This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating). Recommended endoscopes for this instrument are Olympus's series CYF series, and Olympus's electrosurgical instruments such as electrosurgical snare, hot biopsy forceps. Other Olympus electrosurgical devices or instruments can be used with this subject device. Be sure to check compatibility for each device in each instruction manual. The PSD-20 unit offers Monopolar, output modes; 5 Cut modes (PURE, BLEND 1/2/3/4), 1 Coagulation mode, (NORMAL COAGULATION), It offers several features to ensure the safe operation of the unit. For example, the voltage output level setting and a monitor circuit detect irreqularity or improper connections.

AI/ML Overview

This document is a 510(k) summary for the Olympus PSD-20 Electrosurgical System. It outlines the safety and effectiveness of the device by comparing it to predicate devices. However, it does not include information about acceptance criteria or a study designed to prove the device meets specific performance metrics.

Specifically, the provided text does not contain the following information:

A table of acceptance criteria and reported device performance.
Sample size used for a test set, data provenance, or number of experts for ground truth.
Adjudication method, MRMC comparative effectiveness study results, or standalone algorithm performance.
The type of ground truth used, sample size for a training set, or how training set ground truth was established.

Instead, the document focuses on:

Device Identification: Sponsor, contact, common name, device name, classification.
Predicate Devices: Lists two Olympus electrosurgical units (K970797 and K970184) as substantially equivalent.
Device Description:
- Summary: Describes its use with Olympus accessories, endoscopes (CYF series), and electrosurgical instruments (snare, hot biopsy forceps) for flexible cystoscopic treatment (cutting and coagulating). Mentions Monopolar output, 5 Cut modes, 1 Coagulation mode, and safety features.
- Design: States compliance with voluntary standards IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2 (EMC).
- Materials: Notes no patient-contacting materials in the PSD-20 itself, and ancillary equipment with patient-contacting materials have no new materials.
- Technology: Describes it as providing electrical power to accessories via high-frequency electrical current for endoscopic urological treatment, with no special technology.
Indication for Use: Flexible cystoscopic treatment (cutting and coagulating) including hemostasis of superficial bleeding, treatment of bladder tumors, and treatment of stenosis inside the urinary tract.
FDA Clearance Letter: Confirms substantial equivalence to predicate devices and clearance to market.

In summary, this document is a regulatory submission for device clearance based on substantial equivalence, not a performance study proving specific acceptance criteria related to an AI or diagnostic algorithm.

Summary

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K023280

510(k) Summary of Safety and Effectiveness SMDA

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807 subpart E, Section 807.92.

A. Sponsor /Manufacturer Name and Address

1. Applicant Olympus Optical Co., Ltd. 2-3-1 Shinjuku Monolis Nishi-shinjuku Shinjuku-ku, Tokyo, Japan, 163-0914 Establishment registration number : 8010047
Initial Importer 2. Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 Establishment registration number : 2429304
1. Contact Person Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157
Tel 631-844-5688 Fax 631-844-5416

B. Device Name. Common Name

1. Common/Usual Name
  Electrosurgical Unit and its ancillary equipment.
1. Device Name
  Olympus PSD-20 Electrosurgical System and its associated accessories
1. Classification
  21 CFR 876.4300 Endoscopic electrosurgical unit and accessories, Class II

C. Identification of the predicate or legally marketed device

The following devices are substantially equivalent device in consideration to its characteristics or specification.

Model Name	510(k)	Applicant
Olympus PSD-20 ElectrosurgicalUnit and its associated accessories(For GI application )	K970797	Olympus Optical Co., Ltd.
Olympus UES-20 Electrosurgical Unitsand its associated accessories(For urology application)	K970184	Olympus Optical Co., Ltd.

D. Device Description

DEC 1 9 2002

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K023280

1. Summary

This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for flexible cystoscopic treatment (cutting and coagulating)
Recommended endoscopes for this instrument are Olympus's series CYF series, and Olympus's electrosurgical instruments such as electrosurgical snare, hot biopsy forceps. Other Olympus electrosurgical devices or instruments can be used with this subject device. Be sure to check compatibility for each device in each instruction manual. The PSD-20 unit offers Monopolar, output modes; 5 Cut modes (PURE, BLEND 1/2/3/4), 1 Coagulation mode, (NORMAL COAGULATION), It offers several features to ensure the safe operation of the unit. For example, the voltage output level setting and a monitor circuit detect irreqularity or improper connections.

2. Design

This device has been designed to be complying with the following voluntary standards.

· IEC 60601-1
· IEC 60601-2-2
· IEC 60601-2-18
· IEC 60601-1-2 (EMC)

3. Materials

There aren't any patient contacting material in PSD-20 itself. Some ancillary equipment have patient contact materials, however there are no new patient contacting material in those devices.

4. Technology

This device does not have any special technology or characteristic i.e. this device is intended to provide electrical power to accessories (such as biopsy) via the use of high frequency electrical current waveform passing into the tissue during endoscopic urological treatment.

E. Indication for Use

Hemostasis of superficial bleeding
Treatment of bladder tumors
Treatment of stenosis inside urinary tract.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract figures or lines representing health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Optical Company, LTD. Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157

Re: K023280

Trade/Device Name: Olympus PSD-20 Electrosurgical System Regulation Number: 878.4400 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: GEI Dated: September 30, 2002 Received: October 1. 2002

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 (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.

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

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Page 2 - Ms. Laura Storms-Tyler

.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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C Provost

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

Enclosure

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KO232 510(k) Number(if known): Device Name: Olympus PSD-20 Electrosurgical System and its associated accesso

Indications for Use:

Hemostasis of superficial bleeding
Treatment of bladder tumors
Treatment of stenosis inside urinary tract.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Miriam C. Provost

vision of Ger. : Restorative

Neurology: : ces.

K 623280

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.