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.

AI/ML Overview

The document provided is a 510(k) Summary for a medical device called "Disposable Laparoscope Trocar." This summary describes the device and its equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about acceptance criteria for a device performance study in the context of diagnostic accuracy, AI, or human reader performance.

Instead, the "acceptance criteria" discussed are related to standard engineering and biocompatibility tests for a surgical instrument. The study described is a series of non-clinical bench tests and an in-vivo animal study to demonstrate the safety and foundational performance characteristics of the trocar.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the benchmarks set by the predicate and reference devices, and by compliance with relevant ISO and ASTM standards. The reported device performance is mainly comparative to these existing devices and standards.

Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Subject Device K201641)
Biocompatibility: Complied with ISO 10993 standards for Cytotoxicity, Sensitization, Intracutaneous, System Toxicity, Pyrogen.	Comply with ISO 10993 standards (for Cytotoxicity, Sensitization, Intracutaneous, System Toxicity, Pyrogen)
Insertion Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 4.2 N, B5LT Average 2.35 N)	RJTC-A5: Average 2.25 NRJTC-A15: Average 4.08 N
Removal Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 10.19 N, B5LT Average 6.27 N)	RJTC-A5: Average 6.37 NRJTC-A15: Average 10.31 N
Leak Resistance: No Leakage	No Leakage
Snap Feature Retention Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 11.98 N, B5LT Average 1.69 N)	RJTC-A5: Average 1.8 NRJTC-A15: Average 11.8 N
Sterilization Assurance Level (SAL): 10^-6	10^-6
Endotoxin Limit: 20 EU per device	20 EU per device
Ethylene Oxide Sterilization Residuals: Complies with ISO 10993-7:2008	(Tested, implied compliance)
Bacterial Endotoxin Limit: Complies with USP <85>	(Tested, implied compliance)
Seal Strength: Complies with ASTM F88/F88M-15	(Tested, implied compliance)
Seal Leaks (Dye Penetration): Complies with ASTM F1929-15	(Tested, implied compliance)
Tip Integrity: Maintained after insertion (from in vivo study)	(Evaluated, implied satisfactory)
Visualization Performance (for optical type): Adequate (from in vivo study)	(Evaluated, implied satisfactory)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for each specific bench test, but implied to be sufficient for statistical validity in engineering tests. For the in vivo study, it mentions a "porcine model," implying a number of animal subjects were used, but the exact count is not given.
Data Provenance: Not specified where these tests were conducted, beyond the applicant being Beijing Biosis Healing Biological Technology Co., Ltd. (China). The tests are presumably retrospective data collected during device development.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the evaluation involves physical and chemical property testing, not subjective expert assessment of clinical data or images.

4. Adjudication Method for the Test Set

This is not applicable. Objective measurements and established testing protocols are used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a physical surgical tool (trocar), not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical surgical tool and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these tests are the established definitions and methodologies within the cited ISO and ASTM standards, as well as the performance characteristics of legally marketed predicate devices. For biocompatibility, it's the biological response as per standardized tests. For mechanical properties, it's the quantifiable physical measurements.
For the in vivo study, the ground truth would be the direct observation of insertion force, fixation force, visualization, and tip integrity in a live biological model.

8. The Sample Size for the Training Set

This is not applicable as there is no "training set" in the context of a physical medical device. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Summary

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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

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
1. 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

1. 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:

Device Description:

1. Identification of Predicate Device
  510(k) Number: K180208 Product Name: Disposable Endoscopic Trocar
1. Identification of Reference Device
  510(k) Number: K032676 Product Name: Endopath Bladeless Trocar
1. 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 LaparoscopeTrocar has applications inabdominal, thoracic, andgynecologic minimally invasivesurgical procedures to establish apath of entry for endoscopicinstruments. The trocar may beused with or withoutvisualization for primary andsecondary insertions.	The Disposable EndoscopicTrocar has applications inabdominal, thoracic, andgynecologic minimally invasivesurgical procedures to establisha path of entry for endoscopicinstruments. The trocar may beused with or withoutvisualization for primary andsecondary insertions.	The ENDOPATH BladelessTrocar has applications inabdominal, thoracic andgynecologic minimallyinvasive procedures toestablish a path of entry forendoscopic instruments. Thetrocar may be used with orwithout visualization forprimary and secondaryinsertions.
Main component	Puncture NeedlePuncture sleeveObstruct valve bodyInjection switchInjection valveSealing capGas barrier sealLower retaining ringSealing ringUpper retaining ringElastic seal ringFixed coverPositioning guide coverSecure cover	ObturatorObturator HandleScope locking Cam (ExceptFLPC5, FLOC10, FLPC12)Obturator Locking Button(housed in obturator handle)Outer SealOuter Seal Release Lever(Except FLPC5, FLPC10,FLPC12)StopcockTrocar Smooth SleeveTrocar Stability SleeveOptical ElementBladeless Tip	ObturatorSleeveUniversal sealRelease leverCamera scope-locking tabRecessed stopcock valveBladeless 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 part801
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 Contactingcomponent			Obturator	Obturator
	Puncture Needle	Trocar Smooth Sleeve	Sleeve
	Puncture Sleeve	Optical Element	Bladeless optical tip
		Bladeless Tip
Patient ContactingMaterial	Polycarbonate (PC)	ABS-1, MN,095-30-16-15/PC/Stainless 12Cr18Ni9/ Stainless 06Cr19Ni10	Unknown
Biocompatibility
Cytotoxicity
Sensitization	Comply with ISO 10993standards	Comply with ISO 10993standards	Comply with ISO 10993standards
Instracutaneous
System Toxicity
Pyrogen
Insertion force (N)	RJTC-A5: Average 2.25RJTC-A15: Average 4.08	BLTC12: Average 4.2	B5LT: Average 2.35
Removal force (N)	RJTC-A5: Average 6.37RJTC-A15: Average 10.31	BLTC12: Average 10.19	B5LT: Average 6.27
Leak resistance	No Leakage	No Leakage	No Leakage
Snap featureretention force (N)	RJTC-A5: Average 1.8RJTC-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

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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.

Regulation Number and Section

§ 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.