HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH

K080948 · Olympus Medical Systems Corporation · HET · Sep 26, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K080948
• Device Name: HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
• Applicant: Olympus Medical Systems Corporation
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Indications for Use

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 Story

HD EndoEYE Laparo-Thoraco Videoscope (LTF-VH) is a flexible video endoscope for visualization during thoracic and abdominal endoscopic surgery. Device captures optical images of internal cavities; transmits video signals to external video system center (CV-180) and light source (CLV-180). Features Narrow Band Imaging (NBI) function, toggled via ON/OFF switch, to enhance visualization of tissue structures. Operated by physicians in clinical settings (OR/clinic). Scope ID function allows CV-180 to identify NBI-compatible hardware. Output displayed on monitor for real-time surgical guidance. Benefits include improved visualization via NBI and high-definition imaging, aiding clinical decision-making during minimally invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison to predicate device.

Technological Characteristics

Flexible video endoscope; 90° field of view; 0° direction of view; 100° four-way angulation. Includes NBI illumination capability. Compatible with CV-180/CLV-180 video system. Connectivity via proprietary Scope ID function. Sterilization method not specified.

Indications for Use

Indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs, in patients requiring such procedures.

Regulatory Classification

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.

Predicate Devices

• OES Laparo-Thoraco Videoscope Type V LTF-V (K955403)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone] Email:[e-mail] 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 accessories<br>21 CFR 876.1500 Endoscope and accessories |
| ■ | Product Code: | GCJ/ HET/NWB |
| ■ | Classification Panel: | Obstetrics/ Gynecology<br>Gastroenterology/ 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<br>(part of this submission) | Predicate Device | PD's 510(k)<br>No. |
|-----------------------------------------------------------------------|-----------------------------------------------|--------------------|
| HD EndoEYE Laparo-Thoraco Videoscope<br>OLYMPUS LTF Type VH<br>LTF-VH | OES Laparo-Thoraco Videoscope Type V<br>LTF-V | K955403 |

OLYMPUS MEDICAL SYSTEMS CORP.

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

TELEPHONE [phone], TELEFAX [phone]

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### 4. 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..

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:

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 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 Device<br>LTF-VH | Predicate Device<br>LTF-V<br>(K955403) | | | | |
|-----------------------------------------|---------------------------------------------------------|-----------------------------------------------------|--|--|--|--|
| Field of View | 90° | 70° | | | | |
| Direction of View | 0° | 0° | | | | |
| Optical System | color | color | | | | |
| Angulation | UP : 100°<br>DOWN : 100°<br>RIGHT : 100°<br>LEFT : 100° | UP : 90°<br>DOWN : 90°<br>RIGHT : 90°<br>LEFT : 90° | | | | |
| Working Length | 370mm | 330mm | | | | |
| Inner Diameter of<br>Instrument Channel | NA | NA | | | | |
| ON/OFF switch for<br>NBI function | Provided | Not provided | | | | |

#### marison of Snecifications

#### OLYMPUS MEDICAL SYSTEMS CORP.

2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE [phone], TELEFAX [phone]

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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 [phone], TELEFAX [phone]

: 上一篇:

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone] or [phone] 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

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.

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

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