← Product Code [GCJ](/productcode/GCJ) · K201641
# Disposable Laparoscope Trocar (K201641)
_Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · GCJ · Aug 6, 2020 · Gastroenterology, Urology · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K201641
## Device Facts
- **Applicant:** Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
- **Product Code:** [GCJ](/productcode/GCJ.md)
- **Decision Date:** Aug 6, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic
## Indications for Use
The Disposable Laparoscope 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.
## Device Story
Disposable manual surgical instrument; establishes entry path for endoscopic tools in abdominal, thoracic, gynecologic procedures. Comprises puncture needle, sleeve, valve body, sealing components. Available in 5mm, 10mm, 12mm, 15mm diameters. Used by surgeons in clinical settings. Provides access for instruments; maintains pneumoperitoneum via sealing mechanisms. Benefits patient by facilitating minimally invasive surgery.
## Clinical Evidence
No clinical study included. Bench testing only: instrument insertion/removal forces, leak resistance, snap feature retention, and in vivo porcine model evaluation for penetration/fixation force and tip integrity. Biocompatibility (ISO 10993) and sterilization validation performed.
## Technological Characteristics
Polycarbonate construction. Manual operation. EO sterilization (SAL 10^-6). Available in 5, 10, 12, 15mm diameters. Complies with ISO 10993 (biocompatibility), ASTM F88/F88M-15 (seal strength), ASTM F1929-15 (leak detection), and USP <85> (endotoxin).
## Regulatory 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
- Disposable Endoscopic Trocar ([K180208](/device/K180208.md))
## Reference Devices
- Endopath Bladeless Trocar ([K032676](/device/K032676.md))
## Submission Summary (Full Text)
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August 6, 2020
Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K201641
Trade/Device Name: Disposable Laparoscope Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 27, 2020 Received: June 16, 2020
Dear Diana 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
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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) 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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K201641
Device Name Disposable Laparoscope Trocar
The Disposable Laparoscope 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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# 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: K201641
- 1. Date of Preparation: 08/06/2020
- 2. Sponsor Identification
# Beijing Biosis Healing Biological Technology Co., Ltd.
No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, 102600, Beijing, China.
Establishment Registration Number: 3016668451
Contact Person: Jiali Zhou Position: RA Tel: +86-10-61252660 Fax: +86-10- 61252030 Email: zhoujiali@biosishealing.com
- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (Alternative Contact Person)
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net
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#### Identification of Proposed Device 4.
Trade Name: Disposable Laparoscope Trocar Common Name: General& Plastic Surgery
Regulatory Information Classification Name: Endoscope and Accessories Classification: II; Product Code: GCJ; Regulation Number: 21CFR 876.1500 Review Panel: General& Plastic Surgery;
### Indication for Use:
The Disposable Laparoscope 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.
### Device Description:
The proposed device is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed device is available in 5mm, 10mm, 12mm, 15mm four diameters to accommodate different sizes surgical instrument.
- 5. Identification of Predicate Device
510(k) Number: K180208 Product Name: Disposable Endoscopic Trocar
- 6. Identification of Reference Device
510(k) Number: K032676 Product Name: Endopath Bladeless Trocar
- 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- > ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
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- > USP <85> Bacterial Endotoxin Limit
- > ASTM F88/F88M-15 Standard Test Method For Seal Strength Of Flexible Barrier Materials.(Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by > Dye Penetration
- > ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
- > ISO 10993-11:2017 Biological Evaluation of Medical Device- Part 11: Tests for Systemic Toxicity
Bench tests were conducted on the proposed device and predicate device, which include
- > Instrument Insertion and Removal Forces Test
- > Leak Resistance Test
- > Snap Feature Retention Force Test
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 tests were conducted on the proposed device, the test items include Cytotoxicity test, Instracutaneous test, Skin Sensitization, System Toxicity test and Pyrogen Test.
Sterilization and sterile barrier package testing were performed on the proposed device, which include
- A EO and ECH residue test
- > Endotoxin Limit test
- > Seal strength test
- > Dye penetration test
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
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#### 9. Substantially Equivalent (SE) Comparison
| ITEM | Subject Device | Predicate Device | Reference Device | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | K201641 | K180208 | K032676 | |
| Product Code | GCJ | GCJ | GCJ | |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | |
| Class | II | II | II | |
| Indication for Use | The Disposable Laparoscope
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 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 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. | |
| Main component | Puncture Needle
Puncture sleeve
Obstruct valve body
Injection switch
Injection valve
Sealing cap
Gas barrier seal
Lower retaining ring
Sealing ring
Upper retaining ring
Elastic seal ring
Fixed cover
Positioning guide cover
Secure cover | Obturator
Obturator Handle
Scope locking Cam (Except
FLPC5, FLOC10, 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 | Obturator
Sleeve
Universal seal
Release lever
Camera scope-locking tab
Recessed stopcock valve
Bladeless optical tip | |
| Single Use | Single Use | Single Use | Single Use | |
| Operation Mode | Manually | Manually | Manually | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Complied with 21 CFR part
801 | |
| Diameter (mm) | Available in 5, 10, 12 and 15 | Available in 5, 10 and 12 | Available in 5, 8, 11 and 12 | |
| Length (mm) | Available in 96, 98, 99 and 111 | 100 | Available in 75, 100 and 150 | |
| Patient Contacting
component | | | Obturator | Obturator |
| | Puncture Needle | Trocar Smooth Sleeve | Sleeve | |
| | Puncture Sleeve | Optical Element | Bladeless optical tip | |
| | | Bladeless Tip | | |
| Patient Contacting
Material | Polycarbonate (PC) | ABS-1, MN,
095-30-16-15/PC/Stainless 12Cr
18Ni9/ Stainless 06Cr19Ni10 | Unknown | |
| Biocompatibility | | | | |
| Cytotoxicity | | | | |
| Sensitization | Comply with ISO 10993
standards | Comply with ISO 10993
standards | Comply with ISO 10993
standards | |
| Instracutaneous | | | | |
| System Toxicity | | | | |
| Pyrogen | | | | |
| Insertion force (N) | RJTC-A5: Average 2.25
RJTC-A15: Average 4.08 | BLTC12: Average 4.2 | B5LT: Average 2.35 | |
| Removal force (N) | RJTC-A5: Average 6.37
RJTC-A15: Average 10.31 | BLTC12: Average 10.19 | B5LT: Average 6.27 | |
| Leak resistance | No Leakage | No Leakage | No Leakage | |
| Snap feature
retention force (N) | RJTC-A5: Average 1.8
RJTC-A15: Average 11.8 | BLTC12: Average 11.98 | B5LT: Average 1.69 | |
| Sterilization | | | | |
| Method | EO sterilized | Irradiation | Irradiation | |
| SAL | 10-6 | 10-6 | 10-6 | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | 20 EU per device | |
# Table 1 Comparison of Disposable Laparoscope Trocar
4 / 5
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# 10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.
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**Source:** [https://fda.innolitics.com/device/K201641](https://fda.innolitics.com/device/K201641)
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