(28 days)
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.
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.
This document is a 510(k) Premarket Notification for a Laparoscope Lens Shield Device (LENS) for which the device is a laparoscopic accessory lens shield device 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.
The document describes modifications to a previously cleared predicate device (K170103) to accommodate laparoscopes with a 5mm outer diameter (the previous model accommodated 10mm). The submission is a "Special 510(k) Notification," indicating that the modifications do not raise new questions of safety or effectiveness. As such, the performance testing focuses on demonstrating that these modifications maintain substantial equivalence to the predicate device.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics for the modified device in the manner typically seen for diagnostic AI/ML devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating that the modified device performs similarly to the predicate device and meets established medical device standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Pass relevant tests for tissue contact, to ensure no adverse biological reactions.Mechanical Function and Structural Integrity: Design specifications are fulfilled, and safety/function are not affected by modification. | Biocompatibility: Passed cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogenicity tests in accordance with ISO 10993-5, 10993-10, 10993-11, and USP Chapter <151>.Mechanical Testing: Demonstrated that design specifications are fulfilled and modifications do not affect safety and function. |
| Functional Performance (Maintain Intra-operative View): Intended use is fulfilled post-modification. | Functional Testing: Demonstrated that the intended use is fulfilled in an animal model, and design modifications do not affect the function and intended use of the device. |
| Substantial Equivalence to Predicate: No additional or different questions of safety or effectiveness are raised compared to the predicate device (K170103). | Demonstrated through comparison of intended use, technological characteristics, and performance testing, confirming no new safety or effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of cases or specific specimens.
- Data Provenance:
- Biocompatibility: Tested materials (implicitly, the materials used in the modified device). No geographic provenance for materials is given.
- Mechanical Testing: Performed on the modified device itself.
- Functional Testing: Performed in an animal model. No specific details on the animal model (e.g., species, number of subjects) or geographic origin are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This device is a physical medical device (a lens shield), not a diagnostic AI/ML algorithm that requires expert-established ground truth for its performance evaluation (e.g., for image interpretation). The evaluation focuses on physical, chemical, and biological performance characteristics, verified through established testing protocols and animal studies.
4. Adjudication Method for the Test Set
- Not Applicable. As noted above, this is a physical device, and its performance evaluation does not involve diagnostic interpretation or adjudication typically associated with AI/ML systems where ground truth is derived from human expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No such study was done. This is a physical accessory device, not a diagnostic AI/ML algorithm that assists human readers in interpreting medical images. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is a physical medical device, not an algorithm. Its function is to physically shield a laparoscope lens, not to perform a standalone diagnostic interpretation.
7. Type of Ground Truth Used
- Biocompatibility: Ground truth is established by meeting the specific pass/fail criteria outlined in the referenced ISO and USP standards (e.g., no cytotoxicity, no irritation, no systemic toxicity above thresholds).
- Mechanical Testing: Ground truth is established by verifying that the device meets its design specifications and maintains structural integrity under tested conditions.
- Functional Testing: Ground truth is established by observing that the device fulfills its intended use (maintaining the intra-operative view by shielding the lens) in the animal model. This is an observational functional assessment rather than a diagnostic "ground truth."
8. Sample Size for the Training Set
- Not Applicable. This is a physical medical device. It does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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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 (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
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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) |
|---|
| ------------------------------------------------- |
| 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. SubmitterMailing Address | Medeon Biodesign, Inc7F, 116, HouGang St,Taipei, Taiwan 11170Phone: +886 2 2881 6686Establishment Registration No.: 3012452802 |
| Contact Person | Tsung-Yu, HsiehSr. 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 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 alaparoscopic accessory lens shielding device consistingof 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. |
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| Page 2/5 | ||
|---|---|---|
| MEDEONMedeon Biodesign, Inc. | Special 510(k) NotificationLaparoscope Lens Shield Device (LENS) | |
| The outer sheath provides protection and cover for theinner sheath and shielding film. It is intended tomaintain the intra-operative view of the surgical siteduring minimally invasive surgery by physicallyshielding 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 lensshield device, for various sizes of laparoscopesincluding standard and bariatric laparoscope, intended tomaintain the intra-operative view of the surgical siteduring minimally invasive surgery by physicallyshielding the laparoscope lens from debris, grease,blood, and bodily fluids. |
| Special Conditions forUse Statement(s): | For prescription use only | |
| 6. | TechnologicalCharacteristics andSubstantialEquivalenceComparison withPredicate: | Modifications in design and material of the previously510(k) cleared Laparoscope Lens Shield Device(K170103) resulted in one (1) additional model toaccommodate laparoscopes with 5mm outer diameter.A comparison of the device features, intended use, andother information demonstrates that the modified deviceis substantially equivalent to the predicate device assummarized in Table 1.The differences raise no additional or different questionsof safety or effectiveness. |
| Similarities | ||
|---|---|---|
| Predicate device (K170103)Model #L042 | Modified deviceModel #US030-SO | |
| Device Specification | 10mm/ 0° / 42cm | 5mm/ 0° / 30cm |
| Similarities | ||
| Predicate device (K170103)Model #L042 | Modified deviceModel #US030-SO | |
| Intended Use | Laparoscope Lens Shield Device(LENS), a sterile, single-use anddisposable laparoscopic accessorylens shield device, for varioussizes of laparoscopes includingstandard and bariatriclaparoscope, intended to maintainthe intra-operative view of thesurgical site during minimallyinvasive surgery by physicallyshielding the laparoscope lensfrom debris, grease, blood, andbodily fluids. | SameLaparoscope Lens Shield Device(LENS), a sterile, single-use anddisposable laparoscopic accessorylens shield device, for varioussizes of laparoscopes includingstandard and bariatriclaparoscope, intended to maintainthe intra-operative view of thesurgical site during minimallyinvasive surgery by physicallyshielding the laparoscope lensfrom debris, grease, blood, andbodily fluids. |
| Target PatientPopulation | Patient under laparoscopicsurgery | Same |
| Target UserPopulation | Clinician who is qualified to performa laparoscopic surgery | Same |
| Anatomical Site | Abdominopelvic cavity | Same |
| Where Used | Hospital O.R. room | Same |
| Contraindications | There are no knowncontraindications for modified device | Same |
| Method ofIntroduction | Predicate device is introduced intoabdominopelvic cavity via a trocar | Same |
| Performance | Enable to maintain the intra-operative view when it gets soiledby debris | Same |
| Biocompatible forIntended Use | Limited exposure, externalcommunication device of tissuecontact.Pass biocompatibility tests inaccordance with the requirements ofFDA guidance Use of InternationalStandard ISO- 10993-1,"Biological Evaluation of MedicalDevices, Part 1: Evaluation andTesting within a risk managementprocess", dated 06-16-2016 | SamePass the cytotoxicity, sensitization,irritation, acute systemic toxicity, andpyrogenicity tests. |
| Similarities | ||
| Predicate device (K170103)Model #L042 | Modified deviceModel #US030-SO | |
| SterilizationMethod | Ethylene Oxide sterilization, SAL of10-6 | Same |
| Energy source | No energy source | Same |
| Compatibility | Laparoscope:10mm/ 0° / 42cm (bariatric) | Laparoscope:5mm/ 0° /30cm (standard) |
| Trocar:12mm | Trocar:5 mm |
Table 1: Substantially Equivalent Table
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K192891
Page 3/5
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. | K192891Page 5/5 | |
|---|---|---|
| Special 510(k) NotificationLaparoscope 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.
§ 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.