Laparoscope Lens Shield Device

K151117 · Medeon Biodesign, Inc. · GCJ · Aug 20, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K151117
• Device Name: Laparoscope Lens Shield Device
• Applicant: Medeon Biodesign, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 20, 2015
• Decision: SESE
• Submission Type: Traditional
• 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, 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.

Device Story

Laparoscope Lens Shield Device (LENS) is a sterile, single-use, disposable accessory for laparoscopes used in hospital operating rooms. The device consists of a multi-lumen sheath assembly (one outer and two inner sheaths) that slides over a 10mm, 30cm laparoscope. It functions as a physical barrier using a PET film to shield the lens from debris, grease, blood, and bodily fluids during abdominopelvic surgery. The device is introduced via a 12mm trocar. It requires no energy source. Clinicians use the device to maintain intra-operative visualization, preventing the need to remove the laparoscope for cleaning, thereby potentially reducing surgical time and improving procedural efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-5, -10, -11), sterilization validation (ISO 11135:2014), mechanical integrity testing, and image quality assessments (resolution, distortion, field of view, depth of view, and color) to ensure performance specifications were met.

Technological Characteristics

Multi-lumen sheath assembly (one outer, two inner sheaths) with PET film barrier. Compatible with 0°, 10mm, 30cm laparoscopes and 12mm trocars. No energy source. Sterilized via Ethylene Oxide (SAL 10^-6). Biocompatibility per ISO 10993 standards.

Indications for Use

Indicated for patients undergoing minimally invasive laparoscopic surgery to maintain clear visualization of the surgical site by shielding the laparoscope lens from debris, grease, blood, and bodily fluids. No known contraindications.

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

• Clear-Vu System (K080613)

Submission Summary (Full Text)

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

August 20, 2015

Medeon Biodesign, Inc. % Greta Chang Sr. Manager of Regulatory, Quality and Clinical Affairs Lin & Associate, LLC 9223 Cambridge Manor Court Potomac, MD 20854

Re: K151117

> Trade/Device Name: Laparoscope Lens Shield Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: July 13, 2015 Received: July 15, 2015

Dear Greta Chang,

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K151117

#### 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, 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.

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

| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-variant-numeric: normal;"> <span style="font-variant-east-asian: normal;"> <span style="font-kerning: auto;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </span> </span> </span> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-variant-numeric: normal;"> <span style="font-variant-east-asian: normal;"> <span style="font-kerning: auto;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </span> </span> </span> |

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# Section 5 510(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: TBD

.

| 1. | Submitter | |
|----|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mailing Address | Medeon Biodesign, Inc<br>7F, 116, HouGang St,<br>Taipei, Taiwan 11170 |
| | | Phone: [phone] |
| | | Establishment Registration No.: NA (1st submission) |
| | Contact Person | Greta Chang<br>Sr. Manager of Regulatory, Quality & Clinical Affair |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | E-mail: | [e-mail] |
| | Date Prepared | April 24, 2015 |
| 2 | Device Name | |
| | Common or usual name | Laparoscope Lens Shield Device (LENS) |
| | Product Code | GCJ |
| | Device | Endoscope and accessories |
| | CFR Classification | CFR Part 876.1500 |
| | Device Class | II |
| | Classification Panel | Gastroenterology/Urology |
| 3 | Predicate Device Name | |
| | 510(k) number: | K080613 |
| | Trade or proprietary or<br>model name: | Clear-Vu System |
| | Manufacturer: | Minimally Invasive Devices, LLC |
| 4 | Device Description: | The Laparoscope Lens Shield Device (LENS) is a |
| | | laparoscope accessory lens shielding device consisted of<br>multi-lumen sheath that slides over the laparoscope. The<br>sheaths assembly consists of 3 concentric sheaths: one<br>outer and two inner sheaths. The outer sheath provides<br>protection and cover for the inner sheath and shielding |
| | | film. It is intended to maintain the intra-operative view of |

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| MEDEON Medeon Biodesign, Inc. Traditional 510(k) Notification Laparoscope Lens Shield Device (LENS) | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids The Laparoscope Lens Shield Device (LENS) is intended to be used by clinicians through prescription use only. | | | |
| 5. | <b>Intended Use:</b> | Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, 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. | |
| | Special Conditions for Use Statement(s): | For prescription use only | |
| 6. | <b>Technological Characteristics and Substantial Equivalence Comparison with Predicate:</b> | A comparison of the device features, intended use, and other information demonstrates that the Laparoscope Lens Shield Device (LENS) is substantially equivalent to the predicate device as summarized in <b>Table 1</b> . The differences raise no different question of safety and effectiveness. | |

| Similarities | | | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Device name | Subject device: Laparoscope Lens<br>Shield Device (LENS) | Predicate device: Clear-Vu | | |
| Intended Use | Laparoscope Lens Shield Device<br>(LENS), a sterile, single-use and<br>disposable laparoscopic accessory<br>lens shield device, is intended to<br>maintain the intra-operative view of<br>the surgical site during minimally<br>invasive surgery by physically<br>shielding the laparoscope lens from<br>debris, grease, blood, and bodily<br>fluids | Clear-Vu System is a single-use,<br>disposable laparoscopic accessory<br>device intended to facilitate intra-<br>operative defogging and cleaning of<br>the lens of a laparoscope during<br>minimally-invasive surgery while<br>maintaining visualization of the<br>surgical site. | | |
| Target patient<br>Population | Patient under laparoscopic surgery | Same | | |
| Target User<br>Population | Clinician who is qualified to perform<br>a laparoscopic surgery. | Same | | |
| Anatomical<br>Site | Abdominopelvic cavity | Same | | |
| Where Used | Hospital O.R. room | Same | | |

# Table 1

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| Similarities | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Device name | Subject device: Laparoscope Lens<br>Shield Device (LENS) | Predicate device: Clear-Vu |
| Contraindicati<br>ons | There's no known contraindications<br>for subject device | Same |
| Method of<br>Introduction | Subject device is introduced into<br>abdominopelvic cavity via a trocar. | Same |
| Compatibility<br>Other Devices | Laparoscope :0°, 10mm, 30cm scope<br>Trocar: 12mm | Same |
| Performance | Able to maintain laparoscopic view<br>when it get soiled by debris | Same |
| Biocompatible<br>for Intended<br>Use | Limited exposure, external<br>communication device of tissue<br>contact<br>Pass the cytotoxicity, sensitization,<br>irritation, and acute systemic toxicity | Same |
| Differences | | |
| Device name | Subject device: Laparoscope Lens<br>Shield Device (LENS) | Predicate device: Clear-Vu |
| Sterilization<br>Method | Ethylene Oxide sterilization, SAL of<br>10-6 | Radiation sterilization, SAL of 10-6 |
| Energy source | No energy source | CO2 Gas |
| Physical<br>barrier | PET film | CO2 Gas |

# 7. Performance Testing

& MEDEON

Performance testing has been carried out to demonstrate that this device meets the performance specification for its intended use. The following tests were performed on the device.

## Biocompatibility testing

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 Draft Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", dated 04-23-2013
- ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- . 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.

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## Sterilization validation

Sterilization validation was conducted in accordance with ISO 11135:2014 "Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices". Sterilization has been validated to achieve a Sterility Assurance Level (SAL) of 10 - .

# Mechanical testing

Laparoscope Lens Shield Device (LENS)'s mechanical function and structure integrity were tested and demonstrated that the design specification from design input are fulfilled. Mechanical safety tests were also conducted to demonstrate that the insertion portion of the device remains intact during the surgery and raises no safety concern.

# Image quality test

Laparoscope Lens Shield Device (LENS) had been tested for view quality during laparoscopic procedures regarding the resolution, distortion, field of view, depth of view, and color, to demonstrate that adequate view quality of laparoscopy is maintained to a safe and effective clinical use.

8. Conclusion. Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the Laparoscope Lens Shield Device (LENS) is substantially equivalent to the predicate device and raises no different question of safety or effectiveness.