(174 days)
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and / or therapy in various medical disciplines, such as urology and gynecology
The resectoscopes consist of working elements, standard and continuous-irrigation resectoscope sheaths, coagulation and cutting electrodes, standard, timerlake (deflecting) and visual obturators, and endoscopes. The working element is the carrier of the endoscope and guide element to the electrodes. The standard resectoscope sheath is inserted together with obturators in to the body opening to enable an atraumatic passage. After removal of the obturators, the shaft provides a guidance for the working element and rinsing charge, while the distal sheath simultaneously serves as a cutting-edge. The obturator fills the hollow sheaths. The visual obturator in combination with the endoscope is used to insert the sheath under vision. The standard electrodes are used for combined cutting and coagulation of soft tissue, e.g. prostate or myoma. The inside of the patient is visualized when the endoscope is inserted into the body through natural or surgically generated access.
This document describes the 510(k) premarket notification for Richard Wolf Medical Instruments Corporation's Resectoscopes E-Line. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through a detailed study with specific acceptance criteria and outcome measures.
Therefore, many of the requested sections (1-9) which typically apply to studies designed to prove a device meets specific performance criteria are not directly applicable or are not explicitly stated in this type of submission.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or a direct performance table are provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices by asserting that "The new technological characteristics have not diminished safety or effectiveness."
Instead of performance criteria, the summary mentions:
- Improved Design: "The resectoscopes improved design and material achieves a more efficient operation."
- Reduced Spring Force: "The new E-Line working elements have a spring forced reduced by 55% from the earlier generation, while the sliding ability is improved. The resulting operation shows less signs of fatigue."
- Higher Wear Resistance: "The material used for the new E-Line resectoscope sheath insulation at the cut-off edge is ceramic rather than GFK which results in higher wear resistance."
- Lighter Housing: Sheaths made from Titan rather than brass/new silver, resulting in a housing "approximately 20% lighter than its predecessor."
- Improved Sealing: E-Line electrode insulation made from Hytrel instead of Teflon, which "produces size accuracy and improves sealing."
- Improved Temperature Resistance and Processing: By replacing Maranyl with Radel.
These are design improvements and material changes, not quantifiable performance metrics with pre-defined acceptance thresholds in the context of a clinical or standalone performance study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/not specified. The submission does not detail a study involving a specific test set of cases or data.
- Data Provenance: Not applicable/not specified.
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)
Not applicable. No "ground truth" establishment for a test set is described, as no clinical study or performance evaluation requiring expert consensus for diagnostic accuracy is reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is mentioned.
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
Not applicable. This device is a medical instrument (resectoscope), not an AI/imaging diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" was established as there was no study requiring it for performance evaluation.
8. The sample size for the training set
Not applicable. This device is a medical instrument, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Information that is provided in the document regarding the "study" (performance data):
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"Performance Data 5.0" Section:
- "No performance standards are known." This explicitly states that there were no pre-existing, recognized performance standards the device aimed to meet through a specific study.
- Conformity to European Device Directive: "The devices conform to the relevant provisions of European Device Directive 93/42/EEC." This indicates compliance with regulatory requirements, which often include safety and effectiveness principles.
- Testing Performed: "Endurance tests and steam sterilization tests were performed to guarantee that the devices are safe and effective." This is the primary "study" mentioned for non-clinical performance verification.
- Standard Compliance (for HF devices): "The HF devices were tested for conformity with the specified standards ANSI/AAMI HF 18, IEC 601-2-2 / IEC 601-2-18." This refers to electrical safety and electromagnetic compatibility standards, not clinical performance.
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"Clinical Tests 6.0" Section:
- "No clinical tests were performed." This is a critical piece of information, confirming that no human subject studies were conducted to assess clinical effectiveness or safety directly for this 510(k) submission. The safety and effectiveness claims are based on substantial equivalence to predicate devices and non-clinical testing.
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"Conclusions Drawn 7.0" Section:
- "The devices were designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals." This summarizes the overall approach: design controls and non-clinical testing for safety and effectiveness, leveraging the substantial equivalence pathway for market clearance.
In summary, this 510(k) submission for the Resectoscopes E-Line relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, coupled with non-clinical endurance and sterilization testing and compliance with electrical safety standards. It does not present a de novo clinical study with defined acceptance criteria for a new performance claim, a test set, or a ground truth as would be typical for a diagnostic or AI device.
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JUL 201998 K980302
ﺳﻌﺮ
일
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P 1 9 3
353 Corporate Woods Parkway Vernon Hills, Illinois 60064 Phone: 847.943.1113 Fax: 847.913.1488
RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION
な
| 510(k) Summary of Safety and Effectiveness | ||||
|---|---|---|---|---|
| Submitter: | Date of Preparation:January 23, 1998 | |||
| Company / Institution Name:Richard Wolf Medical Instruments Corporation | FDA establishment registration number:1418479 | |||
| Division Name (if applicable):N.A. | Phone number (include area code):(847) 913-1113 | |||
| Street Address:353 Corporate Woods Parkway | FAX number (include area code):(847) 913-0924 | |||
| City:Vernon Hills | State/Province:Illinois | Country:USA | ZIP/Postal Code:60061 | |
| Contact Name:Mr. Robert Casarsa | ||||
| Contact Title:Quality Assurance Manager | ||||
| Product Information | ||||
| Trade Name:Resectoscopes E-Line | Model Number:8654, 8655, 8656, 8657, 8658, 8661,8663, 8666, 8668, 8407 to 8439 | |||
| Common Name:Resectoscope | Classification Name:Resectoscope,Resectoscope, Working Element | |||
| Information on devices to which substantial equivalence is claimed: | ||||
| 510(k) Number | Trade or proprietary or model name | Manufacturer | ||
| 1 K895857/A | 1 Continuous Irrigation ResectoscopeSystem, Model 8655 | 1 Richard Wolf | ||
| 2 K953983 | 2 EVAP Electrodes Model 8423,8427, 8410, 8413 | 2 Richard Wolf | ||
| 3 | 3 USA Elite System Resectoscopes | 3 Circon ACMI | ||
| 4 | 4 Resectoscopes 27040-27050, 27143 | 4 Karl Storz |
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981307
1.0 Description
The resectoscopes consist of working elements, standard and continuous-irrigation resectoscope sheaths, coagulation and cutting electrodes, standard, timerlake (deflecting) and visual obturators, and endoscopes. The working element is the carrier of the endoscope and guide element to the electrodes.
The standard resectoscope sheath is inserted together with obturators in to the body opening to enable an atraumatic passage. After removal of the obturators, the shaft provides a guidance for the working element and rinsing charge, while the distal sheath simultaneously serves as a cutting-edge.
The obturator fills the hollow sheaths. The visual obturator in combination with the endoscope is used to insert the sheath under vision. The standard electrodes are used for combined cutting and coagulation of soft tissue, e.g. prostate or myoma.
The inside of the patient is visualized when the endoscope is inserted into the body through natural or surgically generated access.
2.0 Intended Use
Resectoscopes are used for endoscopically controlled ablation of tissue.
Indication: For the examination, diagnosis and/ or therapy in combination with endoscopic accessories in the various medical disciplines, such as, urology, gynecology, and surgery.
Field of Application: TURP (Transurethral Resection of Prostate), TURB (Transurethral Resection of Bladder Tumors), adenomas, myoma resection, soft tissue tumor, endometrium ablation, as well as slitting of the neck of the bladder and incision of the prostate.
Long sheath resectoscopes are used with long urethras.
3.0 Technological Characteristics
The resectoscopes improved design and material achieves a more efficient operation.
The new E-Line working elements have a spring forced reduced by 55% from the earlier generation, while the sliding ability is improved. The resulting operation shows less signs of fatigue.
- The material used for the new E-Line resectoscope sheath insulation at the cut-off edge is ceramic rather than GFK which results in higher wear resistance. The submitted sheaths are made from Titan rather than brass / new silver which produces a housing approximately 20% lighter than its predecessor. Some of the continuous irrigation sheaths are oval which improve the flow-off rate.
- The submitted E-Line electrode insulation is made from Hytrel instead of Teflon which produces size accuracy and improves sealing.
Improved temperature resistance and processing is achieved by replacing Maranyl with Radel.
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P3093
Substantial Equivalence 4.0
The submitted devices pose the same type of questions about safety and effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf, Circon, and Karl Storz.
Performance Data 5.0
No performance standards are known.
The devices conform to the relevant provisions of European Device Directive 93/42/EEC.
Endurance tests and steam sterilization tests were performed to guarantee that the devices are safe and effective.
The HF devices were tested for conformity with the specified standards ANSI/AAMI HF 18, IEC 601-2-2 / IEC 601-2-18.
6.0 Clinical Tests
No clinical tests were performed.
7.0 Conclusions Drawn
The devices were designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals.
By: Robert J. Casale
Robert L. Casarsa Quality Assurance Manager
Date: Jon 23, 98
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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUL 20 1998
Mr. Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K980302
Resectoscopes, Instruments and Accessories E-Line (working elements, standard and continuous irrigation resectoscope sheaths, coagulation and cutting electrodes, and obturators) Dated: April 21, 1998 Received: April 22, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH 21 CFR 876.1500/Procodes: 78 FJL 78 FDC 78 FAS
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we bave 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 ensciment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cometic 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 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, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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/cdrl/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K980302
Device Name:
Resectospes, Instruments and Accessories E-Line, consisting of
working channels, standard and continuous irrigation, resectoscope sheaths,
coagulation and cutting electrodes, standard, timberlake (deflecting) and
visual obturators, and endoscopes
Indications for Use: Intended Use:
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and / or therapy in various medical disciplines, such as urology and gynecology
Revised 7/15/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Peter Satling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K980302 510(k) Number _
Prescription Use
Per CRF 21 CFR 801.109
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Over-The Counter Use
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§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.