The Disposable Lens Cleaning Sheath is an endoscope accessory that uses saline solution and carbon dioxide to remove debris from the lens surface of endoscopes used within the thoracic and abdominal cavities, including female reproductive organs.

Device Description

The subject device is a single use disposable device and is provided to the user sterile. The subject devices consist of an insertion section, main body section, and water/CO2 gas tube section.

The subject devices are used in combination with flexible endoscope and rigid endoscope.

Upon use the device is attached to the compatible endoscope, water source, and gas source to remove debris from the objective lens surface of the endoscope by spraying saline solution and CO2 gas.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Disposable Lens Cleaning Sheath." It describes the device, its intended use, and the non-clinical testing performed to demonstrate its safety and effectiveness. However, it does not contain information about acceptance criteria and device performance in the context of a clinical study or a study involving human readers or expert ground truth.

The document focuses on non-clinical performance and a comparison to a predicate device. Therefore, I cannot extract the specific information requested in the prompt, such as:

A table of acceptance criteria and reported device performance (in a clinical/expert setting).
Sample size used for the test set and data provenance.
Number of experts and their qualifications for establishing ground truth.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
Sample size for the training set.
How ground truth for the training set was established.

The document explicitly states the following, which is relevant to your request about testing:

Acceptance Criteria and Device Performance (Non-Clinical):

The document mentions that:

"Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
"Performance testing including sterilization validation, shelf life, and mechanical performance / bench testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended."

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical, based on summary in the document):

Test Category	Acceptance Criteria (Implicit from "performs as intended" and standard compliance)	Reported Device Performance
Sterilization Validation	Compliance with ISO 11137-1:2006 (Methods VDmax25)	Validated according to ISO 11137-1:2006
Shelf Life Testing	Compliance with ASTM F1980-07 for accelerated aging; expectation of longer stability through real-time aging.	Demonstrated stability based on accelerated aging
Mechanical Performance	Device performs as intended for each item below	Confirmed to perform as intended
- Insertion/Removal	Inserts and removes from endoscope	Performed as intended
- Trocar Insertion	Inserts into trocar	Performed as intended
- Gas Feeding Operation	Gas feeding functionality	Performed as intended
- Spray Feeding Operation	Spray feeding functionality	Performed as intended
- Debris Removal	Effective in removing debris	Performed as intended (Inspection of removing the debris)
- Insertion Section Durability	Durable	Performed as intended
- Main Body Fixing Strength	Secure fixing of main body	Performed as intended
- Package Inspection	Package integrity and quality	Performed as intended
Biocompatibility Testing	Compliance with FDA Guidance "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1," including cytotoxicity, sensitization, and irritation.	Demonstrated biocompatibility according to FDA guidance
Risk Analysis	In accordance with ISO 14971:2007 (in-house acceptance criteria)	Carried out and informed design verification tests

Regarding the other specific points you requested:

Sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth, training set sample size, and ground truth for training set: This information is not available in the provided document. The document describes non-clinical testing for a device, not a diagnostic algorithm or AI system that would typically involve such studies. The device is a "Disposable Lens Cleaning Sheath," an accessory for endoscopes, which implies mechanical and material performance testing rather than diagnostic accuracy studies.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2016

Olympus Medical Systems Corp % Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610

Re: K153773

Trade/Device Name: Disposable Lens Cleaning Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 11, 2016 Received: November 14, 2016

Dear Sheri Musgnung.

This letter corrects our substantially equivalent letter of November 22, 2016.

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

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

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 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" (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/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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153773

Device Name Disposable Lens Cleaning Sheath

Indications for Use (Describe)

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."

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

510(k) SUMMARY K153773 Disposable Lens Cleaning Sheath

November 22, 2016

5.1 General Information

■ Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan192-8507Establishment Registration No: 8010047
■ Official Correspondent:	Sheri L. MusgnungOlympus Corporation of the Americas3500 Corporate Parkway PO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-3147FAX: 484-896-7128Email: sheri.musgnung@olympus.com
■ Manufacturer:	OLYMPUS MEDICAL SYSTEMS CORP.34-3 Hirai, Hinode-machi,Tokyo, Japan 190-0182Establishment Registration No.: 3003637092

5.2 Device Identification

■ Device Trade Name:	Disposable Lens Cleaning Sheath
■ Common Name:	Lens Cleaning Sheath
■ Regulation Number:	876.1500
■ Regulation Name:	Endoscope and accessories
■ Regulatory Class:	II
■ Classification Panel:	General & Plastic Surgery
■ Product Code:	GCI

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

Device TradeName	Common Name	Applicant	510(k) No.
Clear-VuTMSystem(Primarypredicate device)	endoscope lenscleaning anddefoggingdevice	Minimally Invasive Devices,LLC	K080613

Predicate Device Information 5.3

The predicate device has not been subject to a design related recall.

5.4 Device Description

The subject device is a single use disposable device and is provided to the user sterile. The subject devices consist of an insertion section, main body section, and water/CO2 gas tube section.

The subject devices are used in combination with flexible endoscope and rigid endoscope.

Upon use the device is attached to the compatible endoscope, water source, and gas source to remove debris from the objective lens surface of the endoscope by spraying saline solution and CO2 gas.

ર્સ ર ર્ Indications for Use

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

5.6 Comparison of Technological Characteristics

The subject device and predicate device do not have the same technological characteristics. The construction of the device (thread), component materials (sheath and tip material), water supply, gas supply, and method of sterilization are different.

The different technological characteristics of the subject device do not raise different safety or effectiveness questions as comparable device construction, materials, water supply, gas supply, and methods of sterilization have been evaluated in previous 510(k)s for this device type. Accepted scientific methods exist to assess the effects of the different technological characteristics including electrical, software, and performance testing.

5.7 Summary of non-clinical testing

· Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

·Performance testing including sterilization validation, shelf life, and mechanical performance/bench testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.

Sterilization validation

Sterilization validation was carried out with Methods VDmax25 in accordance with ISO11137-1:2006.

Shelf life testing

Shelf life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-07(Reapproved 2011), the standard guide for accelerated aging of sterile barrier systems for medical devices. Three years real-time aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.

Mechanical performance testing

Mechanical performance testing was conducted on the following items to demonstrate the basic performance of the subiect device and confirmed that the subject device performs as intended.

Inserted to the endoscope and remove from the endoscope
Inserting into the trocar
Gas feeding operation
Spray feeding operation
Inspection of removing the debris
Insertion section durability
Fixing strength of the main body
Inspection of the package

{6}------------------------------------------------

Biocompatibility testing

Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1" including cytotoxicity, sensitization, and irritation testing.

· The following standards have been applied to the Disposable Lens Cleaning Sheath.

Standard No.	Standard Title
ISO 10993-1 Fourth Edition:2009-10-15	Biological Evaluation Of Medical Devices - Part1:Evaluation And Testing Within A Risk ManagementProcess [Including: Technical Corrigendum 1 (2010)]
AAMI ANSI ISO 10993-3:2003/(R)2013	Biological Evaluation Of Medical Devices Part 3:Tests For Genotoxicity, Carcinogenicity AndReproductive Toxicity
AAMI ANSI ISO 10993-5:2009/(R)2014	Biological Evaluation Of Medical Devices – Part5:Tests For In Vitro Cytotoxicity
ISO 10993-10 Third Edition:2010-08-01	Biological Evaluation Of Medical Devices - Part 10:Tests For Irritation And Skin Sensitization
AAMI/ANSI/ISO 10993-11:2006/(R)2010	Biological Evaluation Of Medical Devices Pat11 :Tests For Systemic Toxicity
ISO 11137-1 First Edition:2006-04-15	Sterilization Of Health Care Products - Radiation -Part 1: Requirements For Development, ValidationAnd Routine Control Of A Sterilization Process ForMedical Devices [Including: Amendment 1 (2013)]
ISO 11137-2 Third Edition:2013-06-01	Sterilization Of Health Care Products - Radiation -Part 2: Establishing The Sterilization Dose
ASTM F1980-07(Reapproved 2011)	Standard Guide For Accelerated Aging Of SterileBarrier Systems For Medical Devices
ISO 14971 Second Edition:2007-03-01	Medical Devices - Application Of Risk ManagementTo Medical Devices

5.8 Conclusion

The Disposable Lens Cleaning Sheath is substantially equivalent to the proposed predicate device.

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.