Laparoscope Lens Shield Device (LENS)

K192891 · Medeon Biodesign, Inc. · GCJ · Nov 7, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K192891
• Device Name: Laparoscope Lens Shield Device (LENS)
• Applicant: Medeon Biodesign, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 7, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

Laparoscope Lens Shield Device (LENS) is a sterile, single-use, disposable accessory for laparoscopes; consists of multi-lumen sheath with two concentric sheaths (outer and inner) and shielding film. Device slides over laparoscope; introduced into abdominopelvic cavity via trocar. Operates by physically shielding laparoscope lens from debris, grease, blood, and bodily fluids during minimally invasive surgery. Used in hospital OR by qualified clinicians. Provides clear intra-operative view; prevents need for repeated laparoscope removal for cleaning; benefits patient by potentially reducing surgery time.

Clinical Evidence

No clinical data. Performance testing included biocompatibility (ISO 10993-1, -5, -10, -11, USP <151>), mechanical testing for structural integrity, and functional testing in an animal model to confirm intended use.

Technological Characteristics

Multi-lumen sheath assembly with two concentric sheaths and shielding film. No energy source. Sterilized via Ethylene Oxide (SAL 10^-6). Biocompatibility per ISO 10993-1. Designed for 5mm/0°/30cm laparoscopes.

Indications for Use

Indicated for patients undergoing minimally invasive laparoscopic surgery. Used by clinicians qualified to perform laparoscopic surgery to maintain intra-operative visualization by shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

Regulatory Classification

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.

Predicate Devices

• Laparoscope Lens Shield Device (K170103)

Submission Summary (Full Text)

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November 7, 2019

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

Re: K192891

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: October 9, 2019 Received: October 10, 2019

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Long Chen, PhD 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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## Indications for Use

510(k) Number (if known) K192891

#### Device Name

Laparoscope Lens Shield Device (LENS)

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div style="display:inline-flex"><input checked="" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-flex"><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# Section 6. 510(k) Summary

### 510(k) Summary of Safety and Effectiveness

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: | K192891 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 9 October 2019 |
| 1. Submitter<br>Mailing Address | Medeon Biodesign, Inc<br>7F, 116, HouGang St,<br>Taipei, Taiwan 11170<br>Phone: [phone]<br>Establishment Registration No.: 3012452802 |
| Contact Person | Tsung-Yu, Hsieh<br>Sr. Specialist of Regulatory, Quality & Clinical Affairs |
| Phone: | [phone] ext.130 |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| 2 Device Name | |
| Common or usual name | Laparoscope Lens Shield Device (LENS) |
| Trade Name | ClickClean |
| Product Code | GCJ |
| Device | Endoscope and accessories |
| CFR Classification | CFR Part 876.1500 |
| Device Class | II |
| Classification Panel | Gastroenterology/Urology |
| 3 Predicate k number | K170103 |
| 4 Device Description: | The Laparoscope Lens Shield Device (LENS) is a<br>laparoscopic accessory lens shielding device consisting<br>of multi-lumen sheath that slides over the laparoscope.<br>The sheath assembling consists of 2 concentric sheaths:<br>one outer and one end-to-end connected inner sheaths. |

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| | | Page 2/5 |
|----|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MEDEON<br>Medeon Biodesign, Inc. | Special 510(k) Notification<br>Laparoscope Lens Shield Device (LENS) |
| | | The outer sheath provides protection and cover for the<br>inner sheath and shielding film. It is intended to<br>maintain the intra-operative view of the surgical site<br>during minimally invasive surgery by physically<br>shielding the laparoscope lens from debris, grease,<br>blood, and bodily fluids. |
| 5. | Intended Use: | Laparoscope Lens Shield Device (LENS), a sterile,<br>single-use and disposable laparoscopic accessory lens<br>shield device, for various sizes of laparoscopes<br>including standard and bariatric laparoscope, intended to<br>maintain the intra-operative view of the surgical site<br>during minimally invasive surgery by physically<br>shielding the laparoscope lens from debris, grease,<br>blood, and bodily fluids. |
| | Special Conditions for<br>Use Statement(s): | For prescription use only |
| 6. | Technological<br>Characteristics and<br>Substantial<br>Equivalence<br>Comparison with<br>Predicate: | Modifications in design and material of the previously<br>510(k) cleared Laparoscope Lens Shield Device<br>(K170103) resulted in one (1) additional model to<br>accommodate laparoscopes with 5mm outer diameter.<br>A comparison of the device features, intended use, and<br>other information demonstrates that the modified device<br>is substantially equivalent to the predicate device as<br>summarized in Table 1.<br>The differences raise no additional or different questions<br>of safety or effectiveness. |

| Similarities | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate device (K170103)<br>Model #L042 | Modified device<br>Model #US030-SO |
| Device Specification | 10mm/ 0° / 42cm | 5mm/ 0° / 30cm |
| Similarities | | |
| | Predicate device (K170103)<br>Model #L042 | Modified device<br>Model #US030-SO |
| Intended Use | Laparoscope Lens Shield Device<br>(LENS), a sterile, single-use and<br>disposable laparoscopic accessory<br>lens shield device, for various<br>sizes of laparoscopes including<br>standard and bariatric<br>laparoscope, intended to maintain<br>the intra-operative view of the<br>surgical site during minimally<br>invasive surgery by physically<br>shielding the laparoscope lens<br>from debris, grease, blood, and<br>bodily fluids. | Same<br>Laparoscope Lens Shield Device<br>(LENS), a sterile, single-use and<br>disposable laparoscopic accessory<br>lens shield device, for various<br>sizes of laparoscopes including<br>standard and bariatric<br>laparoscope, intended to maintain<br>the intra-operative view of the<br>surgical site during minimally<br>invasive surgery by physically<br>shielding the laparoscope lens<br>from debris, grease, blood, and<br>bodily fluids. |
| Target Patient<br>Population | Patient under laparoscopic<br>surgery | Same |
| Target User<br>Population | Clinician who is qualified to perform<br>a laparoscopic surgery | Same |
| Anatomical Site | Abdominopelvic cavity | Same |
| Where Used | Hospital O.R. room | Same |
| Contraindications | There are no known<br>contraindications for modified device | Same |
| Method of<br>Introduction | Predicate device is introduced into<br>abdominopelvic cavity via a trocar | Same |
| Performance | Enable to maintain the intra-<br>operative view when it gets soiled<br>by debris | Same |
| Biocompatible for<br>Intended Use | Limited exposure, external<br>communication device of tissue<br>contact.<br>Pass biocompatibility tests in<br>accordance with the requirements of<br>FDA guidance Use of International<br>Standard ISO- 10993-1,<br>"Biological Evaluation of Medical<br>Devices, Part 1: Evaluation and<br>Testing within a risk management<br>process", dated 06-16-2016 | Same<br>Pass the cytotoxicity, sensitization,<br>irritation, acute systemic toxicity, and<br>pyrogenicity tests. |
| Similarities | | |
| | Predicate device (K170103)<br>Model #L042 | Modified device<br>Model #US030-SO |
| Sterilization<br>Method | Ethylene Oxide sterilization, SAL of<br>10-6 | Same |
| Energy source | No energy source | Same |
| Compatibility | Laparoscope:<br>10mm/ 0° / 42cm (bariatric) | Laparoscope:<br>5mm/ 0° /30cm (standard) |
| | Trocar:<br>12mm | Trocar:<br>5 mm |

# Table 1: Substantially Equivalent Table

K192891

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K192891
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Special 510(k) Notification Laparoscope Lens Shield Device (LENS)

�medeon

Medeon Biodesign, Inc.

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& MEDEON Medeon Biodesign, Inc.

## 7. Performance Testing

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

## Biocompatibility testing

Per material changes, the biocompatibility evaluation and testing of the Laparoscope Lens Shield Device (LENS) was 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
- . 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.

## Functional testing

Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled. Design modifications do not affect the function and intended use of device.

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| | Medeon Biodesign, Inc. | K192891<br>Page 5/5 |
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| | | Special 510(k) Notification<br>Laparoscope Lens Shield Device (LENS) |
| | | |

## 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.