(91 days)
Dyonics endoscopes are indicated for use in laparoscopic and thoracic surgical procedures to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals.
The Smith & Nephew Dyonics Endoscopes transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a rod lens optical system. Selected endoscopes have working channels to accommodate surgeon preference.
The provided text is a 510(k) summary for the Smith & Nephew Dyonics Endoscopes. It states that the device is substantially equivalent to a predicate device (Karl Storz Endoscopy Laparoscopes/Thoracoscopes) and details its intended use and general function.
However, this document does not contain any information about acceptance criteria, specific device performance metrics, or details of a study (clinical or otherwise) that would "prove" the device meets such criteria.
The 510(k) process for this type of device (circa 1998) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance endpoints and acceptance criteria in the same way a Premarket Approval (PMA) would. The review focuses on design, materials, function, and intended use, asserting that minor differences do "raise no new issues of safety and effectiveness."
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through comparison, not through reporting acceptance criteria and a study proving those criteria are met.
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MAY 1 8 1998
510(k) Summary Smith & Nephew, Inc., Endoscopy Division Dyonics Endoscopes
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 978-749-1000 lefax: 978-749-1599
Smith == Nephew
Substantial Equivalence:
The Smith & Nephew Dyonics Endoscopes are substantially equivalent in design, materials, function, and intended use to the line of Laparoscopes/Thoracoscopes offered by Karl Storz Endoscopy.
Predicate Device:
The predicate device for this submission is the line of Laparoscopes/Thoracoscopes offered Karl Storz Endoscopy Telescope for use in thoracic surgical procedures.
Summary of Device Function:
The Smith & Nephew Dyonics Endoscopes transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a rod lens optical system. Selected endoscopes have working channels to accommodate surgeon preference.
Intended Use of Device:
Dyonics endoscopes are indicated for use in laparoscopic and thoracic surgical procedures to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals.
Comparison of Technological Characteristics of Predicate Device:
The basic technologies, design and function of the Smith & Nephew Dyonics line of endoscopes is substantially equivalent in materials, design and function to Laparoscopes/Thoracoscopes offered by Karl Storz Endoscopy. The minor differences in product specifications raise no new issues of safety and effectiveness.
Debnah L. Conner
Deborah J. Connors Sr. Regulatory Affairs Specialist
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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 features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 1998
Ms. Deborah Connors Senior Regulatory Affairs Specialist Smith & Nephew, Incorporated 160 Dascomb Road Andover, Massachusetts 01810
Re: K980604 Trade Name: Smith & Nephew Dyonics Endoscopes and Accessories Regulatory Class: II Product Code: GCJ February 13, 1998 Dated: Received: February 17, 1998
Dear Ms. Connors:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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, market the devices, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirement, 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 devices 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.
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Page 2 - Ms. Connors
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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/dsmamain.html".
Sincerely yours,
C. Colin M. Witten, Ph.D.
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosures
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510(k) Number : K 98060 4
Device Name : Smith & Nephew, Inc., Endoscopy Division Dyonics Endoscopes
Indications for Use :
Dyonics endoscopes are indicated for use in laparoscopic and thoracic surgical procedures to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980604 |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
,
Over-the-Counter. ____________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.