(160 days)
The intended use for Söhniks Endoscopy, Inc.'s Cystoscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of the urether, prostate, bladder, and other urologic problems. This device is used m a visualization device and can be used in conjunction with other instruments to perform various diagnostic and therapeutic procedures.
The Söhniks Cystoscopes are reusable manually operated surgical devices that are provided in non-sterile and must be cleaned and sterilized by the user prior to use. The parts that contact the body are composed of surgical grade stainless steel, which has a long history of biocompatibility for human use.
Based on the provided text, there is no acceptance criteria and no study that demonstrates the device meets acceptance criteria.
The document is a 510(k) summary for a "Cystoscope," which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. The core of a 510(k) submission is to argue substantial equivalence, not to prove performance against specific acceptance criteria through a clinical study.
Here's why the requested information cannot be extracted from this document:
- Type of Document: This is an FDA 510(k) summary and approval letter. It focuses on regulatory approval based on "substantial equivalence" to existing devices, not on detailed performance studies with acceptance criteria.
- Content: The document describes the device, its intended use, device description, and claims substantial equivalence to predicate devices (e.g., "The basic design, materials and intended uses are the same and the device is constructed with the same materials as a [predicate device name, e.g., K023783], there are no new issues of safety and effectiveness."). It doesn't present data from a clinical trial or performance study against specific, quantified acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions because the provided text does not contain the information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.
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Image /page/0/Picture/0 description: The image shows the text "SOHNIKS ENDOSCOPY, Inc.". The text is in bold, with "SOHNIKS" in a larger font size than "ENDOSCOPY, Inc.". There is a line separating the two lines of text. The text is black on a white background.
Ko 33/91
930 Blue Gentian Road
Suite 1400
MAR - 9 2004
(651) 452-4059 Fax (651) 452-4056
Eagan, MN 55121
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of I his summary of 3 of the sirest and 21 CFR 807.92. All data in this document is accurate and complete to the best of Söhniks Endoscopy's knowledge.
- Söhniks Endoscopy, Inc. Applicant: 930 Blue Gentian Road Suite 1400 Eagan, MN 55121 651-452-4059 phone 651-452-4056 fax
Marc Hoskins Contact:
Device ID: Cystoscope
Indication: The intended use for Söhniks Endoscopy, Inc.'s Cystoscopes are for examining, diagnosing, Indication. The intention as to: Bommo interior problems of the urethra, prostate, bladder, and other urologic problems. Visualizing and to are in acading the meetice and can be used in conjunction with other instruments to perform various diagnostic and therapeutic procedures.
Device Description: The Söhniks Cystoscopes are reusable manually operated surgical devices that are provided in Device Description. The Obiting Off.ooseppes are provide non-sterile and must be cleaned and sterilized v, Jo, and 70 degree arroution of the contact that contact the body are composed of surgical grade stainless steel, by the user proce to cases assn assnow has a long history of biocompatibility for human use.
Substantial Equivalence: The Söhniks Cystoscope is substantially equivalent to its predicate devices. The basic Substantials and intended uses are the same and the device is constructed with the same materials as a design, materials and more (#K023783), there are no new issues of safety and effectiveness.
signature
Marc Hoskins Regulatory Affairs
Söhniks Endoscopy, Inc. 09/01/03
Cystoscope and Accessories 510 (k) Submission
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2004
Mr. Marc Hoskins Regulatory Affairs SOHNIKS Endoscopy, Inc. 930 Blue Gentian Road Suite 1400 EAGAN MN 55121
Re: K033191
Trade/Device Name: Cystoscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FAJ Dated: February 23, 2004 Received: February 23, 2004
Dear Mr. Hoskins:
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 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 (CS) 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) I his ictier will and myou to substantial equivalence of your device of your device to a legally prematicated 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. 1xxx | (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/cdrfw/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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510(k) Number:
Device Name: Cystoscope
Indications for Use:
The intended use for Söhniks Endoscopy, Inc.'s Cystoscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of the urether, prostate, bladder, and other urologic problems. This device is used m a visualization device and can be used in conjunction with other instruments to perform various diagnostic and therapeutic procedures.
DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Nancy brazdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.
(Optional Format 3-10-98)
§ 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.