(79 days)
Not Found
No
The description focuses on electrosurgical modes and safety features, with no mention of AI or ML.
Yes
The device is described for "flexible cystoscopic treatment (cutting and coagulating)" for conditions like "Hemostasis of superficial bleeding," "Treatment of bladder tumors," and "Treatment of stenosis inside urinary tract," which are therapeutic interventions.
No
The provided text describes an instrument designed for flexible cystoscopic treatment (cutting and coagulating) for procedures such as hemostasis, treatment of bladder tumors, and stenosis inside the urinary tract. These are therapeutic procedures, not diagnostic ones.
No
The device description clearly describes a hardware electrosurgical unit (PSD-20) with various output modes and safety features, intended to be used with other hardware components like endoscopes and electrosurgical instruments. It does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical treatment (cutting and coagulating) within the urinary tract and bladder. This is an in vivo procedure, meaning it is performed on a living organism.
- Device Description: The description details an electrosurgical unit designed to be used with endoscopes and other accessories for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on the analysis of such specimens.
Therefore, this device is an electrosurgical unit used for therapeutic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- 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) including:
- Hemostasis of superficial bleeding
- Treatment of bladder tumors
- Treatment of stenosis inside urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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
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
-
- 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
-
- 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
-
- Common/Usual Name
Electrosurgical Unit and its ancillary equipment.
- Common/Usual Name
-
- Device Name
Olympus PSD-20 Electrosurgical System and its associated accessories
- Device Name
-
- Classification
21 CFR 876.4300 Endoscopic electrosurgical unit and accessories, Class II
- Classification
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 Electrosurgical | ||
| Unit and its associated accessories | ||
| (For GI application ) | K970797 | Olympus Optical Co., Ltd. |
| Olympus UES-20 Electrosurgical Units | ||
| and its associated accessories | ||
| (For urology application) | K970184 | Olympus Optical Co., Ltd. |
D. Device Description
DEC 1 9 2002
1
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
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) including:
- Hemostasis of superficial bleeding
- Treatment of bladder tumors
- Treatment of stenosis inside urinary tract.
2
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
3
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
4
KO232 510(k) Number(if known): Device Name: Olympus PSD-20 Electrosurgical System and its associated accesso
Indications for Use:
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) including:
-
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Miriam C. Provost
vision of Ger. : Restorative
- Neurology: : ces.
K 623280