(106 days)
No
The document describes a set of surgical electrodes and their intended use in urological procedures. There is no mention of AI or ML in the intended use, device description, or any other section. The device is a physical instrument for tissue manipulation.
Yes
The device is used in urological surgical procedures for resection, ablation, removal, vaporization, cutting, and coagulation of soft tissue, which directly treats medical conditions.
No
This device is designed and intended for use in surgical procedures involving the resection, ablation, removal, cutting, or vaporization of soft tissue, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components like an active tip, insulator, guiding tube, telescope clip, and arm (shaft), indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that these devices are "bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required." They are used during surgical procedures to directly interact with and modify tissue within the body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to perform surgical actions on tissue in situ.
Therefore, this device falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate. bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used to treating cancer of the prostate.
The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, cutting, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.
Product codes (comma separated list FDA assigned to the subject device)
FAS, GEI, FJL
Device Description
The HF-Resection Electrodes and HF Resection Button Electrode for Plasma Vaporization consist of an active tip. PTFE color code identification, an insulator between the electrode tube, a quiding tube, telescope clip and arm (shaft).
The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons.
As an accessory the sterile device recognition cable is enclosed. The cable enables the use of the Gyrus ACMI PK Superpulse System (K100816) with the Olympus HF Electrosurgical Resection and Vaporization Electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, bladder and bladder neck
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.
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
Date Prepared: September 7, 2010
K102781
, l
JAN 1 1 2011
General Information Section 1
| Applicant | Olympus Winter & Ibe GmbH
Kuehnstrasse 61 * 22045 Hamburg * Germany
Establishment Registration No: 9610773 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Stacy Abbatiello Kluesner, M.S., RAC
Regulatory Affairs & Quality Assurance
Olympus America Inc.
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610
Phone: 484-896-5405
FAX: 484-896-7128
Email: Stacy.Kluesner@Olympus.com
Establishment Registration No.: 2429304 |
| Manufacturer | Olympus Winter and Ibe GmbH
Kuehnstrasse 61 * 22045 Hamburg * Germany
Establishment Registration No.: 9610773 |
Section 2 Device Identification
| Device Name: | HF Electrosurgical Resection and Vaporization Electrode Series,
for use with the Gyrus ACMI PK® PlasmaKinetic Superpulse System |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Cutting & Coagulation & Accessories
Electrode, Electrosurgical, Active, Urological |
| Regulation Number: | 21 CFR 878.4400
21 CFR 876.4300
21 CFR 876.1500 |
| Regulation Name: | Electrosurgical cutting and coagulation and accessories
Endoscopic electrosurgical unit and accessories |
| Regulatory Class: | II |
| Product Code: | FAS, GEI, FJL |
| Classification Panel: | General and Plastic Surgery, Gastroenterology, and Urology |
Section 3 Predicate Device Information
Predicate Devices for HF Resection Electrodes (Type H281)
| 510(k) | Device Name | Manufacturer |
|---|---|---|
| K100275 | WA22302D, WA22503D, | |
| WA22306D, WA22507D, | ||
| WA22521C, WA22523C, | ||
| WA22351C, WA22355C | Olympus |
1
Predicate Devices for HF Resection Button Electrode for Plasma Vaporization (Type H281)
| 510(k) | Device Name | Manufacturer
A CONTRACT CALL PROPERTY |
|--------------------------------------------------------------|-------------|------------------------------------------|
| A BREAL A BREAL A B A B A A A A A A A A A A A A
K100275 | WA22557C | Olympus |
Section 4 Device Description
The HF-Resection Electrodes and HF Resection Button Electrode for Plasma Vaporization consist of an active tip. PTFE color code identification, an insulator between the electrode tube, a quiding tube, telescope clip and arm (shaft).
The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons.
As an accessory the sterile device recognition cable is enclosed. The cable enables the use of the Gyrus ACMI PK Superpulse System (K100816) with the Olympus HF Electrosurgical Resection and Vaporization Electrodes.
Section 5 Indications for Use
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used to treating cancer of the prostate.
The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, cutting, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.
Section 6 Comparison of Technological Characteristics
The HF Resection Electrodes and the HF Resection Button Electrode for Plasma Vaporization are basically identical to the predicate devices in intended use, design and material specifications.
Section 7 Conclusion
When compared to the predicate devices, HF Resection Electrodes and the HF Resection Button Electrode for Plasma Vaporization do not incorporate any significant changes that could affect the safety or effectiveness of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an emblem featuring a stylized image of an eagle or bird with three wing-like shapes. The emblem is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Olympus Winter & Ibe GmbH % Olympus America Inc. Ms. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance 3500 Corporate Parkway, P.O. Box 610 Center Valley, Pennsylvania 18034-0610
JAN 1 1 2011
Re: K102781
Trade/Device Name: HF-Resection Electrode Series (Models WA22602D, WA22603D, WA22606D, WA22607D, WA22621C, WA22623C, WA22632D, WA22651C, WA22655C) HF-Resection Electrode for Plasma Vaporization (Model WA22657C) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS, GEI Dated: December 9, 2010 Received: December 13, 2010
Dear Ms. Abbatiello Kluesner:
:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
: 上一篇:
:
and the state of the state of the states of the states
.
.
:
3
Page 2 - Ms. Stacy Abbatiello Kluesner, M.S., RAC
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
JAN 1 1 2011
Device Name: HF-Resection Electrode Series
Model Numbers: WA22602D, WA22603D, WA222606D, WA22607D, WA22621C, WA 22623C, WA22632D WA22651C, WA22655C
Indications For Use:
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate. bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment.
These devices are not intended to be used to treating cancer of the prostate.
Prescription Use ✔ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division of Surgical, Orthopedic, Orthopedic,
Division of Surgical, Orthopedic, Division of Surges
and Restorative Devices and Restorative Devices
510(k) Number -
5
510(k) Number (if known):
Device Name: HF- Resection Electrode for Plasma Vaporization
JAN 1 1 2011
Model Number: WA22657C
Indications For Use:
The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment.
These devices are not intended to be used in treating cancer of the prostate.
AND/OR
Prescription Use ✔ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, and Restorative Devices
K102781 510(k) Number .