(262 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of the trocar, with no mention of AI or ML capabilities.
No.
The device is a surgical instrument used to create a path for other endoscopic instruments, not to directly treat a medical condition or disease.
No
The device description clearly states its purpose is to establish a path of entry for endoscopic instruments during surgical procedures, not to diagnose medical conditions.
No
The device description clearly outlines physical components (Puncture Needle, Puncture Sleeve, Injection Valve, Cap, Safety lock) and describes physical performance tests (insertion force, leak resistance, in vivo penetration force, etc.), 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" during surgical procedures. This is a surgical tool used in vivo (within the body) to facilitate a procedure.
- Device Description: The description details a physical instrument used for puncturing and creating a channel into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside the body. This device is a surgical instrument used inside the body.
N/A
Intended Use / Indications for Use
The devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
Product codes
GCJ
Device Description
The proposed devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, are basic equipment used during laparoscopic surgical, which consist of Puncture Needle, Puncture Sleeve, Injection Valve, Cap and Safety lock. They are available in multiple configurations, including bladed type, bladeless type and optical type. In order to obtain access to the surgical site during laparoscopic surgery, the Puncture Needle is introduced into Puncture Sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the Injection Valve at its proximal end and once the abdominal/thoracic wall is punctured, the puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. Generically, puncture needle and sleeve are available in a range of lengths and diameters to accommodate different sizes surgical instrument
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)
Non-Clinical Test Conclusion:
Following non clinical tests were conducted. Performance Tests, both bench and in vivo study, were performed on both the proposed devices and predicate devices. The results demonstrated that the performances of the proposed device are substantial equivalent to those of the predicate device. Results of biocompatibility, sterility and packaging tests demonstrated that the proposed devices met their specifications and requirements.
Performance Tests - Bench:
- Instrument Insertion and Removal Force Test;
- A Leak Resistance Test;
- Snap Feature Retention Force Test.
Performance Tests - in vivo Study:
An in vivo study was conducted on porcine model to evaluate the penetration force, fixation force and visualization performance (for optical type only), in addition, tip integrity was also evaluated after each insertion.
Biocompatibility:
- Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity;
- Irritation and Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
- A Pyrogen Study per ISO 10993-11:2006 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity;
Sterility and Packaging:
- ISO 10993-7:2008 Biological Evaluation Of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
- ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- USP Endotoxin Limit 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 26, 2019
Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. % Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K190029
Trade/Device Name: Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, and Disposable Bladed Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 26, 2019 Received: August 28, 2019
Dear Ms. Hong:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190029
Device Name
Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar
Indications for Use (Describe)
The devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K190029
-
- Date of Preparation: 09/23/2019
-
- Sponsor Identification Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. No.51 Shuishan Road, Zhonglou Economic Development Zone, Changzhou, 213023, China. Establishment Registration Number: 3013534295
Contact Person: Boping Ma Position: General Manager Tel: +86-519-88830515 Fax: +86-519-86865852 Email: mbp129@126.com
-
- Designated Submission Contact Persons Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Contact Persons Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
-
- Identification of Proposed Device Device Trade Name: Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar Device Common Name: Disposable Trocar/Cannula
Regulatory Information: Classification Name: Laparoscope, General & Plastic Surgery; Classification: II; Product Code: GCJ; Regulation Number: 876.1500; Review Panel: General & Plastic Surgery;
- Identification of Proposed Device Device Trade Name: Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar Device Common Name: Disposable Trocar/Cannula
4
510(k) Number: K190029
Intended Use Statement:
The proposed devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.
Device Description
The proposed devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, are basic equipment used during laparoscopic surgical, which consist of Puncture Needle, Puncture Sleeve, Injection Valve, Cap and Safety lock. They are available in multiple configurations, including bladed type, bladeless type and optical type. In order to obtain access to the surgical site during laparoscopic surgery, the Puncture Needle is introduced into Puncture Sleeve to accomplish cannula penetration of the abdominal wall. The sleeve is connected to the Injection Valve at its proximal end and once the abdominal/thoracic wall is punctured, the puncture needle is removed. The sleeve acts as a channel for the introduction of the endoscopes and instruments. Generically, puncture needle and sleeve are available in a range of lengths and diameters to accommodate different sizes surgical instrument
-
- Identification of Predicate Devices
Predicate Device 1 510(k) Number: K122511 Product Name: ENDOPATH® XCEL® Bladeless Trocar with OPTIVIEWTM Technology
- Identification of Predicate Devices
Predicate Device 2 510(k) Number: K062362 Product Name: Autosuture Modified Versaport Trocar with Fixation Sleeve
6. Non-Clinical Test Conclusion
Following non clinical tests were conducted. Performance Tests, both bench and in vivo study, were performed on both the proposed devices and predicate devices. The results demonstrated that the performances of the proposed device are substantial equivalent to those of the predicate device. Results of biocompatibility, sterility and packaging tests demonstrated that the proposed devices met their specifications and requirements.
Performance Tests - Bench
- Instrument Insertion and Removal Force Test; A
- A Leak Resistance Test;
-
Snap Feature Retention Force Test.
Performance Tests - in vivo Study
An in vivo study was conducted on porcine model to evaluate the penetration force, fixation force and visualization performance (for optical type only), in addition, tip integrity was also evaluated after each insertion.
Biocompatibility
- Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for In A Vitro Cytotoxicity;
-
Irritation and Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part
5
10: Tests for Irritation and Skin Sensitization;
-
A Pyrogen Study per ISO 10993-11:2006 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity;
Sterility and Packaging -
ISO 10993-7:2008 Biological Evaluation Of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
-
ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
-
USP Endotoxin Limit Test
-
- Clinical Testing No clinical study was done.
-
- Substantially Equivalent (SE) Comparison
| Table 1 Comparison for Disposable Bladeless Trocar and Disposable Optical Trocar with predicate device |
|---|
| (K122511) |
| ITEM | Proposed Device
Disposable Bladeless Trocar | Proposed Device
Disposable Optical Trocar | Predicate Device 1
K122511 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | II | II | II |
| Regulation No. | 876.1500 | 876.1500 | 876.1500 |
| Product Code | GCJ | GCJ | GCJ |
| Intended Use | The device has applications in
abdominal, thoracic, and
gynecologic minimally
invasive surgical procedures to
establish a path of entry for
endoscopic instruments. | The device has applications in
abdominal, thoracic, and
gynecologic minimally
invasive surgical procedures
to establish a path of entry for
endoscopic instruments. | The ENDOPATH®
XCEL® Bladeless 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. |
| Configuration | Puncture Needle
Puncture Sleeve
Reducer Cap | Puncture Needle
Puncture Sleeve
Reducer Cap | Puncture Needle
Puncture Sleeve
Reducer Cap |
| Single Use | Single Use | Single Use | Single Use |
| Operation Mode | Manually | Manually | Manually |
| Accessory | Puncture sleeve, reducer cap | Puncture sleeve, reducer cap | No accessory |
| Safety features | No safety feature | No safety feature | No safety feature |
6
| Label/Labeling | Comply with 21, CFR Section 801 | Comply with 21, CFR Section 801 | Comply with 21, CFR Section 801 |
|---|---|---|---|
| Shaft Diameter | Available in 3, 5, 8, 10, 12, and 15mm | Available in 5, 8, 10 and 12mm | Available in 5 and 12mm |
| Shaft Length | Available in 75 and 100mm | Available in 75 and 100mm | Available in 75, 100 and 150mm |
| Material | ABS, PC, PE, Colorant, Rubber | ABS, Stainless Steel, PC, PE, Rubber, Colorant | Unknown |
| Trocar Width | 52.4mm, 61.4m | 52.4mm, 61.4mm | Unknown |
| Total Length | 158mm, 184mm, 172mm, 197mm | 158mm, 172mm, 184mm, 197mm | Unknown |
| Needle Tip Shape | Fin | Fin | Fin |
| Sterilization | EO sterilized | EO sterilized | Irradiation sterilized |
| SAL | 10-6 | 10-6 | 10-6 |
| Endotoxin Limit | 20 EU per device | 20 EU per device | 20 EU per device |
| Shelf life | 2 years | 2 years | 3 years |
| Packaging method | Sealing method | Sealing method | Sealing method |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | |
| Skin Irritation | No irritation | No irritation | Comply with ISO 10993 |
| Sensitization | No sensitization | No sensitization | |
| Pyrogen | No pyrogen | No pyrogen |
| ITEM | Proposed Device | Predicate Device 2 |
|---|---|---|
| Disposable Bladed Trocar | K062326 | |
| Classification | II | II |
| Regulation No. | 876.1500 | 876.1500 |
| Product Code | GCJ | GCJ |
| Intended Use | The device has applications in abdominal, | |
| thoracic, and gynecologic minimally | ||
| invasive surgical procedures to establish a | ||
| path of entry for endoscopic instruments. | The autosutureTM Modified VERSAPORTTM | |
| trocar with fixation sleeve is intended for use | ||
| in a variety of gynecologic, general, thoracic | ||
| and urologic endoscopic procedures to create | ||
| and maintain a port of entry | ||
| Configuration | Puncture Knife | |
| Puncture Sleeve | ||
| Reducer Cap | ||
| Puncture Needle | Puncture Knife | |
| Puncture Sleeve | ||
| Reducer Cap | ||
| Puncture Needle | ||
| Single Use | Single Use | Single Use |
| Operation Mode | Manually | Manually |
| Accessory | Puncture sleeve, reducer cap | No accessory |
| Safety features | Yes | Yes |
7
| Label/Labeling | Comply with 21, CFR Section 801 | Comply with 21, CFR Section 801 |
|---|---|---|
| Shaft Diameter | Available in 5, 8, 10 and 12mm | Available in 5, 11 and 12mm |
| Shaft Length | Available in 75 and 100mm | Short, regular, long |
| Material | ABS, Stainless Steel, PC, PE, Rubber, Colorant | Unknown |
| Trocar Width | 52.4mm, 61.4mm | Unknown |
| Total Length | 158mm, 172mm, 184mm, 198mm | Unknown |
| Needle Tip Shape | Blunt | Blunt |
| Sterilization | EO sterilized | EO sterilized |
| SAL | 10-6 | 10-6 |
| Endotoxin Limit | 20 EU per device | 20 EU per device |
| Shelf life | 2 years | 3 years |
| Packaging method | Sealing method | Sealing method |
| Cytotoxicity | No cytotoxicity | Comply with ISO 10993 |
| Skin Irritation | No irritation | |
| Sensitization | No sensitization | |
| Pyrogen | No pyrogen |
Any technical differences have been justified, both scientifically and using performance testing. These do not affect the safety or effectiveness of the proposed device.
CONCLUSION
Based on testing and comparison with the predicate devices shows no adverse indications or results. It is our determination that the proposed device is safe, effective and performs within its design specifications and is substantially equivalent to the predicate devices.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.