The Lagis Endoscopic Instruments Disposable Grasper has application in a variety of general, urologic, gyneoologic and endoscopic procedure for grasping and clamping of tissue and small tubular structures.

Device Description

The Lagis Endoscopic Instruments Disposable Grasper with 5mm diameter insulated shaft, 33cm in length, is designed for introduction and use through all appropriately sized trocar sleeves or larger sized trocar sleeves with the use of a converter. Same as predicate devices, the Lagis Endoscopic Instruments Disposable Grasper has a pair of plastic handles, which are compressed and released to close or open the instrument forceps. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Due to different functional requirements, the instrument forceps can be of various designs such as fenestrated/atraumatic/flat/ Endo-Clinch/Babcock/CROCE-OLMI grasping forceps. The materials of construction are similar to the predicate devices and are satisfactorily tested for cytotoxicity, sensitization, intracutaneous reactivity and systematic toxicity per ISO 10993 and 21 CFR, Part 58 requirements.

AI/ML Overview

The provided text is a 510(k) Summary for the Lagis Endoscopic Instruments Disposable Grasper. It describes the device, its intended use, and states that performance bench tests were conducted. However, it does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the specifics of a study proving device performance in the context of AI/medical imaging.

Here's an attempt to answer based only on the provided text, with clear indications of what information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Acceptable results
Sterilization validation	Acceptable results
Material characteristics	Acceptable results
Functional characteristics	Acceptable results
Performance characteristics	Acceptable results
Corrosion performance	Acceptable results (with respect to predicate devices)
Bending performance	Acceptable results (with respect to predicate devices)
Safety	Device is safe (conclusion)
Effectiveness	Device is effective (conclusion)
Performs as intended	Device performs well as intended (conclusion)
Substantial Equivalence to Predicate Device	Substantially equivalent to the predicate device (conclusion)

Note: The document generally states "acceptable results" or "safe, effective and performs well as intended" without providing specific thresholds or metrics for the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "performance bench tests" but does not detail the number of devices or trials.
Data Provenance: Not specified. The document describes bench tests which are typically laboratory-based, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The study described involved "performance bench tests" of a physical medical instrument, not an AI or imaging device requiring expert ground truth establishment from medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided, as the study was bench testing of a physical device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study pertains to a physical surgical instrument, not an AI system or imaging device requiring human reader analysis.

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

This information is not applicable. The device is a physical endoscopic grasper, not an algorithm. The "performance bench tests" can be considered "standalone" in that they evaluate the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically applied to medical imaging/AI is not directly relevant here. For the bench tests, the "ground truth" would be established engineering specifications, material properties, and functional requirements against which the device's performance was measured. The document states tests were conducted to "verify design characteristics and to ensure that the device can be used as intended."

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical medical instrument, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided (see point 8).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2015

Lagis Enterprise Company, Ltd Ms. Cora Chen RD Staff No. 29, Gong 1st Road, Dajia, Taichung 437 Taiwan

Re: K141902

Trade/Device Name: Lagis Endoscopic Instruments Disposable Grasper Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 20, 2015 Received: April 23, 2015

Dear Ms. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

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

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Indications for Use

510(k) Number (if known) K141902

Device Name

Lagis Endoscopic Instruments Disposable Grasper

Indications for Use (Describe)

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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Section 5: 510(k) Summary

SUBMITTED BY: Lagis Enterprise Co., Ltd. No. 29, Gong 1st Rd., Dajia, Taichung 437, Taiwan Cora Chen 886-4-26820767 #3111 CONTACT PERSON: 886-4-26820756 DATE PREPARED: April 20, 2015 SUBJECT DEVICE: Lagis Endoscopic Instruments Disposable Grasper Lagis Endoscopic Instruments TRADE NAME: COMMON NAME: Endoscopic Instruments General & Plastic Surgery CLASSIFICATION NAME: (21 CFR 876.1500, Product Code: GCJ) K930933: ENDOPATH® Endoscopic PREDICATE DEVICE: Surgical Instruments DEVICE DESCRIPTION: The Lagis Endoscopic Instruments Disposable Grasper with 5mm diameter insulated shaft, 33cm in length, is designed for introduction and use through all appropriately sized trocar sleeves or larger sized trocar sleeves with the use of a converter. INDICATION FOR USE: The Lagis Endoscopic Instruments

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Disposable Grasper has applications in a variety of general, urologic, gynecologic, and endoscopic procedures for grasping and clamping of tissue and small tubular structures.

Same as predicate devices, the Lagis Endoscopic Instruments Disposable Grasper has a pair of plastic handles, which are compressed and released to close or open the instrument forceps. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Due to different functional requirements, the instrument forceps can be of various designs such as fenestrated/atraumatic/flat/ Endo-Clinch/Babcock/CROCE-OLMI grasping forceps. The materials of construction are similar to the predicate devices and are satisfactorily tested for cytotoxicity, sensitization, intracutaneous reactivity and systematic toxicity per ISO 10993 and 21 CFR, Part 58 requirements.

TECHNOLOGICAL CHARACTERISTICS:

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RFORMANCE SUMMARY:

Performance bench tests were carried out to verify design characteristics and to ensure that the device can be used as intended. The studies included biocompatibility, sterilization, validation, material characteristics, functional and performance characteristics of the devices. Test results demonstrated acceptable results with respect to predicate devices in corrosion and bending performances, etc. Based on the information provided herein and the Decision-Making Process Chart (Section 12.2), we conclude that the Lagis Endoscopic Instruments Disposable Grasper is safe, effective and performs well as intended, and also substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.

CONCLUSIONS:

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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.