The PSD-60 has been designed to be used with OLYMPUS endoscope (fiberscope, videoscope and rigid scope) compatible with electrosurgical accessories and other ancillary equipment for general, laparoscopic and endoscopic electrosurgery ( cutting, coagulation, including soft tissue coagulation).

The argon plasma coagulation unit has been designed to be used with the electrosurgical unit, OLYMPUS PSD-60 for argon plasma coagulation (APC) of living tissues in treatment using OLYMPUS endoscope compatible with electrosurgery, argon plasma coagulation accessories and other ancillary equipment for endoscopic electrosurgery (coagulation).

Device Description

The PSD-60 is an Electrosurgery unit and is used in conjunction with a OLYMPUS ENDO-PLASMA, or can be used alone. The PSD-60 has a 7-segment LCD (Liquid Crystal Display) that provides the user with an on-screen setting and operational information. The unit has various cutting and coagulation modes with defined effect levels to provide the physician flexibility in applications (i.e. Its ability is to generate the HF current.). The system has automatic start and stop features. When activated, the device has an alarm as well as a visual error system (i.e. malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered.). Upon activation, energy delivered from the PSD-60 to the tissue is displayed in watts on the 7-segment display. Also, the unit can be used in association with an OLYMPUS compatible ENDOPLASMA Argon plasma coagulator. The unit is non-sterile and is reusable.

The OLYMPUS ENDOPLASMA is an Argon plasma coagulation system and is used in conjunction with an OLYMPUS PSD-60. The PSD-60 provides high frequency (HF) voltage to electrically charge Argon gas from the ENDOPLASMA to form plasma in the gas stream when in close proximity to tissue. Current density concentrates at the tissue surface from ENDOPLASMA (probe) causes coagulation. The ENDOPLASMA with the PSD-60 has a 7-segment LCD (Liquid Crystal Display) that provides the user with an on-screen setting operational information. Software in the PSD-60 controls the microprocessor chip in an ENDOPLASMA. The PSD-60/ENDOPLASMA are programmable and have error monitoring features. There is a communications bus cable for the PSD-60 to communicate with an ENDOPLASMA. A pressure reducer with sensor is provided to regulate the Argon gas going into the ENDOPLASMA. The ENDOPLASMA and its accessory are supplied non-sterile and are reusable. Cleaning/ disinfection, and sterilization (as applicable) are provided in the respective user manual. The ENDOPLASMA membrane filter is also a part of the system. The filter is disposable single-use. The filter is connected between the ENDOPLASMA (at the Argon gas port) and connector hose. The filter creates a barrier to protect the ENDOPLASMA from potential contamination. Filters are supplied sterile by means of ethylene oxide and are disposable (single use). They are sterilized by the manufacturer and the sterilization cycle has been validated.

Accessories include: Footswitch, P-cord, APC-cable, APC-probe, Irrigation adapter, Pressure reducer, S-cord.

AI/ML Overview

The provided text is a 510(k) summary for an Electrosurgical Unit, and it explicitly states that clinical data is not necessary for evaluation of safety and efficacy because the device is substantially equivalent to legally marketed predicate devices. This means there isn't a study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or improvement over human readers.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document as such studies were not deemed necessary for this type of submission.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided as clinical performance data or specific acceptance criteria (e.g., sensitivity, specificity) derived from such data are not presented in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, implying that their performance is acceptable, and this new device performs similarly.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or clinical study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided. No clinical ground truth establishment is described or deemed necessary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided. No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was NOT done. This device is an electrosurgical unit, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is hardware (an electrosurgical unit), not an algorithm. Performance is assessed through compliance with voluntary standards and comparison to predicate physical devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical performance. The "ground truth" for this device's safety and effectiveness essentially relies on documented compliance with recognized voluntary standards (e.g., IEC, UL, EN, AAMI/ANSI) and the established safe and effective use of its predicate devices. The document implies that engineering and performance testing (e.g., HF current generation, alarm systems, communication protocols) demonstrating compliance with these standards serves as the "ground truth" for its functional and safety claims.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary of Device Acceptance (based on the provided text):

The Electrosurgical Unit PSD-60, ENDOPLASMA, and Accessories were accepted by the FDA based on a demonstration of substantial equivalence to legally marketed predicate devices and compliance with recognized voluntary standards.

The 510(k) summary explicitly states: "When compared to the predicate devices, PSD-60 and ENDOPLASMA do not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect safety and effectiveness. Therefore, clinical data is not necessary for evaluation of safety and efficacy."

Key points for acceptance:

Substantial Equivalence: The device was compared to predicate devices like ERBE VIO300D, OLYMPUS UES-20, ERBE VIO APC2, and ERBE APC300.
Compliance with Voluntary Standards: The device was designed to comply with a list of IEC, UL, EN, and AAMI/ANSI standards, including:
- IEC 60601-1-1
- IEC 60601-1-4
- UL2601-1
- IEC 60601-1-2 (EMC)
- EN60529
- AAMI/ANSI HF-18
- IEC 60601-2-2
- IEC 60601-2-18
- IEC 60601-1
No significant changes: The manufacturer asserted that there were no significant changes in intended use, method of operation, materials, or design compared to predicate devices that would impact safety and effectiveness.

Summary

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FEB 2 2 2005

Page 1 of 4

November 15, 2004

SMDA 510(k) SUMMARY 042274 Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

A. GENERAL INFORMATION

1. Applicant
  Name & Address:

Shirakawa Olympus corporation 3-1. Aza Ookamiyama Ooaza Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, 961-8061, Japan 3002808148

Registration Number:

1. Initial Importer Name & Address:
  OLYMPUS AMERICA INC. Two Corporate Center Drive, Melville, NY 11747-9058 2429304

Registration Number:

3. Submission Correspondence Name

Address

Telephone Facsimile E-mail address Registration Number
Laura Storms-Tyler Director Regulatory Affair and Quality Assurance OLYMPUS AMERICA INC. Two Corporate Center Drive, Melville, NY 11747-9058 631-844-5688 631-844-5554 Laura Storm-Tyler@olympus.com 2429304

B. DEVICE IDENTIFICATION

1. Common/Usual Name

Electrosurgical Unit, Argon Plasma Coagulation Unit and Accessories

2.Device Name
Electrosurgical Unit PSD-60, ENDOPLASMA, ACCESSORIES

3. Classification Name

	Classification panel	Product code	Class
878.4400	Electrosurgical cutting and coagulationdevice and accessories	GEI	II
876.4300	Endoscopic Electrosurgical Unit andaccessories	KNS	II

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C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CL EQUIVALENCE

510(k)# Manufacturer Class P-Code Model ERBE Elektromedizin II GEI #K023886 ERBE VIO ESU, Model VIO300D GmbH OLYMPUS GEI #K970184 II UES-20 Electrosurgical System and associated Accessories KNS #K030194 OLYMPUS II XUES-41 Endoscopic Electrosurgical unit ERBE Elektromedizin GEI ERBE VIO APC, Model APC-2 #K024047 لل GmbH

The following listed devices are seem to be as predicate devices in consideration of its characteristic and the following table shows regulatory history.

D. DEVICE DESCRIPTION

1. Summary

1. PSD-60 technology
  The PSD-60 is an Electrosurgery unit and is used in conjunction with a OL YMPUS ENDO-PLASMA, or can be used alone. The PSD-60 has a 7-segment LCD (Liquid Crystal Display) that provides the user with an on-screen setting and operational information.

The unit has various cutting and coagulation modes with defined effect levels to provide the physician flexibility in applications (i.e. Its ability is to generate the HF current.). The system has automatic start and stop features. When activated, the device has an alarm as well as a visual error system (i.e. malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered.).

Upon activation, energy delivered from the PSD-60 to the tissue is displayed in watts on the 7-segment display. Also, the unit can be used in association with an OLYMPUS compatible ENDOPLASMA Argon plasma coagulator. The unit is non-sterile and is reusable.

2)ENDOPLASMA technology

The OLYMPUS ENDOPLASMA is an Argon plasma coagulation system and is used in conjunction with an OLYMPUS PSD-60.

The PSD-60 provides high frequency (HF) voltage to electrically charge Argon gas from the ENDOPLASMA to form plasma in the gas stream when in close proximity to tissue. Current density concentrates at the tissue surface from ENDOPLASMA (probe) causes coagulation. The ENDOPLASMA with the PSD-60 has a 7-segment LCD (Liquid Crystal Display) that provides the user with an on-screen setting operational information.

Software in the PSD-60 controls the microprocessor chip in an ENDOPLASMA. The PSD-60/ENDOPLASMA are programmable and have error monitoring features. There is a communications bus cable for the PSD-60 to communicate with an ENDOPLASMA. A pressure reducer with sensor is provided to regulate the Argon gas going into the ENDOPLASMA. The ENDOPLASMA and its accessory are supplied non-sterile and are reusable. Cleaning/ disinfection, and sterilization (as applicable) are provided in the respective user manual .

249

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Page 3 of 4

The ENDOPLASMA membrane filter is also a part of the system. The filter is disposable single-use. The filter is connected between the ENDOPLASMA (at the Argon gas port) and connector hose. The filter creates a barrier to protect the ENDOPLASMA from potential contamination. Filters are supplied sterile by means of ethylene oxide and are disposable (single use). They are sterilized by the manufacturer and the sterilization cycle has been validated

3) Accessories

1) Footswitch

A footswitch is provided to the physician as a means to activate a mode of the PSD-60 by depressing a foot petal. A footswitch has two pedals. One is for cutting, and the other is for coagulating.

2 P-cord

P-cord is provided to connect the single use of patient plate to the PSD-60.

3 APC-cable

APC-cable is provided to transmit HF energy and argon gas to ENDOPLASMA probe.

4 APC-probe
APC-probe is provided to mix HF energy and argon gas to form ENDOPLASMA and provide plasma energy to the surface of tissue.
5 Irrigation adapter
Irrigation adapter is provided to clean the ENDOPLASMA probe.
6 Pressure reducer
Pressure reducer is provided to reduce pressure provided from the gas cylinder.
7 S-cord
S-cord is provided to connect the metal part of Endoscope to the PSD-60.

2. Design

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

· IEC60601-1-1 · IEC 60601-1-4 · UL2601-1
・IEC 60601-1-2 (EMC) ・EN60529 · AAMI/ANSI HF-18 · IEC 60601-2-2
· IEC 60601-2-18

· IEC 60601-1

3. Materials

There aren't any patient contacting materials in PSD-60 and ENDOPLASMA. Some ancillary equipment have patient contact materials, however, there are no new patient contacting materials in those devices.

4. Intended Use of the device

The PSD-60 has been designed to be used with OLYMPUS endoscope (fiberscope, video scope and rigid scope) compatible with electrosurgical accessories and other ancillary equipment for general, laparoscopic and endoscopic electrosurgery ( cutting, coagulation, including soft tissue coagulation).

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Page 4 of 4

E. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS

Theory of the operation of OLYMPUS PSD-60 and ENDOPLASMA are that the electrical energy generation in PSD-60 is supplied to human fissue via endoscopic therapy devices in order to cut and coagulate the human tissue. The system can cut and coagulate the human tissue by high frequency energy. This system is equivalent to the predicate devices, ERBE VIO300D (K023886), OLYMPUS UES-20 (K970184), ERBE VIO APC2 (K024047) and ERBE APC300 (K963189).

F. CONCLUSION

When compared to the predicate devices, PSD-60and ENDOPLASMA do not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect safety and effectiveness. Therefore, clinical data is not necessary for evaluation of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 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 human figure with three arms or lines extending from the body.

FEB 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Shirakawa Company, Ltd. c/o Mr. Daniel W. Lehtonen Intertek Testing Service 70 Codman Hill Road Boxborough, Massachusetts 01779

Rc: K042274

Trade/Device Name: Electrosurgical Unit PSD-60, ENDOPLASMA, Accessorics Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 4, 2005 Received: February 7, 2005

Dear Mr. Lehtonen:

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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Daniel W. Lehtonen

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C Provost

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

Enclosure

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Indications for Use

510(k) Number (if known): Device Name:

K042274 K042214
Electrosurgical Unit PSD-60, ENDOPLASMA, Accessories

Indications for Use:

The PSD-60 has been designed to be used with OLYMPUS endoscope (fiberscope, The PSD-80 has been designed to be assures and other casin also creation in culti videoscope and ligid scope) companible with Shoulded groupeny ( cutting, coagulation, including soft tissue coagulation).

The argon plasma coagulation unit has been designed to be used with the electrosurgical The argon plasma coagulation until has been doulghou (APC) of living tissues in treatment)
unit, OLYMPUS PSD-60 for argon plasma coagulation (APC) of living tissues angelophi unit, OLYMPUS PSD-0010r argon plasma obagalation (include mannus coagulation) using OLYMPUS endoscope companible than areas.sepic electrosurgery (coagulation).

Over-The-Counter-Use AND/OR × Prescription Use (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_Ho4 2274

1 of Page

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.