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 endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs.

Device Description

The HD EndoEYE - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy The HD Lhoon is "Thigh Dominal cavities which is basically identical to the predicate device, OES Laparo- Thoraco Videoscope, for the same application areas.

The major difference from the predicate device is only the NBI function added to the subject device.

When the CLV-180 and CV-180 or the OTV-S7Pro and CLV-S40Pro are combined with HD EndoEYE, both an endoscopic image by white light illumination and that by NBI illumination can be observed within the thoracic and abdominal cavities. The CV-180 identifies when an NBI-compatible scope is connected, by using the Scope ID function provided with the scopes.

AI/ML Overview

The provided text is a 510(k) summary for the Olympus HD EndoEYE, a high-definition digital video laparoscope. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria in the way a clinical trial report would.

Here's an analysis based only on the provided text, as if it were a direct answer to your request. However, it's crucial to understand that this 510(k) summary does not contain the detailed study information you've requested regarding acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone proficiency studies).

The document primarily relies on a comparison of specifications to demonstrate substantial equivalence, implying that if the new device's technical characteristics are similar or improved without introducing new safety/effectiveness concerns compared to legally marketed devices, it meets regulatory requirements.

Based on the provided K090980 510(k) Summary for the HD EndoEYE:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the form of performance thresholds for a study. Instead, it compares the technical specifications of the subject device (HD EndoEYE) to its predicate devices. The "reported device performance" is essentially presented as its specifications, which are deemed acceptable because they are similar or superior to the legally marketed predicate devices without significant changes affecting safety or effectiveness.

Specification	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (HD EndoEYE)
Field of View	70° (OES), 90° (LTF-VH)	80°
Depth of Field	18-100 mm (OES), 15-100mm (LTF-VH)	20 to 120 mm
Direction of View	0°, 30° (OES), 0° (LTF-VH)	0°, 30°, 45°
Outer Diameter of Distal End	11 mm (OES), 10mm (LTF-VH)	10 mm
Optical System	Color	Color
Working Length	320mm (OES), 370mm (LTF-VH)	250-390mm
NBI Function	Not provided (OES), Provided (LTF-VH)	Provided

Study Proving Acceptance Criteria:

The "study" presented here is a comparison of specifications between the subject device and its predicate devices. The conclusion states: "When compared to the predicate devices, the HD EndoEYE 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." This implies that by being substantially equivalent or demonstrating comparable technical performance to already-approved devices, it meets the inherent "acceptance criteria" for regulatory clearance.

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

The document does not specify a test set sample size or any clinical data provenance (e.g., country of origin, retrospective/prospective study) in the context of device performance testing.
The review is based on a comparison of technical specifications and an assessment of substantial equivalence.

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

The document does not mention experts being used to establish ground truth for a test set in the context of a performance study.
The "ground truth" for this 510(k) submission is the functional equivalence and safety assessment against legally marketed devices.

4. Adjudication Method for the Test Set:

Not applicable. No test set performance study with adjudication is described in the provided text.

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

No MRMC comparative effectiveness study is mentioned. The document does not describe any human reader studies, either comparing human readers with AI assistance or in general. The device is a laparoscopic imaging system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is an imaging instrument (hardware), not a standalone algorithm. Its performance is assessed through its physical and optical specifications, not an algorithmic output.

7. Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" is primarily technical specifications and functional characteristics of already legally marketed predicate devices, against which the new device is compared to establish substantial equivalence. No clinical outcome or pathology data is presented for this purpose.

8. Sample Size for the Training Set:

Not applicable. This document is for a medical device (laparoscope), not an AI algorithm requiring a training set.

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

Not applicable. As above, no training set or AI algorithm is discussed.

Summary of what is not found in the document regarding your request:

The provided 510(k) summary is a regulatory filing for substantial equivalence, not a detailed clinical or performance study report in the traditional sense described by your questions. It focuses on comparing the new device's technical characteristics and intended use to existing predicate devices. Therefore, specific details about acceptance criteria derived from a performance study, sample sizes for test/training sets, expert qualifications, ground truth establishment (other than general device specifications), or clinical study methodologies (like MRMC or standalone performance evaluations) are not present in this document.

Summary

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

Ko9o980

JUN 2 9 2009

510(k) SUMMARY

HD EndoEYE - High Definition Digital Video Laparoscope

1. General Information

Applicant:

Olympus Winter & Ibe GmbH Kuehnstrasse 61 * 22045 Hamburg * Germany Establishment Registration No: 9610773

Kuehnstrasse 61 * 22045 Hamburg * Germany Establishment Registration No: 9610773

Stacv Abbatiello Kluesner M.S., RAC Official Correspondent: 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:

WA50011A/WA50013A/WA50013L/WA50013T/WA50015L

HD EndoEYE - High Definition Digital Video Laparoscope

Common Name:

Device Identification

Device Name:

HD EndoEYE

Class:

Regulation Number / Name:

21 CFR 876.1500 Endoscope and Accessories 21 CFR 874.4720 Mediastinoscope and Accessories 21 CFR 884.1720 Gynecologic Laparoscope and Accessories

Product Code:

GCJ, NLM, KOG, NWB EWY NMH/HET

Classification Panel:

Gastroenterology/ Urology Ear Nose & Throat Obstetrics/Gynecology

OLYMPUS Winter & Ibe GmbH Kuehnstrasse 61 * 22045 Hamburg * Germany TELEPHONE +49-40-66966-2999, TELEFAX +49-40-66966-2109

11 - 2

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

Image /page/1/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and appears to be a standard typeface. The letters are closely spaced, creating a solid block of text. The background is white, providing a strong contrast that makes the word stand out.

A 0909080
Pg 2 of 3

3. Legally Marketed Device to which Substantial Equivalence is claimed

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

Table 11.1 Subject & Predicate Devices

Subject Device(Part of this submission)	Predicate Device	PD's510(k)No.
HD EndoEYEWA50011A, WA50013A,WA50013L, WA50013T, WA50015L	A4941A, A4943A OES Laparo-ThoracoVideoscope	K955456
	HD EndoEYE Laparo-ThoracoVideoscope OLYMPUS LTF-VH	K080948

4. Device Description

The major difference from the predicate device is only the NBI function added to the subject device.

5. Indications for Use

HD EndoEYE High Definition Digital Video Laparoscope:

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.

6. Comparison of Technological Characteristics

The HD EndoEYE is mainly similar to the predicate devices in specifications without NBI function. Comparison between the subject and predicate devices is shown below.

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

Image /page/2/Picture/0 description: The image contains a partial view of the letters 'US' on the left side. To the right of these letters, there is handwritten text that appears to read 'K090980' on the first line. Below this, there is additional handwritten text that seems to say 'Pg 30'.

Table 11.2 Comparison of Specifications

Specifications	Subject DeviceHD Endo EYE	Predicate DeviceOES	Predicate DeviceLTF-VH
Field of View	80°	70°	90°
Depth of field	20 to 120 mm	18 to 100 mm	15-100mm
Direction of View	0°, 30°, 45°	0°, 30°	0°
Outer Diameter of Distal End	10	11	10mm
Optical System	Color	Color	Color
Working Length	250-390mm	320mm	370mm
Switch for NBI function	Provided	Not provided	Provided

7. Conclusion

When compared to the predicate devices, the HD EndoEYE 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.

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

Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three curved lines that resemble a bird or a symbol representing health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 29 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Winter & Ibe GmbH % Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olymous America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K090980

Trade/Device Name: HD EndoEYE Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NWB Dated: April 3, 2009 Received: April 14, 2009

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.

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

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

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Danny Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

OLYMPUS

Indications for Use

090980 510(k) Number (if known): Device Name: HD EndoEYE

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ー

Hulu Numan

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

ENDOEYE : 86615 :"",""

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.