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.

Device Description

The HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH is a flexible video endoscope used for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs which is basically identical to the predicate devices, LTF-V, for the same application areas. The major difference from the predicate device is only the NBI function added to the subject device. The new endoscope is basically identical to the predicate device shown in above Table in intended use, and similar in specifications, performance without NBI observation.

AI/ML Overview

This 510(k) submission describes the Olympus HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH, a device substantially equivalent to the predicate device OES Laparo-Thoraco Videoscope Type V (K955403). The primary difference is the addition of an NBI (Narrow Band Imaging) function.

This is a medical device submission and does not typically include clinical study data in the way an AI/ML software device would for performance metrics. The information provided focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria with clinical studies. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable or cannot be extracted from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

No specific performance acceptance criteria or quantitative performance metrics are provided in the document. The submission focuses on demonstrating substantial equivalence in specifications and intended use.

Acceptance Criteria Category	Reported Device Performance
Intended Use	Identical to predicate device (endoscopy and endoscopic surgery within thoracic and abdominal cavities including female reproductive organs).
Technological Characteristics	Field of View: 90° (Predicate: 70°) Direction of View: 0° (Identical) Optical System: Color (Identical) Angulation: UP: 100°, DOWN: 100°, RIGHT: 100°, LEFT: 100° (Predicate: 90° in all directions) Working Length: 370mm (Predicate: 330mm) Instrument Channel Inner Diameter: NA (Identical) NBI Function: Provided (Predicate: Not provided)
Safety and Effectiveness	No significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate device.

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission focused on substantial equivalence based on device specifications and intended use, not a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth establishment with experts is not detailed for this type of submission.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC studies are described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth" for diagnostic performance. The "ground truth" here refers to the validated specifications and safety/effectiveness of the predicate device against which the subject device is compared.

8. The sample size for the training set

Not applicable. This is not an AI/ML device subject to training data.

9. How the ground truth for the training set was established

Not applicable.

Summary

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KC80748 p 1 of 3

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510(k) SUMMARY

SEP 2 6 2008

EVIS EXERA II 180 SYSTEM

1. General Information

트 OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047 트 Official Correspondent: Laura Storms-Tyler Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway, PO Box 610 Center Valley PA 18034-0610 Phone: (484) 896-5688 Facsimile: (484) 896-7128 Email:Laura.storms-tyler@olympus.com Establishment Registration No: 2429304 Aizu Olympus Co., Ltd. . Manufacturer: 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595

2. Device Identification

■	Device Name:	HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH
■	Common Name:	Laparo-Thoraco Videoscope
■	Class:	II
	Regulation Number / Name:	21 CFR 884.1720 Gynecologic laparoscope and accessories21 CFR 876.1500 Endoscope and accessories
■	Product Code:	GCJ/ HET/NWB
■	Classification Panel:	Obstetrics/ GynecologyGastroenterology/ Urology,

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.

Subject & Predicate Devices

Subject Device(part of this submission)	Predicate Device	PD's 510(k)No.
HD EndoEYE Laparo-Thoraco VideoscopeOLYMPUS LTF Type VHLTF-VH	OES Laparo-Thoraco Videoscope Type VLTF-V	K955403

OLYMPUS MEDICAL SYSTEMS CORP.

2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN

TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174

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4. Device Description

The major difference from the predicate device is only the NBI function added to the subject device. The new endoscope is basically identical to the predicate device shown in above Table in intended use, and similar in specifications, performance without NBI observation..

When the CLV-180 and CV-180 are combined with the new LTF-VH, both an endoscopic image by white light illumination and that by NBI illumination can be observed within the thoracic and abdominal cavities including female reproductive organs. The CV-180 identifies a NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes.

5. Indications for Use

HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH:

6. Comparison of Technological Characteristics

The LTF-VH is mainly similar to the predicate device, LTF-V in specifications without NBI fuinction.

Comparison between the subject and predicate devices is shown below.

Specifications	Subject DeviceLTF-VH	Predicate DeviceLTF-V(K955403)
Field of View	90°	70°
Direction of View	0°	0°
Optical System	color	color
Angulation	UP : 100°DOWN : 100°RIGHT : 100°LEFT : 100°	UP : 90°DOWN : 90°RIGHT : 90°LEFT : 90°
Working Length	370mm	330mm
Inner Diameter ofInstrument Channel	NA	NA
ON/OFF switch forNBI function	Provided	Not provided

marison of Snecifications

OLYMPUS MEDICAL SYSTEMS CORP.

2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-42-642-2891, TELEFAX +81-42-642-3174

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K080948p 3 of 3

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6. Conclusion

and the comments of the count

...

When compared to the predicate devices, the LTF-V 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.

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174 313

: 上一篇:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura Storms-Tyler Vice President Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K080948

Trade/Device Name: HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH Regulation Number: 21 CFR §884.1720. Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET, GCJ and NWB

Dated: August 27, 2008 Received: August 28, 2008

Dear Ms. Storms-Tyler:

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 individions for use stated in the enclosure) to legally marketed predicate devices marketed in intention commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmouts or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or to 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, I using 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 such 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.

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Page 2

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/odrh/industry/support/index.html.

Sincerely yours.

Jozpu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K080948 510(k) Number (if known): Device Name: HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH

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)

Hules Hever

(Division Sign-Off)

Division of Reproductive, Abdominal,

510(k) Number

and Radiological Dev

Page 1 of 1

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.