(91 days)
Not Found
Not Found
No
The description focuses on traditional optical and fiber optic technology for visualization and illumination, with no mention of AI/ML terms or functionalities like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
Explanation: This device is an endoscope used for visualization and access during surgery. It does not actively treat a disease or condition, which is a characteristic of a therapeutic device.
No.
The device is described as an endoscope for visualization and manipulation during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is a physical endoscope with glass fiber optics and a rod lens optical system, which are hardware components.
Based on the provided information, the Dyonics endoscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. They perform tests on samples like blood, urine, tissue, etc., outside of the body (in vitro).
- The Dyonics endoscope is used within the body (in vivo) for visualization and manipulation during surgical procedures. Its purpose is to provide a direct view of internal structures.
The description clearly states its use in "laparoscopic and thoracic surgical procedures to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals." This is a description of an in vivo surgical instrument, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
body cavities, hollow organs and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The line of Laparoscopes/Thoracoscopes offered by Karl Storz Endoscopy.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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.
2
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
3
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)