(84 days)
Not Found
Not Found
No
The description focuses on traditional optical components (fiber optics, lenses, prisms) for illumination and visualization, with no mention of AI/ML terms or image processing capabilities beyond basic visualization.
No.
This device is an endoscope used for visualization during surgery, not for providing therapy or treatment. Its function is to illuminate and visualize the surgical site, which is a diagnostic or procedural aid function, not a therapeutic one.
No
The device is indicated for providing illumination and visualization during endoscopic surgery, not for diagnosing conditions.
No
The device description clearly states it is a physical endoscope with glass fiber optics, optical lenses, and prisms, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an endoscope used for endoscopic surgery to provide illumination and visualization of the surgical site within the body. It is used to aid in surgical procedures, not to analyze samples taken from the body.
- Intended Use: The intended use is for surgical procedures on superficial vessels and fascia of the lower extremities. This is an in-vivo application.
Therefore, the function and intended use of this endoscope fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 5mm x 300mm Images Endoscope is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.
Product codes
GCJ
Device Description
The Smith & Nephew Images 5mm x 300mm Endoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a series of optical lenses and prisms. The endoscope allows it to gain access to the surgical site.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
lower extremities
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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AUG 1 2 1997
11850
510(k) Summary
Smith & Nephew, Inc., Endoscopy Division Images 5mm x 300mm Endoscope
Substantial Equivalence:
The Smith & Nephew Images 5mm x 300mm Endoscope is substantially equivalent in design, materials, function, and intended use to the 5mm x 300mm telescope offered by Karl Storz Endoscopy as part of the KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities.
Predicate Device:
The predicate device for this submission is the Karl Storz Endoscopy Telescope for use in endoscopic surgery of superficial veins and fascia of the lower extremities.
Summary of Device Function:
The Smith & Nephew Images 5mm x 300mm Endoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a series of optical lenses and prisms. The endoscope allows it to gain access to the surgical site.
Intended Use of Device:
The 5mm x 300mm Images Endoscope is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.
Comparison of Technological Characteristics of Predicate Device:
The basic technologies, design and function of the Smith & Nephew Images 5mm x 300mm Endoscope is substantially equivalent in materials, design and function to the Karl Storz Endoscopy 5mm x 300mm Telescope for use in endoscopic surgery of superficial veins and fascia of the lower extremities and raises of safety and effectiveness.
Delores J. Conners
Deborah J. Connors Regulatory Affairs Specialist
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 508-749-1000 Telefax: 508-749-1599
Smith - Nephew
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract image of an eagle with three human profiles incorporated into its design. 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
Ms. Deborah J. Connors Regulatory Affairs Specialist Smith & Nephew, Inc., Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810
AUG 1 2 1997
Re: K971850
Trade Name: Images Endoscopes and Accessories Regulatory Class: II Product Code: GCJ Dated: May 19, 1997 Received: May 20, 1997
Dear Ms. Connors:
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 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 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 Regulations, 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 (OS) 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.
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Page 2 - Ms. Deborah J. Connors
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) 594-4595. 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/dsmamain.html".
Sincerely vours.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number :
Device Name : Smith & Nephew, Inc., Endoscopy Division Images Endoscopes
Indications for Use :
The 5mm x 300mm Images Endoscope (REF. 7205XXX) is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use v (Per 21 CFR 801.109)
OR
Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
lecoell
(Division Sign-Off)
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Division or General Restorative Devices
510(k) Number K971850