(63 days)
Not Found
78 KOG
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use describes a mechanical function.
No
The intended use describes the device as an accessory for repeated insertion and removal of instruments with an endoscope, not as a device that treats a disease or condition.
No
The device's intended use is described as facilitating repeated insertion and removal of instruments during endoscopy or other medical procedures, which is a procedural function, not a diagnostic one. There is no mention of it analyzing data, detecting conditions, or providing information about a patient's health status.
No
The provided 510(k) summary is incomplete and lacks a device description. The intended use mentions an endoscope or other medical instrument, which are hardware devices. Without a description of the device itself, it's impossible to determine if it's software-only or a hardware component used with these instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used with an endoscope or other medical instrument for repeated insertion and removal. This indicates a device used in vivo (within the body) during a medical procedure, not a device used in vitro (outside the body) to examine specimens.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The provided description does not align with this definition.
N/A
Intended Use / Indications for Use
To be used with an endoscope or other medical instrument when repeated insertion and removal of the instrument is anticipated.
Product codes
78 KOG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
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.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/0/Picture/3 description: The image shows a partial view of a logo or emblem, focusing on the upper-left portion. The visible part includes stylized, curved lines that appear to be part of a larger design, possibly representing a symbol or abstract shape. The word "DEPARTA" is partially visible along the left edge, oriented vertically, suggesting the logo belongs to a department or organization with a longer name.
1 1998 DEC .
Thomas C. Wehman, Ph.D. Regulatory Affairs Conway Stuart Medical. Inc. 735 Palomar Street Sunnyvale, CA 94086
Re: K983415
Conway Stuart Medical Delivery Sheath Dated: September 18, 1998 Received: September 29, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 KOG
Dear Dr. Wehman:
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 Onality System Regulation (OS) for Medical Devices: General regulation (2) 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
Lillian Yin, Ph.D.
Director, Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Indications for Use
| 510(k) Number (if known): | K983415 |
|---|---|
| Device Name: | Conway Stuart Medical Delivery Sheath |
| Indications for Use: | To be used with an endoscope or other medical instrument |
| when repeated insertion and removal of the instrument is | |
| anticipated. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use OR (Optional format 1-2-06)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983415
Proprietarv Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Conway Stuart Medical. Inc.