OLYMPUS CD-6C-1 COAGULATION ELECTRODE

K971328 · Olympus America, Inc. · FFE · Jul 1, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971328
• Device Name: OLYMPUS CD-6C-1 COAGULATION ELECTRODE
• Applicant: Olympus America, Inc.
• Product Code: FFE · Gastroenterology, Urology
• Decision Date: Jul 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.

Device Story

The Olympus CD-6C-1 is a coagulation electrode designed for use with Olympus BF-240 bronchovideoscopes. It functions as an electrosurgical accessory to perform cauterization or achieve hemostasis within the upper airways and tracheobronchial tree. The device is operated by a physician during endoscopic procedures. It delivers electrosurgical energy to the target tissue to manage bleeding or perform cautery. The device is a mechanical accessory and does not involve software or automated algorithms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical coagulation electrode designed for endoscopic use. Mechanical device; no software, electronics, or energy source integral to the electrode itself (requires external electrosurgical generator).

Indications for Use

Indicated for electrosurgical cauterization or hemostasis in the upper airways and tracheobronchial tree when used with Olympus BF-240 Bronchovideoscopes.

Regulatory Classification

Identification

A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Olympus CD-1L/U Coagulation Electrode (Preamendment)
• Olympus KD Series Sphinctertomes (K955247)

Submission Summary (Full Text)

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971328

JUL - 1 1997

## 510 (k) SUMMARY OLYMPUS CD-6C-1 ELECTROSURGICAL SYSTEM

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.

| Device Name: | Olympus CD-6C-1 Coagulation Electrode. |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Coagulation Electrodes |
| Classification Name: | 21 CFR 876.4300, Class II<br>Endoscopic Coagulation Electrode and Accessories. |
| Predicate Devices: | Olympus CD-1L/U Coagulation Electrode (Preamendment)<br>Olympus KD Series Sphinctertomes (K955247) |
| Prepared & Submitted By:<br>(Contact Person) | Mr. Subhash Patel<br>Olympus America Inc.<br>Endoscope Division<br>Two Corporate Center Drive<br>Melville, New York 11747-3157<br>[phone] |
| Summary Preparation<br>Date: | 04/07/97 |

## Statement of Intended Use:

ﻤﺴﻠﺴﺔ

Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Subhash R. Patel Regulatory Affairs Associate Endoscope Division ………………… Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157

JUL == 1 1997

Re: K971328

> Trade Name: Olympus CD-6C-1 Coagulation Electrode Regulatory Class: II Product Code: FFE Dated: April 7, 1997 Received: April 10, 1997

Dear Mr. Patel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Subhash R. Patel

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number (if known): | Not assigned yet | K971328 |
|---------------------------|------------------|---------|
|---------------------------|------------------|---------|

Device Name:

Olympus CD-6C-1 Coagulation Electrode.

Indications for Use:

Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21CFR 801.109) ✓ OR Over-the Counter Use
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