SMALL INTESTINAL VIDEOSCOPE SYSTEM

K051551 · Olympus Medical Systems Corporation · KNT · Jun 28, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051551
• Device Name: SMALL INTESTINAL VIDEOSCOPE SYSTEM
• Applicant: Olympus Medical Systems Corporation
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jun 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This system is a makes of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.

Device Story

Small Intestinal Videoscope System facilitates visualization and surgical access within the digestive tract; utilizes sequential inflation of two balloons to anchor and advance endoscope deep into small intestine; system includes videoscope, light source, video center, balloon controller, splinting tube, and ancillary accessories (biopsy forceps, electrosurgical units); operated by physicians in clinical settings; provides real-time video output to monitor for diagnostic or therapeutic guidance; enables minimally invasive procedures; patient benefits include access to previously difficult-to-reach areas of the small bowel.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes videoscope, balloon controller, and splinting tube. Features 140° field of view, 3-100 mm depth of field, 0° forward viewing. Insertion tube/distal end diameter 9.2 mm. Balloon controller operates at 5.4 kPa ± 2.6 kPa. Connectivity via standard Olympus video system center. Materials identical to predicate Olympus devices.

Indications for Use

Indicated for patients requiring endoscopy or endoscopic surgery within the upper and lower digestive tract, including the esophagus, stomach, duodenum, small intestine, and colon, via oral or anal insertion.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• PCF-160AL/I (K001241)
• XSIF-1TQ140A Small Intestinal Videoscope (K031256)
• Fujinon Double Balloon Enteroscopy System (K040048)

Reference Devices

• EN-450P5/20 (K040048)
• TS-12140
• PB-10

Submission Summary (Full Text)

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K051551

# JUN 2 8 2005

2005.6.8

## SMDA 510(k) SUMMARY SMALL INTESTINAL VIDEOSCOPE SYSTEM

This summary of 510(k) safety and effectiveness information is being submitted in accordance with This summary of 5 ro(K) Safety and 21CFR, Part 807, Subpart E, Section 807.92.

## 1. GENERAL INFORMATION

| Applicant | Aizu Olympus Co., Ltd<br>500 Aza Muranishi Ooaza<br>Niidera, Monden-machi<br>Aizuwakamatsu-shi, Fukushima, JAPAN 965-8520<br>Establishment Registration No.: 9610595 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent | Akiko Fukagawa<br>Olympus Medical Systems Corp.<br>2951 Ishikawa-cho,<br>Hachioji-shi, Tokyo, 192-8507, Japan<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br>Establishment Registration No.: 8010047 |
| Official Correspondent | Laura Storms-Tyler<br>Director, Regulatory Affairs and Quality Assurance<br>Olympus America Inc.<br>Two Corporate Center Drive, Melville,<br>NY 11747-9058<br>Phone: [phone]<br>Fax: [phone]<br>Establishment Registration No.: 2429304 |

### 2. Device Identification

| Trade Name: | SMALL INTESTINAL VIDEOSCOPE SYSTEM |
|--------------------|-----------------------------------------------------------------|
| Common Name: | Small Intestinal Videoscope |
| Regulation Number: | 21CFR 876.1500/876.5980 |
| Regulation Name: | Endoscope and accessories/Gastrointestinal tube and accessories |
| Class: | II |
| Product Code: | 78 FDA/KNT |

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#### 3. Predicate Device

The following listed devices are considered as predicate devices in consideration of their characteristics, and the following table shows their regulatory histories.

| Model | 510(k) # | Manufacturer | Class | Product Code |
|----------------------------------------------|----------|-------------------------------------|-------|--------------|
| PCF-160AL/I | K001241 | Olympus Optical Co., LTD | II | 78 FDF |
| XSIF-1TQ140A<br>Small Intestinal Videoscope | K031256 | Olympus Opt-electronics Co.,<br>LTD | II | 78 FDA / KOG |
| Fujinon Double Balloon<br>Enteroscopy System | K040048 | Fujinon, Inc. | II | 78 FDA / KNT |

#### 4. Device Description

The subject device, Small I surgery within the small intrisune.

The subject device utilizes senuential geolovment of two bailouns, one attached to an gastrointestinal . ment of the endoscope

well within the small intestine. The suppor over can access inrough the small intestine via either oral or anal introduction.

#### 5. Intended Use of the device

SMALL INTESTW !
This system is a makes of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.

#### 6. Comparison of Technological Characteristics

Below is the comparison table between the subject devices and predicate device.

#### COMPARISON OF SPECIFICATIONS (With K001241 and K031256) MODEL: XSIF-160DB(Subject Device) vs. XSIF-1TQ140A and PCF-160ALI(Predicate Devices)

| Specifications | XSIF-160DB<br>(Subject Device) | XSIF-1TQ140A<br>(Predicate Device) | PCF-160AL/I<br>(Predicate Device) |
|-----------------------------------------|--------------------------------|------------------------------------|-----------------------------------|
| Field of View | 140° | 140° | 140° |
| Depth of Field | 3~100 mm | 3~100 mm | 3~100 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing | 0° Forward Viewing |
| Outer Diameter of<br>Distal End | φ 9.2 mm | φ 10.9 mm | φ 11.3 mm |
| Outer Diameter of<br>Insertion Tube | φ 9.2 mm | φ 11.3 mm | φ 11.5 mm |
| Working Length | 2000 mm | 2350mm | 1680mm (L)<br>1330mm (I) |
| Inner Diameter of<br>Instrument Channel | φ 2.8 mm | φ 3.7mm | φ 3.2 mm |

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#### COMPARISON OF SPECIFICATIONS(With K040048) MODEL: XSIF-160DB(Subject Device) vs. EN-450P5/20(Predicate Device)

| Specifications | XSIF-160DB<br>(Subject Device) | EN-450P5/20<br>(Predicate Device) |
|--------------------------------------|--------------------------------|-----------------------------------|
| Field of View | 140° | 120° |
| Depth of Field | 3~100 mm | 5~100 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing |
| Outer Diameter of Distal End | φ 9.2 mm | φ 8.5 mm |
| Outer Diameter of Insertion Tube | φ 9.2 mm | φ 8.5 mm |
| Inner Diameter of Instrument Channel | φ 2.8 mm | φ 2.2 mm |

## MODEL: XST-BY(Subject Device) vs. TS-12140(Predicate Device)

| Specifications | XST-BY<br>(Subject Device) | TS-12140<br>(Predicate Device) |
|----------------|----------------------------|--------------------------------|
| Outer Diameter | φ 14.8 mm | φ 12.2 mm |
| Inner Diameter | φ 11mm | φ 10 mm |
| Working Length | 1320 mm | 1350 mm |
| Total Length | 1400 mm | 1450 mm |

## MODEL: MAJ-1440(Subject Device) vs. PB-10(Predicate Device)

| Specifications | MAJ-1440<br>(Subject Device) | PB-10<br>(Predicate Device) |
|-------------------------|------------------------------|-----------------------------|
| Set Pressure of Balloon | 5.4 kpa + - 2.6 kpa | 5.6 kpa + - 2 kpa |
| Power Supply | 120V/230V | 120V/230V |
| Dimensions | 370(W)×242(H)×473.5(D) | 300(W)×200(H)×300(D) |
| Weight | 19.5 kg | 8.7 kg |

#### 7. Materials

All the patient contact materials used in the SMALL INTESTINAL VIDEOSCOPE SYSTEM are identical to those used in the legally marketed Olympus devices.

## 8. Summary including conclusion drawn from non-clinical tests

When compared to the predicate devices, SMALL INTESTINAL VIDEOSCOPE SYSTEM do not the safety and offectiveness, In intended use, method of operation, material, or design that could affect the safety and effectiveness. In addition, the provided of operation, or design that could and efficacy of the subject system.

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JUN 2 8 2005

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Food and Drug Administration 9200 Corporate Boulevard Rockville -MD 20850

Olympus Medical Systems Corporation c/o Neil E. Devine. Jr. Intertek Testing Services NA. Inc. 3033 Madison Avenue, SE GRAND RAPIDS MI 49548

Re: K051551

Trade/Device Name: Small Intestine Videoscope System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: FDA Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Product Code: KNT Regulatory Class: II Dated: June 10, 2005 Received: June 13, 2005

#### Dear Mr. Devine:

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 (Premarket Approval), 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,

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 nanufacturing 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.

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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 prodicated 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

A051551 510(k) Number(if known):

Device Name: SMALL INTESTINAL VIDEOSCOPE SYSTEM

Indications for Use:

## SMALL INTESTINAL VIDEOSCOPE SYSTEM

This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.

Daniel G. Severson

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

Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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OR

Concurrence of CDRH, Office of Device Evaluation (ODE)