(28 days)
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.
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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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: | K192891 |
---|---|
Date Prepared: | 9 October 2019 |
1. Submitter | |
Mailing Address | Medeon Biodesign, Inc |
7F, 116, HouGang St, | |
Taipei, Taiwan 11170 | |
Phone: +886 2 2881 6686 | |
Establishment Registration No.: 3012452802 | |
Contact Person | Tsung-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 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 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 #L042 | Modified device | |
Model #US030-SO | ||
Device Specification | 10mm/ 0° / 42cm | 5mm/ 0° / 30cm |
Similarities | ||
Predicate device (K170103) | ||
Model #L042 | Modified device | |
Model #US030-SO | ||
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. | 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 | ||
Population | Patient under laparoscopic | |
surgery | Same | |
Target User | ||
Population | Clinician who is qualified to perform | |
a laparoscopic surgery | Same | |
Anatomical Site | Abdominopelvic cavity | Same |
Where Used | Hospital O.R. room | Same |
Contraindications | There are no known | |
contraindications for modified device | Same | |
Method of | ||
Introduction | Predicate device is introduced into | |
abdominopelvic cavity via a trocar | Same | |
Performance | Enable to maintain the intra- | |
operative view when it gets soiled | ||
by debris | Same | |
Biocompatible for | ||
Intended Use | Limited 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 06-16-2016 | Same | |
Pass the cytotoxicity, sensitization, | ||
irritation, acute systemic toxicity, and | ||
pyrogenicity tests. | ||
Similarities | ||
Predicate device (K170103) | ||
Model #L042 | Modified device | |
Model #US030-SO | ||
Sterilization | ||
Method | Ethylene Oxide sterilization, SAL of | |
10-6 | 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
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
Page 5/5 |
|--|------------------------|----------------------------------------------------------------------|
| | | 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.