(139 days)
No
The device description and performance studies focus on mechanical and optical properties of a surgical trocar, with no mention of AI or ML.
No
The device is described as a surgical instrument used to create a port of entry for other instruments in endoscopic procedures, assisting in the initial access but not directly treating a disease or condition itself.
No
This device is a surgical instrument used to create a port of entry for other endoscopic instruments; it does not analyze or interpret patient data to determine a medical condition or disease.
No
The device description clearly details a physical, hand-held surgical instrument (trocar) with various hardware components (sleeve, obturator, seals, stopcock valve). It is described as a sterile, single-patient use device that is irradiation sterilized. This is not a software-only device.
Based on the provided information, the U-IGNITE Bladeless Trocar 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 during surgical procedures. This is a surgical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a surgical instrument for puncturing tissue and providing access for other surgical tools. It does not describe a device used to examine specimens like blood, tissue, or urine for diagnostic information.
- Lack of Diagnostic Function: The device's function is purely mechanical and provides access. It does not perform any tests or analyses on biological samples to diagnose a condition.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device in a surgical context (puncture performance, air leakage, insertion stability, etc.), not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The U-IGNITE Bladeless Trocar does not fit this definition.
N/A
Intended Use / Indications for Use
The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device 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.
Mentions image processing
Endoscope Visualization Image Quality
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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 K162387
| Submitter: | Tianjin UWell Medical Device
Manufacturing Co., Ltd.
A02, Plant B, No. 278, Hangkong Road, Tianjin Free Trade Zone(Air Port
Industrial Park), Tianjin, 300308 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Fan, Tao General Manager
Phone: (86)18616806984
Email: fant01@uwellmed.com |
| 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
Code | 510(k)
Number |
|----------------------------------------------------------------|------------------------------|-----------------|------------------|
| ENDOPATH XCEL
Bladeless Trocar with
OPTI VIEW Technology | Ethicon Endo-Surgery,
LLC | GCJ | K122511 |
Reference Device:
| Device | Company | Product Code | 510(k) Number |
|---|---|---|---|
| Unimicro Trocar Kit, | |||
| models: Auto-Locking | Unimicro Medical Systems | ||
| (ShenZhen) Company, | GCJ | K141594 |
4
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.
5
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.
6
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
(U-IGNITE Bladeless
Trocar) | Primary Predicate Device
(ENDOPATH XCEL
Bladeless Trocar with
OPTI VIEW Technology) | Reference Device
(Unimicro Trocar Kit,
models: Auto-Locking
Trocar, Hasson) |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models | Bladeless without
Endo-Assistant Part
(BIG & IG models) | Bladeless | Bladeless |
| | Bladeless with Endo-
Assistant Part
(SIG model) | Bladeless with
OPTIVIEW™
Technology | / |
| | / | / | Auto-Locking |
| | / | Dilating Tip | / |
| | / | Blunt Tip (Hasson) | Hasson |
| Comprised
Elements | Cannula sleeve,
Obturator | Cannula sleeve,
Obturator | Cannula sleeve,
Obturator |
| Dimension | Diameter:
5-12 mm | Diameter:
5-12 mm | Diameter:
5-12 mm |
| | Length:
75-150 mm | Length:
75-150 mm | Length:
70-120 mm |
| Classification | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classification
and Code | Class II,
GCJ | Class II,
GCJ | Class II,
GCJ |
| Device
Classification
Name | Laparoscope,
General &
Plastic Surgery | Laparoscope, General
&
Plastic Surgery | Laparoscope, General &
Plastic Surgery |
| Indications
for Use | applications in
endoscopic
procedures to
provide a port of
entry for endoscopic
instruments | Applications in
abdominal, thoracic,
and gynecologic
minimally invasive
surgical procedures to
establish a path of entry
for endoscopic
Instruments. The trocar
may be used with or
without visualization
for primary and
secondary insertions. | Application in a variety of
endoscopic procedures to
provide a port of entry for
endoscopic instruments. |
| Sterilization | Gamma sterilization | Gamma sterilization | EO sterilization |
| Safety
standards | | | K162387 |
| ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-12
ISO 11137-1 | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-12
ISO 11137-1 | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-7
ISO 10993-12
ISO 11135 | |
| Performance
Standards | Not Applicable | Not Applicable | Not Applicable |
| Performance
Testing Item | Obturator & Cannula
Compatibility
Insertion &Cannula
Stability
Trocar System
Puncture
Performance
Trocar sleeve
retention force
Air Leakage as a
whole device
Air Leakage with
obturator
withdrawed
Endoscope
Visualization
Quality
Endo-Assistant Part
Liquid Absorbing
Performance | Obturator & Cannula
Compatibility
Insertion &Cannula
Stability
Trocar System
Puncture Performance
Trocar sleeve retention
force
Air Leakage as a whole
device
Air Leakage with
obturator withdrawed
Endoscope
Visualization Quality
Endo-Assistant Part
Liquid Absorbing
Performance | Obturator & Cannula
Compatibility
Insertion &Cannula
Stability
Trocar System Puncture
Performance
Trocar sleeve retention
force
Air Leakage as a whole
device
Air Leakage with
obturator withdrawed
Not Applicable
Not Applicable |
| Comparison
Summary | The subject device has the same or simpler intended use comparing to predicate
device and reference device.
The subject device has same design, construction, and operation principle comparing
to predicate device, K122511 and reference device K141594.
For both subject device and predicate & reference device, all materials and final
assembled product used can comply with the biocompatibility international standard
ISO 10993-1, with the evidence from Third Party report. And the test results show the
materials used and final product safe biologically.
The technology and performance specification of our product (type SIG series and IG
series), Bladeless Trocar with Endo-assistant part, are same in Essential Components,
physical and general safety feature comparing to the primary predicate device,
K122511 from ENDOPATH XCEL Bladeless Trocar with OPTIVIEW Technology, and
Bladeless XCEL.
Compare to the reference device specified in K141594, our product (type IG, and type
BIG series) and the reference device are same in physical and general safety features
based on bench test results.
The subject device utilizes the same sterilization method, Gamma irradiation
sterilization, as what used in primary predicate device, K122511. This sterilization
method is safer than EO sterilization method used in K141594.
With the same / smaller intended use scope & same principle of operation, and
complying with the similar bench tests, the proposed device, Tianjin UWell Medical | | |
Comparison to Predicate Device and Reference Device
7
8
| 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.