(53 days)
No
The device description and performance studies focus on mechanical cleaning and material properties, with no mention of AI/ML or image processing.
No
The device is described as a cleaning tool for a laparoscope lens to prevent fogging, which is a maintenance function for equipment rather than directly treating a patient's condition.
No
The device is designed to clean the laparoscope lens during surgery to prevent fogging, which is a maintenance/functional task, not a diagnostic one. It does not gather information for diagnosis.
No
The device description clearly outlines physical components such as cleaning swabs, a plastic rod, an outer cannula, an actuator handle, and a bottle of surfactant. The performance studies also focus on the physical properties and function of these components (biocompatibility, cleaning performance, durability, usability). There is no mention of any software component.
Based on the provided information, the LLICS™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to clean a laparoscope lens within the surgical cavity during laparoscopic surgery. This is a direct interaction with a medical device (the laparoscope) inside the body, not the examination of specimens derived from the human body.
- Device Description: The device consists of cleaning swabs and surfactant, designed for mechanical cleaning of a lens. It does not involve reagents or processes for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components, processes, or intended uses related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on biological sample analysis.
The LLICS™ is a surgical accessory designed to improve visualization during a surgical procedure by cleaning the endoscope lens. This falls under the category of a surgical instrument or accessory, not an IVD.
N/A
Intended Use / Indications for Use
The LLICS™ is indicated for use in laparoscopic surgeries to clean the laparoscope lens within the surgical cavity, preventing temperature changes associated with lens fogging.
Product codes (comma separated list FDA assigned to the subject device)
OCT, GCJ, KOG
Device Description
The LLICS sterile system is intended for single-procedure use. Each LLICS package includes two cleaning swabs that can be introduced through an existing surgical trocar or cannula and one bottle of surfactant.
Each cleaning swab consists of a foam tip mounted on a plastic rod, an outer cannula, and an actuator handle.
The surfactant is applied to the foam tip on the cleaning swab. The tip is then retracted into the LLICS cannula before it is introduced through the surgical trocar/cannula. The LLICS cannula helps to keep.the foam tip clean while it passes through the existing surgical trocar/cannula.
Once the LLICS device has passed through the surgical trocar/cannula, the surgeon visualizes the end of the LLICS cannula and uses the actuator handle to deploy the surfactant-moistened foam tip. The actuator handle remains outside the body and can be operated with one hand. The surgeon uses the foam tip to clean the endoscope lens and then retracts the tip into the LLICS cannula. The retracted device can be left in the surgical trocar/cannula for additional cleaning cycles or removed to make the trocar/cannula available for introducing other endoscope accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, surgical nurses, scrub technicians in a surgical suite.
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
- The product was sterilized with E-Beam radiation at higher than the maximum dose prior to testing. Surfactant was applied to the foam tip, as for normal use. The patient-contacting portions of the device were tested for cytotoxicity, sensitization, and irritation. The device passed all tests.
- This suite of biocompatibility testing is typical of the testing required for invasive surgical instruments.
- The test results support safe use of the LLICS system within the surgical cavity.
Cleaning Performance
- Fully assembled, sterilized product was used to clean an endoscope that had been soiled with bacon fat and/or tissue. To better simulate actual use, the LLICS swab was passed through a surgical trocar, and the tester manipulated the swab using only the portions of the device that would remain outside the body during use. A standardized visual reference was used to demonstrate both thorough soiling of the lens and ability of the LLICS system to restore good visibility. The system was able to restore the specified level of visibility over multiple cleaning cycles.
- These test results demonstrate that the materials and design of the LLICS system are appropriate and effective for the intended use.
Durability Testing
- Fully assembled, sterilized product was put through multiple rounds of simulated cleaning cycles to simulate wear on the components and materials. The test cycle includes deployment of the tip, wiping the lens, and retracting the foam tip. The insertion portion of the device remained intact during the testing and no foam was shed after an average of 29 cycles.
- These test results support safe use of the LLICS system within the surgical cavity.
Usability Testing
- Simulated use testing was conducted, involving surgical nurses, scrub technicians, and laparoscopic surgeons. The testing was carried out in a surgical suite. The lens cleaning operation was carried out inside a laparoscopic training unit. The participants had access to the instructions for use but had no other training or assistance prior to or during the test.
- The testing confirmed that the nurses and scrub technicians could remove the device from its sterile packaging and prepare it for use without use errors that could cause the product to be contaminated.
- The testing also confirmed that surgeons could complete the cleaning process under simulated use conditions, without damaging the LLICS swab or the endoscope.
- These test results demonstrate that the product design, packaging, and labeling meet the needs of the intended user population.
- Nurses are able to detect when a foam tip is not intact.
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.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MISDER Medical, LLC % Evergreen Research, Inc. Ms. Nancy Sauer 433 Park Point Drive, Suite 140 Golden, Colorado 80401
Re: K120821
Trade/Device Name: LLICS Laparoscopic Lens Internal Cleaning System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCT, GCJ Dated (Date on orig SE ltr): March 16, 2012 Received (Date on orig SE ltr): March 19, 2012
JUL 2 7 2015
Dear Ms. Sauer.
This letter corrects our substantially equivalent letter of May 11, 2012.
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
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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. 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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 yours,
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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Indications for Use
510(k) Number (if known): K120821
Device Name: Laparoscopic Lens Internal Cleaning System (LLICS™)
Indications for Use:
The LLICS™ is indicated for use in laparoscopic surgeries to clean the laparoscope lens within the surgical cavity, preventing temperature changes associated with lens fogging.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Doyle for man
ivision Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120821
LLICS" 510(k) Amendment 4/19/12 3
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