(85 days)
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.
The Laparoscope Lens Shield Device (LENS) is a laparoscope 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.
The document describes the Medeon Biodesign, Inc. Laparoscope Lens Shield Device (LENS). However, it does not contain a detailed study report that proves the device meets specific acceptance criteria for its performance (e.g., maintaining intra-operative view consistently), nor does it provide a table of acceptance criteria with reported device performance metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.
The provided information primarily focuses on establishing substantial equivalence to a predicate device (K151117) for a modified version of the LENS device, and lists types of tests conducted (biocompatibility, mechanical, functional).
Here's an analysis of what information is available and what is missing based on your specific questions:
1. A table of acceptance criteria and the reported device performance
- Missing. The document confirms that functional testing was performed ("Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled."). However, it does not provide a table of quantitative acceptance criteria for this functional performance (e.g., a specific percentage reduction in lens soiling, or a duration for which the view is maintained without cleaning) nor the reported performance against such criteria. It only states qualitatively that "design modifications do not alter the device function and intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "animal model" for functional testing but does not specify the sample size (e.g., number of animals, number of trials).
- Data Provenance: The document does not specify the country of origin for the animal model data. It is implied to be prospective testing carried out for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not specified. For a device like a lens shield, ground truth would likely be established based on direct observation of the lens cleanliness or image clarity during the functional tests, not typically through expert consensus on interpretations of output. The document does not mention experts or their qualifications being used to establish ground truth for the functional testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are typically relevant for studies where subjective interpretation or classification is involved, often in diagnostic imaging. For a functional device like this, the assessment of "device function and intended use" would likely be based on objective observations (e.g., visual clarity, presence of debris) rather than an adjudication process among multiple reviewers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical laparoscopic accessory, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related metrics are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical shield, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the functional testing, the ground truth would likely be based on:
- Direct observation of the laparoscopic view: Assessment of image clarity, presence or absence of debris on the lens.
- Measurement of physical parameters: Potentially measuring the time before the lens requires cleaning, or the number of cleanings prevented.
- The document states testing was done "to demonstrate that the intended use is fulfilled," which implies a ground truth defined by the successful maintenance of the intra-operative view. However, the specific criteria for this "ground truth" are not detailed.
8. The sample size for the training set
- Not applicable. Historical data or previous versions of the device might implicitly "train" the design process, but for a physical device, there isn't a "training set" in the sense of a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary Table of Available Information vs. Missing Information:
| Feature | Information from Document | Status |
|---|---|---|
| Acceptance Criteria & Performance Table | Not provided. "Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled." | Missing (specific criteria and quantitative results) |
| Test Set Sample Size | "animal model" - specific number not provided. | Missing (specific number) |
| Data Provenance (Test Set) | Implied prospective testing. Country of origin not specified. | Missing (Country) |
| Number & Qualifications of Experts (Test Set GT) | Not applicable / Not mentioned. | N/A / Missing |
| Adjudication Method (Test Set) | Not applicable / Not mentioned. | N/A / Missing |
| MRMC Comparative Effectiveness Study | Not applicable. Device is a physical shield, not AI. | N/A |
| Standalone Performance Study (Algorithm Only) | Not applicable. Device is a physical shield, not an algorithm. | N/A |
| Type of Ground Truth Used | "Device functionality was tested... to demonstrate that the intended use is fulfilled." Likely visual clarity/debris assessment during animal model testing. | Not fully detailed |
| Training Set Sample Size | Not applicable (physical device). | N/A |
| How Ground Truth for Training Set was Established | Not applicable (physical device). | N/A |
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the profile of three human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2016
Medeon Biodesign, Inc. Greta Chang Sr. Manager of Regulatory, Quality & Clinical Affair 7F, 116, HouGang St, Taipei, 11170 Taiwan
Re: K160172 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: March 23, 2016 Received: March 24, 2016
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.
{1}------------------------------------------------
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-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 vours.
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Section 5. Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement on last page |
|---|---|
| 510(k) Number (if known)Pending- K160172 | |
| Device NameLaparoscope Lens Shield Device (LENS) | |
| Indications for Use (Describe)Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessorylens shield device, is intended to maintain the intra-operative view of the surgical site during minimallyinvasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodilyfluids. | |
| 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)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, includingthetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any otheraspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."FORM FDA 3881 (9/13) |
{3}------------------------------------------------
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: TBD
| 1. | Submitter | |
|---|---|---|
| Mailing Address | Medeon Biodesign, Inc7F, 116, HouGang St,Taipei, Taiwan 11170Phone: +886 2 2881 6686Establishment Registration No.: NA (1st submission) | |
| Contact Person | Greta ChangSr. Manager of Regulatory, Quality & Clinical Affair | |
| Phone: | +886 2 2881 6686 | |
| Fax: | +886 2 2881 6907 | |
| E-mail: | greta@medeonbio.com | |
| Date Prepared | January 25, 2016 | |
| 2 | Device Name | |
| Common or usual name | Laparoscope Lens Shield Device | |
| Product Code | GCJ | |
| Device | Endoscope and accessories | |
| CFR Classification | CFR Part 876.1500 | |
| Device Class | II | |
| Classification Panel | Gastroenterology/Urology | |
| 3 | Predicate k number | K151117 |
| 4 | Device Description: | The Laparoscope Lens Shield Device (LENS) is alaparoscope accessory lens shielding device consisting ofmulti-lumen sheath that slides over the laparoscope. Thesheath assembling consists of 2 concentric sheaths: oneouter and one end-to-end connected inner sheaths. Theouter sheath provides protection and cover for the innersheath and shielding film. It is intended to maintain theintra-operative view of the surgical site during minimallyinvasive surgery by physically shielding the laparoscopelens from debris, grease, blood, and bodily fluids. |
{4}------------------------------------------------
| MEDEON | Medeon Biodesign, Inc. | Special 510(k) NotificationLaparoscope Lens Shield Device (LENS) | |
|---|---|---|---|
| న్. | Intended Use: | Laparoscope Lens Shield Device (LENS), a sterile,single-use and disposable laparoscopic accessory lensshield device, is intended to maintain the intra-operativeview of the surgical site during minimally invasivesurgery by physically shielding the laparoscope lens fromdebris, grease, blood, and bodily fluids. | |
| Intended use of the modified device, as described in itslabeling, has not changed as a result of the modification.This is the same intended use as previously cleared forthe LENS K151117. | |||
| Special Conditions forUse Statement(s): | For prescription use only | ||
| 6. | TechnologicalCharacteristics andSubstantial EquivalenceComparison withPredicate: | Modifications to design and material of the previously510(k) cleared Laparoscope Lens Shield Device(K151117) resulted in 3 different models toaccommodate various laparoscopes.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 different questions of safety oreffectiveness. |
| Similarities | ||
|---|---|---|
| Device name | Predicate device:10 mm/0° (L030)(K151117) | Modified device:10 mm/0°(L030), 10mm/30°(L330), and 5 mm/0°(S030) |
| Intended Use | Laparoscope Lens Shield Device(LENS), a sterile, single-use anddisposable laparoscopicaccessory lens shield device, isintended to maintain the intra-operative view of the surgicalsite during minimally invasivesurgery by physically shieldingthe laparoscope lens fromdebris, grease, blood, and bodilyfluids | Same |
| Target patientPopulation | Patient under laparoscopicsurgery | Same |
{5}------------------------------------------------
| Similarities | ||
|---|---|---|
| Device name | Predicate device:10 mm/0° (L030)(K151117) | Modified device:10 mm/0°(L030), 10mm/30°(L330), and 5 mm/0°(S030) |
| Target UserPopulation | Clinician who is qualified toperform a laparoscopic surgery. | Same |
| AnatomicalSite | Abdominopelvic cavity | Same |
| Where Used | Hospital O.R. room | Same |
| Contraindications | There are no knowncontraindications for modifieddevice | Same |
| Method ofIntroduction | Predicate device is introduced intoabdominopelvic cavity via a trocar. | Same |
| Performance | Able to maintain laparoscopic viewwhen it gets soiled by debris | Same |
| Biocompatiblefor IntendedUse | Limited exposure, externalcommunication device of tissuecontact.All patient contacting parts formfinal device pass the cytotoxicity,sensitization, irritation, and acutesystemic toxicity. | Same |
| SterilizationMethod | Ethylene Oxide sterilization, SALof 10-6 | Same |
| Energy source | No energy source | Same |
| Compatibility | Laparoscope: 10 mm/ 0°, 30cmscopeTrocar: 12mm | Laparoscope: 10 mm/0° /30 cm, 10mm/30°/30cm, and 5 mm/0°/30cmTrocar: 12 mm and 7 mm |
7. Performance Testing
& MEDEON
Medeon Biodesign, Inc.
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 Draft Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", dated 04-23-2013
- o ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- o 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin
{6}------------------------------------------------
sensitization
- ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.
Mechanical testing
The modified device's mechanical function and structure integrity were tested and demonstrated that the design specification from design input are fulfilled and the design modifications do not alter the device safety and function.
Functional testing
Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled. Design modifications do not alter the device function and intended use.
- Conclusion. Based on the intended use, technological characteristics, performance testing and comparison to the predicate device, the modified device is substantially equivalent to the predicate device and raises no different question 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.