K Number
K192891
Device Name
Laparoscope Lens Shield Device (LENS)
Date Cleared
2019-11-07

(28 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The description focuses on a physical shielding mechanism for a laparoscope lens and does not mention any computational or analytical functions that would typically involve AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".

No
The device is described as a "laparoscopic accessory lens shield device" intended to maintain the intra-operative view by physically shielding the laparoscope lens. It does not treat or diagnose a disease or condition, which is the primary function of a therapeutic device.

No
The device is described as a laparoscopic accessory lens shield intended to maintain the intra-operative view by physically shielding the laparoscope lens. It does not mention any diagnostic capabilities, such as measuring, detecting, or analyzing conditions.

No

The device description clearly states it is a physical, disposable accessory consisting of sheaths, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to maintain the intra-operative view during minimally invasive surgery by physically shielding the laparoscope lens. This is a surgical accessory used during a procedure to improve visualization, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
  • Device Description: The description details a physical shield that slides over a laparoscope. This aligns with a surgical tool, not a diagnostic test.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on specimens, or providing diagnostic information based on the analysis of these samples.

IVD devices are typically used to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely mechanical and related to improving visualization during surgery.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

GCJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Abdominopelvic cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinician who is qualified to perform a laparoscopic surgery, Hospital O.R. room

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K170103

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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

1

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, 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

2

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)
-------------------------------------------------
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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
Mailing AddressMedeon Biodesign, Inc
7F, 116, HouGang St,
Taipei, Taiwan 11170
Phone: +886 2 2881 6686
Establishment Registration No.: 3012452802
Contact PersonTsung-Yu, Hsieh
Sr. 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 nameLaparoscope Lens Shield Device (LENS)
Trade NameClickClean
Product CodeGCJ
DeviceEndoscope and accessories
CFR ClassificationCFR Part 876.1500
Device ClassII
Classification PanelGastroenterology/Urology
3 Predicate k numberK170103
4 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.

4

Page 2/5
MEDEON
Medeon Biodesign, Inc.Special 510(k) Notification
Laparoscope Lens Shield Device (LENS)
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.
5.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.
Special Conditions for
Use Statement(s):For prescription use only
6.Technological
Characteristics and
Substantial
Equivalence
Comparison with
Predicate:Modifications in design and material of the previously
510(k) cleared Laparoscope Lens Shield Device
(K170103) resulted in one (1) additional model to
accommodate laparoscopes with 5mm outer diameter.
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.
Similarities
Predicate device (K170103)
Model #L042Modified device
Model #US030-SO
Device Specification10mm/ 0° / 42cm5mm/ 0° / 30cm
Similarities
Predicate device (K170103)
Model #L042Modified device
Model #US030-SO
Intended UseLaparoscope 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.Same
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.
Target Patient
PopulationPatient under laparoscopic
surgerySame
Target User
PopulationClinician who is qualified to perform
a laparoscopic surgerySame
Anatomical SiteAbdominopelvic cavitySame
Where UsedHospital O.R. roomSame
ContraindicationsThere are no known
contraindications for modified deviceSame
Method of
IntroductionPredicate device is introduced into
abdominopelvic cavity via a trocarSame
PerformanceEnable to maintain the intra-
operative view when it gets soiled
by debrisSame
Biocompatible for
Intended UseLimited exposure, external
communication device of tissue
contact.
Pass biocompatibility tests in
accordance with the requirements of
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 06-16-2016Same
Pass the cytotoxicity, sensitization,
irritation, acute systemic toxicity, and
pyrogenicity tests.
Similarities
Predicate device (K170103)
Model #L042Modified device
Model #US030-SO
Sterilization
MethodEthylene Oxide sterilization, SAL of
10-6Same
Energy sourceNo energy sourceSame
CompatibilityLaparoscope:
10mm/ 0° / 42cm (bariatric)Laparoscope:
5mm/ 0° /30cm (standard)
Trocar:
12mmTrocar:
5 mm

Table 1: Substantially Equivalent Table

K192891

5

K192891
Page 3/5

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

�medeon

Medeon Biodesign, Inc.

6

& 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 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.

7

| | Medeon Biodesign, Inc. | K192891
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|--|------------------------|----------------------------------------------------------------------|
| | | Special 510(k) Notification
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.