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
Indications for 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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized eagle or bird symbol. The bird symbol is composed of three overlapping profiles, suggesting a sense of community or interconnectedness. The overall design is simple and professional, reflecting the department's role in public health and human services.
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
{1}------------------------------------------------
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
# 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> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 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: +886 2 2881 6686 |
| | | Establishment Registration No.: NA (1st submission) |
| | Contact Person | Greta Chang<br>Sr. Manager of Regulatory, Quality & Clinical Affair |
| | Phone: | +886 2 2881 6686 |
| | Fax: | +886 2 2881 6685 |
| | E-mail: | greta@medeonbio.com |
| | 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 |
{4}------------------------------------------------
| 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
{5}------------------------------------------------
| 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.
{6}------------------------------------------------
## 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.
