(375 days)
Not Found
No
The document describes a physical cleaning and disinfection system for endoscopes using chemicals and a mechanical agitation system. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is indicated for cleaning and high-level disinfection of semi-critical endoscopes, not for treating a disease or condition in a patient.
No
This device is designed to clean and disinfect medical instruments (endoscopes), not to diagnose medical conditions or analyze patient data.
No
The device description explicitly details hardware components such as a stainless steel processing chamber, a push-pull agitation pump, an ozonator, and a neutralization tank, indicating it is a physical system, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use of the LIC Instrument Processing System is for the cleaning and high-level disinfection of heat-sensitive semi-critical endoscopes. This is a process applied to medical devices (endoscopes) to prepare them for reuse on patients.
- Device Description: The device description details a system for processing endoscopes, including cleaning, disinfection, and rinsing. It focuses on the physical and chemical processes involved in reprocessing the endoscopes themselves.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LIC Instrument Processing System does not perform any such examination of human specimens. It acts on the medical device (endoscope) itself.
The device is clearly intended for reprocessing medical instruments used in healthcare settings, which falls under the category of medical device reprocessing equipment, not IVDs.
N/A
Intended Use / Indications for Use
The LIC Instrument Processing System consists of the LIC Instrument Processor, the Manzi Detergent MD10, the Manzi Sterilant MS10, and filtered ozonated final rinse water.
The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate ( MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor.
The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
Product codes
FEB
Device Description
The LIC Instrument Processing System consists of a LIC Instrument Processor, a proprietary Manzi sterilant, MS10; a proprietary enzymatic Manzi Detergent, MD10; and internally generated filtered ozonated final rinse water. The LIC Instrument Processing System requires no connectors to be attached to the endoscope.
The LIC Instrument Processor is a self-contained stand-alone system designed to clean and provide high level disinfection of semi-critical endoscopes using the MD10 detergent, the MS10 sterilant, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the semi-critical endoscopes without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle that provides cleaning to a protein residual level ≤ 6.4 ug / cm², followed by hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection of the instrument being processed and final rinses with filtered ozonated water.
The hardware for the LIC Instrument Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, a neutralization tank, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable semi-critical endoscopes trays, baffle inserts, and printer paper.
The LIC Instrument Processor is designed to: (1) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations.
MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the LIC Instrument Processor. MD10 is intended to be used with the LIC Instrument Processor only.
MS10 is a peracetic acid based liquid chemical sterilant packaged in single use containers for attachment to the LIC Instrument Processor. MS10 is intended to be used with the LIC Instrument Processor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care workers.
health care settings
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
Simulated use testing was conducted to demonstrate the efficacy of the Filtered Ozonated Final Rinse Water of the LIC Instrument Processing System. The LIC Filtered Ozonated Final Rinse Water System was challenged where > 10 € microbial loading was introduced into the Filtered Ozonated Final Rinse Water System and tested after the water was processed to the systems operational specifications. The test results showed a > 6 spore log reduction with no CFUs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Qualification Testing - FDA Guidance: The LIC Instrument Processing System was tested and found to conform to the requirements of the "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities", dated August, 1993". (Results: Process Parameter Tests - Passed, Simulated Use Tests - Passed, Cleaning Efficacy - Passed, Disinfection Efficacy - Passed, Rinsing Efficacy - Passed, Other Tests - Passed, Combined Process - Passed, In - Use Tests - Passed, Software Documentation - Passed, Toxicological Evaluation of Residues - Passed).
Process Parameter Test: The LIC Instrument Processing System was tested to demonstrate that the device performs as intended. The test results showed that the LIC Instrument Processing System achieves and maintains the specified physical process parameters, automatically aborts the cycle if the specified parameters are not achieved, detects the defined fault conditions, and provides the designated alarms and instructions in the event of fault condition detection.
Cleaning Efficacy Testing -- LIC Instrument Processing System Cleaning Step: Challenged by endoscopes containing both protein loaded soil and TOC loaded soil.
- Protein Laden Soil: up to 1080 µg/cm² yielded remaining protein levels of 10 € microbial loading introduced into the Filtered Ozonated Final Rinse Water System. (Results: > 6 spore log reduction with no CFUs).
Toxicological Evaluation of Residues: Evaluated safety of residual chemicals after processing. (Results: Processing cycle reduces detergent and sterilant residuals to non-toxic levels).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Remaining protein levels of
§ 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
LIC INSTRUMENT PROCESSOR Page XV - 1 Pre-Market Notification 510(k) K101158 IC Systems, in Section XV. 510(k) Summary Applicant's Name, Address, Telephone, Fax, Contact Person Langford IC Systems, Inc. 310 S. Williams Blvd, Suite 270 Tucson, Arizona 85711 MAY - 6 2011
Contact Person
E-mail:
Tel: Fax:
Terry Langford President and CEO, Langford IC Systems, Inc. Tel: 520-745-6201 520-745-6286 Fax: terrylangford(@licsystems.com E-mail:
520-745-6201
520-745-6286
Preparation Date: April 21, 2011
1.0 CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Pending Name - Class II Common / Usual Name: Washer - Endoscope and Accessories Device Classification: 21 CFR § 876.1500. - Endoscope and accessories Product Code: FEB Proprietary Name: LIC Instrument Processing System; and Proprietary Name: Manzi MS10 Sterilant
2.0 PREDICATE DEVICE
The LIC Instrument Processing System (K101158) claims equivalence to the Manzi Mach 1 Instrument Cleaner - Processor System (K060458) found substantially equivalent on 10/12/2006. The predicate device is cleared for use with the MS10 Sterilant concentrate (MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.
3.0 INDICATIONS FOR USE
The LIC Instrument Processing System consists of the LIC Instrument Processor, the Manzi Detergent MD10, the Manzi Sterilant MS10, and filtered ozonated final rinse water.
The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate ( MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor.
The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
1
| LANCFORD IC Systems, INC. |
|---|
| --------------------------- |
LIC INSTRUMENT PROCESSOR
Pre-Market Notification 510(k) K101158 Section XV. 510(k) Summary
The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
4.0 DESCRIPTION OF THE DEVICE
The LIC Instrument Processing System consists of a LIC Instrument Processor, a proprietary Manzi sterilant, MS10; a proprietary enzymatic Manzi Detergent, MD10; and internally generated filtered ozonated final rinse water. The LIC Instrument Processing System requires no connectors to be attached to the endoscope.
The LIC Instrument Processor is a self-contained stand-alone system designed to clean and provide high level disinfection of semi-critical endoscopes using the MD10 detergent, the MS10 sterilant, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the semi-critical endoscopes without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle that provides cleaning to a protein residual level ≤ 6.4 ug / cm², followed by hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection of the instrument being processed and final rinses with filtered ozonated water.
The hardware for the LIC Instrument Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, a neutralization tank, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable semi-critical endoscopes trays, baffle inserts, and printer paper.
The LIC Instrument Processor is designed to: (1) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations.
MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the LIC Instrument Processor. MD10 is intended to be used with the LIC Instrument Processor only.
MS10 is a peracetic acid based liquid chemical sterilant packaged in single use containers for attachment to the LIC Instrument Processor. MS10 is intended to be used with the LIC Instrument Processor.
5.0 COMPARISON TO THE PREDICATE DEVICE
The LIC Instrument Processing System is equivalent in operational principles to the Manzi Mach 1 Instrument Cleaner-Processor System cleared in K060458 10/12/2006. Both devices are intended for high quality cleaning and high level disinfection of flexible endoscopes, use no connectors, operate with the endoscopes in submerged solution, and utilize a detergent and sterilant cleared by the FDA. Both devices process one endoscope at a time. The devices differ in the Indications for Use as described in the table below:
| Manzi Mach 1 as Configured in K060458 | LIC Instrument Processor |
|---|---|
| The Manzi Mach 1 Instrument Cleaner Processor | The LIC Instrument Cleaner Processor System is |
| System is indicated for use with the MD10 Detergent | indicated for use with the MD10 Detergent and the |
| and the High Level Disinfectant MS10 concentrate ( | High Level Disinfectant MS10 concentrate ( MEC |
| MEC 0.49% PAA, minimum contact temperature of | 0.49% PAA, minimum contact temperature of 120° F |
| 120° F for a contact time of 15 minutes) for cleaning | for a contact time of 5 minutes) for cleaning and high |
| and high level disinfecting flexible bronchoscopes used | level disinfecting of heat sensitive flexible endoscopes |
| in health care settings by health care workers. | used in health care settings by health care workers. |
6.0 SUMMARY OF NONCLINICAL TESTS FOR THE LIC INSTRUMENT PROCESSOR
2
6.1 Qualification Testing - FDA Guidance
The LIC Instrument Processing System was tested and found to conform to the requirements of the "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities", dated August, 1993". The table below identifies the qualifications performed and the results obtained:
| Requirement | Results | |
|---|---|---|
| G. | Performance Data | |
| 1 Process Parameter Tests | Passed | |
| 2 Simulated Use Tests | Passed | |
| 2.c. Effectiveness Tests | ||
| 2.c.(1) Cleaning Efficacy | Passed | |
| 2.c.(2) Disinfection Efficacy | Passed | |
| 2.c.(3) Rinsing Efficacy | Passed | |
| 2.c.(4) Other Tests | Passed | |
| 2.c.(5) Combined Process | Passed | |
| 3. In - Use Tests | Passed | |
| H. | Software Documentation | Passed |
| I. | Toxicological Evaluation of Residues | Passed |
6.2 Process Parameter Test
The LIC Instrument Processing System was tested to demonstrate that the device performs as intended. The test results showed that the LIC Instrument Processing System achieves and maintains the specified physical process parameters, automatically aborts the cycle if the specified parameters are not achieved, detects the defined fault conditions, and provides the designated alarms and instructions in the event of fault condition detection.
6.3 Cleaning Efficacy Testing -- LIC Instrument Processing System Cleaning Step
The LIC Instrument Processing System's cleaning step was challenged by endoscopes containing both protein loaded soil and TOC loaded soil and tested for cleaning efficacy. The test results demonstrate that the LIC Instrument Processing System when challenged with endoscopes contaminated with a Protein Laden Soil up to 1080 µg/cm² yielded remaining protein levels of 10 € microbial loading was introduced into the Filtered Ozonated Final Rinse Water System and tested after the water was processed to the systems operational specifications. The test results showed a > 6 spore log reduction with no CFUs.
6.7 Toxicological Evaluation of Residues
The safety of residual chemicals remaining on endoscopes after processing in the LJC Instrument Processing System was evaluated. The test results showed that that the LJC Instrument Processing System processing cycle reduces detergent and sterilant residuals to non-toxic levels.
7.0 SUMMARY OF NONCLINICAL TESTS for the MANZI MS10
7.1 Qualification Testing - FDA Guidance
The Manzi MS 10 Sterilant was tested to and met the requirements of the current edition of "Guidance for Industry and FDA Reviewers, Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants / High Level Disinfectants", dated January 3, 2000. The table below identifies the qualifications performed, the applicable Guidance Section, and the results obtained:
| FDA Guidance Requirement | Results | |
|---|---|---|
| 5.4 | Potency Test | Passed |
| 5.5 | Simulated Use Tests | Passed |
| 5.6 | In-Use Tests | Passed |
| 6.0 | Biocompatibility | Passed |
7.2 Qualification Testing - AOAC Tests
| Microbiological Efficacy Summary | ||
|---|---|---|
| Test Method | Test Organisms | Results |
| Sporicidal Activity of Sterilants; AOAC | ||
| Official Method 966.04 | Bacillus subtilis | |
| Clostridium sporogenes | MS10 is sporicidal | |
| Fungicidal Activity of Sterilants; | ||
| AOAC Official Method 955.17 | Trichophyton mentagrophytes | MS10 is fungicidal |
| Use-Dilution Method; AOAC Official | ||
| Method 955.14, 955.15, 964.02 | Salmonella choleraesuis | |
| Staphylococcus aureus | ||
| Pseudomonas aeruginosa | MS10 is bactericidal | |
| Virucidal Testing | Poliovirus Type I | MS10 is virucidal |
| Quantitative Tuberculocidal Test | Mycobacterium bovis | MS10 is tuberculocidal |
8.0 OVERALL PERFORMANCE CONCLUSIONS
4
| K101158 p 5 of 5 | |
|---|---|
| Summary of FDA Requests and LIC Responses - Telecon April 20, 2011 Page 6 | |
| LIC LANGFORD IC SYSTEMS, INC | LIC INSTRUMENT PROCESSOR |
| Pre-Market Notification 510(k) K101158 | |
| Section XV. 510(k) Summary Page XV - 5 |
The studies demonstrate that the LIC Instrument Processing System is safe and effective for the cleaning and high level disinfection of heat sensitive semi-critical endoscopes within the stated indications for use for the LIC Instrument Processor, the Manzi MS10 Sterilant, and the Manzi Detergent, MD10, and establishes substantial equivalence of the LJC Instrument Processing System to the predicate device identified in Section 2.0 above.
LIC qualification and validation testing has demonstrated that the LIC Instrument Processing System will clean endoscopes to a remaining protein level of The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate ( MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor.
The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | Page 1 of |
| Infection Control, Dental Devices | |
| 510(k) Number: | K101158 |