LAPARO-THORACO VIDEOSCOPE XLTF-VAW

K053382 · Olympus Medical Systems Corporation · GCJ · May 26, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053382
• Device Name: LAPARO-THORACO VIDEOSCOPE XLTF-VAW
• Applicant: Olympus Medical Systems Corporation
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

Device Story

The LAPARO-THORACO VIDEOSCOPE XLTF-VAW is a rigid endoscope used for visualization during thoracic and abdominal endoscopic surgeries. It captures optical images of internal cavities and transmits them to a video system center (VISERA OTV-S7V) for display on a monitor. The device features an integrated inner channel for irrigation, differing from the predicate LTF-V which used a sheath-based irrigation method. Operated by physicians in clinical settings, the device allows for real-time visualization of internal anatomy, facilitating diagnostic and therapeutic procedures. The output enables the surgeon to navigate and perform surgical interventions, potentially reducing invasiveness compared to open surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid endoscope with 0° forward viewing. Features an inner irrigation channel. Specifications: 90° field of view, 15-100 mm depth of field, 10.5 mm distal end diameter, 330 mm working length. Angulation: 100°/100°/60°/60°. Connects to VISERA Video System Center OTV-S7V. No software algorithm or electronic processing described.

Indications for Use

Indicated for use in endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs, when used with compatible VISERA video systems and ancillary equipment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LTF-V LAPARO THORACO VIDEOSCOPE (K955403)
• A4907 LENS CLEANING SHEATH (K955403)
• GIF-Q160Z EVIS EXERA GASTROINTESTINAL VIDEOSCOPE (K011151)

Submission Summary (Full Text)

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MAY 26 2006

October xx, 2005

# 510(k) SUMMARY

# LAPARO-THORACO VIDEOSCOPE XLTF-VAW

#### General Information 1.

- Applicant: 트
- Official Correspondent: ■

Manufacturer 199

Olympus Medical Systems Corp. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047

Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA Phone: [phone] FAX: [phone] Email:[e-mail] Establishment Registration No: 2429304

Olympus Medical Systems Corp. 34-3 Hirai Hinode-machi, Nishitama-gun, Tokyo, 190-0812, Japan Establishment Registration Number: 3003637092

#### 2. Device Identification

- LAPARO-THORACO VIDEOSCOPE XLTF-VAW I Device Name LAPARO-THORACOVIDEOSCOPE E Common Name 21 CFR 876.1500/884.1720 Regulation Number 1월 Endoscope and accessories Regulation Name 트 Gynecologic laparoscope and accessories II 1 Regulatory Class GCJ/HET ■ Product Code Classification Panel Laparoscope, general & plastic surgery 트
Laparoscope, gynecologic (and accessories)

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#### Predicate Device Information 3.

- (1) Device Name: Common Name: 510(k) No. Manufacturer:
- (2) Device Name: Common Name: 510(k) No. Manufacturer:

(3) Device Name:

Common Name: 510(k) No. Manufacturer:

LTF-V LAPARO THORACO VIDEOSCOPE LAPARO THORACO VIDEOSCOPE K955403 Olympus Optical Co., Ltd.

A4907 LENS CLEANING SHEATH LENS CLEANING SHEATH K955403 Olymous Optical Co., Ltd.

GIF-Q160Z EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE K011151 Olympus Optical Co., Ltd.

#### Device Description 4.

The subject device, LAPARO-THORACO VIDEOSCOPE XLTF-VAW is designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

The subject device has a different lens cleaning method from the predicate Olympus LAPARO THORACO VIDEOSCOPE LTF-V. For the predicate device, air and water for lens cleaning are supplied through the sbace between the endoscope's insertion and a sheath attached to it. The subject device also uses a sheath but irrigation are performed through the inner channels of the videoscope. The basic structure of the inner channel is substantially equivalent to that of the predicate device, GIF-Q160Z.

### 5. Indications for Use

This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

### 6. Comparison of Technological Characteristics

The XLTF-VAW is basically identical to the predicate device in intended use, and similar in specifications except for the addition of endoscope inner channel. Comparison between the subject and predicate devices is shown in Table 1.

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K053382 p 3/3

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| Specifications | Subject Device<br>XLTF-VAW | Predicate Device<br>LTF-V | Predicate Device<br>GIF-Q160Z |
|---------------------------------------|----------------------------|---------------------------|----------------------------------|
| Field of View | 90° | 70° | 140° (WIDE)<br>75° (TELE) |
| Depth of Field | 15~100 mm | 18~100 mm | 8~100 mm(WIDE)<br>1.5~3 mm(TELE) |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing | 0° Forward Viewing |
| Outer Diameter of<br>Distal End | \$ $\phi$ 10.5 mm | \$ $\phi$ 11.0 mm | \$ $\phi$ 10.8 mm |
| Bending Section<br>Angulation UP/DOWN | 100° /100° /60° /60° | 90° /90° /90° /90° | 210° /90° /100° /100° |
| Working Length | 330 mm | 330 mm | 1,030 mm |
| Endoscope inner<br>channel | Provided | Not provided | Provided |

### 7. Conclusion

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When compared to the predicate device, the XLTF-VAW 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.

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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 consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 26 2006

Olympus Medical Systems Corporation c/o Ms. Laura Storms-Tyler Executive Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-9058

Re: K053382

Trade/Device Name: Laparo-Thoraco Videoscope, Model XLTF-VAW Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Product Code: HET Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: GCJ Regulatory Class: II Dated: May 5, 2006 Received: May 9, 2006

### Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nove and have and have determined the device is substantially equivalent (for the indications for reservated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass suited in also environment date of the Medical Device Amendments, or to devices that provision in the Just 1770, and cordance 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 (Premarket A powal), 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.

Image /page/3/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The logo is circular in shape and contains the letters FDA in bold. The text is written in a decorative font.

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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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon 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

510(k) Number (if known):

K05382

Device Name: LAPARO-THORACO VIDEOSCOPE XLTF-VAW

Indications For Use:

This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

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)

Daniel A. Ingram

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Dev

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510(k) Number