ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES

K062517 · Olympus Medical Systems Corporation · KGE · Dec 22, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062517
• Device Name: ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
• Applicant: Olympus Medical Systems Corporation
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FD-1L/U-1 Hot Biopsy Forceps: This instrument has been designed to be used with Olympus endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract. FD-410LR Single Use Electrosurgical Hemostatic Forceps: This instrument has been designed to be used with Olympus endoscopes to cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

Device Story

Electrosurgical Hemostatic Forceps Series (FD-1L/U-1 and FD-410LR) are endoscopic accessories used with high-frequency electrosurgical units. The devices deliver high-frequency current to tissue within the digestive tract to perform cauterization, coagulation, and hemostasis; the FD-1L/U-1 also enables tissue collection. Operated by physicians during endoscopic procedures, the forceps provide a mechanical and electrical interface for targeted tissue treatment. The output is the application of thermal energy to achieve hemostasis or tissue removal. Benefits include minimally invasive management of bleeding or tissue sampling during endoscopy.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

Endoscopic electrosurgical forceps. Components include forceps/cup mechanism for tissue contact and high-frequency current delivery. Designed for use with Olympus endoscopes. Single-use (FD-410LR).

Indications for Use

Indicated for patients requiring tissue collection, cauterization, coagulation, or hemostasis within the digestive tract via endoscopic procedure. Used with Olympus endoscopes.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• FD-1L/U-1 Hot Biopsy Forceps (K955052)
• LSVP International Hot Biopsy Forceps (K971204)

Submission Summary (Full Text)

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DEL 9 2 2006

Ko62517

Fig. 1 of 2

August 9, 2006

# 510(k) SUMMARY

.

# Electrosurgical Hemostatic Forceps Series

### 1_ General Information

| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-850<br>Establishment Registration No: 8010047 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Laura Storms-Tyler<br>Executive Director<br>Regulatory Affairs & Quality Assurance<br>Olympus America Inc.<br>3500 Corporate Parkway<br>PO Box 610<br>Center Valley, PA 18034-0610, USA<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail]<br>Establishment Registration No: 2429304 |
| Manufacturer: | Aomori Olympus<br>248-1 Okkonoki 2-chome Kuroishi-shi,<br>Aomori, Japan, 036-0367<br>Establishment Registration Number: 9614641 |
| <b>2 Device Identification</b> | |
| Device Trade Name: | Electrosurgical Hemostatic Forceps Series |
| Common Name: | Electrosurgical Hemostatic Forceps |
| Regulation Number: | 21 CFR 876.4300/876.1500 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories<br>Endoscope and accessories |
| Regulatory Class: | II |
| Classification Panel: | Gastroenterology and urology<br>General and Plastic Surgery Devices |
| Product Code: | 78 KGE |

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Kcb2517

Pg 2 of 2

#### Predicate Device Information 3

| Device Name | Common Name | 510(k) No. | Manufacturer |
|------------------------------------------|-----------------------|------------|-------------------------------|
| FD-1L/U-1 Hot Biopsy<br>Forceps | Hot Biopsy<br>Forceps | K955052 | Olympus Medical Systems Corp. |
| LSVP International<br>Hot Biopsy Forceps | Hot Biopsy<br>Forceps | K971204 | LSVP International, Inc. |

## 4 Device Description

The FD-1L/U-1 has been 510(k) cleared in K955052 for collecting tissue in the digestive tract. The subject FD-1L/U-1 has identical specification as the predicate cleared in K955052. This 510(k) submission is for the purpose of adding coagulation and hemostasis to the intended use. The FD-410LR is intended to be used for coagulation and hemostasis only. Although its cup shape is different from that of the FD-1L/U-1, coagulation and hemostasis abilities are the same.

## 5 Indications for Use

### FD-1L/U-1 Hot Biopsy Forceps

This instrument has been designed to be used with Olympus endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

### FD-410LR Single Use Electrosurgical Hemostatic Forceps

This instrument has been designed to be used with Olympus endoscopes to cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

### Comparison of Technological Characteristics 6

The FD-1L/U-1 and FD-410LR are basically identical to the predicate device in intended use, and similar in specifications except for addition of coagulation and hemostasis indications.

## 7 Conclusion

When compared to the predicate device, the FD-1L/U-1 and FD-410LR do not incorporate any significant changes that could affect the safety or effectiveness of the device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olumpus America Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

DEC 2 2 2006

Re: K062517

Trade/Device Name: Electrosurgical Hemostatic Forceps Series Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KGE Dated: November 28, 2006 Received: December 1, 2006

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 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.

Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The central element is the FDA acronym in a stylized font, with the word "Centennial" written below it in cursive. Three stars are arranged beneath the word "Centennial". The logo is surrounded by a circular border with text, though the text is difficult to read due to the image quality.

Protecting and Promoting Public Health

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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.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). 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/cdrl/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): // (122517

Device Name: Electrosurgical Hemostatic Forceps Series Indications For Use:

### FD-1L/U-1 Hot Biopsy Forceps

This instrument has been designed to be used with Olympus endoscopes to collect tissue, coagulate and perform hemostasis using high-frequency current within the digestive cauterize, tract.

# FD-410LR Single Use Electrosurgical Hemostatic Forceps

This instrument has been designed to be used with Olympus endoscopes to cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

Prescription Use V (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)

David A. Syzm

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

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