISO 11135:2014.
The performance testing conducted on subject device and predicate devices are listed below:
- Obturator Compatibility A
- A Insertion & Cannula Stability
- A Air Leakage
- Trocar Insertion/ Removal force A
All the test results demonstrate Disposable Abdominal Trocars, Bladeless Trocars, Optical Trocars) meet the requirements of its pre-defined acceptance criteria and intended uses.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 7, 2023
Jiangsu Channel Medical Device Co., Ltd % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave Shanghai 200122 China
Re: K232866
Trade/Device Name: Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 15, 2023 Received: September 15, 2023
Dear Mr. Wu:
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/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
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 (OS) 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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Digitally signed by Mark Trumbore -S Trumbore -S Date: 2023.11.07
11.07 -05 08:42:27 -05'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices
2
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
510(k) Number (if known) K232866
Device Name
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
Indications for Use (Describe)
The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars) is used to puncture the abdominal wall of human body during laparoscopy and operation to establish the working channel for abdominal surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Jiangsu Channel Medical Device Co., Ltd. Fourth Floor, G3,999# Qujia Road, Qiandeng Town, Kunshan, Jiangsu, China 215341
K232866
510(K) Summary
Document prepared date: 2023/11/04
A. Applicant:
Contact Person: Eric Huang Title: General Manager Jiangsu Channel Medical Device Co., Ltd. Address: Fourth Floor, G3,999# Qujia Road, Qiandeng Town, Kunshan, Jiangsu, China 215341 Tel: +0086-512-36857161 Email: chen.huang@channel-mdi.com
Submission Correspondent: Primary Contact: Mr. Jarvis Wu Title: Regulatory Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com
Secondary Contact: Mr. Raymond Luo Title: Senior Regulatory Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050
Email: zxfda(@sungoglobal.com
B. Device:
Trade Name: Disposable Abdominal Trocars (Bladed Trocars, Optical Trocars, Optical Trocars) Common Name: Disposable Surgical Trocar /Cannula
Regulatory Information
Classification Name: Laparoscope, General & Plastic Surgery Classification: Class II Product code: GCJ Regulation Number: 876.1500
C. Predicate device:
Primary Predicate Device: K141594 Product name: Unimicro Trocar kit Model: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar. Unimicro Medical Systems (ShenZhen) Co., Ltd.
Secondary Predicate Device: K172038 Product name: Trocar, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar
5
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
D. Intended use of the device:
The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is used to puncture the abdominal wall of human body during laparoscopy and operation to establish the working channel for abdominal surgery.
E. Device Description:
The Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are available in total of eight (8) sizes.
The Disposable Abdominal Trocars (Bladed Trocars), knows as Auto-Locking Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladed Trocars) is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered.
The Disposable Abdominal Trocars (Bladeless Trocars) has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Disposable Abdominal Trocars (Bladeless Trocars) is available in one (1) size: 5mm.
The Disposable Abdominal Trocars (Optical Trocars), knows as Visible Trocar, has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a blunt tip, which is designed for open Laparoscopy. The Disposable Abdominal Trocars (Optical Trocars) is available in four (4) sizes: 5mm, 10mm, 12mm. This device allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve and a stopcock.
Based on the filter valve, the Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) are divided into two (2) product series: CNTCI series without smoke evacuation function and CNTCII series with smoke evacuation. The cannula consists of sleeve, stopcock valve, valve lever, gas check valve and lip seal. The obturator consists of fixed base, obturator tube and obturator tip. There are various specifications available depending on the inner diameter and length of sleeve.
| Device | Subject Device | Primary Predicate Device | Secondary Predicate
Device |
|--------------|---------------------------------------------|--------------------------------------------------|-------------------------------------------------------------------|
| Manufacturer | Jiangsu Channel Medical
Device Co., Ltd. | Unimicro Medical Systems
(ShenZhen) Co., Ltd. | WickiMed (Huizhou)
Medical Equipment
Manufacturing Co.,Ltd. |
| 510K number | K232866 | K141594 | K172038 |
| Product Name | Disposable Abdominal
Trocars | Unimicro Trocar kit | Trocar |
F. Comparison with predicate device
6
Jiangsu Channel Medical Device Co., Ltd.
| Fourth Floor, G3,999# Qujia Road, Qiandeng Town, Kunshan, Jiangsu, China 215341 | ||
|---|---|---|
| Classification | Class II Device (21 CFR 876.1500) | Class II Device (21 CFR 876.1500) | Class II Device (21 CFR 876.1500) | |
|---|---|---|---|---|
| Intended use | The Disposable Abdominal | |||
| Trocars (Bladed Trocars, | ||||
| Bladeless Trocars, Optical | ||||
| Trocars) is used to puncture | ||||
| the abdominal wall of human | ||||
| body during laparoscopy and | ||||
| operation to establish the | ||||
| working channel for | ||||
| abdominal surgery. | The Unimicro Trocar kit, | |||
| Model: Auto-Locking | ||||
| Trocar, Hasson Trocar, and | ||||
| Bladeless Trocar has | ||||
| application in a variety of | ||||
| endoscopic procedures to | ||||
| provide a port of entry for | ||||
| endoscopic instruments. | The Trocar Models: Auto- | |||
| Locking Trocar, Bladeless | ||||
| Trocar and Visible Trocar, | ||||
| has application in a variety | ||||
| of endoscopic procedures | ||||
| to provide a port of entry | ||||
| for endoscopic instruments | ||||
| Principles of | ||||
| operation | Trocar inserted into the skin | |||
| incision, and punctured into | ||||
| the abdominal cavity. | ||||
| Removed the puncture cone | ||||
| and made a surgical channel. | Trocar inserted into the skin | |||
| incision, and punctured into | ||||
| the abdominal cavity. | ||||
| Removed the puncture cone | ||||
| and made a surgical | ||||
| channel. | Trocar inserted into the | |||
| skin incision, and | ||||
| punctured into the | ||||
| abdominal cavity. | ||||
| Removed the puncture | ||||
| cone and made a surgical | ||||
| channel. | ||||
| Model | Auto-Locking Trocar | |||
| (Bladed Trocar) | Auto-Locking Trocar | / | ||
| Bladeless Trocar | Bladeless Trocar | / | ||
| Visible Trocar | ||||
| (Optical Trocar) | / | Visible Trocar | ||
| Mainly | ||||
| Structure | Cannula, (blade), universal | |||
| seal, valve, stopcock | Cannula, (blade), universal | |||
| seal, valve, stopcock | Cannula, (blade), universal | |||
| seal, valve, stopcock | ||||
| Specification | Diameter :5-15mm | |||
| Length :110-150mm | Diameter :5-12mm | |||
| Length: 70-120mm | Diameter :5-12mm | |||
| Length :100mm | ||||
| Patient- | ||||
| contacting | ||||
| structure | ATR | Blade, Cutting head, Cannula | Blade, Cutting head, | |
| Cannula | Blade, Cutting head | |||
| Cannula | ||||
| BTR | Cutting head, Cannula | Cutting head, Cannula | Cutting head, Cannula | |
| VTR | Cutting head, Cannula | / | Cutting head, Cannula | |
| Patient- | ||||
| contacting | ||||
| Materials | ATR | Stainless Steel, PC | Stainless Steel, PC, ABS | Stainless Steel, PC, ABS |
| BTR | PC, | PC, ABS | PC, ABS | |
| VTR | PC | / | PC | |
| Safety | ||||
| standards | ISO 10993-1 | |||
| ISO 10993-5 | ||||
| ISO 10993-7 | ||||
| ISO 10993-10 | ||||
| ISO 10993-11 | ||||
| ISO 10993-12 | ||||
| ISO 10993-23 | ||||
| ISO 11135 | ISO 10993-1 | |||
| ISO 10993-5 | ||||
| ISO 10993-7 | ||||
| ISO 10993-10 | ||||
| ISO 10993-12 | ||||
| ISO 11135-1 | ISO 10993-1 | |||
| ISO 10993-5 | ||||
| ISO 10993-7 | ||||
| ISO 10993-10 | ||||
| ISO 10993-11 | ||||
| ISO 10993-12 | ||||
| ISO 11135 | ||||
| Performance | ||||
| testing items | Obturator compatibility | Obturator compatibility | Obturator compatibility | |
| Insertion & cannula stability | Insertion & cannula stability | Insertion & cannula stability | ||
| Air leakage | Air leakage | Air leakage | ||
| Trocar Insertion/ Removal force | Trocar Insertion/ Removal force | Trocar Insertion/ Removal force | ||
| Sterilization | EO Sterilized | EO Sterilized | EO Sterilized | |
| Disposable | Yes | Yes | Yes |
7
Jiangsu Channel Medical Device Co., Ltd. Fourth Floor, G3,999# Qujia Road, Qiandeng Town, Kunshan, Jiangsu, China 215341
Different analysis:
The subject and predicate devices have the similar intended use. The subject and predicate devices designs are nearly identical. Both are single-use devices, and structure and technology characteristic are identical. The differences in specification and patient-contacting materials between the subject and predicate devices do not raise conc questions of safety and effectiveness.
G. Non-Clinical Testing
A series of tests were performed to assess the safety and effectiveness of the Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars). Biocompatibility tests were conducted in accordance with ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-12:2021 and ISO 10993-23:2021. The biocompatibility tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity and Material-Mediated Pyrogenicity. Sterilization was performed per ISO 11135:2014.
The performance testing conducted on subject device and predicate devices are listed below:
- Obturator Compatibility A
- A Insertion & Cannula Stability
- A Air Leakage
- Trocar Insertion/ Removal force A
All the test results demonstrate Disposable Abdominal Trocars, Bladeless Trocars, Optical Trocars) meet the requirements of its pre-defined acceptance criteria and intended uses.
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
Based on the comparison and analysis above, the subject device Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars), is as safe, as effective, and performs as well as the legally marketed predicate devices.