(108 days)
For examination, diagnosis and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in urology, surgery, and GYN.
The flexible fiberscopes consist of a flexible insertion part, a control part and an eyepiece for direct view or connection to a video camera.
This document, K980401, describes the premarket notification for "Flexible Fiberscopes and Accessories" by Richard Wolf Medical Instruments Corporation. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving a device meets specific performance acceptance criteria.
Therefore, many of the requested details about acceptance criteria and a study to prove performance cannot be extracted from this document, as such a study was explicitly stated as not performed.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report performance against such criteria. It states, "No known FDA performance standard exists."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document explicitly states: "Clinical tests performed were not performed."
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 clinical tests were performed, so no ground truth was established through expert review for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical tests were performed, hence no test set or adjudication method.
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 is a medical device for direct visualization, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (fiberscope), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical tests were performed, and thus no ground truth was established in this context. The document relies on design and testing to assure safety and effectiveness rather than clinical ground truth derived from patient data.
8. The sample size for the training set
Not applicable. This document is for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device.
Summary of Device Safety and Effectiveness Demonstration:
Instead of a study with acceptance criteria, the document demonstrates substantial equivalence by:
- Technological Characteristics: Stating "There are no significant technological changes or characteristics to the new devices compared to the existing devices" and detailing minor improvements like increased pixels/fibers for higher resolution.
- Intended Use: Consistent with predicate devices.
- Substantial Equivalence Claim: Comparing the device to several pre-enactment and 510(k) cleared flexible fiberscopes from Richard Wolf, Circon, Karl Storz, and Olympus.
- Performance Data: Reporting that the electrodes in combination with the fiberscopes were tested to meet appropriate sections of ANSI/AAMI standard HF18 (on high frequency devices) and IEC601-1/IEC601-2-2. These are engineering performance standards for electrical safety and electromagnetic compatibility, not clinical performance criteria.
- Conclusion: The devices are "designed and tested to assure their safety and effectiveness when used according to the instructions manual," relying on engineering standards and design verification rather than clinical outcomes.
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353 Corporatio Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488
RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION
142
MAY 2 1 1999
| 510(k) Summary of Safety and Effectiveness | MAY 21 1998 |
|---|---|
| -------------------------------------------- | ------------- |
| Date of Preparation: | May 1, 1998 |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| FDA establishment registration number: | 14 184 79 |
| 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 L. Casarsa |
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | Flexible fiberscopes and accessories |
|---|---|
| Model number: | 7305.xxx |
| Common name: | Flexible fiberscopes |
| Classification name: | Flexible endoscopes |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 | K962172 | Flexible Mini-Fiberscopes | Richard Wolf |
| 2 | Flexible CystoNephroscope ACN | Circon/ ACMI | |
| 3 | Flexible Hysteroscope, AUR-FH | Circon/ACMI | |
| 4 | Cysto-Urethro-Fiberscope 11272 AA | Karl Storz | |
| 5 | Flexible Hysteroscope, 11261 BB | Karl Storz | |
| 6 | Flexible Cystofiberscope CYF-3 | Olympus | |
| 7 | Hysterofiberscope, HYF-1T | Olympus |
1.0 Description
The flexible fiberscopes consist of a flexible insertion part, a control part and an eyepiece for direct view or connection to a video camera.
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MEDICAL INSTR
K980401
2.12
2.0 Intended Use
Flexible fiberscopes are used for examination, diagnosis, and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in urology, surgery, and OB/GYN.
3.0 Technological Characteristics
There are no significant technological changes or characteristics to the new devices compared to the existing devices.
The tip of the sheath has an active deflection up to 360°, depending on the fiberscope. The deflecting position can be locked with a brake at the 7305.001. The image is transmitted via objective, fiber bundle and eyepiece for direct view or connection to a video camera. The total number of pixels and the fibers per mm2 are increased to get an image with higher resolution. Biopsy material can be taken by the wide working channel, which is simultaneously used for irrigation. Auxiliary instruments such as grasping forceps, stone extractors or HF button electrode are inserted via a proximal mounted insertion cock with supply and discharge. A leakage test unit or a gas sterilization valve can be connected to an attachment of the fiberscope.
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf in the urology branch. In addition, the submitted devices are substantially equivalent to devices sold by Circon, Karl Storz and Olympus.
5.0 Performance Data
No known FDA performance standard exists. The electrodes in combination with the fiberscopes were tested to meet the appropriate sections of the ANSI/ AAMI standard on high frequency devices HF18 and IEC601-1/ IEC601-2-2.
6.0 Clinical Tests
Clinical tests performed were not performed.
7.0 Conclusions Drawn
These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.
By: Robert L Casasa
Robert L. Casarsa Quality Assurance Manager
Date: May 1, 1998
9 - 2
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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Casarsa Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
MAY 2 | 1998
Re: K980401 Flexible Fiberscopes and Accessories Dated: May 1, 1998 Received: May 4, 1998 Regulatory Class: II 21 CFR §876.1500 and §884.1690 Product Code: 78 FAJ GCJ, and 84 HIH
Dear Mr. Casarsa:
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, narket 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 (21 CFR Part 820) and that, through periodic OS 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.
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 pronotion 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/cdrb/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radial -------------------------------------------------------------------------------------------------------------------------------------------------------------------Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K980401
Device Name: __ Flexible Fiberscopes and Accessories (7305.001, 7305.011)
Intended Use:
For examination, diagnosis and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in urology, surgery, and GYN.
(PLEASE DO NOT WRITE BELOW TIJIS LINE - CONTINUE ON ANOTHER PAGE IF NEFFICED)
Robert R. Satting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K984401
Prescription Use
Per 21 CFR 801.109
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Over-The Counter_
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.