(84 days)
The Universal Operating Hysteroscope Set is used for dilating the cervical channel, the cavum uteris (using fluid or CO2 gas), and for visualization of the tubal ostia. The scope is applied via the natural passage.
The universal operating hysteroscope set has exchangeable inner sheaths that are inserted into the endoscope containing an angled eyepiece. The endoscope tube consists only of the pure optical system with the light fibers. This allows enough room for various inner sheaths with the operating channel, combined with outer sheaths. The submitted universal hysteroscope set is an inexpensive alternative for compact instruments for outpatient gynecologists.
The provided text indicates that no clinical tests were performed to prove the device meets acceptance criteria. Therefore, the following information cannot be extracted from the given document:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Instead, the document states:
5.0 Performance Data
No performance standards are known.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
This indicates that the device's safety and effectiveness were established through design and engineering tests (not specified in detail) and by claiming substantial equivalence to predicate devices, rather than through specific performance metrics derived from a clinical study.
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K0331/3
Page 1 of B
DEC 2 3 2003
Image /page/0/Picture/2 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in a bold, sans-serif font, with "WOLF" being significantly larger than "RICHARD". Below the name is the text "Medical Instruments Corporation" in a smaller font. To the right of the text is a square graphic containing an abstract image of a wolf.
353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com
12.0 510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: | |
|---|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | September 29, 2003 |
| Division name (if applicable): | N.A. | FDA establishment registration number: |
| 14 184 79 | ||
| Street address: | 353 Corporate Woods Parkway | Phone number (include area code): |
| City: | Vernon Hills | ( 847 ) 913 1113 |
| State/Province: | Illinois | FAX number (include area code): |
| Country: | USA | ( 847 ) 913 0924 |
| ZIP / Postal Code: | IL 60061 | |
| Contact name: | Mr. Robert L. Casarsa | |
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | Model number: |
|---|---|
| Universal Operating Hysteroscope Set by Solima - Zupi | 8753.xxx |
| Common name: | Classification name: |
| Operating Hysteroscopy Set | Hysteroscope and Accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-amendment | 1 Hysteroscopes and Accessories 4998, 8998 | 1 Richard Wolf |
| 2 K880314/B | 2 Hysteroscope Autonom 4995 | 2 Richard Wolf |
| 3 K000673 | 3 Hysteroscope Operating Sheaths and Inserts | 3 Richard Wolf |
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1.0 Description
The universal operating hysteroscope set has exchangeable inner sheaths that are inserted into the endoscope containing an angled eyepiece. The endoscope tube consists only of the pure optical system with the light fibers. This allows enough room for various inner sheaths with the operating channel, combined with outer sheaths. The submitted universal hysteroscope set is an inexpensive alternative for compact instruments for outpatient gynecologists.
2.0 Intended Use
The Universal Operating Hysteroscope Set is used for dilating the cervical channel, the cavum uteris (using fluid or CO2 gas), and for visualization of the tubal ostia. The scope is applied via the natural passage.
Technological Characteristics 3.0
The advantage of the exchangeable inner sheaths is that the same endoscope, which is the part with the highest costs, can be used for various applications with optimized outer diameter, when changing only the inner sheath with the associated outer sheath. Due to the angled eyepiece, the insertion of the instruments is straight. This implies more user comfort.
A silicate image bundle is used instead of rod lens system to attain a bright picture with a small diameter of optical system. In addition the optical system is more flexible and the risk of rupture of the optical system is reduced.
The various inner sheaths with their associated outer sheaths (color coded) are connected to the endoscope by automatic snap-in locking mechanism, which facilitates the connection of the sheath to the insert. Due to the channel in the inner sheaths, the combination can be used with intermittent irrigation or also with continuous flow irrigation, if they have an additional channel in the outer sheath.
The automatic silicone diaphragm valve at the instrument port allows single-handed operation.
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing preamendment and 510(k)-devices sold by Richard Wolf and competitors.
5.0 Performance Data
No performance standards are known.
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K 33/13
Page 3 of 3
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
1.0.00 A. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. .....
Robert L. Casarsa Quality Assurance Manager
By:
Date: Dec 12, 2003
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Co. 353 Corporate Woods Parkway VERNON HILLS IL 60061
Re: K033113
Trade/Device Name: Universal Operating Hysteroscope Set by Solima-Zupi Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Dated: September 29, 2003 Received: September 30, 2003
Dear Mr. Casarsa:
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 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.
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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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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) you may obtain. 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,
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5.0 Indications for Use
Kossil3 510(k) Number (if known):
Universal Operating Hysteroscope Set by Solima – Zupi Device Name:
The Universal Operating Hysteroscope Set is used for diating the cervical Intended use: The Universal Operating Trysterosoope BCO2 gas), and for visualization of chainer, the cavum accris (donig read of the natural passage.
Revised 12/12/03
(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 of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K033113 |
| Prescription UsePer 21 CFR 801.109 | OR | Over-The Counter __________ |
|---|---|---|
| ---------------------------------------- | ---- | ----------------------------- |
(Optional Format 1'2-96)
§ 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.