(35 days)
Not Found
No
The description focuses on a physical shielding mechanism and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is described as a shield for a laparoscope lens, intended to maintain a clear view during surgery. It does not exert any direct therapeutic action on the patient. Its function is to facilitate the surgical procedure rather than to treat a disease or condition.
No
The device is described as an accessory that shields a laparoscope lens to maintain an intra-operative view, not to collect or analyze data for diagnosis.
No
The device description explicitly states it is a "laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope," indicating it is a physical 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 on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a physical shield that slides over a laparoscope. This is a mechanical device for surgical use, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device's function is purely to improve 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
Intended User: Clinician who is qualified to perform a laparoscopic surgery
Care Setting: 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:
Evaluation and testing conducted in accordance with:
- 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:
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 results: The performance testing demonstrated substantial equivalence to the previously cleared predicate, and raises no different question of safety or effectiveness.
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.
0
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740
Section 5. 510k Indications for Use Statement
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 : | K170103 |
|---|---|
| Date Prepared | 11 January 2017 |
| 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 | |
| Phone: | |
| Fax: | |
| E-mail: | Greta Chang |
| Sr. Manager of Regulatory, Quality & Clinical Affair | |
| +886 2 2881 6686 | |
| +886 2 2881 6907 | |
| greta@medeonbio.com | |
| 2 Device Name | |
| Common or usual name | Laparoscope, general & plastic surgery |
| Trade Name | |
| Product Code | |
| Device | |
| CFR Classification | |
| Device Class | |
| Classification Panel | Laparoscope Lens Shield Device (LENS) |
| GCJ | |
| Endoscope and accessories | |
| CFR Part 876.1500 | |
| II | |
| Gastroenterology/Urology | |
| 3 Predicate k number | K160172 |
| 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 |
4
| Medeon Biodesign, Inc. | | | Special 510(k) Notification
Laparoscope Lens Shield Device (LENS) |
|------------------------|-----------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | 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. |
| 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
(K160172) resulted in 2 different models to
accommodate various sizes of laparoscopes.
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 different questions of safety or
effectiveness. |
| Similarities | ||
|---|---|---|
| Predicate device (K160172) | Modified device, total 2 models | |
| Device | ||
| Specification | 10mm/ 0° / 30cm | 10mm/ 0° / 30cm |
| 10mm/ 0° / 42cm |
Table 1: Substantially Equivalent Table
5
| 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 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. | 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 the cytotoxicity, sensitization, | ||
| irritation, and acute systemic toxicity. | Same | |
| Sterilization | ||
| Method | 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 |
6
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.