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 the female reproductive organs.

Device Description

The ENDOEYE HD II - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy and endoscopic surgery within the abdominal cavities, which is basically identical to the predicate devices for the same application areas.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Olympus EndoEYE HD II, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not present a formal table of acceptance criteria with corresponding performance metrics for the Olympus EndoEYE HD II as one might expect from a detailed clinical or performance study report. Instead, it describes various non-clinical tests and validations performed to demonstrate substantial equivalence to predicate devices.

However, based on the information provided, we can infer the types of acceptance criteria and the confirmation that the device met these criteria through testing.

Acceptance Criterion (Inferred from Non-Clinical Testing)	Reported Device Performance / Confirmation
Safety:
Risk analysis in accordance with ISO 14971:2007	Risk analysis was carried out, and design verification tests were identified and performed as a result of this assessment.
Compliance with IEC 60601-1 (General medical electrical equipment safety)	Applied
Compliance with IEC 60601-1-1 (Safety requirements for medical electrical systems)	Applied
Compliance with IEC 60601-2-18 (Safety for endoscopic equipment)	Applied
Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	Applied
Material safety (identical to predicate device)	"The subject device has identical materials as the predicate device."
Performance:
Image Resolution	Verification testing for resolution was conducted.
Color Correctness	Verification testing for color correctness was conducted.
Spectrum Analysis	Spectrum analysis was conducted.
Fog Free Functionality	Validation of the Fog Free function was conducted.
Durability after multiple sterilization cycles	Testing to confirm the durability of the device after multiple sterilization cycles was conducted.
Reprocessing:
Reprocessing validation in accordance with FDA guidance	"Reprocessing validation was carried out in accordance with 'Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996.'"
Compliance with DIN EN ISO 17664 (Processing of medical devices)	Applied
Compliance with DIN EN ISO 17665-1 (Sterilization of health care products - Moist heat)	Applied
Compliance with DIN EN ISO 14161 (Sterilization of health care products - Biological indicators)	Applied
Compliance with ISO 11138, part 3 (Sterilization of health care products - Biological indicators - Moist heat)	Applied
Compliance with DIN EN 556-1, Part 1 (Sterilization of medical devices - Requirements for medical devices to be designated "STERILE")	Applied
Compliance with DIN EN 285 (Sterilization - Steam sterilizers - Large sterilizers)	Applied
Software Validation:
Compliance with FDA Guidance for software in medical devices	"The software validation activities were performed in accordance with the FDA Guidance, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
Software Level of Concern	"The device software is considered a 'Minor Level of Concern.'"

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

The document describes non-clinical testing for performance, safety, and reprocessing. It does not mention a "test set" in the context of clinical data or human evaluation (e.g., patient images). Therefore:

Sample Size for Test Set: Not applicable as no clinical test set/data is described. The testing involved physical devices and their components.
Data Provenance: Not applicable as no clinical data is described. The tests were likely conducted internally by the manufacturer (Olympus Winter & Ibe GmbH) in Germany.

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

This information is not provided in the document. Since the testing described is non-clinical/technical (e.g., resolution, sterilization, durability), the "ground truth" would be established by engineering and quality assurance standards and measurements, not by medical experts interpreting data like radiologists.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the non-clinical nature of the described testing. Adjudication methods are typically used in studies involving human interpretation of data where consensus among experts is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical performance, not through a comparative clinical study with human readers assessing diagnostic performance.

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

No, a standalone algorithm study is not mentioned. The device is a video laparoscope, a physical instrument for visualization during surgery, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for the described non-clinical testing would be based on objective technical specifications, engineering standards, and validated measurement techniques. For example:

Resolution: Measured against established optical resolution charts/targets.
Color Correctness: Measured against color calibration standards.
Sterilization Effectiveness: Demonstrated through biological indicator kill rates and physical/chemical indicators conforming to sterilization standards (e.g., DIN EN ISO 17665-1).
Durability: Assessed by subjecting devices to a specified number of sterilization cycles and then re-evaluating performance against initial specifications.
Software Functionality: Verified against software requirements specifications.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical instrument, not an AI/machine learning algorithm that requires a "training set" of data.

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

This information is not applicable as there is no training set for an AI/machine learning algorithm described.

Summary

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

K111788

JAN 1 3 2012

January 13, 2012

General Information ﮩ

Olympus Winter & Ibe GmbH l Applicant Kuehnstrasse 61 * 22045 Hamburg * Germany Establishment Registration No: 9610773
I Official Correspondent Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway, PO Box 610 Center Valley PA 18034-0610 Phone: (484) 896-5405 Facsimile: (484) 896-7128 Email: Stacy.kluesner @olympus.com Establishment Registration No: 2429304
Olympus Winter & Ibe GmbH Manufacturer Kuehnstrasse 61 * 22045 Hamburg Germany Establishment Registration Number: 9610773

2. Device Identification

. Device Name Olympus EndoEYE HD II
. Common Name High Definition Digital Video Laparoscope
Regulation Number 21 CFR 876.1500 21 CFR 874.4720 21 CFR 884.1720
Regulation Name Endoscope and Accessories Mediastinoscope and Accessories Gynecologic Laparoscope and Accessories
. Regulatory Class ll
Product Code GCJ /NLM/KOG/ NWB EWY NMH/HET
I Classification Panel Gastroenterology/Urology Ear Nose& Throat Obstetrics/Gynecology

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

Legally Marketed Device to which Substantial Equivalence is claimed 3.

The following table shows the subject and predicate device to which we claim substantial equivalence.

Subject Device (Part of this submission)	Predicate Device	PD's 510(k) No.
HD EndoEYE II- WA50040A, 10 mm, 0°, autoclavable- WA50042A, 10 mm, 30°, autoclavable- WA50050A, 5.4 mm, 0°, autoclavable- WA50052A, 5.4 mm, 30°, autoclavable	HD EndoEYEWA50011A, WA50013A, WA50013L, WA50013T, WA50015L	K090980
	HD EndoEYE Laparo-ThoracoVideoscope OLYMPUS LTF-VH	K080948
Table 1. Subject & Predicate Devices

Device Description 4 ...

Indications for Use ഗ്

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 surqery within the thoracic and abdominal cavities including the female reproductive organs.

Comparison of Technological Characteristics 6.

The subject EndoEYE HD II is nearly identical to the predicate HD EndoEYE device. It has identical spefications to the predicate device except for; (1) a wider field of view, (2) incorpotion of a Fog Free Function, (3) a greater range in the depth of field and (4) multible CCDs.

Specifications	Predicate Device Predicate Device
	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Image /page/2/Picture/1 description: The image shows the word "OLYMPUS" in bold, black letters. The font is sans-serif and the letters are tightly spaced. The word is centered and takes up most of the frame.

		K090980	K080948
Device name	EndoEYE HD II	HD EndoEYE	HD EndoEyeLaparo-ThoracoVideoscope
510(k) number		K955456	K080948
Type	WA50040A,WA50042A,WA50050A,WA50052A	WA50011A,WA50013A,WA50013L,WA50013T,WA50015L	LTF-VH
Field of View	90°	80°	90°
Depth of field	20 to 200 mm	10 to 120 mm	15-100 mm
Direction of View	0°, 30°	0°, 30°, 45°	0°
Outer Diameterof Distal End	5.4 mm, 10mm	10 mm	10 mm
Optical System	Color	Color	Color
Working Length	325 or 300 mm	250 - 390 mm	370 mm
Switch for NBIfunction	Provided	Provided	Provided
Number of CCDchips	2 (WA50040A &WA50042A)1 (WA50050A &WA50052A)	1	1

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 verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."

The subject device has identical materials as the predicate device.

The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."

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

Image /page/3/Picture/1 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word is in black color and the background is white.

The following standards have been applied to the subject EndoEYE HD II devices:

· IEC 60601-1
· IEC 60601-1-1
· IEC 60601-2-18
· IEC 60601-1-2
· ISO 14971
· DIN EN ISO 17664
· DIN EN ISO 17665-1
· DIN EN ISO 14161
· ISO 11138, part 3
· DIN EN 556-1, Part 1
· DIN EN 285

Performance testing conducted included validation of the Foq Free function, verification testing for resolution and color correctness, spectrum analysis and testing to confirm the durability of the device after multiple sterilization cycles.

8. Conclusion

When compared to the predicate devices, the ENDOEYE HD II does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device and therefore is substantially equivalent to the idenfied predicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Olympus Winter & Ibe GmbH % Ms. Stacy Abbatiello Kluesner, M.S., RAC Project Manager Olympus America Inc. 3500 Corporate Parkway CENTER VALLEY PA 18034

JAN 1 3 2012

Re: K111788

Trade/Device Name: ENDOEYE HD II Type WA50040A, WA50042A, WA50050A, WA50052A

Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: January 10, 2012 Received: January 11, 2012

Dear Ms. Kluesner:

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 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

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

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,
. Benjamin K. twka

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

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

Indications for Use

510(k) Number (if known): ______ K111788

ENDOEYE HD II Device Name: Type WA50040A, WA50042A, WA50050A, WA50052A

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concerrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111788

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.