(75 days)
Not Found
No
The description details a mechanical device for surgical access and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No.
The device is a surgical instrument used to establish a path for other endoscopic instruments, not to treat a medical condition itself.
No
Explanation: The device, a Disposable Endoscopic Trocar, is used to establish an entry path for surgical instruments during minimally invasive procedures. Its function is to facilitate surgery, not to identify or monitor medical conditions.
No
The device description explicitly lists physical components made of materials like stainless steel and plastic, and the performance studies include tests for physical properties like peel strength, flexibility, and leakage, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a path of entry for endoscopic instruments" in surgical procedures. This is a surgical tool used during a procedure on the body, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details the physical components and function of a surgical trocar, which is used to create access for instruments. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Reagents or assays
The testing performed (sterility, peel strength, biocompatibility, etc.) is consistent with a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Product codes
GCJ
Device Description
The Fengh Medical Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
A Disposable Endoscopic Trocar is mainly composed of Obturator Handle, Outer Seal Release Lever. Trocar Stability Sleeve, Obturator Locking Button, Trocar Stability Sleeve, etc. Materials being used include Stainless 12Cr18Ni9, Stainless 06Cr19Ni10, ABS plastic, PC. All the components of Disposable Endoscopic Trocar are evaluated by cytotoxicity test, sensitization test, intracutaneous mucosa stimulation test, Systemic toxicity(acute) test and Pyrogenicity test. Therefore, it will not cause bad stimulations, allergic reactions or other harm to human tissue or mucosa. Furthermore, no toxic substances will be separated out during the use of Disposable Endoscopic Trocar.
Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, and gynecologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
| Table 1 | Tests |
|---|---|
| Clinical | Not Applicable |
| Non-Clinical Testing: | Sterility Test |
| Peel Strength | |
| Flexibility | |
| Fitness | |
| Leakage | |
| Roughness | |
| Dimension | |
| Appearance | |
| Insertion & Cannula Stability | |
| Trocar sleeve retention force | |
| Endoscope Visualization Quality | |
| Biocompatibility Testing: | In Vitro Cytotoxicity Test |
| Skin Sensitization Test | |
| Intracutaneous reactivity Test | |
| Acute Systemic Toxicity | |
| Pyrogen Test |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 9, 2018
Fengh Medical Co., Ltd. Jun Zhou Regulatory Affairs Manager D3 No. 6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin, 214437 Cn
Re: K180208
Trade/Device Name: Disposable Endoscopic Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 8, 2018 Received: February 12, 2018
Dear Jun Zhou:
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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer R. Stevenson -S3
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180208
Device Name Disposable Endoscopic Trocar
Indications for Use (Describe)
The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows a logo for FENG Medical. The logo is in blue and teal. The word "FENG" is in blue, and the word "Medical" is in a smaller font below the "G" in FENG.
Fengh Medical Co., Ltd. 510(k) Submission Trocar
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
02/20/2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | Fengh Medical Co., Ltd. |
|---|---|
| Company Address: | D3 No.6 Dongsheng West Road, Jiangyin National High |
| tech Zone, 214437 Jiangsu, China | |
| Contact Person: | Jun Zhou |
| Phone: | 86 - 15906171661 |
| Email: | zj_fenghmedical@163.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Disposable Endoscopic Trocar |
|---|---|
| Common Name: | General & Plastic Surgery |
| Product Code: | GCJ |
| Regulation Number: | 21 CFR 876.1500 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of predicates within this submission is as follow:
| Predicate I | |
|---|---|
| Manufacturer: | Ethicon Endo-Surgery, Inc |
| Trade Name: | ENDOPATH III Bladeless Trocars |
| ENDOPATH III Blunt Tip Trocars | |
| ENDOPATH III Dilating Tip Trocars | |
| Common Name: | ENDOPATH III Trocar System |
| Product Code: | GCJ |
| Classification Name: | General& Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500 |
| Classification: | Class II |
| FDA 510 (k) Number: | K032676 |
SECTION 6 - 2 of 7
4
Image /page/4/Picture/0 description: The image shows the text 'K180208 p 3/7'. This appears to be an identifier or code, possibly a document or page number. The 'p' likely stands for 'page', indicating that this is page 3 of a 7-page document. The 'K180208' could be a unique identifier for the document itself.
Image /page/4/Picture/1 description: The image shows a logo for FENG Medical. The logo consists of the word "FENG" in blue, with a stylized "h" in a circle to the right. To the left of "FENG" are two Chinese characters in a similar blue color. Below the "h" is the word "Medical" in a smaller font.
Fengh Medical Co., Ltd. 510(k) Submission Trocar
5. Description of the Device [21 CFR 807.92(a)(4)]
The Fengh Medical Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and econdary insertions.
A Disposable Endoscopic Trocar is mainly composed of Obturator Handle, Outer Seal Release Lever. Trocar Stability Sleeve, Obturator Locking Button, Trocar Stability Sleeve, etc. Materials being used include Stainless 12Cr18Ni9, Stainless 06Cr19Ni10, ABS plastic, PC. All the components of Disposable Endoscopic Trocar are evaluated by cytotoxicity test, sensitization test, intracutaneous mucosa stimulation test, Systemic toxicity(acute) test and Pyrogenicity test. Therefore, it will not cause bad stimulations, allergic reactions or other harm to human tissue or mucosa. Furthermore, no toxic substances will be separated out during the use of Disposable Endoscopic Trocar.
Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.
6. Intended Use [21 CFR 807.92(a)(5)]
The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
7. Technological Characteristic [21 CFR 807.92(a)(6)]
Optical Entry
- Visualization is optically guided by a 0° endoscope .
- . Enables visualization of tissue layers during insertion Durable Universal Seal
SECTION 6 - 3 of 7
5
风和FE
Fengh Medical Co., Ltd. 510(k) Submission Trocar
- . No reducer caps needed
- Maintains insufflation ●
Camera Scope-Locking Tab
- Holds camera locked in place during visually guided entry ●
- Helps provide visual clarity and protects camera from scratching or falling out . Integrated Stability Thread Design
- Maximizes abdominal wall retention for minimal trocar slip-outs ●
Bladeless Optical Tip
- Separates, rather than cuts, along tissue fibers ●
- . Reduced risk of abdominal wall injuries
8. Testing
| Table 1 | Tests |
|---|---|
| Clinical | Not Applicable |
| Non-Clinical Testing: | Sterility Test |
| Peel Strength | |
| Flexibility | |
| Fitness | |
| Leakage | |
| Roughness | |
| Dimension | |
| Appearance | |
| Insertion & Cannula Stability | |
| Trocar sleeve retention force | |
| Endoscope Visualization Quality | |
| Biocompatibility Testing: | In Vitro Cytotoxicity Test |
| Skin Sensitization Test | |
| Intracutaneous reactivity Test | |
| Acute Systemic Toxicity | |
| Pyrogen Test |
9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
| Table 2 | Proposed Device | Predicate Device |
|---|---|---|
| Device Name | Disposable Endoscopic Trocar | ENDOPATH@ III Bladeless |
| Trocars | ||
| Trade Name | Disposable Endoscopic Trocar | ENDOPATH@ III Bladeless |
| Trocars | ||
| ENDOPATH@ III Blunt Tip | ||
| Trocars | ||
| ENDOPATH@ III Dilating | ||
| Tip Trocars | ||
| Device | ||
| Classification | II | II |
| Regulation | ||
| Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code | GCJ | GCJ |
| Intended Use | The Disposable Endoscopic | |
| Trocar has applications in | ||
| abdominal, thoracic, and | ||
| gynecologic minimally invasive | ||
| surgical procedures to establish | ||
| a path of entry for endoscopic | ||
| instruments. The trocar may be | ||
| used with or without | ||
| visualization for primary and | ||
| secondary insertions. | The ENDOPATH III Bladeless | |
| Trocar has applications in | ||
| abdominal, thoracic, and | ||
| gynecologic minimally | ||
| invasive procedures to | ||
| establish a path of entry for | ||
| endoscopic instruments. The | ||
| trocar may be used with or | ||
| without visualization for | ||
| primary and secondary | ||
| insertions. | ||
| The ENDOPATH III Dilating | ||
| Tip Trocar has applications in | ||
| thoracic, gynecologic | ||
| laparoscopy and other | ||
| abdominal procedures to | ||
| establish a path of entry for | ||
| endoscopic instruments. | ||
| The ENDOPATH III Blunt Tip | ||
| Trocar has applications in | ||
| thoracic, gynecologic, | ||
| laparoscopic and other | ||
| abdominal procedures to | ||
| establish a path of entry for | ||
| minimally invasive | ||
| instruments. | ||
| Sizes (Diameter) | 5mm | 5mm |
| N/A | 8mm | |
| 10mm | N/A | |
| N/A | 11mm | |
| 12mm | 12mm | |
| N/A | 15mm | |
| Size (Length) | N/A | 75mm |
| 100mm | 100mm | |
| N/A | 150mm | |
| Principles of | ||
| During the operation, the trocar | During the operation, the | |
| operation | sleeve and the obturator are | |
| used together. The surgeon uses | ||
| the obturator to expand the | ||
| incision of the abdomen and | ||
| penetrates the trocar sleeve | ||
| through the abdominal surface | ||
| of the human body into the | ||
| abdominal cavity, thereby | ||
| delivering gas to the abdominal | ||
| cavity and establishing a path of | ||
| entry for endoscopic | ||
| instruments. | trocar sleeve and the obturator | |
| are used together. The surgeon | ||
| uses the obturator to expand | ||
| the incision of the abdomen | ||
| and penetrates the trocar sleeve | ||
| through the abdominal surface | ||
| of the human body into the | ||
| abdominal cavity, thereby | ||
| delivering gas to the abdominal | ||
| cavity and establishing a path | ||
| of entry for endoscopic | ||
| instruments. | ||
| Main | ||
| Components | Obturator | |
| Obturator Handle | ||
| Scope locking Cam (Except | ||
| FLPC5, FLPC10, FLPC12) | ||
| Obturator Locking Button | ||
| (housed in obturator handle) | ||
| Outer Seal | ||
| Outer Seal Release Lever | ||
| (Except FLPC5,FLPC10, | ||
| FLPC12) | ||
| Stopcock | ||
| Trocar Smooth Sleeve | ||
| Trocar Stability Sleeve | ||
| Optical Element | ||
| Bladeless Tip | ||
| N/A | ||
| N/A | Obturator | |
| Obturator Handle | ||
| Scope locking Cam (housed in | ||
| obturator handle) | ||
| Obturator Locking Button | ||
| (housed in obturator handle) | ||
| Outer Seal | ||
| Outer Seal Release Lever | ||
| Stopcock | ||
| Trocar Smooth Sleeve | ||
| Trocar Stability Sleeve | ||
| Optical Element | ||
| Bladeless Tip | ||
| Bladeless Tip Symbol | ||
| Pistol Handle | ||
| Patient | ||
| Contacting | ||
| Structure | Obturator | |
| Trocar Smooth Sleeve | ||
| Trocar Stability Sleeve | ||
| Optical Element | ||
| Bladeless Tip | Obturator | |
| Trocar Smooth Sleeve | ||
| Trocar Stability Sleeve | ||
| Optical Element | ||
| Bladeless Tip | ||
| Patient | ||
| Contacting | ||
| Material | ABS-1, MN, 095-30-16- | |
| 15/PC/Stainless 12Cr18Ni9 | ||
| (Except FLPC5, FLPC10, | ||
| FLPC12)/Stainless 06Cr19Ni10 | ||
| (Except FLPC5, FLPC10, | ||
| FLPC12) | N/A | |
| Sterilization | Sterilized using Irradiation | N/A |
| Application | ||
| Sites | Abdominal | |
| Thoracic | Abdominal | |
| Thoracic | ||
| Number of Ports | 1 | 1 |
| Single Use | Yes | Yes |
| Obturator & | ||
| Cannula | ||
| Compatibility | Sleeve and Obturator should fit | |
| well without any interference. | ||
| Max clearance between sleeve | ||
| and Obturator: D≤0.3mm | ||
| The tip of Obturator should be | ||
| fully out of sleeve when fit. | N/A | |
| Insertion | ||
| &Cannula | ||
| Stability | When the obturator pulled out | |
| Trocar sleeve, the friction | ||
| should not exceed 5N. | N/A | |
| Trocar System | ||
| Puncture | ||
| Performance | Obturator roughness Ra must | |
| not be bigger than 0.4μm. | N/A | |
| Trocar sleeve | ||
| retention force | Apply a pressure of 5N ± 1N | |
| on both sides of the thread area, | ||
| the pull-out force of the sleeve | ||
| should not less than 10N. | N/A | |
| Air Leakage as a | ||
| whole device | There should be no leakage | |
| under 4kPa pressure between | ||
| stopcock and sealing cap. | N/A | |
| Air Leakage | ||
| with obturator | ||
| withdrawed | Choke valve should have good | |
| gas blocking performance. | ||
| Bubbles should be less than 20 | ||
| under 4KPa pressure. | N/A | |
| Endoscope | ||
| Visualization | ||
| Quality | Accommodate an appropriately | |
| sided 0° endoscope. | N/A | |
| Biocompatibility | In Vitro Cytotoxicity Test | |
| Skin Sensitization Test | ||
| Intracutaneous reactivity Test | ||
| Acute Systemic Toxicity | N/A |
SECTION 6 - 4 of 7
6
Image /page/6/Picture/1 description: The image contains a logo with both Chinese characters and English text. The Chinese characters "风和" are displayed in a teal color, followed by the English word "FENG" in a darker blue. Below the "G" in "FENG", the word "Medical" is written in a smaller font size.
Fengh Medical Co., Ltd.
Trocar
SECTION 6 - 5 of 7
7
Image /page/7/Picture/1 description: The image shows the logo for Fenghe Medical. The logo consists of two Chinese characters followed by the word "FENG" in blue, sans-serif font. To the right of "FENG" is a stylized image of a human figure in blue, with the word "Medical" in smaller font below it.
Fengh Medical Co., Ltd.
Trocar
SECTION 6 - 6 of 7
8
Image /page/8/Picture/1 description: The image shows the logo for FENG Medical. The logo consists of the Chinese characters "风和" on the left, followed by the word "FENG" in blue, and then a stylized "h" inside a circle, also in blue. Below the "h" is the word "Medical" in a smaller font.
Fengh Medical Co., Ltd. 510(k) Submission Trocar
10. Conclusion [21 CFR 807.92(b)(3)]
The Disposable Endoscopic Trocar substantially equivalent to predicate device because both devices use identical technology and same intended use, also testing standards are identical with the predicates. The differences between both devices are insignificant in terms of safety and effectiveness.