(183 days)
Not Found
No
The description focuses on standard electrosurgical and argon plasma coagulation technology, mentioning features like LCD displays, various modes, automatic start/stop, and error monitoring. There is no mention of AI, ML, or any capabilities that would suggest learning or adaptive algorithms based on data.
Yes
The device performs electrosurgery, including cutting and coagulation of living tissues, which are therapeutic interventions. The argon plasma coagulation unit specifically performs argon plasma coagulation (APC) for treatment.
No
The device is described as an electrosurgery unit and an argon plasma coagulation unit, used for cutting and coagulation of living tissues, which falls under therapeutic/interventional procedures, not diagnostic ones.
No
The device description clearly outlines hardware components such as an Electrosurgery unit (PSD-60), an Argon plasma coagulation system (ENDOPLASMA), LCD displays, communication cables, a pressure reducer, and various accessories (footswitch, cords, probes, filters). While software is mentioned as controlling the microprocessor chip in the ENDOPLASMA, the device is fundamentally a hardware system with integrated software, not a software-only medical device.
Based on the provided information, the PSD-60 device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the PSD-60 is used for electrosurgery (cutting, coagulation) and argon plasma coagulation (APC) of living tissues within the body during general, laparoscopic, and endoscopic procedures.
- Device Description: The description details how the device generates high-frequency current and/or plasma to interact directly with tissue for therapeutic purposes.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or conditions. The PSD-60's function is to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
GEI, KNS
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:
- 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.
- P-cord: P-cord is provided to connect the single use of patient plate to the PSD-60.
- APC-cable: APC-cable is provided to transmit HF energy and argon gas to ENDOPLASMA probe.
- 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.
- Irrigation adapter: Irrigation adapter is provided to clean the ENDOPLASMA probe.
- Pressure reducer: Pressure reducer is provided to reduce pressure provided from the gas cylinder.
- S-cord: S-cord is provided to connect the metal part of Endoscope to the PSD-60.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found (implied medical setting for surgical procedures)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
#K023886, #K970184, #K024047, K963189
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
-
- Applicant
Name & Address:
- Applicant
Shirakawa Olympus corporation 3-1. Aza Ookamiyama Ooaza Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, 961-8061, Japan 3002808148
Registration Number:
-
- Initial Importer Name & Address:
OLYMPUS AMERICA INC. Two Corporate Center Drive, Melville, NY 11747-9058 2429304
- Initial Importer Name & Address:
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 coagulation | ||
| device and accessories | GEI | II | |
| 876.4300 | Endoscopic Electrosurgical Unit and | ||
| accessories | KNS | II |
xf
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Page 2 of (4)
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
-
- 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.
- PSD-60 technology
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 .
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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).
3
Page 4 of 4
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).
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.
4
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.
5
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
6
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
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