(104 days)
THE INTENDED USE FOR THE RESECTOSCOPE AND WORKING ELEMENTS IS IN UROLOGICAL PROCEDURES TO ENDOSCOPICALLY REMOVE, CUT, COAGULATE, AND OR TRANSECT TISSUE IN THE BLADDER, PROSTRATE, AND URETHRA. THE SURGEON PERFORMS THE EXAMINATION THROUGH THE URETHRA. THE DOCTOR CONTROLS THE BACK AND FORTH MOVEMENT OF THE ELECTRODE USING FINGER CONTROLS. THE WORKING ELEMENTS ALSO HOUSE A CYSTOSCOPE FOR VISALIZATION. THE HIGH FREQUENCY CABLE TRANSMITS ELECTRICAL CURRENT
The Resectoscope is a reuasble non sterile urological instrument used with disposable sterile, single use electrodes for electro-cautery. The sheath and electrodes will be marketed in 24-27 French sizes.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.
The document describes a 510(k) premarket notification for a medical device called the MAHE Resectoscope. It details:
- Device Description: A reusable, non-sterile urological instrument used with disposable, sterile, single-use electrodes for electro-cautery.
- Intended Use: Endoscopic removal, cutting, coagulation, and/or transection of tissue in the bladder, prostate, and urethra during urological procedures.
- Technological Characteristics: Claims substantial equivalence to a predicate device (Karl Storz and Wolf) based on similar materials, function, indications for use, and overall design.
- Regulatory Information: The FDA's review and determination of substantial equivalence to a legally marketed predicate device, allowing the device to be marketed.
The content focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with acceptance criteria.
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AUG - 5 1999
K991426 PAGE 1 OF 1
510 (k) SUMMARY
| SUBMITTED BY: | MAHE International, Inc2002 Ridley BlvdNashville, TN 37203 |
|---|---|
| CONTACT PERSON: | Winfried Reich |
| DATE PREPARED: | 8 JULY 1999 |
| PROPRIETARY NAME: | MAHE INSTRUMENTS |
| COMMON NAME: | Resectoscope |
| CLASSIFICATION NAME: | Resectoscope |
| PREDICATE DEVICE: | Karl Storz and Wolf |
DESCRIPTION OF THE DEVICE:
The Resectoscope is a reuasble non sterile urological instrument used with disposable sterile, single use electrodes for electro-cautery. The sheath and electrodes will be marketed in 24-27 French sizes.
INTENDED USE.
The intended use for the Resectoscope and working elements is in urological procedures to endoscopically remove, cut, coagulate, and or transect tissue in the bladder, prostrate, and urethra. The surgeon performs the examination through the urethra. the doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. the high frequency cable transmits electrical current
TECHNOLOGICAL CHARACTERISTICS
The MAHE Resectoscope and working elements is equivalent to the referenced predicate device in that they are fabricated from similar materials, have the same function, equivalent indications for use and similar overall design.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its body, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1999
Mr. Winfried Reich Official Correspondent Mahe International, Inc. 2002 Ridley Blvd. Nashville, TN 37203
Re: K991426 Mahe Resectoscope Dated: July 8, 1999 Received: July 16, 1999 Regulatory Class: II 21 CFR §876.1500/Procode: 78 FAS, FDC and FJL
Dear Mr. Reich:
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 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 (QS) for Medical Devices: General regulation (21 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 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 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, 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: 991426
Device Name: RESECTOSCOPE WITH WORKING ELEMENT AND ACCESSORIES
INDICATION FOR USE.
THE INTENDED USE FOR THE RESECTOSCOPE AND WORKING ELEMENTS IS IN UROLOGICAL PROCEDURES TO ENDOSCOPICALLY REMOVE, CUT, COAGULATE, AND OR TRANSECT TISSUE IN THE BLADDER, PROSTRATE, AND URETHRA. THE SURGEON PERFORMS THE EXAMINATION THROUGH THE URETHRA. THE DOCTOR CONTROLS THE BACK AND FORTH MOVEMENT OF THE ELECTRODE USING FINGER CONTROLS. THE WORKING ELEMENTS ALSO HOUSE A CYSTOSCOPE FOR VISALIZATION. THE HIGH FREQUENCY CABLE TRANSMITS ELECTRICAL CURRENT
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) CONCURRENCE OF CDRJ, OFFICE OF DEVICE EVALUATION (ODE)
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(Division Sign-Off)
PRESCRIPTION USE (PER 21 CFR 801-109)
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Division of Reproductive, Abdominal and Radiological Devil HE-COUNTER USE 510(k) Number
§ 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.