(193 days)
Not Found
No
The device description and performance studies focus on the mechanical function and physical properties of the trocars, with no mention of AI or ML capabilities.
No
The device provides a port of entry for instruments during endoscopic procedures but does not directly treat a disease or condition.
No
Explanation: The device is described as providing a port of entry for endoscopic instruments and/or endoscopes, which is a surgical tool, not a diagnostic one. Its function is to facilitate access for other instruments, not to diagnose a condition itself.
No
The device description clearly states it is composed of physical components (cannula and obturator) and is a single-use, sterilized product, indicating it is a hardware medical 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 provide a port of entry for endoscopic instruments and/or endoscopes during endoscopic procedures. This is a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical device (trocars) used for surgical access. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
The device is clearly intended for surgical access during endoscopic procedures, which falls under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Disposable Trocars includes Normal trocars (model A), Balloon trocars (model B), Thread trocars (model C) and Single-port trocars (Model E). They are generally composed of cannula and obturator, with or without filter/cleaning ring/protector.
The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope. If needed, the CO2 can be infused through the valve. The product is sterilized by Ethylene oxide and is a single-use product.
Normal trocars have 3 different cannulas (normal cannula, normal cannula with filter, normal cannula with cleaning ring) and 5 different obturators (Ingot-type, Optical obturator A. Optical obturator B. Auto-shielded obturator, Blunt obturator). Normal cannula consists of Cannula Body, Cannula Tube Seat, Choke Valve, Sheath Cap and Stopcock. It may be equipped with a filter or cleaning ring as an accessory. Cleaning ring is equipped inside the cannula and used for removing blood and foreign matter from the laparoscope. Filter is detachable, installed in stopcock, and used for filtering out any foreign matter that spills out of the body during surgery. Stopcock can be used for insufflation if needed. Ingot-type obturator is easy to insertion which consists of Needle Tip, Needle Tube and Needle Seat. Optical obturator A has a transparent needle tip while Optical obturator B has a transparent needle tip and needle tube. Needle tube of these two optical obturators is hollow which allows laparoscope go inside to see if it has passed the abdominal wall. Auto-shielded obturator has a hided blade which only showing up in puncturing process. Blunt obturator has a blunt needle tip which can protect internal organ during the procedure. Normal trocars are available from 3-15mm of diameter and 65-160mm of length.
Balloon Trocars are equipped an inflatable balloon with a fixed (Balloon cannula A) or movable holder (Balloon cannula B) to provide stabilization during a laparoscopic procedure. The Cannula consists of Balloon, Cannula body, Holder A, One-way vale, Cannula Tube Seat, Stopcock, Sheath Cap and Choke Valve. Stopcock can be used for insufflation if needed. Movable holder can be slid down to adjust its height at a desired position for stabilization. There are five different obturators as same as normal trocars: lngot-type, Optical obturator A, Optical obturator B, Auto-shielded obturator, Blunt obturator. Balloon Trocars are available in from 3-15mm of diameter and 55-140mm of length.
Thread trocars consists of a thread obturator and a Thread cannula A (thoracic trocars) or B (Orthopedics trocars). Threaded cannula enhances stability when exchanging instruments. Thread cannula B consists of Cannula body, Cannula Tube Seat, Stopcock, Sheath Cap and Choke Valve while Thread cannula A does not have a stopcock. Stopcock can be used for insufflation if needed. Thoracic trocars are available in from 5-20mm of diameter and 65-85mm of length. Orthopedics trocars are designed for Orthopedics laparoscopic surgery and available in from 5-20mm of diameter and 65-120mm of length.
Single-port Trocars are designed to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive endoscopic surgery. It consists of cannula, universal seal system, a variable height protector or fixed height protector, with or without obturator. Single port cannula A and B use same materials and only different in shapes. Universal seal system A supports the free combination and arrangement of trocar with different numbers and sizes to meet different surgical needs. Obturator is used with Single port cannula A. Universal seal system B is fully transparent and visible for surgical operation. Besides, soft material makes it good for handling the endoscopic instruments and reducing surgical compression congestion to the patient skin. Universal seal system C has a larger handling space than system B. Protector, which has fixed height or variable height, is used for protect surgical incision.
Due to the different structure and function, diameter, length of the Cannula and Obturator, and package amount, there are many combinations for final product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The Disposable Trocars has been evaluated by our Design Engineer and through performance studies and bench testing, as attached in Appendix C. Testing encompassed appearance, Obturator Compatibility, Insertion & Cannula Stability, Air Leakage, balloon rigidity, fixation device retention, etc. All the test results were "PASS". The performance of Disposable Trocars meets the technical standard requirements of Hangzhou Kangji Medical Instrument Co., Ltd. as compared to the predicate.
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.
K112358, K211577, K141715, K093372, K073719
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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 9, 2024
Hangzhou Kangji Medical Instrument Co., Ltd. % Esther Zhang Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China
Re: K233263
Trade/Device Name: Disposable Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 28, 2023 Received: September 29, 2023
Dear Esther Zhang:
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.
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"
1
(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 OS 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 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-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 Trumbore -S Date: 2024.04.09 12:02:16 -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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Disposable Trocars
Indications for Use (Describe)
The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) summary K233263
| Submitter
Device submitter: Hangzhou Kanqji Medical Instrument Co., Ltd.
No. 1668 Chuniiang East Road. Economic Development Zone. Tongly. Hangzhou, 311501, China.
Contact person: Martin Sun
Manager of Regulatory Affairs Phone: +86-0571-69901712 Fax: +86-0571-69901712 Email: martin.sun@kanqji.com
Date: April 9, 2024
II Device
Trade Name of Device: Disposable Trocars Common Name: Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope, General & Plastic Surgery Requlatory Class: II Product code: GCJ Review Panel: General and Plastic Surgery
III Correspondent
Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R.China Contact: Esther ZHANG Email: Esther.zhang@llins-tech.com
IV Device description
The Disposable Trocars includes Normal trocars (model A), Balloon trocars (model B), Thread trocars (model C) and Single-port trocars (model E). They are generally composed of cannula and obturator, with or without filter/cleaning ring/protector.
The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope. If needed, the CO2 can be infused through the valve. The product is sterilized by Ethylene oxide and is a single-use product.
Normal trocars have 3 different cannulas (normal cannula, normal cannula with filter, normal cannula with cleaning ring) and 5 different obturators (Ingot-type, Optical obturator A. Optical obturator B. Auto-shielded obturator, Blunt obturator). Normal cannula consists of Cannula Body, Cannula Tube Seat, Choke Valve, Sheath Cap and Stopcock. It may be equipped with a filter or cleaning ring as an accessory. Cleaning ring is equipped inside the cannula and used for removing blood and foreign matter from the laparoscope. Filter is detachable, installed in stopcock, and used for filtering out any
4
foreign matter that spills out of the body during surgery. Stopcock can be used for insufflation if needed. Ingot-type obturator is easy to insertion which consists of Needle Tip, Needle Tube and Needle Seat. Optical obturator A has a transparent needle tip while Optical obturator B has a transparent needle tip and needle tube. Needle tube of these two optical obturators is hollow which allows laparoscope go inside to see if it has passed the abdominal wall. Auto-shielded obturator has a hided blade which only showing up in puncturing process. Blunt obturator has a blunt needle tip which can protect internal organ during the procedure. Normal trocars are available from 3-15mm of diameter and 65-160mm of length.
Balloon Trocars are equipped an inflatable balloon with a fixed (Balloon cannula A) or movable holder (Balloon cannula B) to provide stabilization during a laparoscopic procedure. The Cannula consists of Balloon, Cannula body, Holder A, One-way vale, Cannula Tube Seat, Stopcock, Sheath Cap and Choke Valve. Stopcock can be used for insufflation if needed. Movable holder can be slid down to adjust its height at a desired position for stabilization. There are five different obturators as same as normal trocars: lngot-type, Optical obturator A, Optical obturator B, Auto-shielded obturator, Blunt obturator. Balloon Trocars are available in from 3-15mm of diameter and 55-140mm of length.
Thread trocars consists of a thread obturator and a Thread cannula A (thoracic trocars) or B (Orthopedics trocars). Threaded cannula enhances stability when exchanging instruments. Thread cannula B consists of Cannula body, Cannula Tube Seat, Stopcock, Sheath Cap and Choke Valve while Thread cannula A does not have a stopcock. Stopcock can be used for insufflation if needed. Thoracic trocars are available in from 5-20mm of diameter and 65-85mm of length. Orthopedics trocars are designed for Orthopedics laparoscopic surgery and available in from 5-20mm of diameter and 65-120mm of length.
Single-port Trocars are designed to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive endoscopic surgery. It consists of cannula, universal seal system, a variable height protector or fixed height protector, with or without obturator. Single port cannula A and B use same materials and only different in shapes. Universal seal system A supports the free combination and arrangement of trocar with different numbers and sizes to meet different surgical needs. Obturator is used with Single port cannula A. Universal seal system B is fully transparent and visible for surgical operation. Besides, soft material makes it good for handling the endoscopic instruments and reducing surgical compression congestion to the patient skin. Universal seal system C has a larger handling space than system B. Protector, which has fixed height or variable height, is used for protect surgical incision.
Due to the different structure and function, diameter, length of the Cannula and Obturator, and package amount, there are many combinations for final product.
V Indications for use
The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope.
5
VI Substantial Equivalence
| Model of
proposed
| device | Predicate device | Manufacturer | 510(k) No. |
|---|---|---|---|
| K112358 | Unimax Trocar System | Unimax Medical | |
| Systems Inc. | GCJ | ||
| K211577 | SoftFix™ Balloon Trocar | Unimax Medical | |
| Systems Inc. | GCJ | ||
| K141715 | Glove Port | NELIS | OTJ |
| K093372 | SILS™ Port | COVIDIEN LP | GCJ |
| K073719 | ASC TriPort Laparoscopic | ||
| Access Device | Advanced Surgical | ||
| Concepts. | GCJ |
able Trocars are substantially equivalent to the predicate devices: osed Dien
Comparison of technological characteristics with the predicate devices
6
| Device
feature | Subject Device
(Model A/B/C) | Predicate Device K112358
(Unimax Trocar System) | Predicate Device
K211577( SoftFixTM
Balloon Trocar) | Comment |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Class | II | II | II | Equivalent |
| Product code | GCJ | GCJ | GCJ | Equivalent |
| Regulation
number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Equivalent |
| Intended use | The Disposable Trocars
have application in a variety
of endoscopic procedures to
provide a port of entry for
endoscopic instruments
and/or endoscope. | The Unimax Trocar System, Model:
Auto-Locking Trocar, Bladeless
Trocar, Visible Trocar, Hasson
Trocar, Dilating Trocar Secondary
Trocar, and Thoracic Trocar has
application in a variety of endoscopic
procedures to provide a port of
entry for endoscopic instruments. | The SoftFixTM Balloon
Trocar have application in a
variety of endoscopic
procedures to provide a port
of entry for endoscopic
instruments into the body
cavity of patients. | Equivalent. |
| Models | Normal trocars (Model A) | Bladeless, Visible and auto-
locking,
Secondary trocars | / | Different
Comment |
| | Balloon trocars (Model B) | Hasson trocars | Balloon trocar (bladed
obturator with safety lock for
the shield, bladeless
obturator, optical obturator,
hasson obturator, cannula
sleeve with a stopcock for
insufflation) | 1 |
| | Thread trocars (Model C) | Thoracic trocars | / | |
| | | Dilating trocars | | |
| Device structure | Cannula with or without
cleaning ring/filter, balloon
cannula, cannula with
stopcock for insufflation,
obturator | Cannula with stopcock for insufflation,
obturator | Cannula with a stopcock for
insufflation, obturator | |
| Specification | Diameter: 3-15mm
Length: 60-160mm | Diameter: 3-15mm
Length: 65-150mm | Diameter: 5-12mm
Length: 70-100mm | Similar
Comment 2 |
| Reuse durability | Single use | Single use | Single use | Equivalent |
| Sterilization | EO | EO | EO | Equivalent |
| Single use | Yes | Yes | Yes | Equivalent |
| Performance | Obturator Compatibility;
Insertion & Cannula Stability;
Air Leakage; balloon rigidity;
fixation device retention | Obturator Compatibility;
Insertion&Cannula Stability;
Air Leakage | Obturator Compatibility;
Insertion & Cannula Stability;
AirLeakage; balloon rigidity;
fixation device retention | Equivalent |
| Biocompatibility | ISO 10993-1, ISO 10993-5,
ISO 10993-10, ISO 10993-
7, ISO 10993-12 | ISO 10993-1, ISO 10993-5, ISO
10993-10, ISO 10993-7, ISO 10993-
12 | ISO 10993-1, ISO 10993-5,
ISO 10993-10, ISO 10993-
7, ISO 10993-12 | Equivalent |
Table 1 Substantial equivalence discussion- Model A/B/C
7
8
Discussion:
Comment 1
The subject device and the predicate device have intended use, to applicate in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The obturator and cannula have miner difference on needle tip and cannula accessories (e.g. cleaning, filter), while these differences have been validated by performance test and do not influence use. This difference does not affect the clinical safety of the subject device.
Comment 2
The Disposable Trocars are available in a range of Length is only to allow entry of other endoscopic instruments and does not have any effect on device performance. Additionally, length information is printed on the Obturator. Choice of Trocar specification depends on user's preference and clinical need. The differences on length do not raise new and effectiveness.
Conclusion:
The Disposable Trocars (Model A/B/C) have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.
9
| Device feature | Subject Device
(Model E Single-
port
Trocars) | Predicate
DeviceK141715
(Glove Port) | Predicate
DeviceK093372
(SILS™
Port) | Predicate
DeviceK073719
(ASC TriPort
Laparoscopic
Access
Device) | Comment |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Class | II | II | II | II | Equivalent |
| Regulation number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Equivalent |
| Intended use | The Disposable Trocars have
application in a variety of
endoscopic procedures to
provide a port of entry for
endoscopic instruments
and/orendoscope.
Single-port Trocars are
designed to provide access for
multiple instruments and/or
endoscope to the abdominal
cavity through a single incision
during minimally invasive
endoscopic surgery. | The Glove Port is
intended to provide
access for multiple
instruments and/or
endoscope to the
abdominal cavity
through a single
incision during
minimally invasive
laparoscopic
surgery. | The SILS™ Port is
indicated for
multiple instrument or
camera access to the
abdominal cavity
through a singleincision
for performingminimally
invasive laparoscopic
procedures. | The ASC TriPort
Laparoscopic Access
Device is intended
foruse as a multiple
instrument and/or
camera port during
minimally invasive
abdominal
laparoscopic surgery. | Equivalent |
Table 2 Substantial equivalence discussion-Single-port trocars (Model E)
10
| Model | E01, E02, E03, E04, E05, E06, E07, E08 | Glove Port Original; Glove Port H; Glove Port A; Glove Port AT | SILS™ Port | ASC
Laparoscopic Access
Device | TriPort Similar Comment 1 |
|------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------|---------------------------|
| Port number | 34 | 34 | 34 | 3 | |25 | 10
| Absolute size | 1025mm | 1025mm | 25mm | |
| Material | Polycarbonate, silicone | Polyurethane | Silicone | Silicone | Different
Comment
2 |
| Installation and
abdominal wall
inner fixation | Inner ring of the protector
being fixed inside the
abdominal wall inside. | Wound retractor
ring being fixed
inside the
abdominal wall
inside. | Distal ring being fixed in
the abdominal wallinside. | Non-fixed | Equivalent |
| Sterilization | EO gas sterilization | EO gas sterilization | Gamma sterilization | Gamma sterilization | Different
Comment
3 |
11
Discussion:
Comment 1
The subject device and the predicate devices are endoscopic instrument access ports that are used to perform the same function as a trocar. They are all retracts a small abdominal incision to allow endoscopic instruments to pass through to abdomen, and maintains pneumoperitoneum in the abdomen during the surgical procedure, whether or not endoscopic instruments are passing through the port. The difference in models, port number and size will not influence their intended use. Besides, surgeons will select port number and size based on actual needs during procedure. Furthermore, these differences have been addressed by performance test and do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
Comment 2
The materials of the subject device and the predicate devices are partially different. However, the materials have been tested according to ISO 10993 series standards and performance test. The results showed they're biocompatible with human body and no impact of air leakage, connection firmness, Cannula stabilization and other functions. This difference does not affect the effectiveness and safety.
Comment 3
The sterilization method of the subject device and the predicate devices are partially different. However, the subject device was ensured sterility by sterilization validation. Therefore, the differences on sterilization do not raise new questions about safety and effectiveness.
Conclusion:
The Disposable Trocars (Model E) have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.
Comparison Summary:
The subject and predicate devices have the same intended use and application. The subject and predicate device designs are similar. They are single-use devices. The differences in technological characteristics between the subject and predicate devices (i.e., needle tip, different size, port number) do not raise different questions of safety and effectiveness.
VII Summary of non-clinical testing Performance testing
12
The Disposable Trocars has been evaluated by our Design Engineer and through performance studies and bench testing, as attached in Appendix C. Testing encompassed appearance, Obturator Compatibility, Insertion & Cannula Stability, Air Leakage, balloon rigidity, fixation device retention, etc. All the test results were "PASS". The performance of Disposable Trocars meets the technical standard requirements of Hangzhou Kangji Medical Instrument Co., Ltd. as compared to the predicate.
Biocompatibility testing
Biocompatibility of the Disposable Veress needles was evaluated in accordance with ISO 10993-1:2018 for the body contact category. The following tests were performed, as recommended:
| Cytotoxicity | ISO 10993-5:2009 |
|---|---|
| Sensitization | ISO 10993-10:2021 |
| Irritation | ISO 10993-23:2021 |
| Acute Systemic toxicity | ISO 10993-11:2017 |
| Pyrogenicity | USP |
Sterilization and shelf life testing
- EO sterilization validation per EN ISO 11135-1, 11737-1,11737-2 A
- A Transportation test per ASTM D4169
- A Packaging validation per ISO 11607-1/-2
- The 3 years shelf life of the device is determined based on stability study which A includes ageing test.
-
Bacterial Endotoxin Testing per USP-NF:2023
VIII Conclusion
The Disposable Trocars is substantially equivalent to its predicate devices as listed in VI Substantial Equivalence. The differences between the predicate and subject device do not raise any new or different questions of safety or effectiveness. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.