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.

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.

AI/ML Overview

This device is the LLICS™ Laparoscopic Lens Internal Cleaning System. The provided text is a 510(k) summary, which describes the device and its equivalence to legally marketed devices, rather than a detailed study report that establishes novel acceptance criteria and proves the device meets them through clinical or large-scale non-clinical studies for new indications.

The document primarily focuses on demonstrating substantial equivalence to existing devices (D.H.E.L.P. heated endoscope lens protector and Clear Field Sterile Wipes, and other laparoscopic accessories regarding trocar insertion). Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device.

Given this context, the acceptance criteria and study information are presented differently than for a brand new, high-risk device where a comparative effectiveness study or large standalone study might be expected. The "acceptance criteria" here are largely based on the performance of the predicate devices and general safety/effectiveness principles for similar instruments.

Here's an attempt to extract and synthesize the requested information, acknowledging the limitations inherent in a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance
Biocompatibility	No cytotoxicity, sensitization, or irritation.	Passed all tests for cytotoxicity, sensitization, and irritation after E-Beam sterilization.
Cleaning Performance	Ability to restore specified level of visibility in a soiled endoscope over multiple cleaning cycles.	"Able to restore the specified level of visibility over multiple cleaning cycles" on endoscopes soiled with bacon fat and/or tissue.
Durability	Insertion portion remains intact, no foam shed after multiple cleaning cycles.	Insertion portion remained intact, and no foam was shed after an average of 29 cycles during simulated cleaning.
Usability	Healthcare professionals (nurses, scrub technicians) can prepare the device without contamination. Surgeons can complete cleaning without device/endoscope damage. Nurses can detect non-intact foam tip.	Nurses and scrub technicians could prepare the device without use errors. Surgeons could complete cleaning without damage in simulated conditions. Nurses were able to detect when a foam tip was not intact.
Sterility Testing	No information provided in the summary. Implies standard sterility assurance levels for medical devices.	Product sterilized with E-Beam radiation at higher than maximum dose prior to biocompatibility testing.
Intended Use Equivalence	Same general intended use as predicate devices: preserve/restore visibility by removing soil and preventing fogging.	"Same general intended use" as predicate devices. Differences in terminology (lens cleaning vs. defogging) do not create a new intended use or new safety concerns.
Safety of Trocar Insertion	Safe introduction into surgical cavity via trocar/cannula, similar to other laparoscopic accessories.	Similar to other laparoscopic instruments (e.g., PMC Laparoscopic Instruments) that are introduced via trocar/cannula. No specific adverse events reported.

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility: The summary does not specify the number of devices or experimental units used for each biocompatibility test (cytotoxicity, sensitization, irritation).
- Data Provenance: Not specified, but generally performed by accredited testing laboratories as part of pre-market submissions. Retrospective in relation to the submission date, but the tests were performed specifically for this device.
Cleaning Performance: The specific number of endoscopes, cleaning cycles, or repetitions is not specified.
- Data Provenance: Bench testing, likely in a controlled laboratory setting. Retrospective.
Durability Testing: "Average of 29 cycles" for foam shedding suggests multiple devices or tests were performed, but the exact sample size is not provided.
- Data Provenance: Bench testing, likely in a controlled laboratory setting. Retrospective.
Usability Testing: Involved "surgical nurses, scrub technicians, and laparoscopic surgeons." The number of participants for each group is not specified.
- Data Provenance: Simulated use testing in a surgical suite. Retrospective.
Training Set Sample Size:
- Biocompatibility: No specific training set for this type of test; it's a direct pass/fail assessment against established biological response criteria.
- Cleaning/Durability/Usability: Not applicable for these non-clinical tests in the context of a "training set" as one would consider for an AI/ML algorithm. These are direct performance evaluations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The summary does not detail the use of "experts" in the traditional sense for establishing ground truth for the test set beyond the general implication that the tests simulate real-world conditions and are evaluated by technical personnel.
For Cleaning Performance, a "standardized visual reference" was used to assess visibility, which would imply a pre-defined objective standard rather than direct expert consensus on each individual test.
For Usability Testing, the participants (surgical nurses, scrub technicians, laparoscopic surgeons) were the "users" being observed, and their ability to perform tasks correctly indicated usability, rather than them establishing a separate "ground truth" for the device's performance. The "ground truth" for usability here would be the successful completion of tasks as defined by the study protocol.
The document does not mention any formal "expert consensus" process or specific expert qualifications for establishing ground truth in the way one might for diagnostic accuracy studies (e.g., radiologists reviewing images).

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) is described. The tests appear to be direct performance evaluations against pre-defined criteria (e.g., visual reference for cleaning, integrity for durability, successful task completion for usability, biological response for biocompatibility).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This type of study is typically conducted for diagnostic AI devices comparing human performance with and without AI assistance. The LLICS™ is a surgical tool, not a diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable in the context of this device. The LLICS™ is a mechanical cleaning system and does not involve an algorithm. Its performance is standalone in the sense that its physical function is evaluated, but it is always used by a human surgeon.

7. The Type of Ground Truth Used

Biocompatibility: Established biological response criteria (e.g., ISO 10993 standards for cytotoxicity, sensitization, irritation).
Cleaning Performance: "Standardized visual reference" for visibility, and objective assessment of removal of bacon fat/tissue. This is an objective measurement against a defined standard.
Durability Testing: Objective assessment of material integrity (e.g., "insertion portion remained intact," "no foam shed").
Usability Testing: Observational data of task completion and absence of use errors by trained medical professionals, against predefined successful completion criteria.
No pathology, outcomes data, or expert consensus (in the diagnostic sense) was used as ground truth for proving performance. The ground truth is primarily based on objective physical performance and user interaction.

8. The Sample Size for the Training Set

Not applicable. The LLICS™ is a mechanical device, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The device developers would have designed and prototyped the device, and tested various iterations, but this is part of engineering development, not algorithm training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm.

Summary

{0}------------------------------------------------

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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three human profiles facing to the right.

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

{1}------------------------------------------------

Page 2 -

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

{2}------------------------------------------------

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

Page 1 of 1

{3}------------------------------------------------

< | 20 821

Page 1 of 3

5. 510(k) Summary

MAY 1 1 2012

Sponsor Information

MISDER Medical. LLC PO Box 518 Niwot, CO 80544 Phone: 303-834-8846 Fax: 303-652-4991

Contact Person: Ken Maydew

This 510(k) summary was prepared on April 18, 2012.

Device Identification

Proprietary Name: LLICS™ Laparoscopic Lens Internal Cleaning System

Common or Usual Name: Endoscope Lens Cleaning Device

Classification Name: Endoscope and/or Accessories

Classification: Class II, Gastroenterology/Urology, GCJ, KOG

Intended Use

The LLICS™ is used to clean the lens of a laparoscope or other endoscope without removing the device from the surgical cavity. Cleaning the laparoscope inside the surgical cavity helps to prevent fogging of the lens due to temperature changes.

Comparison to Legally Marketed Devices

The LLICS™ system is substantially equivalent to the D.H.E.L.P. heated endoscope lens protector manufactured by New Wave Surgical. This product was cleared by 510(k) K062779. It is also substantially equivalent to Clear Field Sterile Wipes, manufactured by Tucson Medical Corporation. This product was cleared under 510(k) K974454.

The LLICS system has the same general intended use as these legally marketed devices. They are all intended to preserve or restore visibility through the endoscope by removing soil and preventing fogging of the lens. The 510(k)-cleared indication statements differ in that the predicate devices do not specifically list lens cleaning, only defogging. This difference in terminology does not create a new intended use and does not raise new safety concerns.

The LLICS system relies on the same basic principle as these legally marketed products. The endoscope lens is cleaned using a piece of foam or soft cloth moistened with a cleaning/defogging solution.

The LLICS system and the D.H.E.L.P. system both use strategies to maintain endoscope temperature as a means to prevent fogging of the endoscope lens. LLICS maintains endoscope

{4}------------------------------------------------

temperature by allowing the surgeon to clean the lens within the surgical cavity. DHELL maintains endoscope temperature by providing a battery-powered heated chamber in which to clean the lens.

The LLICS system differs from these two legally marketed devices in that it is introduced into the surgical cavity through a trocar/cannula. However, many other endoscope accessories are introduced into the surgical cavity via a surgical trocar/cannula. One example is the PMC Laparoscopic Instruments, manufactured by PMC Medical, GmbH. These laparoscopic accessories were cleared through 510(k) K 101193.

Device Description

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.

Summary of Non-Clinical Test 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 patientcontacting 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

{5}------------------------------------------------

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.

KI 20821

. 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.

Conclusions

The LLICS system is substantially equivalent to other legally marketed endoscope accessories, including laparoscope lens defogging devices and a variety of manual laparoscope accessories that are introduced into the surgical cavity during laparoscopic procedures.

Regulation Number and Section

§ 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.