Laparoscope Lens Shield Device (LENS)

K170103 · Medeon Biodesign, Inc. · GCJ · Feb 16, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K170103
• Device Name: Laparoscope Lens Shield Device (LENS)
• Applicant: Medeon Biodesign, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 16, 2017
• 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; slides over laparoscope lens. Used in hospital OR during minimally invasive surgery; operated by qualified clinicians. Physically shields laparoscope lens from debris, grease, blood, and bodily fluids; maintains clear intra-operative view of surgical site. Introduced into abdominopelvic cavity via trocar. Benefits patient by ensuring continuous visualization during surgery, reducing need for lens cleaning.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, -5, -10, and -11. Mechanical testing confirmed structural integrity and design specifications. Functional testing performed in an animal model to verify intended use and performance.

Technological Characteristics

Sterile, single-use, disposable multi-lumen sheath; two concentric sheaths (outer/inner) with shielding film. Compatible with 10mm/0° laparoscopes (30cm and 42cm lengths). No energy source. Ethylene Oxide sterilization (SAL 10^-6). Biocompatible per ISO 10993 standards.

Indications for Use

Indicated for patients undergoing laparoscopic surgery. Used by clinicians qualified to perform laparoscopic surgery in hospital OR settings. 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

• Laparoscope Lens Shield Device (K160172)

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

February 16, 2017

Medeon Biodesign, Inc. Greta Chang Sr. Manager of Regulatory, Ouality & Clinical Affair 7f, 116. Hougang Street Taipei, 11170 Taiwan

Re: K170103 Trade/Device Name: Laparoscope Lens Shield Device (LENS) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: January 11, 2017 Received: January 12, 2017

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.

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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 devicerelated 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,

# 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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# Section 5. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K170103

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) | |
|--------------------------------------------------|---------------------------------------------|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services [phone]

Section 5. 510k Indications for Use Statement

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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 : | K170103 |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 11 January 2017 |
| 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<br>Phone:<br>Fax:<br>E-mail: | Greta Chang<br>Sr. Manager of Regulatory, Quality & Clinical Affair<br>[phone]<br>[phone]<br>[e-mail] |
| 2 Device Name<br>Common or usual name | Laparoscope, general & plastic surgery |
| Trade Name<br>Product Code<br>Device<br>CFR Classification<br>Device Class<br>Classification Panel | Laparoscope Lens Shield Device (LENS)<br>GCJ<br>Endoscope and accessories<br>CFR Part 876.1500<br>II<br>Gastroenterology/Urology |
| 3 Predicate k number | K160172 |
| 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 |

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| Medeon Biodesign, Inc. | | | Special 510(k) Notification<br>Laparoscope Lens Shield Device (LENS) |
|------------------------|-----------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | one outer and one end-to-end connected inner sheaths.<br>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>(K160172) resulted in 2 different models to<br>accommodate various sizes of laparoscopes.<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 different questions of safety or<br>effectiveness. |

| | Similarities | |
|-------------------------|----------------------------|------------------------------------|
| | Predicate device (K160172) | Modified device, total 2 models |
| Device<br>Specification | 10mm/ 0° / 30cm | 10mm/ 0° / 30cm<br>10mm/ 0° / 42cm |

# Table 1: Substantially Equivalent Table

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| | | Special 510(k) Notification |
|--------|------------------------|---------------------------------------|
| MEDEON | Medeon Biodesign, Inc. | Laparoscope Lens Shield Device (LENS) |

| Similarities | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate device (K160172) | Modified device, total 2 models |
| 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<br>of the surgical site during<br>minimally invasive surgery by<br>physically shielding the<br>laparoscope lens from debris,<br>grease, blood, and 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 the cytotoxicity, sensitization,<br>irritation, and acute systemic toxicity. | Same |
| Sterilization<br>Method | Ethylene Oxide sterilization, SAL of<br>$10^{-6}$ | Same |
| Energy source | No energy source | Same |
| Similarities | | |
| | Predicate device (K160172) | Modified device, total 2 models |
| Compatibility | Laparoscope:<br>10mm/ 0° / 30cm (standard) | Laparoscope:<br>10mm/ 0° /30cm (standard)<br>10mm/ 0° /42cm (bariatric) |
| | Trocar:<br>12mm | Trocar:<br>12 mm |

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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

Per material change, 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, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- ISO 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.

# 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.

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 different question of safety or effectiveness.