Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

Device Description

The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

AI/ML Overview

This document pertains to the 510(k) premarket notification for the "Laparoscope Lens Shield Device (LENS)" by Medeon Biodesign, Inc., designated K200902. The focus of the information provided within this document is on establishing substantial equivalence to a predicate device (K192891) for a slightly modified version of the device, specifically to accommodate a 5mm/30°/30cm standard laparoscope.

Therefore, the acceptance criteria and study proving the device meets these criteria are primarily comparative and based on demonstrating that the modifications do not negatively impact the safety or effectiveness already established for the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is based on demonstrating substantial equivalence for a modified device to a predicate device, the "acceptance criteria" here are implicitly related to ensuring the modified device performs comparably and safely to the predicate. The performance testing focuses on verifying that the changes do not introduce new risks or reduce performance.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility	No change in patient-contacting materials or manufacturing process. Biocompatibility maintained per ISO 10993 standards (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity).	"No change in patient contacting materials and manufacturing process, therefore, additional testing is not required." Biocompatibility is supported by the established biocompatibility of the predicate device (K192891) which successfully passed tests per FDA guidance ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and USP Chapter <151>. Performance: Met (by reference to predicate).
Mechanical Performance	Design specifications fulfilled; safety and function not affected by modifications. Equivalent performance to predicate: Light reflection, Field of view, Direction of view, Distal end structure insertion, Bond joint.	"The mechanical function and structure integrity of modified device were tested to demonstrate that the design specifications from design input are fulfilled and the design modifications do not affect safety and function of the device." All listed mechanical tests (Light reflection, Field of view, Direction of view, Distal end structure insertion, Bond joint) were "successfully performed with the same test methods as for the predicate device, and all the results were passed." Performance: Met.
Sterilization	Sterilization method and Sterility Assurance Level (SAL) maintained.	"Ethylene Oxide sterilization, SAL of 10^-6." (Same as predicate). Performance: Met (by comparison to predicate).
Energy Source	No energy source used.	"No energy source." (Same as predicate). Performance: Met (by comparison to predicate).

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

The document does not explicitly state the sample size (number of devices) used for the mechanical performance tests. It mentions "The following mechanical tests have been successfully performed," implying that a sufficient number of samples were tested to demonstrate compliance.

Sample Size: Not explicitly stated, but implies a sufficient number of devices were tested to validate mechanical performance.
Data Provenance: The tests were conducted internally by Medeon Biodesign, Inc. ("The mechanical function and structure integrity of modified device were tested..."). The document does not specify the country of origin of the data beyond Taiwan, where the submitter is located. The tests appear to be prospective as they were performed specifically for this 510(k) submission to demonstrate substantial equivalence of the modified device.

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

Not applicable in this context. This is a medical device (laparoscope lens shield) that operates on physical principles (shielding debris, maintaining view). The "ground truth" for its performance is directly measurable through engineering and mechanical tests (e.g., light reflection, field of view). It is not a diagnostic device that requires expert interpretation of outputs to establish ground truth (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is established through direct physical/mechanical testing, not through expert consensus or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This device is a physical accessory designed to maintain a clear surgical view, not a diagnostic imaging AI algorithm. Therefore, human reader performance (with or without AI assistance) is not a relevant metric for this device.

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

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established through direct engineering and mechanical measurements against pre-defined specifications (design input). For example, "Field of view test" and "Light reflection test" would have clear, measurable pass/fail criteria.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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April 30, 2020

Medeon Biodesign, Inc. Tsung-Yu Hsieh Sr.Specialist of Regulatory, Quality and Clinical Affairs 7F, 116 HouGang St., Taipei, Taiwan 11170

Re: K200902

Trade/Device Name: Laparoscope Lens Shield Device (LENS) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 1, 2020 Received: April 3, 2020

Dear Tsung-Yu Hsieh:

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

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) N/A K200902

Device Name Laparoscope Lens Shield Device (LENS)

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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FORM FDA 3881 (7/17)

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510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.

The assigned 510(k) Number:Date Prepared:	TBD31 March 2020
1. Submitter
Mailing Address	Medeon Biodesign, Inc7F, 116, HouGang St,Taipei, Taiwan 11170Phone: +886 2 2881 6686Establishment Registration No.: 3012452802
Contact Person	Tsung-Yu, HsiehSr. Specialist of Regulatory, Quality & Clinical Affairs
Phone:	+886 2 2881 6686 ext.130
Fax:	+886 2 2881 6907
E-mail:	tsungyu.hsieh@medeonbio.com

2 Device Name

Common or usual name Trade Name Product Code Device CFR Classification Device Class Classification Panel

Laparoscope Lens Shield Device (LENS) ClickClean GCJ Endoscope and accessories CFR Part 876.1500 II Gastroenterology/Urology

3 Predicate k number

4 Device Description:

K192891

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shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

Laparoscope Lens Shield Device (LENS), a sterile, Intended Use: single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

Special Conditions for Use Statement(s):

For prescription use only

1. Technological Characteristics and Substantial Equivalence Comparison with Predicate:
  Modifications in dimension and material of the previously 510(k) cleared Laparoscope Lens Shield Device (K192891) resulted in one (1) additional model to accommodate 5 mm/ 30°/ 30 cm standard laparoscope.

A comparison of the device features, intended use, and other information demonstrates that the modified device is substantially equivalent to the predicate device as summarized in Table 1.

The differences raise no additional or different questions of safety or effectiveness.

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Table 1: Substantially Equivalent Table
Similarities
	Predicate device (K192891)Model: US030-SO	Modified deviceModel: S330-SP
DeviceSpecification	5mm/ 0° / 30cm	5mm/ 30° / 30cm
Intended Use	Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.	SameLaparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
Target PatientPopulation	Patient under laparoscopic surgery	Same
Target UserPopulation	Clinician who is qualified to perform a laparoscopic surgery	Same
Anatomical Site	Abdominopelvic cavity	Same
Where Used	Hospital O.R. room	Same
Contraindications	There are no known contraindications for modified device	Same
Method ofIntroduction	Predicate device is introduced into abdominopelvic cavity via a trocar	Same
Performance	Enable to maintain the intra-operative view when it gets soiled by debris	Same
Similarities
	Predicate device (K192891)	Modified device
	Model: US030-SO	Model: S330-SP
Biocompatible forIntended Use	Limited exposure, externalcommunication device of tissuecontact.Pass biocompatibility tests inaccordance with the requirements ofFDA guidance Use of InternationalStandard ISO- 10993-1, "BiologicalEvaluation of Medical Devices, Part1: Evaluation and Testing within arisk management process", dated 06-16-2016, including cytotoxicity,sensitization, irritation, acutesystemic toxicity, and pyrogenicitytests.	SameNo change in patient contactingmaterials and manufacturing process,therefore, additional testing is notrequired.
SterilizationMethod	Ethylene Oxide sterilization, SAL of10-6	Same
Energy source	No energy source	Same
Compatibility	Laparoscope:5mm/ 0° /30cm (standard)	Laparoscope:5mm/ 30° /30cm (standard)
	Trocar:5 mm	Trocar:5 mm

Table 1: Substantially Equivalent Table

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7. Performance Testing

The following performance testing for the design modification demonstrated substantial equivalence to the previously cleared predicate:

Biocompatibility testing

Compared to the predicate device, there is no changes in patient contacting materials and manufacturing process. Therefore, additional testing is not required, and the biocompatibility of the modified Laparoscope Lens Shield Device (LENS) could be supported with the established biocompatibility of the predicate device which is based on the evaluation and testing successfully conducted in accordance with the following standards and guidance, as recognized by the FDA:

. FDA Guidance - Use of International Standard ISO- 10993-1, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management process", dated 06-16-2016
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2009 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization

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. ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.
. United State Pharmacopeia (USP) Chapter <151> Rabbit Pyrogen Test

Mechanical testing

The mechanical function and structure integrity of modified device were tested to demonstrate that the design specifications from design input are fulfilled and the design modifications do not affect safety and function of the device. The following mechanical tests have been successfully performed with the same test methods as for the predicate device, and all the results were passed, including Light reflection test, Field of view test, Direction of view test, Distal end structure insertion test and Bond joint test.

8. Conclusion

Based on the intended use, technological characteristics, comparison to the predicate device and performance testing, the modified device is substantially equivalent to the predicate device and raises no additional or different questions of safety or effectiveness.

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.