U-IGNITE Bladeless Trocar

K162387 · Tianjin Uwell Medical Device Manufacturing Co., Ltd. · GCJ · Jan 11, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K162387
• Device Name: U-IGNITE Bladeless Trocar
• Applicant: Tianjin Uwell Medical Device Manufacturing Co., Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.

Device Story

U-IGNITE Bladeless Trocar is a sterile, single-use, hand-held surgical instrument; consists of a radiolucent sleeve and obturator. Used by surgeons to manually puncture tissue layers to create a laparoscopic port. Obturator features a rounded conical point; some models include a clear optical element to accommodate a 0-degree endoscope for visualization during insertion. 'Endo-assistant' models include a design feature to reduce endoscope lens smudging caused by bodily fluids during instrument exchange. Cannula includes a stopcock valve for gas insufflation/desufflation and a dual-seal system (in 12mm models) to maintain pneumoperitoneum. Device is used in clinical/OR settings. Output is a physical port for instrument access; visualization is provided via the user's endoscope. Benefits include safe tissue access and maintenance of pneumoperitoneum during endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included obturator/cannula compatibility, insertion/cannula stability, air leakage (whole device and with obturator withdrawn), trocar system puncture performance (animal simulation), trocar sleeve retention force (animal simulation), endoscope visualization image quality, and Endo-Assistant part liquid absorbing performance. Biocompatibility testing conducted per ISO 10993-1, -5, -10, -12 and sterilization per ISO 11137-1/-2.

Technological Characteristics

Rigid, hand-held, bladeless trocar. Materials: radiolucent sleeve and obturator. Dimensions: 5-12 mm diameter, 75-150 mm length. Features: optional optical element for endoscope, stopcock valve for luer lock gas insufflation, dual-seal system (12mm models). Sterilization: Gamma irradiation. Connectivity: None. Software: None.

Indications for Use

Indicated for use in endoscopic procedures to provide a port of entry for endoscopic instruments in patients undergoing minimally invasive surgery.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• ENDOPATH XCEL Bladeless Trocar with OPTI VIEW Technology (K122511)

Reference Devices

• Unimicro Trocar Kit, models: Auto-Locking (K141594)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 11, 2017

Tianjin UWell Medical Device Manufacturing Co. Ltd. Mr. Tao Fan General Manager A02, Plant B, No. 278, Hangkong Rd, Tianjin Free Trade Zone Tianjin, China 300308 CN

Re: K162387

Trade/Device Name: U-IGNITE Bladeless Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 10, 2016 Received: August 25, 2016

Dear Mr. Fan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Post Market Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162387

Device Name U-IGNITE Bladeless Trocar

Indications for Use (Describe)

The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic 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 K162387

| Submitter: | Tianjin UWell Medical Device<br>Manufacturing Co., Ltd.<br>A02, Plant B, No. 278, Hangkong Road, Tianjin Free Trade Zone(Air Port<br>Industrial Park), Tianjin, 300308 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Fan, Tao General Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | Jan., 4, 2017 |
| Device Trade Name: | U-IGNITE Bladeless Trocar |
| Device Common Name: | Disposable Surgical Trocar / Cannula |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Class: | II |
| Regulation Number: | 876.1500 |
| Panel: | General & Plastic Surgery |
| Product Code: | GCJ |

## Primary Predicate Device:

| Device | Company | Product<br>Code | 510(k)<br>Number |
|----------------------------------------------------------------|------------------------------|-----------------|------------------|
| ENDOPATH XCEL<br>Bladeless Trocar with<br>OPTI VIEW Technology | Ethicon Endo-Surgery,<br>LLC | GCJ | K122511 |

## Reference Device:

| Device | Company | Product Code | 510(k) Number |
|----------------------------------------------|-------------------------------------------------|--------------|---------------|
| Unimicro Trocar Kit,<br>models: Auto-Locking | Unimicro Medical Systems<br>(ShenZhen) Company, | GCJ | K141594 |

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#### 3. Indications for Use:

The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.

#### 3. Product Description:

It is a rigid hand-held surgical instrument with a rounded conical point used to manually puncture a bodily entry point to assist in the location and positioning of gently part the surrounding soft tissue. The trocar assembly punctures the muscle and tissue layers in the body. The trocar assembly's obturator is removed leaving the cannula to provide a port through which laparoscopes and other laparoscopic instruments can be introduced. The cannula sealing system shall be able to maintain pneumoperitoneum.

The U-IGNITE Bladeless Trocar is a sterile single patient use instrument consisting of a radiolucent sleeve and obturator in various sizes diameter. The obturator contains a clear, taped optical element. The obturator accommodate an appropriate sized 0 degree endoscope and provide visibility of individual tissue layers during insertion. Basic type do not have the optical element for its obturator.

In addition, the U-IGNITE Bladeless Trocar with Endo-assistant part is a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocarinduced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.

The trocar sleeves for the 12 mm devices contain two seals, an outer integrated removable self-adjusting seal that accommodates instruments ranging from 5mm to 12 mm in diameter where indicated and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdraw through the trocar. The 5 mm trocar sleeve does not contain an integrated removable outer seal and accommodates only 5 mm instruments.

A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

This is an irradiation sterilized single use disposable device to avoid cross infection.

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#### Product Specification

| Trocar | | | |
|--------------|----------------|-------------|------------------------------|
| Product Code | Allow Size(mm) | Length (mm) | Comments |
| IG5ST | 5 | 75 | Without Endo. Assistant part |
| IG5LT | 5 | 100 | Without Endo. Assistant part |
| SIG5ST | 5 | 75 | With Endo. Assistant part |
| SIG5LT | 5 | 100 | With Endo. Assistant part |
| BIG5ST | 5 | 75 | Basic Type |
| BIG5LT | 5 | 100 | Basic Type |
| BIG8LT | 8 | 100 | Basic Type |
| IG10LT | 10 | 100 | Without Endo. Assistant part |
| IG10XT | 10 | 150 | Without Endo. Assistant part |
| SIG10LT | 10 | 100 | With Endo. Assistant part |
| SIG10XT | 10 | 150 | With Endo. Assistant part |
| IG12ST | 12 | 75 | Without Endo. Assistant part |
| IG12LT | 12 | 100 | Without Endo. Assistant part |
| SIG12ST | 12 | 75 | With Endo. Assistant part |
| SIG12LT | 12 | 100 | With Endo. Assistant part |
| BIG12ST | 12 | 75 | Basic Type |
| BIG12LT | 12 | 100 | Basic Type |

Basic type is a simplified version of normal type without Endo-Assistant part.

#### 4. Non-Clinical Testing

A series of safety tests were performed to access the safety and effectiveness of the U-IGNITE Bladeless trocar. The safety tests were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12, and ISO 11137-1/-2. The performance testing conducted on subject device and predicate device are listed below:

- Obturator & Cannula Compatibility
- Insertion &Cannula Stability
- Air Leakage as a whole device
- Trocar System Puncture Performance (animal simulation test)
- Trocar sleeve retention force (animal simulation test)
- Air Leakage with obturator withdrawed
- Endoscope Visualization Image Quality
- Endo-Assistant Part Liquid Absorbing Performance

All the test results demonstrate U-IGNITE Bladeless trocar meet the requirements of its predefined acceptance criteria and intended uses.

#### 5. Clinical Data Evaluation:

Based on this literature review no new risks that have not already been identified in the instructions for use or the previously reviewed literature have been noted.

After search from websites cited, post manufacturing experience and data, no clinical incident is reported that is the cause of the trocar device itself.

Identified hazards, such as the occurrence of incisional hernias and injuries to internal viscera and vessels are hazards that are ordinarily associated with operative procedures in the anatomical regions examined regardless of method.

These post-manufacturing experience/ risks are considered & evaluated periodically in our own risk analysis management system, e.g. the Instruction for Use updating based on the literature review result.

Summary of the referred literature and expert opinions that the method is safe and that the device fulfils its intended purpose and clinical performance.

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#### 6. Substantial Equivalence Determination

The indications for use and technology characteristics of the proposed U-IGNITE Bladeless Trocar, and the substantial equivalence to the predicate devices have been demonstrated via data collected in design verifications. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its indications for use. And the differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

The comparison to predicate devices as below table.

| Item | Proposed Device<br>(U-IGNITE Bladeless<br>Trocar) | Primary Predicate Device<br>(ENDOPATH XCEL<br>Bladeless Trocar with<br>OPTI VIEW Technology) | Reference Device<br>(Unimicro Trocar Kit,<br>models: Auto-Locking<br>Trocar, Hasson) |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models | Bladeless without<br>Endo-Assistant Part<br>(BIG & IG models) | Bladeless | Bladeless |
| | Bladeless with Endo-<br>Assistant Part<br>(SIG model) | Bladeless with<br>OPTIVIEW™<br>Technology | / |
| | / | / | Auto-Locking |
| | / | Dilating Tip | / |
| | / | Blunt Tip (Hasson) | Hasson |
| Comprised<br>Elements | Cannula sleeve,<br>Obturator | Cannula sleeve,<br>Obturator | Cannula sleeve,<br>Obturator |
| Dimension | Diameter:<br>5-12 mm | Diameter:<br>5-12 mm | Diameter:<br>5-12 mm |
| | Length:<br>75-150 mm | Length:<br>75-150 mm | Length:<br>70-120 mm |
| Classification | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classification<br>and Code | Class II,<br>GCJ | Class II,<br>GCJ | Class II,<br>GCJ |
| Device<br>Classification<br>Name | Laparoscope,<br>General &<br>Plastic Surgery | Laparoscope, General<br>&<br>Plastic Surgery | Laparoscope, General &<br>Plastic Surgery |
| Indications<br>for Use | applications in<br>endoscopic<br>procedures to<br>provide a port of<br>entry for endoscopic<br>instruments | Applications in<br>abdominal, thoracic,<br>and gynecologic<br>minimally invasive<br>surgical procedures to<br>establish a path of entry<br>for endoscopic<br>Instruments. The trocar<br>may be used with or<br>without visualization<br>for primary and<br>secondary insertions. | Application in a variety of<br>endoscopic procedures to<br>provide a port of entry for<br>endoscopic instruments. |
| Sterilization | Gamma sterilization | Gamma sterilization | EO sterilization |
| Safety<br>standards | | | K162387 |
| ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-12<br>ISO 11137-1 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-12<br>ISO 11137-1 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-7<br>ISO 10993-12<br>ISO 11135 | |
| Performance<br>Standards | Not Applicable | Not Applicable | Not Applicable |
| Performance<br>Testing Item | Obturator & Cannula<br>Compatibility<br>Insertion &Cannula<br>Stability<br>Trocar System<br>Puncture<br>Performance<br>Trocar sleeve<br>retention force<br>Air Leakage as a<br>whole device<br>Air Leakage with<br>obturator<br>withdrawed<br>Endoscope<br>Visualization<br>Quality<br>Endo-Assistant Part<br>Liquid Absorbing<br>Performance | Obturator & Cannula<br>Compatibility<br>Insertion &Cannula<br>Stability<br>Trocar System<br>Puncture Performance<br>Trocar sleeve retention<br>force<br>Air Leakage as a whole<br>device<br>Air Leakage with<br>obturator withdrawed<br>Endoscope<br>Visualization Quality<br>Endo-Assistant Part<br>Liquid Absorbing<br>Performance | Obturator & Cannula<br>Compatibility<br>Insertion &Cannula<br>Stability<br>Trocar System Puncture<br>Performance<br>Trocar sleeve retention<br>force<br>Air Leakage as a whole<br>device<br>Air Leakage with<br>obturator withdrawed<br>Not Applicable<br>Not Applicable |
| Comparison<br>Summary | The subject device has the same or simpler intended use comparing to predicate<br>device and reference device.<br>The subject device has same design, construction, and operation principle comparing<br>to predicate device, K122511 and reference device K141594.<br>For both subject device and predicate & reference device, all materials and final<br>assembled product used can comply with the biocompatibility international standard<br>ISO 10993-1, with the evidence from Third Party report. And the test results show the<br>materials used and final product safe biologically.<br>The technology and performance specification of our product (type SIG series and IG<br>series), Bladeless Trocar with Endo-assistant part, are same in Essential Components,<br>physical and general safety feature comparing to the primary predicate device,<br>K122511 from ENDOPATH XCEL Bladeless Trocar with OPTIVIEW Technology, and<br>Bladeless XCEL.<br>Compare to the reference device specified in K141594, our product (type IG, and type<br>BIG series) and the reference device are same in physical and general safety features<br>based on bench test results.<br>The subject device utilizes the same sterilization method, Gamma irradiation<br>sterilization, as what used in primary predicate device, K122511. This sterilization<br>method is safer than EO sterilization method used in K141594.<br>With the same / smaller intended use scope & same principle of operation, and<br>complying with the similar bench tests, the proposed device, Tianjin UWell Medical | | |

Comparison to Predicate Device and Reference Device

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K162387

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| | Unimicro Trocar Kit, with respect to the following characteristics: |
|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ● | Design |
| ● | Operation principle |
| ● | Constructed materials, |
| ● | Performance characteristics |
| ● | Perceived safety of the device |
| | Any minor structure, material, dimensional or labeling differences between the predicate & reference device and the subject device do not pose risk to their performance and usage. |

#### 7. Conclusion

After analyzing bench tests, safety testing data, it can be concluded that: U-IGNITE Bladeless Trocar is as safe and effective as the predicate device and reference device.