(35 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.
The Medeon Biodesign, Inc. Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device designed to maintain the intra-operative view during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids. The device was deemed substantially equivalent to a previously cleared predicate device (K160172).
Here's an analysis of the acceptance criteria and supporting studies, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly define quantitative acceptance criteria for device performance as would be expected for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing intended use, technological characteristics, and showing that design modifications do not negatively impact safety or effectiveness.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on substantial equivalence to K160172) | Reported Device Performance (LENS - K170103) |
|---|---|---|
| Intended Use | Maintain intra-operative view by shielding laparoscope lens from debris, grease, blood, and bodily fluids. | Same as predicate device. |
| Target Patient Population | Patients undergoing laparoscopic surgery. | Same as predicate device. |
| Target User Population | Clinicians qualified to perform laparoscopic surgery. | Same as predicate device. |
| Anatomical Site | Abdominopelvic cavity. | Same as predicate device. |
| Where Used | Hospital O.R. room. | Same as predicate device. |
| Contraindications | No known contraindications. | Same as predicate device. |
| Method of Introduction | Introduced into abdominopelvic cavity via a trocar. | Same as predicate device. |
| Performance (Functional) | Enable to maintain the intra-operative view when it gets soiled by debris. | Same as predicate device (demonstrated in animal model). |
| Biocompatibility | Limited exposure, external communication device of tissue contact. Pass cytotoxicity, sensitization, irritation, and acute systemic toxicity tests. | Passed cytotoxicity, sensitization, irritation, and acute systemic toxicity tests as per ISO 10993 standards. |
| Sterilization Method | Ethylene Oxide sterilization, SAL of 10-6. | Same as predicate device. |
| Energy Source | No energy source. | Same as predicate device. |
| Compatibility (Laparoscope) | 10mm/0°/30cm (standard) | 10mm/0°/30cm (standard) and 10mm/0°/42cm (bariatric). |
| Compatibility (Trocar) | 12mm | 12mm |
| Mechanical Integrity | Design specifications fulfilled, and design modifications do not affect safety and function. | Demonstrated through mechanical testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes performance testing which can be likened to a "test set" for evaluation.
- Biocompatibility Testing: The sample size for biocompatibility testing is not explicitly stated in terms of number of devices or test repetitions. The provenance is implied to be laboratory testing conducted according to recognized international standards (ISO 10993).
- Mechanical Testing: The sample size for mechanical testing is not explicitly stated. This would involve specific numbers of devices or components undergoing various mechanical stresses. The provenance is implied to be laboratory testing.
- Functional Testing: "Device functionality was tested in the animal model." The document does not specify the number of animals used, the species, or other details of the animal model. The provenance is an animal study.
Given the nature of the device (a physical accessory, not an AI/ML system), the concept of "country of origin of the data" and "retrospective or prospective" as typically applied to clinical data or AI training/test sets is not directly applicable here. The testing described is primarily in-vitro (biocompatibility, mechanical) and pre-clinical (animal model functional).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable in the context of this device and the provided document. The ground truth for biocompatibility is established by the results of standardized assays against ISO 10993 criteria, not expert consensus. The "ground truth" for mechanical integrity is adherence to design specifications verified through engineering tests. The "ground truth" for functional testing in the animal model would be the observable ability of the device to shield the lens and maintain the intra-operative view, likely assessed by the surgical team performing the animal procedure, but explicit expert involvement and qualifications for establishing this "ground truth" are not detailed.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for AI/ML devices to resolve discrepancies in expert interpretation of medical images or data. The testing described for this physical device does not involve such expert review or adjudication processes for its performance metrics.
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
This question is not applicable. The device is a physical laparoscopic accessory, not an AI/ML system, and therefore does not involve "human readers" or "AI assistance" in the sense of an MRMC study for diagnostic or prognostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical laparoscopic accessory, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is implicitly derived from:
- Biocompatibility: Adherence to established biological safety standards (ISO 10993) based on laboratory assays.
- Mechanical Integrity: Compliance with engineering design specifications validated through mechanical testing.
- Functional Performance: Observable effectiveness in maintaining intra-operative view in an animal model. This would likely be clinical observation by the surgical team in the animal study.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not an AI/ML system, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as it relates to AI/ML systems which this device is not.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Medeon Biodesign, Inc. Greta Chang Sr. Manager of Regulatory, Ouality & Clinical Affair 7f, 116. Hougang Street Taipei, 11170 Taiwan
Re: K170103 Trade/Device Name: Laparoscope Lens Shield Device (LENS) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: January 11, 2017 Received: January 12, 2017
Dear Greta Chang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5. Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170103
Device Name
Laparoscope Lens Shield Device (LENS)
Indications for Use (Describe)
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740
Section 5. 510k Indications for Use Statement
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Section 6. 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.
| The assigned 510(k) Number : | K170103 |
|---|---|
| Date Prepared | 11 January 2017 |
| 1. SubmitterMailing Address | Medeon Biodesign, Inc7F, 116, HouGang St,Taipei, Taiwan 11170Phone: +886 2 2881 6686Establishment Registration No.: 3012452802 |
| Contact PersonPhone:Fax:E-mail: | Greta ChangSr. Manager of Regulatory, Quality & Clinical Affair+886 2 2881 6686+886 2 2881 6907greta@medeonbio.com |
| 2 Device NameCommon or usual name | Laparoscope, general & plastic surgery |
| Trade NameProduct CodeDeviceCFR ClassificationDevice ClassClassification Panel | Laparoscope Lens Shield Device (LENS)GCJEndoscope and accessoriesCFR Part 876.1500IIGastroenterology/Urology |
| 3 Predicate k number | K160172 |
| 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 |
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| Medeon Biodesign, Inc. | Special 510(k) NotificationLaparoscope Lens Shield Device (LENS) | ||
|---|---|---|---|
| one outer and one end-to-end connected inner sheaths.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(K160172) resulted in 2 different models toaccommodate various sizes of 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 | ||
|---|---|---|
| Predicate device (K160172) | Modified device, total 2 models | |
| DeviceSpecification | 10mm/ 0° / 30cm | 10mm/ 0° / 30cm10mm/ 0° / 42cm |
Table 1: Substantially Equivalent Table
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| Special 510(k) Notification | ||
|---|---|---|
| MEDEON | Medeon Biodesign, Inc. | Laparoscope Lens Shield Device (LENS) |
| Similarities | ||
|---|---|---|
| Predicate device (K160172) | Modified device, total 2 models | |
| Intended Use | Laparoscope Lens Shield Device(LENS), a sterile, single-use anddisposable laparoscopic accessorylens shield device, is intended tomaintain the intra-operative viewof the surgical site duringminimally invasive surgery byphysically shielding thelaparoscope lens from debris,grease, blood, and bodily 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 the cytotoxicity, sensitization,irritation, and acute systemic toxicity. | Same |
| SterilizationMethod | Ethylene Oxide sterilization, SAL of$10^{-6}$ | Same |
| Energy source | No energy source | Same |
| Similarities | ||
| Predicate device (K160172) | Modified device, total 2 models | |
| Compatibility | Laparoscope:10mm/ 0° / 30cm (standard) | Laparoscope:10mm/ 0° /30cm (standard)10mm/ 0° /42cm (bariatric) |
| Trocar:12mm | Trocar:12 mm |
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7. Performance Testing
The following performance testing for the design modification demonstrated substantial equivalence to the previously cleared predicate:
Biocompatibility testing
Per material change, the biocompatibility evaluation and testing of the Laparoscope Lens Shield Device (LENS) was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- FDA Guidance - Use of International Standard ISO- 10993-1, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management process". dated 06-16-2016
- . ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.
Mechanical testing
The mechanical function and structure integrity of modified device were tested to demonstrate that the design specifications from design input are fulfilled and the design modifications do not affect safety and function of the device.
Functional testing
Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled. Design modifications do not affect the function and intended use of device.
- Conclusion Based on the intended use, technological characteristics, comparison to the predicate device and performance testing, the modified device is substantially equivalent to the predicate device and raises no different question of safety or effectiveness.
§ 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.