This instrument is intended to be used with a video system center, light source, documentation equipment, monitor. hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

Device Description

The LTF-S190-5 is a video endoscope consisting of three parts: the control section, the insertion section, and the connector section. The device uses an objective lens and light guide lens for capturing images/videos from the distal end of the endoscope.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Device Performance / Result
Reprocessing	All reprocessing methods (Sterilizer/Sterilization process) were validated following FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015). The acceptance criteria were met.
Biocompatibility	Tested in accordance with FDA's Guidance for Industry and FDA Staff, Use of International Standard ISO 10993-1, and specific sub-parts:
	- Cytotoxicity (ISO 10993-5:2009)
	- Intracutaneous (ISO 10993-10:2010)
	- Sensitization (ISO 10993-10:2010)
	- Acute Systemic Toxicity (ISO 10993-11:2006)
	- Rabbit Pyrogen (USP <151>, USP <37>)
	The device was shown to be non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic, and non-pyrogenetic.
Software V&V	Software verification and validation testing conducted following FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The device met all requirements.
Electrical Safety	Tested in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, and IEC 60601-2-18:2009. The system complies with these standards.
EMC	Tested in accordance with IEC 60601-1-2:2014. The system complies with this standard.
Bench Performance	Bench testing included:
	- Thermal safety test
	- Composite durability test
	- Color (imaging) performance
	- Photobiological Safety
	Device performance was assessed against design requirements, including process verification, design verification, and design validation. The device met all acceptance criteria.

2. Sample Size for Test Set and Data Provenance

The provided text describes various engineering and performance tests (reprocessing, biocompatibility, software V&V, electrical safety, EMC, and bench performance). These types of tests typically do not involve "test sets" in the clinical sense with human data. Instead, they involve testing the physical device, its materials, and its software against established technical and safety standards.

No "sample size" for a clinical test set is mentioned.
No "data provenance" (e.g., country of origin, retrospective/prospective) for clinical data is mentioned, as clinical data was not part of this submission's performance data section. The submission focuses on substantial equivalence based on technical characteristics and non-clinical performance data.

3. Number of Experts and Qualifications for Ground Truth Establishment

Not applicable. The performance data presented are based on engineering tests and adherence to recognized standards, not on expert-established ground truth from clinical cases.

4. Adjudication Method for Test Set

Not applicable. There is no clinical test set requiring adjudication in the provided performance data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This evaluation focuses on the safety and effectiveness of the device itself, rather than comparing human reader performance with and without AI assistance. The device is a videoscope, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical videoscope, not an algorithm, so a standalone algorithm-only performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is defined by:

Established national and international standards (e.g., FDA guidance documents, ISO 10993, ANSI/AAMI ES 60601-1, IEC 60601-1-2)
Manufacturer's design specifications and requirements.

8. Sample Size for Training Set

Not applicable. This device is a physical videoscope, not a machine learning model, so there is no concept of a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set mentioned or implied for this device.

Summary

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September 17, 2021

Olympus Medical Systems Corp. % Jon Gilbert Regulatory Affairs Consultant for Olympus Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

K201832 Re:

Trade/Device Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5 Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET, GCJ, NWB Dated: August 13, 2021 Received: August 16, 2021

Dear Jon Gilbert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201832

Device Name ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5

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)
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510(k) Summary

I. GENERAL INFORMATION

■ 510(k) Submitter:	OLYMPUS MEDICAL SYSTEMS CORP.
	2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507,
	Japan

Contact Person: Jon Gilbert c/o Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 906-361-3237 Fax: 484-896-7128 Email: jgilb.raca@gmail.com
Aizu Olympus Co., Ltd., ■ Manufacturing site: 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan

Date Prepared: September 14, 2021

II. DEVICE IDENTIFICATION

■ Device Name	ENDOEYE FLEX DEFLECTABLE VIDEOSCOPEOLYMPUS LTF-S190-5
■ Common Name	VIDEOSCOPE
■ Regulation Number	21 CFR 884.1720
■ Regulation Name	Gynecologic laparoscope and accessories
■ Regulatory Class	II
■ Product Code	HET; Laparoscope, Gynecologic (And Accessories)GCJ; Laparoscope, General & Plastic SurgeryNWB; Endoscope, Accessories, Narrow Band Spectrum

Classification Panel Obstetrics/Gynecology

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Image /page/4/Picture/0 description: The image shows the Olympus logo in blue, with a gold line underneath. To the right of the logo, the text "Traditional 510(k) Notification" is present. Below the logo, the text "ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5" is displayed.

III. PREDICATE DEVICE

Device name	510(k) Submitter	510(k) No.
ENDOEYE FLEX 3DDEFLECTABLE VIDEOSCOPEOLYMPUS LTF-190-10-3D	OLYMPUS MEDICALSYSTEMS CORP.	K123365

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

IV. DEVICE DESCRIPTION

■ General Description of the subject device

This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

Principle of Operation

V. INDICATIONS FOR USE

ENDOBYE ELEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5

This instrument is intended to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs

COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH VI. THEPREDICATE DEIVCE

The detailed comparison chart between subject device and predicate devices are as follows.

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	Subject Device (SD)	Predicate Device (PD)
Item	LTF-S190-5	LTF-190-10-3D
Indications for Use	This instrument is intended tobe used with a video systemcenter, light source,documentation equipment,monitor, hand instruments,electrosurgical unit, and otherancillary equipment forendoscopy andendoscopicsurgery within the thoracicand abdominal cavitiesincluding female reproductiveorgans.	This instrument is intended to beused with Olympus video systemcenter, light source, documentationequipment, 3D processor, monitor,hand instruments, electrosurgicalunit, and other ancillary equipmentfor endoscopy and endoscopicsurgery. This instrument isindicated for use within the thoracicand abdominal cavities includingfemale reproductive organs.This instrument must not be usedfor observation or treatment of theheart and must not contact the heartor any area near the heart. Inaddition, this instrument must notcome into contact with any deviceor therapeutic accessory thatcontacts the heart or any area nearthe heart.
Environment of use	Healthcare facility/hospital	Healthcare facility/hospital
Single/ Repeat use	Repeat use	Repeat use
Sterile/ Non-sterile	Non-sterile	Non-sterile
Sterilization method	Ethylene oxide, Autoclave,Hydrogen peroxide (Sterrad100S/ NX)	Ethylene oxide, Hydrogen peroxide(Sterrad NX)
Field of View	85°	80°
Direction of View	0° (Forward viewing)	0° (Forward viewing)
Depth of Field	18-100 mm	18-100 mm
Type of CCD	Color CCD	Color CCD
Number of CCD Chip	1	2
Narrow Band Imagingobservation	Available	Available
Insertion TubeDiameter	Distal end size: Ø 5.4 mmInsertion tube outer Diameter(Maximum): Ø5.4 mm	Distal end size: Ø 10 mmInsertion tube outer Diameter(Maximum): Ø 10 mm
Working Length	370 mm	370 mm
Channel inner diameter	No instrument channel	No instrument channel
Angulation Range	U/D:100°/100°R/L:100°/100°	U/D:100°/100°R/L:100°/100°
Item	Subject Device (SD)LTF-S190-5	Predicate Device (PD)LTF-190-10-3D
Patient contactingmaterial	Bending rubber: Fluoro RubberDistal end/ Distal cover/Insertion tube/ Pin: Stainless steelGlue: Epoxy ResinLens: Glass	Bending rubber: Fluoro RubberDistal end / Insertion tube: Stainless steelGlue: Epoxy ResinLens: Glass
Duration and type ofcontact	External communicating device in contact with mucosal membranes, damaged mucosal membranes and tissue/bone/dentin.The contact duration is limited exposure (i.e. contact is up to 24 hours).	External communicating device in contact with mucosal membranes, damaged mucosal membranes and tissue/bone/dentin.The contact duration is limited exposure (i.e. contact is up to 24 hours).

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K201832 Page 4 of 5

The indications for use of the subject device do not raise different questions of safety and effectiveness when compared to the predicate device. The subject and predicate devices have the same intended use of providing visualization during thoracic and abdominal surgery, including the female reproductive organs. The differences in technological characteristics do not raise new questions of safety and effectiveness.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

1) Reprocessing validation testing

All reprocessing methods including the Sterilizer/Sterilization process were validated in accordance with the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015. The acceptance criteria were met.

2) Biocompatibility testing

Biocompatibility testing for the LTF-S190-5 final product was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process''.

Cytotoxicity Study Using the Colony Assay (ISO 10993-5:2009) ।
i Intracutaneous Study in Rabbits (ISO 10993-10:2010)
Guinea Pig Maximization Sensitization Test (ISO 10993-10:2010) ।
Acute Systemic Toxicity Study in Mice (ISO 10993-11:2006) i

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-Rabbit Pyrogen Study (USP <151>, USP <37>)
The device was shown to be non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic, and non-pyrogenetic.

3) Software verification and validation testing

Software verification and validation testing for the LTF-S190-5 was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The device met all requirements.

4) Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the LTF-S190-5. The system complies with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC. The device met all requirements.

5) Performance testing - Bench

Bench testing for the LTF-S190-5 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed the design requirements, and included process verification, design verification, and design validation. The device met all acceptance criteria.

Thermal safety test
Composite durability test
Color (imaging) performance
Photobiological Safety

VIII. CONCLUSIONS

The indications for use and technological characteristics of the LTF-S190-5 do not raise different questions of safety and effectiveness as compared to the predicate. The performance testing demonstrate that the subject device is as safe and effective as the predicate. Therefore, and the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.