(85 days)
The Olympus PSD-20 has been intended to cut and coagulate tissues within the gastrointestinal (GI) tract. The PSD-20 is designed to be used in conjunction with the electrosurgical accessories and the designated Olympus endoscopes that are applicable for electrosurgery.
The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.
The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes and videoscopes) applicable for electrosurgery, light sources and ancillary equipment.
This document describes the Olympus PSD-20 Electrosurgical System, a medical device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in the provided text.
Based on the provided information, I can offer the following:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The 510(k) summary for the Olympus PSD-20 Electrosurgical System focuses on demonstrating substantial equivalence to a predicate device (Olympus PSD-10 Electrosurgical Unit K911904) rather than presenting specific acceptance criteria and performance data for the new device. The document indicates that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document does not describe a test set or data provenance for a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not available in the provided text. The document does not mention the establishment of ground truth by experts for a test set.
4. Adjudication Method for the Test Set
Not available in the provided text. No adjudication method is described as there is no mention of a test set requiring such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an electrosurgical system, not an imaging or diagnostic device that would typically involve human readers for interpretation. Therefore, an MRMC study with AI assistance is not relevant to this type of device.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
Not applicable. This device is an electrosurgical system, not an algorithmic diagnostic tool. It requires a trained physician for its operation, so a "standalone" algorithmic performance study without human involvement is not relevant.
7. Type of Ground Truth Used
Not available in the provided text. There is no mention of a performance study that would establish ground truth for the device's function in terms of diagnosing or interpreting medical conditions. The device performs cutting and coagulation.
8. Sample Size for the Training Set
Not applicable. The document describes a medical device, not an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, the establishment of its ground truth is not relevant.
Summary of Device and its Equivalence Basis:
The Olympus PSD-20 Electrosurgical System is intended for general and endoscopic electrosurgery (cutting and coagulation) in the gastrointestinal (GI) tract. The 510(k) submission successfully demonstrated that this device is substantially equivalent to the predicate device, Olympus PSD-10 Electrosurgical Unit (K911904). This substantial equivalence determination means that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. The focus of the 510(k) process is typically on comparing the new device's technological characteristics, indications for use, and performance data to those of the predicate device, rather than conducting new, extensive clinical trials with specific acceptance criteria as would be expected for novel, high-risk devices.
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MAY 28 1997 K970797
510 (k) SUMMARY OLYMPUS PSD-20 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 PSD-20 Electrosurgical System and itsassociated accessories. |
|---|---|
| Common/Usual Name: | Electrosurgical Units |
| Classification Name: | 21 CFR 878.440, Class IIElectrosurgical Cutting and Coagulation Device andAccessories. |
| 21 CFR 876.4300, Class IIEndoscopic Electrosurgical Unit and Accessories. | |
| Predicate Devices: | Olympus PSD-10 Electrosurgical Unit (K911904) |
| Prepared & Submitted By:(Contact Person) | Mr. Subhash PatelOlympus America Inc.Endoscope DivisionTwo Corporate Center DriveMelville, New York 11747-3157(516) 844-5481 |
| Summary PreparationDate: | 02/24/97 |
Statement of Intended Use:
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PSD-20 Electrosurgical Unit
The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes and videoscopes) applicable for electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.
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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1997
Mr. Subhash R. Patel Regulatory Affairs Associate Endoscope Division Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157
Re: K970797
Trade Name: Olympus PSD-20 Electrosurgical System and its associated accessories Regulatory Class: II Product Code: GEI Dated: February 27, 1997 Received: March 4, 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 your device can be found in the Code of Federal Regulations, Title 21, Paris 800 to 895. A substantially coulvalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Subhash R. Patel
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 your 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 (301) 594-4595. 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" (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 (800) 638-2041 or (301) 443-6597 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 (Revised: May 16, 1997)
510(k) Number (if known):
Device Name:
Olympus PSD-20 Electrosurgical System and its associated accessories.
Indications for Use:
The Olympus PSD-20 has been intended to cut and coagulate tissues within the gastrointestinal (GI) tract. The PSD-20 is designed to be used in conjunction with the electrosurgical accessories and the designated Olympus endoscopes that are applicable for electrosurgery.
The Olympus PSD-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(per 21CFR 801.109) | OR | Over-the Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ----------------------------------------- | ---- | -------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Dental Restorative Devices | |
| 510(k) Number | K970797 |
§ 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.