(85 days)
Not Found
No
The description focuses on a physical shielding mechanism and does not mention any computational or analytical functions that would typically involve AI/ML.
No.
The device is intended to maintain the intra-operative view of the surgical site by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids, which is a supportive function during surgery, not a direct treatment or diagnosis for a disease or condition.
No
The device is a laparoscope accessory designed to protect the lens from debris, not to diagnose medical conditions or provide diagnostic information. Its intended use is to maintain viewing clarity during surgery.
No
The device description clearly states it is a physical, sterile, single-use, and disposable laparoscopic accessory lens shield device consisting of multi-lumen sheaths. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically shield the laparoscope lens during surgery to maintain the view. This is a mechanical function performed in vivo (within the body) during a surgical procedure.
- Device Description: The device is described as a sheath that slides over a laparoscope. This is a surgical accessory used during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health, diagnosis, or condition.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device's function is purely to facilitate the surgical procedure by maintaining the visual field.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
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: 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
- ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- 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 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.
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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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
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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 on last page |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known)
Pending- K160172 | |
| 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, 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. | |
| 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, including
the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information 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, Inc | |
| 7F, 116, HouGang St, | ||
| Taipei, Taiwan 11170 | ||
| Phone: +886 2 2881 6686 | ||
| Establishment Registration No.: NA (1st submission) | ||
| Contact Person | Greta Chang | |
| Sr. 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 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. |
4
| | MEDEON | Medeon Biodesign, Inc. | Special 510(k) Notification
Laparoscope Lens Shield Device (LENS) |
|-----|--------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| న్. | 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. |
| | | | Intended use of the modified device, as described in its
labeling, has not changed as a result of the modification.
This is the same intended use as previously cleared for
the LENS K151117. |
| | Special Conditions for
Use Statement(s): | | For prescription use only |
| 6. | Technological
Characteristics and
Substantial Equivalence
Comparison with
Predicate: | | Modifications to design and material of the previously
510(k) cleared Laparoscope Lens Shield Device
(K151117) resulted in 3 different models to
accommodate various 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 | ||
|---|---|---|
| Device name | Predicate device: | |
| 10 mm/0° (L030) | ||
| (K151117) | Modified device: | |
| 10 mm/0°(L030), 10 | ||
| mm/30°(L330), and 5 mm/0°(S030) | ||
| 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 | |
| Target patient | ||
| Population | Patient under laparoscopic | |
| surgery | Same |
5
| Similarities | ||
|---|---|---|
| Device name | Predicate device: | |
| 10 mm/0° (L030) | ||
| (K151117) | Modified device: | |
| 10 mm/0°(L030), 10 | ||
| mm/30°(L330), and 5 mm/0°(S030) | ||
| 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 |
| Contraindicatio | ||
| ns | There are no known | |
| contraindications for modified | ||
| device | Same | |
| Method of | ||
| Introduction | Predicate device is introduced into | |
| abdominopelvic cavity via a trocar. | Same | |
| Performance | Able to maintain laparoscopic view | |
| when it gets soiled by debris | Same | |
| Biocompatible | ||
| for Intended | ||
| Use | Limited exposure, external | |
| communication device of tissue | ||
| contact. | ||
| All patient contacting parts form | ||
| final device 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 |
| Compatibility | Laparoscope: 10 mm/ 0°, 30cm | |
| scope | ||
| Trocar: 12mm | Laparoscope: 10 mm/0° /30 cm, 10 | |
| mm/30°/30cm, and 5 mm/0°/30cm | ||
| Trocar: 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.